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... Bone loss after acute sex-hormone removal via gonadectomy prior to skeletal maturity most striking in male but not female animals 1,2 1 1 1,3 Nick Momeni , Alyson Essex , Padmini Deosthale , Lilian Plotkin of Anatomy, Cell Biology, & Physiology, Indiana University School of Medicine, Indianapolis, IN 46202; 2 Marian University College of Osteopathic Medicine, Indianapolis, IN 46222, 3Roudebush Veterans Administration Medical Center, Indianapolis, IN 46202. BV/TV 0.10 35 30 25 20 # 15 * 10 0 5 * 0.02 0.00 0.25 Sham OVX Sham OVX 2 wk post-op 4 wk post-op Female Sham ORX Sham ORX 2 wk post-op 4 wk post-op Male Figure 1 Bone Volume/ Tissue Volume, Trabecular Thickness, Trabecular Number, and Volumetric Tissue Mineral Density (v-TMD) from male and female sham and operated animals 2 and 4 weeks post gonadectomy. N = 4-5/group. Volumetric -Tissue Mineral Density (v-TMD) 4 0.20 # * 2 Sham ORX 2 wk post-op Sham ORX 4 wk post-op Male * * * 1 0.15 0.10 # * * Sham OVX Sham OVX 2 wk post-op 4 wk post-op Female 0.00 Sham OVX Sham OVX 2 wk post-op 4 wk post-op Female Sham ORX Sham ORX 2 wk post-op 4 wk post-op Male Figure 2 4 weeks post-gonadectomy, males lose cortical bone volume, but both males and females lose TMD TMD 1.2 * 1.0 * Sham OVX Sham OVX 2 wk post-op 4 wk post-op Female Male 0.4 7 0.2 6 Endocortical BS Male Female 3 INDIANA UNIVERSITY SCHOOL OF MEDICINE Future studies will be needed to assess the cellular mechanisms responsible for this sex-dependent bone volume and mineral density loss with acute sex hormone removal. 1) Mohamad, Nur Vaizura, et al. A Concise Review of Testosterone and Bone Health. Clinical Interventions in Aging, Volume 11, 2016, pp. 13171324., https://doi.org/10.2147/cia.s115472. 1 0 Sex hormones, particularly androgens in males, are crucial for proper development of the skeletal system. Testosterone seems to play a role in maintaining cancellous bone in males. The large decreases in bone volume and tissue mineral density suggest without proper exposure to sex hormone levels, bone achieves a lower peak bone mineral density. References 4 2 Figure 2 Tissue Mineral Density (TMD), Cortical Area, and Endocortical Bone Surface from male and female sham and operated animals 2 and 4 weeks post gonadectomy. N = 5/group. * = p <0.05 via Two-way ANOVA vs. Sham , #= p <0.05 via Two-Way ANOVA. Conclusions * 5 Sham OVX Sham OVX 2 wk post-op 4 wk post-op Male mice demonstrated a larger decline in both cancellous and cortical bone after removal of sex hormones. * Sham ORX Sham ORX 2 wk post-op 4 wk post-op 0.6 Sham ORX Sham ORX 2 wk post-op 4 wk post-op The acute removal of sex hormones prior to skeletal maturity negatively impacts the tissue mineral density of bone in both male and female mice. Cortical Area 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 0.8 0.0 * = p <0.05 via Two-way ANOVA vs. Sham , #= p <0.05 via Two-Way ANOVA. 0.05 mm2 3 Summary Cancellous bone is more sensitive than cortical bone to the decline in circulating sex hormones. 0.04 Trabecular Number Materials & Methods Images of the femurs were obtained using a SkyScan 1176 micoCT. The microCT images of the individual femurs were then reconstructed using Nrecon and DataViewer software. To analyze the cortical and trabecular bone separately, region of interests (ROIs) were drawn around the trabecular and cortical areas of each femur. Analysis programs were then executed to report the data of the cortical and trabecular bone volume. Tissue mineral density (TMD) was normalized to a phantom using houndsafield units. * Sham OVX Sham OVX 2 wk post-op 4 wk post-op Female Sham ORX Sham ORX 2 wk post-op 4 wk post-op Male g/cm3 Females undergo a rapid depletion of their estrogen levels once they enter menopause. It is understood that this decline in estrogen levels leads to increased activity of osteoclasts, more bone resorption, and ultimately a higher likelihood of developing osteoporosis. Males do not undergo a similar rapid loss of testosterone. This difference in depletion of sex hormones explains why women age 50 and older have a higher lifetime risk of fracture than men age 50 and older (1). However, it is common for males to lose testosterone levels as they age, and this loss of testosterone impacts bone mineral density. A previous study found that older men with higher testosterone levels better maintained their bone mineral density and had lower fracture risks (2). Other studies have postulated that testosterone stimulates osteoblasts to produce trabecular bone and aids osteocytes in preventing trabecular bone loss (3). While this provides insight into how chronic loss of testosterone impacts bone health, this study was aimed at discovering how acute removal of sex hormones impacted male and female mice. * * 5 0.06 * mm % # 0.08 0 Background Trabecular Thickness mm Menopause, an age-related loss of sex hormone production in women, is one of the most common causes of osteoporosis. Previous work has established that this loss of sex hormones, in particular estrogen, causes dramatic loss of bone volume and strength. Similarly, removal of sex steroids results in acute loss of bone mass in adult animals. Mouse models of sex steroid-deficiency include surgery removing the sex organs (orchidectomy, ORX, for males; ovariectomy, OVX, for females) are commonly used to understand the role of sex steroids in bone, but are typically preformed at animal maturity (16 weeks of age) and are analyzed six weeks post-operation. This study aimed to determine whether acute removal of the male or female sex hormones prior to maturity would impact the cortical and trabecular bone volume. Gonadectomy or sham operations were performed on mice at 11 weeks of age, and femurs were then harvested either 2 weeks (13 weeks of age) or 4 weeks postsurgery (15 weeks of age). Analysis of the cortical and cancellous bone volume of the femur were assessed by microCT. In cancellous bone, male animals two and four weeks ORX demonstrated decreases in the following parameters compared to sham operated, agematched controls (2 week; 4 week): bone volume (BV/TV, -70.9%; -86.6%), tissue mineral density (V-TMD, -8.69%; -17.9%), trabecular thickness (TbTh, -31.9%; -27.8%), and trabecular number (TbN, -57.5%; -81.4%). In cancellous bone, female animals two and four weeks OVX demonstrated decreases in the following parameters compared to sham operated, agematched controls: BV/TV (-61.2%; -41.0%), V-TMD (-30.7%; -15.6%), and TbN (-64.0%; 42.4%). In cortical bone, male animals four weeks ORX demonstrated decreases in the following parameters compared to sham operated, age-matched controls: cortical area (13.8%), Endocortical bone surface (-7.10%), and TMD (-10.2%). In cortical bone, female animals four weeks OVX demonstrated decreases in only TMD (-7.50%) compared to sham operated, age-matched controls. In summary, the acute removal of sex hormones has a larger impact on cancellous bone in both males and females, with male animals showing increasing bone loss as time progressed. Further studies are needed to understand the underlying mechanisms behind the progressive bone loss seen in males after sex hormone depletion. Figure 1 Trabecular bone loss in both male and female animals after both 2 and 4 weeks post gonadectomy, but only males have decreased volumetric tissue mineral density g/mm3 Abstract 1/mm 1 Department 2) Chin, Kok-Yong, and Soelaiman Ima-Nirwana. Sex Steroids and Bone Health Status in Men. International Journal of Endocrinology, vol. 2012, 2012, pp. 17., https://doi.org/10.1155/2012/208719. Sham ORX Sham ORX 2 wk post-op 4 wk post-op Male Sham OVX OVX Sham 2 wk post-op 4 wk post-op Female 3) Golds, Gary, et al. Male Hypogonadism and Osteoporosis: The Effects, Clinical Consequences, and Treatment of Testosterone Deficiency in Bone Health. International Journal of Endocrinology, vol. 2017, 2017, pp. 115., https://doi.org/10.1155/2017/4602129. DEPARTMENT OF ANATOMY, CELL BIOLOGY, & PHYSIOLOGY  ...

... The Effects of Elongation Strain on Human Choroid Plexus Epithelial Cells as a Model of Traumatic Brain Injury (TBI) Michael Tanchevski, Taylor Hiland, Elizabeth Delery, PhD 1Marian University College of Osteopathic Medicine Background Conclusions Elongation Strain Causes 48-hour Increase in Inflammatory Cytokines In the U.S., there are ~1.5 million reported traumatic brain injuries (TBI) per year with varying degrees of severity that inflict injury at the cellular level The Choroid Plexus (CP) plays a significant role in brain homeostasis The CP has also been severely understudied in the context of TBIs 1 Figure 1: Line graphs show the quantified change in production of 4 pro-inflammatory cytokines over time in the 2 hit vs 2 hit control conditions. Data shows exceptional increase in cytokine production across: IL-1a, MIF, CCL2, and CXCL2. Most specifically, significant increases are observed between 24-48 hours post-injury in the 2 hit condition. These results corroborate with the delayed symptomatic presentation seen in TBI. This project offers support to the documented clinical manifestations of a delayed symptom presentation seen with head injury There is a significant inflammatory cellular response to mild head injury, most notably @ 48 hours post hit The data sheds light on the inflammatory role that the Choroid Plexus can invariably inflict during head injury From our study, it is evident that choroid plexus epithelial cells are susceptible to injury from head trauma and that these subtle changes can be deleterious both structurally and functionally Our protocol serves as a valid model for other cell types to further explore the trauma response seen with TBIs and better understand the consequences of secondary inflammatory insults John Leiff, MD Objective Elucidate the extent of structural and neurochemical changes that occur in human choroid plexus epithelial cells (HuCPECs) in response to physical trauma 2A Future Directions Flex Cell International Corporation, 2021 2B Methods The FlexCell tension system was used to induce mechanical stimulation and elongation strain to the HuCPECs. HuCPECs structural integrity was analyzed using immunohistochemistry for tight junction proteins. Microarrays were used to analyze cytokine production and glutamate secretion. Figure 2: A. Bar graphs show the overall comparison of cytokine production between 2 hit and 2 hit control across pro & anti-inflammatory cytokines. B. Bar graphs comparing the change in cytokine production within the 2 hit condition between the 24 and 48 hour time points. Not only is there a substantial increase across the board for 2x hit conditions in general (A), the most noteworthy is at the window of 1-2 days post injury where both pro and anti-inflammatory cytokines exhibit substantial increases in production (B). Cytokine array: measuring new cytokine production across each time point in addition to total production Longer time points how persistent is the inflammatory response? Increase Flex Cell hit magnitude and parameters to better model TBI vs mild head injury Collecting supernatant between the 1st and 2nd hits for the 2 hit condition as a means to compare the difference during the incubation period Acknowledgements Dr. William Thompson, IUSM MUCOM Research Committee  ...

... DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 1 DNP Project Proposal: Nurse Practitioners Knowledge and Behaviors in Recommending Colorectal Cancer Screening Julie K. Dorsett Marian University, Department of Graduate Nursing DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 2 Table of Contents Abstract ........................................................................................................................................... 3 Background ..................................................................................................................................... 4 Problem Statement .......................................................................................................................... 7 Organizational Gap Analysis of Project Site ............................................................................... 8 Review of Literature ....................................................................................................................... 9 Theoretical Framework ................................................................................................................. 14 Goals, Objectives and Expected Outcomes .................................................................................. 16 Project Design/Methods ................................................................................................................ 16 Data Collection ............................................................................................................................. 18 Ethical Considerations/Protection of Human Subjects ................................................................. 19 Data Analysis and Results ............................................................................................................ 20 Conclusion .................................................................................................................................... 28 References ..................................................................................................................................... 29 Appendix A ................................................................................................................................... 34 Appendix B ................................................................................................................................... 39 Appendix C ................................................................................................................................... 41 Appendix D ................................................................................................................................... 43 DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 3 Abstract The United States Preventative Services Task Force (USPSTF) recommends initiating colorectal cancer screening for asymptomatic, average-risk individuals at age 45, which is a new update to the previous recommendation of age 50. Early detection of colorectal cancer reduces mortality compared to treatment in advanced stages of disease. Strategies shown to increase screening rates include the discussion of multiple modalities for screening, a systematic approach to identifying eligible patients, healthcare provider recommendation and teaching for screening, and overcoming individualized patient barriers to screening. This project was conducted in partnership with the Coalition of Advanced Practice Registered Nurses of Indiana (CAPNI) to better understand the knowledge and recommendation practices of Indiana nurse practitioners. A survey based on a previous study of primary care physicians by Chapman et al. (2012) was distributed to CAPNI membership regarding recommendation practices and utilization of screening guidelines. Colonoscopy was the most commonly recommended screening modality, followed by fecal immunoassay testing with DNA testing (FIT-DNA). No statistically significant difference was found in completion rates between colonoscopy and stool-based tests, as reported by providers. Most participants utilized guidelines from a professional organization to guide their recommendations for screening, but only 37.25% utilized those from the USPSTF. The majority of providers indicated they utilized a chart notification system to identify patients for screening and would offer additional modalities for screening if patients declined their first-recommended modality. USPSTF guidelines changed during the implementation of the project, influencing responses. Additional research with a larger sample size may aid in targeted educational opportunities to increase screening. Keywords: colorectal cancer screening, USPSTF, colonoscopy, FIT-DNA, nurse practitioners DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 4 DNP Project Proposal: Nurse Practitioners Knowledge and Behaviors in Recommending Colorectal Cancer Screening This project is submitted to the faculty of Marian University Leighton School of Nursing as partial fulfillment of degree requirements for the Doctor of Nursing Practice, Family Nurse Practitioner track. A survey was implemented to determine the prevalence of nurse practitioners recommending colorectal cancer screening. Colorectal cancer is the second leading cause of cancer mortality in the United States. Diagnosis is most common in adults aged 65-74 years (United States Preventative Services Task Force [USPSTF], 2016). The United States Preventative Services Task Force [USPSTF] (2021) recommends initiating colorectal cancer screening at age 45 for asymptomatic patients without a family history of colorectal cancer or inherited syndromes. This is a recent update to the recommendation of initiating screening at age 50. Early screening recommendations are based on decreased rates of mortality associated with early detection and treatment compared to detection in advanced disease (Wilkins et al., 2018). Despite the longstanding recommendation of screening initiation at age 50, only 62% of Americans aged 50-75 years are up to date on screenings (Levin et al., 2018). Therefore, an increase in screening in this population is necessary. Background Colorectal cancer five-year survival rates for contained, localized disease is 90%, but the rate decreases to only 14% in metastatic colorectal cancer (Montminy et al., 2019). Statistics supporting the benefits of early detection and treatment contributed to a significant increase in screening and decrease in mortality in the United States since the 1990s (Levin et al., 2018). However, screening rates have plateaued in recent years, falling below the national goal of 80% among those aged 50-75 years (Levin et al., 2018). The National Colorectal Cancer Roundtable DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 5 estimates achieving national rates of colorectal cancer screening of 80% or greater in this population could reduce colorectal cancer mortality by 19%, saving 203,000 lives by 2030 (Meester et al., 2015; National Colorectal Cancer Roundtable, 2017). Despite the overall improvements in colorectal cancer screening and mortality rates, racial and socioeconomic disparities remain. Colorectal cancer incidence has decreased among African Americans since 1989, though not as significantly as for Caucasian Americans (Montminy, 2019). Both African American men (52%) and African American women (41%) are more likely to die from colorectal cancer than their respective Caucasian counterparts. This inequality has been attributed, in part, to lower rates of screening among African Americans than Caucasian Americans. Screening rates among African Americans have increased significantly since 2000 from 32% to 61% in 2015, which was comparable to the rate for Caucasian Americans of 65% (Montminy, 2019). One type of screening recommended by the USPSTF (2021) is colonoscopy. The USPSTF (2021) does not recommend this modality over any other forms of screening, but it has been the most commonly ordered screening test since 2000 (Issa &Noureddine, 2017). Colonoscopy advantages include less frequent testing compared to other modalities and the ability to combine screening and diagnostic follow-up in one procedure (USPSTF, 2016). Despite its common use, characteristics and risks of colonoscopy are unappealing, including the discomfort of bowel preparation, cardiovascular risks during sedation, and the risk of bleeding or bowel perforation (USPSTF, 2021). These disadvantages may be barriers to colorectal cancer screening if other screening options are not discussed. The USPSTF (2021) also recommends stool-based testing, such as guaiac-based fecal occult blood testing (gFOBT), fecal immunoassay testing (FIT), and FIT with DNA testing (FIT- DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 6 DNA), as appropriate screening tests for colon cancer. Providers should emphasize the importance of screening and discuss all screening modalities available; thus, making a collaborative decision with the patient. The American Cancer Society (2017) recommends providers offer options for screening tests because patients who choose their own modality are more likely to adhere to screening recommendations. The recommended screening options do not vary significantly in the number of preventable colorectal cancer deaths, with 20-24 per 1000 people for all methods of screening (Wilkins et al., 2018). The test with the lowest sensitivity and specificity is gFOBT, with a sensitivity of 62-79% and a specificity of 87-96% (Wilkins et al., 2018). Furthermore, gFOBT only detects lesions which are actively bleeding. Therefore, the recommendation is for three consecutive stool samples to be tested in order to reduce false negative results (Elfant, 2015). FIT testing offers a sensitivity of 73-88% and a specificity of 91-95% (Wilkins et al., 2018). Compared to FIT alone, FIT-DNA demonstrates 92% sensitivity but only 90% specificity (Wilkins et al., 2018). The sensitivity and specificity of the colonoscopy is divided into two categories: the detection of adenomas greater than, equal to 6 millimeters and those greater than, or equal to 10 millimeters. For adenomas greater than or equal to 6 millimeters, colonoscopy has a sensitivity of 72.7%-98% and a specificity of 79.6%-93.1% (Ladabaum et al., 2020). When considering the detection of adenomas 10 millimeters or larger, colonoscopy has a sensitivity of 66.7%-93.5% and a specificity of 96%-97.9% (Ladabaum et al., 2020). The range of sensitivities and specificities for each of these screening modalities does not identify a clear best test. Thus, benefits and risks of all screening options should be discussed with the patient for an informed decision to be made. Cost may also act as a barrier to colorectal cancer screening. In 2018, nearly 28 million DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 7 Americans under age 65 were uninsured, with the cost of insurance cited as the most common reason for lacking insurance coverage (Tolbert et al., 2019). Those who lack insurance are less likely to receive preventative healthcare than those with insurance coverage, and earlier-stage cancer detection is associated with having insurance (Tolbert et al., 2019). Lack of insurance coverage is a major barrier to colorectal cancer screening (American Cancer Society, 2020). Similarly, out-of-pocket costs are a barrier for those with insurance coverage. Colorectal cancer screening is typically considered preventative. However, a screening colonoscopy may not be billed as preventative if a polypectomy or biopsy is performed. Therefore, the colonoscopy could be coded as diagnostic or therapeutic thus requiring the patient to pay a higher proportion of charges for services. Furthermore, additional follow-up appointments may also be billed at this increased rate (Montminy et al., 2018). Early detection of colorectal cancer is key in reducing mortality. Less than ideal screening rates and possible barriers to screening support further assessment of patient or provider beliefs, behaviors, or characteristics influencing screening rates. Targeting specific barriers for a specific population may be more effective than generalizing previous findings. Problem Statement The population of interest for this quality improvement project is nurse practitioners working in primary care settings in Indiana caring for patients 50-75 years of age. This group of nurse practitioners is of interest because of their role in recommending and ordering colorectal screening tests for asymptomatic patients at average risk for colorectal cancer. It is important to understand providers knowledge and behaviors regarding colorectal cancer screening. The findings will be compared to the current guidelines for colorectal cancer screening from the USPSTF. Does a survey of Indiana nurse practitioners caring for adults aged 50-75 years DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 8 regarding colorectal cancer screening recommendation practices compared to screening practices recommended in the literature result in knowledge of areas for improvement? Organizational Gap Analysis of Project Site This project will be implemented in partnership with the Coalition of Advanced Practice Registered Nurses of Indiana (CAPNI), a professional organization for Indiana advanced practice registered nurses (APRNs). CAPNI members include nurse practitioners in primary care, which is the population of interest for this project. Ascertaining nurse practitioners knowledge and behaviors related to colorectal cancer screening is integral to identifying potential areas for future research and interventions to improve colorectal cancer screening rates. CAPNIs membership provides an ideal representation of nurse practitioners in Indiana for this project. Search Methodology The literature search was conducted using only PubMed because of accessibility, which may have limited the overall results. Search terms utilized for this search included colorectal cancer screening recommendation, colorectal cancer screening provider, and colorectal cancer screening barrier. Limiters used were articles written in English and published in the last five years. One study was included despite a publication date outside the last five years because of its usefulness in creating a survey. The number of articles found were 1,843 for colorectal cancer screening recommendation, 3,542 for colorectal cancer screening provider, and 535 for colorectal cancer screening barrier. The total number of articles, when eliminating duplicate articles found in more than one search, was 5,148. Further inclusion criteria incorporated article types of systematic reviews, meta-analysis, randomized control trials (RCTs), clinical practice guidelines (CPGs), reviews, and publications from professional groups. This brought the new total number of articles to 1,218. Final inclusion criteria encompassed discussion of provider DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 9 factors in screening rates, patient-reported barriers, and differences in screening rates based on screening modalities offered. From this point, articles were excluded if recommendations were based on screening guidelines not comparable to those of the United States or a mere description of screening modalities. The final number of articles utilized in this review was 14. Review of Literature Patients Colorectal Cancer Screening Decision-Making Facilitators to Screening Patients decisions to undergo colorectal cancer (CRC) screening have been related to a variety of facilitators and barriers. A study of eight focus groups in federally qualified health centers and a systematic review and meta-synthesis of 92 qualitative studies identified four common facilitators for CRC screening, such included peace of mind from early detection and prevention, family or social support, provider recommendation and education, and media promotion of screening and education (Gwede et al., 2015; Honein-AbouHaidar et al., 2016). The focus group identified another motivator to screening: having a personal connection to someone who had CRC (Gwede et al., 2015). In a group-randomized multi-level intervention study of individuals not up-to-date on CRC screening, 74% of participants stated they would participate in a screening test if recommended by a provider, but only 33% reported plans to participate in screening in the next six months (Katz et al., 2018). Barriers to Screening While provider recommendation was identified as a facilitator to CRC screening, lack of provider recommendation was one of many barriers to screening (Gwede et al., 2015; HoneinAbouHaidar et al., 2016; Katz et al., 2018). Additionally, only 86% of surveyed primary care providers (PCPs) reported regular recommendation of CRC screening by any modality DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 10 (Chapman et al., 2012). Katz e al. (2018) conducted a multi-level intervention study including 109 participants who were mailed a screening recommendation letter from their PCP with a brochure from the American Cancer Society regarding CRC screening. The participants were asked to identify barriers to screening, and 23.9% of the participants reported a lack of a recommendation (Katz et al., 2018). This lack of acknowledgement of recommendation via letter was consistent with findings of a qualitative study of 3,415 patients who were recommended fecal immunochemical testing (FIT) by mass mailing, telephone conversation, or clinic visit. Only 7.3% of participants who received the mass mailing returned their FIT, compared to 63.3% of those who had a telephone conversation, and 95.4% of those counseled during a clinic visit (Fleming et al., 2018). Additional barriers reported by patients included factors related to knowledge deficits, specific modalities, and financial concerns. Patients reported they were not aware they needed screening because they did not have a family history of CRC or did not understand the importance of screening (Gwede et al., 2015; Honein-AbouHaidar et al., 2016; Katz et al., 2018). Furthermore, lack of transportation to and from colonoscopies and lack of insurance or concern about cost were identified as deterrents to CRC screening (Gwede et al., 2015; HoneinAbouHaidar et al., 2016; Katz et al., 2018)). The most common barrier identified by 55% of participants in a barrier-related telephone survey was the inconvenient and time-consuming nature of the screening (Katz et al., 2018). This finding was supported by concerns of competing responsibilities and priorities, such as work, being a caregiver, tending to other health concerns, and scheduling conflicts (HoneinAbouHaidar et al., 2016). Others reported coordination of transportation and dietary preparation as time-related inconveniences (Gwede et al., 2015). Additionally, Katz et al. (2018) identified a DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 11 relationship between higher levels of education and income with the increased barriers to screening. The authors hypothesized this may be related to a busy lifestyle or modality of screening recommended to the participants (Katz et al., 2018). This finding was inconsistent with the findings of the American Cancer Society (2020), which reported only 53% of adults 45 years of age or older with less than a high school education were up-to-date on CRC screening compared to 73% of college graduates in the same age group. Provider Strategies to Increase Screening Multiple studies identified patient compliance with screening recommendations or instructions specific to testing modalities as major or minor barriers to CRC screening (Butterly, 2020; Chapman et al., 2012; Schiff et al., 2017). Providers must overcome these barriers and patient-identified barriers to improve CRC screening rates. Only one study found in this literature search assessed the prevalence of provider behaviors to increase screening rates. This study completed a survey of 609 PCPs in Alabama (Chapman et al., 2012). Despite its year of publication, the study was included because it will be used to guide the development of the survey for this project. These PCPs were asked to identify their behaviors regarding recommendations, followup, and technology (Chapman et al., 2012). PCPs indicated they most frequently utilized inoffice discussions to educate patients regarding colorectal cancer screening (95.6%), and 86% reported recommending screening by any modality on a regular basis (Chapman et al., 2012). When asked to identify a preferred modality of CRC screening in asymptomatic, average risk patients over age 50, 52.1% of PCPs selected colonoscopy, compared to 22.8% who preferred inoffice stool tests and 22.1% who chose take-home stool tests (Chapman et al., 2012). The majority of PCPs (84.2%) indicated they would recommend gFOBT over a high sensitivity stool DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 12 test, while only 10.7% indicated they had a solid understanding of FIT screening (Chapman et al., 2012). When following up on take-home stool tests that were not returned, the most common strategies were waiting to address it at the next visit (58.6%) or calling the patient [22.6%] (Chapman et al., 2012). The majority of PCPs (54.2%) indicated they did not use a patient reminder system to track patients who were over age 50, asymptomatic, and at average risk for CRC and were not intending to implement such a system in the near future (Chapman et al., 2012). Organized Screening Approach Each of the authors discussed approaches to screening identified usual care as opportunistic screening, which relies on a routine office visit to trigger a screening recommendation by the provider (Butterly, 2020; Chapman et al., 2012; Coronado et al., 2018; Levin et al., 2018). Only one-third of providers surveyed reported the use of a formal system to notify patients of the need for screening, with 15% utilizing a reminder system in the electronic health record [EHR] (Chapman et al., 2012). This survey was outdated and warrants a current survey to evaluate current systems and increased use of EHR capabilities. Organized screening approaches were used to implement FIT screening and compare rates of completion with those found in usual care in two studies (Coronado et al., 2018; Levin et al., 2018). Coronado et al. (2018) conducted a randomized study comparing the rates of FIT completion of patients at 26 clinics and found a 3.4% increase in FIT completion and 3.8% increase in any modality of screening among the organized screening group compared to the opportunistic group (Coronado et al., 2018). This increase was not as remarkable as the increase in screening of more than 1 million members of an insurance group from 2000-2015. The baseline screening rate in 2000 was 38.9% of eligible members, and the screening rate grew to DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 13 82.7% in 2015 after implementation of the mail-to-home FIT program (Levin et al., 2018). This population also experienced a 25.5% decrease in CRC incidence and a 52.4% decline in CRC mortality (Levin et al., 2018). Additionally, the authors addressed the importance of provider follow-up after a positive FIT test, with a 42% increase in patient participation in follow-up colonoscopies over the 15-year period (Levin et al., 2018). Navigation Navigation is a concept similar to organized screening. A patient navigator is an individual who assists patients in overcoming the barriers preventing them from participating in CRC screening (Butterly, 2020). Navigation was only identified by two articles (Butterly, 2020; Dougherty et al., 2018). Navigation was identified as the most effective intervention to combat barriers to colorectal cancer screening and increased screening rates by 20% (Butterly 2020; Dougherty et al., 2018). Additionally, navigators employed by Exact Sciences, the corporation behind the combination FIT-DNA testing product, Cologuard, contact patients who have not returned samples to the corporation for processing (Butterly, 2020; Weiser et al., 2020). While this navigation by Exact Sciences was identified as a probable influence in increased rates of completion, causality was not determined (Weiser et al., 2020). Screening Modalities Colonoscopy and FIT were the CRC screening modalities most often found in literature. Some patients reported a preference for FIT compared to colonoscopy related to convenience and lack of discomfort, though some were concerned about FIT being unsanitary (Gwede et al., 2015; Honein-AbouHaidar et al., 2016). Other patients prefer colonoscopy because they believe it to be the most accurate modality of screening (Honein-AbouHaidar et al., 2016). Though the motivation for selecting colonoscopy was not reported, 33.6% of participants in the insurance DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 14 group study requested colonoscopy instead of the default modality of FIT (Levin et al., 2018). Colonoscopy remains the most commonly utilized screening test, though recommendations include multiple modalities (Butterly, 2020). Of the 589 physicians who responded, 52.1% reported they would recommend colonoscopy over other modalities of screening (Chapman et al., 2012). A secondary recommendation for CRC was not asked if the patient declined colonoscopy. This recommendation was incongruent with other professional organizations in providing information about multiple screening modalities while utilizing a shared decisionmaking approach with the patient (American Cancer Society, 2020; Schiff et al., 2017; USPSTF, 2016; Wilkins et al., 2018). Summary of Themes Common themes can be derived from the literature. The influence of provider recommendation for screening and the negative effects of not recommending screening highlight the importance of the provider role in promoting CRC screening. Similarly, providers should utilize one-on-one conversations when possible and provide education regarding the purpose of screening. Patients unique barriers to screening, such as time, transportation, and concerns regarding discomfort, should be assessed and considered when making screening recommendations. Providers may achieve an increase in screening rates with the use of an organized approach, navigation, or modalities preferred by patients. Because providers influence the decision to participate in screening and carry the responsibility, data regarding the behaviors of providers related to screening may identify areas for provider improvement. The only identified study in this review was outdated and warrants updating. Theoretical Framework The theoretical framework guiding this project is the Precaution Adoption Process Model DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 15 (PAPM). Weinstein and Sandman (1992) developed the PAPM. The PAPM is specific to healthrelated issues and is comprised of seven stages a person progresses through in gaining knowledge which changes behaviors (Weinstein & Sandman, 2002). The first stage of the PAPM is when the individual is unaware of health issue of interest. When the person becomes informed of the health issue but is not engaged by it, he or she is in stage 2. The third stage is the decision-making stage, which is when the person is engaged with the issue and deciding how to act. This stage can lead to stage 4 or stage 5. Stage 4 ends the PAPM if the person decides not to make any behavioral changes. Stage 5 is the path taken if the individual decides to adopt the health change, and stage 6 is the step of initiating the behavior change. The final stage, stage 7, is the process of maintaining the change over time (Weinstein & Sandman, 2002). In this project, the PAPM will be applied to providers recommending colorectal cancer screening. This project will assess providers current knowledge of colorectal cancer screening recommendations, determine their engagement with the knowledge, and evaluate their actions as a result. This will be achieved through the use of a survey of Indiana nurse practitioners. The authors of the PAPM emphasize the importance of identifying the most common stages individuals are in and tailoring interventions to address hurdles in those stages preventing adoption of the health-related behavior (Weinstein & Sandman, 2002). Prior to the implementation of this project, the last published update of the guidelines for colorectal cancer screening were published in 2016 (United States Preventative Services Task Force [USPSTF], 2020). Because these guidelines have been established for years, most providers are likely aware of the guidelines and probably fall in the later stages of the PAPM, likely in the maintenance phase. However, the United States Preventative Services Task Force DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 16 (USPSTF) released a draft of updated colorectal cancer screening guidelines on October 27, 2020, which would lower the age for initial colorectal cancer screening in asymptomatic adults at average risk to 45 years (USPSTF, 2020). These guidelines were officially adopted May 18, 2021, during the data collection portion of this project, which likely will affect the results of the survey (USPSTF, 2021). The knowledge gleaned by the survey in this project and the PAPM may be useful in relaying updated guidelines to providers or assessing knowledge of the updated guidelines in the future. By determining the stages of the PAPM currently occupied by providers, future projects may use this data to tailor specific interventions to increase providers behaviors in promoting the updated guidelines. Goals, Objectives and Expected Outcomes The main goals of this project are to measure the percentage of nurse practitioners who use the USPSTF guidelines to inform their practices and the percentage who offer screening modalities outside of colonoscopy alone. Another goal is to determine the percentage of nurse practitioners who have a plan for following up with patients who have not undergone screening. This data will be gathered and analyzed via the Qualtrics Survey Platform, which will be managed by this author. Greater than 50% of nurse practitioners are expected to be familiar with the USPSTF guidelines for colorectal cancer screening and use these guidelines to inform their practices. Additionally, it is expected greater than 50% would have a plan to follow up with patients who have not been screened and offer multiple screening modalities, including colonoscopy. Project Design/Methods This quality improvement project will be a program evaluation project utilizing quantitative data. An electronic survey link will be distributed by CAPNI administration via DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 17 email to its current membership. The survey will be based on the survey conducted by Chapman et al. (2012) and will be comprised of 16 multiple choice and Likert scale questions. Reponses will be analyzed to glean knowledge regarding current practices and compared to the recommended practices from the literature. Survey completion and data collection and analysis will be managed via the Qualtrics Survey Platform. Descriptive statistics and chi square analysis will be performed by this author with the assistance of a Marian University statistician. The cost associated with this project is a $50 application fee to CAPNI. The anticipated duration of this project is 7 months. This author has obtained training in ethical research practices and approval from the Marian University Institutional Review Board (IRB) prior to this project. Participation by CAPNI members will be voluntary, anonymous, and explained via an informed consent document. All data will be de-identified and password protected. Project Site and Population Participants will be active members of CAPNI. Participants will be excluded if not currently working as a nurse practitioner. The project will be performed via an electronic survey accessible by email. Methods A representative of CAPNI will email an online survey link to active CAPNI members. The survey will be an adaptation of the survey conducted by Chapman et al. (2012). The survey will consist of 16 multiple choice and Likert scale questions. Measurement Instrument The instrument used in this project is a survey of 16 questions comprised of multiple choice and Likert scale questions. This is based on the survey created by Chapman et al. (2012) DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 18 and adapted to the population of interest and current screening recommendations. A copy of this adapted survey is attached (Appendix A). Data Collection The survey will be managed using the Qualtrics Survey Platform. It will be distributed via an email link to the CAPNI membership, which will be active for one month. The email will contain a letter of informed consent information. A copy of this letter is attached (Appendix B). By clicking on the link to the survey at the end of the letter, participants provide consent. A reminder email will be sent halfway through this period at two weeks by a CAPNI representative. The data collection and analysis will be completed via the Qualtrics Survey Platform by this author. Qualtrics will collect the non-identifiable survey responses in a spreadsheet-style format. The data will also be exported to an Excel spreadsheet as an additional method of ensuring the results are saved. Data Analysis Data will be collected and analyzed using the Qualtrics Survey Platform. The analysis tools available within the Qualtrics Survey Platform will be the primary means of analysis. Descriptive statistical analysis will be used to summarize the most commonly recommended methods of screening and methods of identifying eligible patients. Descriptive statistics will also be used to describe the demographics of the sample population. Chi square testing will be used to compare the results of the survey to those in the Chapman et al. (2012) study for statistically significant differences. The results of the survey will also be compared to the current USPSTF recommendations to identify the percentage of providers following the most current DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 19 recommendations. A Marian University statistics professor, who is serving as a member of the committee for this DNP project, has also agreed to assist with statistical analysis. Cost-Benefit Analysis/Budget The only costs associated with this DNP project are those related to CAPNI. Directly, a $50 research application fee was paid to CAPNI for their consideration of acting as facilitators for this project. Indirectly, CAPNI membership is required to submit a research application, and membership requires dues. This author was already a due-paying member of CAPNI prior to the submission of the research application. Timeline The expected timeline for this project from submission to the Institutional Review Board (IRB) to completion of the project manuscript is 7 months (Appendix C). Initial IRB submission occurred in January 2021, and final approval was acquired in March 2021. The initial CAPNI research request was submitted March 22, 2021, with additional information submitted April 9, 2021. Final approval from CAPNI is pending. Once CAPNI has approved the research request, the Qualtrics survey will be sent to the CAPNI representative responsible for distributing it to the CAPNI membership. It is anticipated the survey will be open for one month. After this onemonth period, the data will be analyzed, and the manuscript will be completed. Ethical Considerations/Protection of Human Subjects This author completed Collaborative Institutional Training Initiative (CITI) training prior to this project to ensure understanding of ethical research. Approval from the Marian University Institutional Review Board was obtained prior to initiating this project (Appendix D). The cover email preceding the survey link provides informed consent information to each potential participant. This author will not have any direct contact with participants and will not have DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 20 access to any identifiable information. All information collected in the survey will be anonymous, and participation is voluntary. There is no risk of harm to participants. The information to be shared with CAPNI after data analysis will be aggregate, so CAPNI members and staff will also not have access to any data possibly linking any responses to individuals. Additionally, the Qualtrics Survey Platform is password protected, and this author is the only person with access to the survey and results. The Excel spreadsheet containing the additional copy of the data is also password protected. Data Analysis and Results Thirty-nine nurse practitioners completed the survey. Of these, four were excluded because they indicated they were not currently practicing. The majority (94.29%) of participants were females. Additionally, 60% were working in a family practice setting. Complete demographic information for the 35 participants is included below in Table 1. Table 1 Sample Demographics Gender Female Male Age Up to 30 years 94.29% (33) 5.71% (2) 0% (0) 31-40 years 37.14% (13) 41-50 years 20% (7) 51-60 years 31.43% (11) Greater than 60 11.43% (4) years Type of Practice Family Practice 60% (21) DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING Internal Medicine 5.71% (2) Specialty 34.29% (12) 21 The majority of participants (80%) reported regularly recommending colorectal cancer screening. Only one participant reported never recommending colorectal cancer screening, three reported occasionally, and three responded seldomly recommending screening. Participants reported they began screening at ages 45 (20%) or 50 (77.14%) years, with one provider reporting they recommend screening to adult patients if the patient has high beta glucuronidase levels (Figure 1). Figure 1 Age of Initial Recommendation for Screening Most providers reported using guidelines from one or more professional organizations to guide their recommendations (88.57%). These organizations included the American Association of Family Practice (15.69%), the American Cancer Society (25.49%), the American College of Gastroenterology (17.65%), the United States Preventative Services Task Force (37.25%), and DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 22 others (3.92%). The majority of respondents reported they would first recommend the screening modality of colonoscopy to an average-risk, asymptomatic patient aged 50 years or older (Figure 2). Figure 2 First Recommended Screening Modality in Asymptomatic, Average-Risk Patient Aged 50+ Years If patients declined the recommended modality, 94.29% (33) reported they would recommend a second modality. Of those who selected colonoscopy as a first-choice modality, 68.42% (13) reported they would recommend FIT-DNA (Cologuard) testing as a second option. Among those who chose FIT-DNA (Cologuard) testing as a first recommendation, 40% (4) indicated they would recommend FIT second, 40% (4) selected gFOBT, and 20 % (2) selected colonoscopy. DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 23 Figure 3 Which Percentage of Patients You Refer for Colonoscopy (Outside of COVID-19 Pandemic) Complete It? Figure 4 Which Percentage of Patients You Order Stool-Based Testing for Complete It? DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 24 Figure 3 and Figure 4 above detail the reported percentage of patients who complete colonoscopies or stool-based testing when ordered. When a colonoscopy has been ordered, most (40%) participants estimated 51-75% of patients complete them, whereas 35.48% of participants estimated 51-75% completed stool-based testing when ordered. Additionally, completion estimates of 75% or greater were similar between stool-based testing (22.58%) and colonoscopy (22.86%). There is no statistically significant difference between the completion estimates of the colonoscopy and stool-based groups (4, N= 70) = 0.665, p= .956 when compared via chi squared testing. Thus, no significant difference in completion rates was found between the modalities. If a stool-based test was ordered but not returned, 54.29% (19) of respondents reported they would address it at the next office visit. A follow-up call would be placed by 20% (7) of participants. A patient portal message or mailed reminder would be utilized by 5.71% (2) and 8.57% (3), respectively. Most participants (60%) reported they did not utilize a systematic approach to identifying patients meeting criteria for screening; patients were identified during a visit. Of the 14 participants using a systematic method to identify patients for screening, 71.43% reported using a notification in the electronic chart as the method. A staff compiled list of patients eligible for screening was reported by 14.29% (2) of participants. Compared to the study performed by Chapman et al. (2012), the use of gFOBT testing was decreased and the use of high-sensitivity stool-based tests was increased in this sample. Chapman et al. (2012) reported 84% of providers ordering stool-based testing ordered gFOBT and 14% ordered high-sensitivity tests. In the sample population from this survey, only 3% of respondents reported they would recommend gFOBT as their first-choice modality for screening. DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 25 Additionally, 32% reported FIT-DNA (Cologuard) testing to be their first-choice test for screening, and 68.42% reported they would recommend FIT-DNA (Cologuard) testing as a second-choice modality if the patient declined colonoscopy. Colonoscopy remained the firstchoice modality for the majority of providers in both surveys, with 56% in the current survey and 52.1% in the Chapman et al. (2012) survey recommending it over other modalities in average risk patients. No statistically significant differences were found in the frequency of recommending colorectal cancer screening between the participants of this survey and the Chapman et al. (2012) survey, (3, N= 620)= 3.915, p= .270. Discussion The increase in use of high-sensitivity stool-based tests and decreased recommendation for gFOBT testing is clinically significant. As discussed previously, gFOBT is the screening modality with the lowest sensitivity and specificity, and gFOBT can only detect actively bleeding lesions (Elfant, 2015; Wilkins, 2018). Conversely, FIT-DNA (Cologuard) testing is 92% sensitive and 90% specific for colorectal cancer detection (Wilkins, 2018). Changes in stool-based testing recommendations must be considered in light of differences between the surveys. When the Chapman et al. (2012) study was published, FIT-DNA (Cologuard) testing was not available. Cologuard gained Food and Drug Administration (FDA) approval in 2014, and the USPSTF included Cologuard in its recommendations for screening in 2016 (Exact Sciences, 2019). The USPSTF published updated guidelines regarding the age to initiate colorectal cancer screening during the survey collection portion of this project. Therefore, it is impossible to determine if participants responses to the question regarding the age they begin recommending screening for patients was based on the existing guidelines or the new guidelines. A future DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 26 project may be warranted to evaluate this practice after the current guidelines have been in place for a longer period of time. It was expected prior to the data collection portion of this project that greater than 50% of participants would be familiar with the USPSTF guidelines for screening and use them to inform their recommendation practices. While this survey revealed that 88.57% of participants utilized some form of professional organization recommendations when recommending colorectal cancer screening, only 37.25% reported utilizing USPSTF guidelines. The USPSTF guidelines were the utilized less often than anticipated, but these guidelines were still reported as the most frequently used guidelines. The population of participants not using any guidelines to inform their care indicates an opportunity for educational outreach on the most up-to-date recommendations. An additional expectation prior to the data collection portion of this project was that greater than 50% of nurse practitioners participating in the survey would have a plan for followup if patients did not complete stool-based testing after it was discussed and ordered. While 88.57% of participants indicated they would follow up with the patient in some form, including at the next visit, via phone, via mail, or via EHR message, the majority (54.29%) reported they would follow up at the next visit. The survey did not allow for participants to indicate how long it may be before they were able to follow up with the patient, i.e. if they would wait for an annual exam. The timeframe in which a provider follows up may impact when the patient completes screening. The phrasing of questions utilized in the survey must be considered when interpreting results because of potential bias. Participants may have responded to survey questions indicating they practice in a particular way because of an identified best practice. However, they may not be truly practicing in that manner. Additionally, participants were asked to estimate patient DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 27 completion of screening, which may not accurately reflect completion rates. These factors must be considered when evaluating clinical implications. There were no statistically significant differences found between completion estimates of colonoscopy-based and stool-based screening. The potential for inaccurate estimates of completion must be considered when interpreting this finding. This finding may suggest there is no advantage to recommending a particular modality over another from the standpoint of completion likelihood. However, more research with actual completion rates should be considered before utilizing this information. Additionally, there was no statistically significant difference in the frequency of recommending colorectal cancer screening between this survey and the Chapman et al. (2012) survey. This finding could indicate there has not been improvement in rates of colorectal cancer screening recommendations by PCPs since 2012. However, factors that could influence the findings must be considered when comparing the two surveys. The concern of inaccurate reporting of practices by participants must be considered. The actual frequency of recommending colorectal cancer screening to patients may not be the same as the reported frequency. Actual recommendation frequencies in a larger, more diverse sample should be considered. When comparing this survey and the survey by Chapman et al. (2012), factors that could influence different findings must be considered. The most significant difference to be considered is the participating populations. This survey included 35 Indiana nurse practitioners who were members of CAPNI, whereas the Chapman et al. (2012) survey included 609 physicians from Alabama working in the fields of family medicine, internal medicine, and obstetrics/gynecology. The Chapman et al. (2012) sample is significantly larger, and the education and background of each of these groups vary. Another consideration in differences between the studies is the DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 28 advancement of technology, particularly the increased use of EHRs to identify patients eligible for screening. The survey in this project was based on the survey used by Chapman et al. (2012). However, there are limitations to the survey used in this project. The survey did not ask participants to specify their field of work if working in a specialty practice. Knowing this information could provide insight as to which types of practices most commonly recommend colorectal cancer screening. Additionally, most of the participants in this survey were females, which may be related to the target population of nurse practitioners. Therefore, screening recommendation practices could not be compared based on provider gender. Finally, providers were asked to estimate the percentage of patients who complete colonoscopy and stool-based screening in their practices. Because the providers were estimating, actual percentages could vary and reveal a statistically significant difference in completion based on modality. Conclusion Early detection of colorectal cancer is essential to early treatment and reduced mortality. Healthcare providers influence patients willingness to complete colorectal cancer screening by recommending screening modalities. This survey identified colonoscopy and FIT-DNA (Cologuard) testing as the most frequently recommended screening modalities among the nurse practitioners who participated. Because USPSTF guidelines updated during the implementation phase of this project, limited data regarding current knowledge of guidelines among the nurse practitioners was available. Additional research regarding knowledge of the updated guidelines, length of time to follow up on outstanding screening, and actual percentage of completed screening tests is warranted. Additionally, educational opportunities regarding current guidelines may be beneficial for providers. DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 29 References American Cancer Society. (2020). Colorectal cancer facts & figures 2020-2022. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-andstatistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-20202022.pdf Butterly, L. F. (2020). Proven strategies for increasing adherence to colorectal cancer screening. Gastrointestinal Endoscopy Clinics of North America, 30(3), 377-392. https://doi.org/10.1016/j.giec.2020.02.003 Chapman, K., Nicholls, K., Sullivan, M. M., Crutchfield, S., Shaw, T., Perkins, A., & Reed, E. (2012). Colorectal cancer screening practices in Alabama: A survey of primary care physicians. Journal of Cancer Education, 27(4), 687-694. https://doi.org/10.1007/s13187-012-0392-6 Coronado, G. D., Petrik, A. F., Vollmer, W. M., Taplin, S. H., Keast, E. M., Fields, S., & Green, B. B. (2018). Effectiveness of a mailed colorectal cancer screening outreach program in community health clinics. Journal of the American Medical Association Internal Medicine, 178(9), 1174-1181. https://doi.org/10.1001/jamainternmed.2018.3629 Dougherty, M. K., Brenner, A. T., Crockett, S. D., Gupta, S., Wheeler, S. B., Coker-Schwimmer, M., Cubillos, L., Malo, T., & Reuland, D. S. (2018). Evaluation of interventions intended to increase colorectal cancer screening rates in the United States. Journal of the American Medical Association Internal Medicine, 178(12), 1645-1658. https://doi.org/10.1001/jamainternmed.2018.4637 Elfant, A. B. (2015). Colorectal cancer screening. The Journal of Family Practice, 64(12), S10S15. https://www.mdedge.com/familymedicine/article/104701/hot-topics-primary-care DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 30 Exact Sciences. (2019). Cologuard gains FDA approval for use in younger Americans, ages 4549. https://investor.exactsciences.com/investor-relations/press-releases/press-releasedetails/2019/Cologuard-Gains-FDA-Approval-For-Use-In-Younger-Americans-Ages-45To-49/default.aspx Fleming, T. J., Benitez, M. G., & Ritterman Weintraub, M. L. (2018). Evaluating the effectiveness of one-on-one conversations to increase colorectal cancer screening in a community-based clinical setting. The Journal of the American Osteopathic Association, 118(1), 26-33. https://jaoa.org/article.aspx?articleid=2668379 Gwede, C. K., Koskan, A. M., Quinn, G. P., Davis, S. N., Ealey, J., Abdulla, R., Vadaparampil, S. T., Elliott, G., Lopez, D., Shibata, D., Roetzheim, R. G., Meade, C. D., & the Tampa Bay Community Cancer Network. (2015). Patients perceptions of colorectal cancer screening tests and preparatory education in federally qualified health centers. Journal of Cancer Education, 30(2), 294-300. https://doi.org/10.1007/s13187-014-0733-8 Honein-AbouHaidar, G. N., Kastner, M., Vuong, V., Perrier, L., Daly, C., Rabeneck, L., Straus, S., & Baxter, N. N. (2016). Systematic review and meta-study synthesis of qualitative studies evaluating facilitators and barriers to participation in colorectal cancer screening. Cancer, Epidemiology, Biomarkers, & Prevention, 25(6), 907-917. https://doi.org/10.1158/1055-9965.EPI-15-0990 Issa, I. A., & Noureddine, M. (2017). Colorectal cancer screening: An updated review of the available options. World Journal of Gastroenterology, 23(28), 5086-5096. https://doi.org/10.3748/wjg.v23.i28.5086 Katz, M. L., Young, G. S., Zimmermann, B. J., Tatum, C. M., & Paskett, E. D. (2018). Assessing colorectal cancer screening barriers by two methods. Journal of Cancer Education, 33(3), DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 31 536-543. https://doi.org/10.1007/s13187-016-1148-5 Levin, T. R., Corley, D. A., Jensen, C. D., Schottinger, J. E., Quinn, V. P., Zauber, A. G., Lee, J. K., Zhao, W. K., Udaltsova, N., Ghai, N. R., Lee, L. T., Quesenberry, C. P., Fireman, B. H., & Doubeni, C. A. (2018). Effects of organized colorectal cancer screening on cancer incidence and mortality in a large, community-based population. Gastroenterology, 155(5), 1383-1391. https://doi.org/10.1053/j.gastro.2018.07.017 Meester, R. G. S., Doubeni, C. A., Zauber, A. G., Goede, S. L., Levin, T. R., Corley, D. A., Jemal, A., & Lansdorp-Vogelaar, I. (2015). Public health impact of achieving 80% colorectal cancer screening rates in the United States by 2018. Cancer, 121(13), 22812285. https://doi.org/10.1002/cncr.29336 Montminy, E. M., Karlitz, J. J., & Landreneau, S. W. (2018). Progress of colorectal cancer screening in United States: Past achievements and future challenges. Preventative Medicine, 120, 78-84. https://doi.org/10.1016/j.ypmed.2018.12.004 National Cancer Institute. (2005). Theory at a glance: A guide for health promotion practice (2nd ed.). U.S. Department of Health and Human Services, National Institutes of Health. https://cancercontrol.cancer.gov/sites/default/files/2020-06/theory.pdf National Colorectal Cancer Roundtable. (2017). About 80% by 2018. http://nccrt.org/wpcontent/uploads/80-by-2018-TALKINGPOINTS-Final-2.16.17.pdf Schiff, G. D., Bearden, T., Swain Hunt, L., Azzara, J., Larmon, J., Phillips, R. S., Singer, S., Bennett, B., Sugarman, J. R., Bitton, A., & Ellner, A. (2017). Primary care collaboration to improve diagnosis and screening for colorectal cancer. The Joint Commission Journal on Quality and Patient Safety, 43(7), 338-350. https://doi.org/10.1016/j.jcjq.2017.03.004 Tolbert, J., Ogrera, K., Singer, N., & Damico, A. (2019). Key facts about the uninsured DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 32 population. Henry J. Kaiser Family Foundation. http://files.kff.org/attachment/IssueBrief-Key-Facts-about-the-Uninsured-Population United States Preventative Services Task Force. (2016). Screening for colorectal cancer: US Preventative Services Task Force recommendation statement. Journal of the American Medical Association, 315(23), 2564-2575. https://doi.org/10.1001/jama.2016.5989 United States Preventative Services Task Force. (2020, October 27). Draft recommendation statement: Colorectal cancer: Screening. https://uspreventiveservicestaskforce.org/uspstf/draft-recommendation/colorectalcancer-screening3 United States Preventative Services Task Force. (2021). Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. Journal of the American Medical Association, 325(19), 1965-1977. https://doi.org/10.1001/jama.2021.6238 Weinstein, N. D., & Sandman, P. M. (1992). A model of the precaution adoption process: Evidence from home radon testing. Health Psychology, 11(3), 170180. https://doi.org/10.1037/0278-6133.11.3.170 Weinstein, N. D., & Sandman, P. M. (2002). The precaution adoption process model and its application. In R. J. DiClemente, R. A. Crosby, & M. C. Kegler (Eds.), Emerging theories in health promotion practice and research: Strategies for improving public health (pp. 16-39). John Wiley & Sons. https://books.google.com/books?hl=en&lr=&id=ddPm7RGE4UEC&oi=fnd&pg=PA16& dq=precaution+adoption+process+model+sandman&ots=FHFFL_thf1&sig=zz66Upf_Me KcrMMkXQktelRL_Gs#v=onepage&q=precaution%20adoption%20process%20model% 20sandman&f=false DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 33 Weiser, E., Parks, P. D., Swartz, R. K., Van Thomme, J., Lavin, P. T., Limburg, P., & Berger, B. M. (2020). Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening: Real-world data from a large cohort of older adults. Journal of Medical Screening. Advance online publication. https://doi.org/10.1177%2F0969141320903756 Wilkins, T. McMechan, D., & Talukder, A. (2018). Colorectal cancer screening and prevention. American Family Physician, 97(10), 658-665. https://www.aafp.org/afp/2018/0515/p658.html DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING Appendix A Survey for Indiana Nurse Practitioners Colorectal Cancer Screening Survey 1. Gender: a. Female b. Male c. Other (specify) 2. Age: a. Up to 30 years b. 31-40 years c. 41-50 years d. 51-60 years e. Greater than 60 years 3. What type of practice do you actively work in? a. Family Practice b. Internal Medicine c. Specialty Practice d. Not actively practicing 4. Which type of area is your practice located in? a. Rural/town b. Medium city c. Large city d. Suburb 34 DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 35 5. How often do you recommend colorectal cancer screening of any kind in your practice? a. Regularly b. Occasionally c. Seldom d. Never 6. At which age do you recommend initial colorectal cancer screening for patients without personal or family histories of colorectal cancer? a. Younger than age 45 b. Age 45 c. Age 50 d. Age 55 e. Other (specify) 7a. Do you use guidelines from a professional organization to guide your colorectal cancer screening recommendations? a. Yes b. No 7b. If so, which guidelines do you utilize? (Select all that apply) a. American Association of Family Practice b. American Cancer Society c. American College of Gastroenterology d. United States Preventative Services Task Force (USPSTF) e. Other (Specify) 8. In an asymptomatic, average-risk patient aged 50 years or older, which screening test DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING would you first recommend? a. Colonoscopy b. Fecal Immunoassay Testing (FIT) c. FIT-DNA (Cologuard) d. Guaiac-based Fecal Occult Blood Testing (gFOBT) e. Sigmoidoscopy f. Other (Specify) 9a. Would you recommend a different screening test if the patient declined screening with your first recommendation? a. Yes b. No 9b. If so, which test would you recommend second? a. Colonoscopy b. Fecal Immunoassay Testing (FIT) c. FIT-DNA (Cologuard) d. Guaiac-based Fecal Occult Blood Testing (gFOBT) e. Sigmoidoscopy f. Other (Specify) 10. What percentage of patients you refer for colonoscopy (outside of pandemic) complete the colonoscopy? a. Less than 25% b. 26-50% c. 51-75% 36 DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 37 d. Greater than 75% e. Unsure 11. What percentage of patients you order stool-based testing (FIT, FIT-DNA/Cologuard, gFOBT) for complete it? a. Less than 25% b. 26-50% c. 51-75% d. Greater than 75% e. Unsure 12. If a stool-based test has been ordered, but you have not received any results, what is your most likely course of patient follow-up? a. Address at next office visit b. Follow-up call c. Patient portal message d. Mailed reminder e. No follow-up f. Other (Specify) 13a. Do you have a systematic method to identify patients meeting screening criteria? a. Yes b. No, patients are identified during a visit 13b. If so, what methods do you utilize? a. Notification in electronic chart b. Staff-compiled list DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING c. Other (specify) Adapted from Chapman, K., Nicholls, K., Sullivan, M. M., Crutchfield, S., Shaw, T., Perkins, A., & Reed, E. (2012). Colorectal cancer screening practices in Alabama: A survey of primary care physicians. Journal of Cancer Education, 27(4), 687-694. https://doi.org/10.1007/s13187-012-0392-6 38 DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 39 Appendix B Cover Email to CAPNI Membership for Participation in Research Dear CAPNI Member, You are being asked to take part in a quality improvement project, Nurse Practitioners Knowledge and Behaviors in Recommending Colorectal Cancer Screenings, being conducted by Julie Dorsett as partial fulfillment of the Doctor of Nursing Practice (DNP) degree requirement under the supervision of Dr. Jeanne Potts in the Department of Nursing Graduate Studies at Marian University, Indianapolis, IN. Nurse Practitioners who are members of the Coalition of Advanced Practice Nurse Practitioners of Indiana (CAPNI) are of interest because of their role in recommending and ordering colorectal screenings for asymptomatic patients at average risk for colorectal cancer. The purpose of this project is to understand nurse practitioners knowledge and behaviors regarding colorectal cancer screening recommendations. The findings will be compared to current colorectal cancer screening guidelines from the United States Preventative Services Task Force (USPSTF). If you agree to participate in this study, you will be asked to complete a short Qualtrics survey concerning knowledge of and recommendations for colorectal cancer screening. The entire survey should not take more than 10-15 minutes to complete. This survey is anonymous and there will not be any information which will link you to the Qualtrics survey. There are no foreseeable risks involved in participating in this project beyond those experienced in everyday life. There are no direct benefits to you from participation, but the results of the project may be helpful when recommending colorectal cancer screenings in the future. DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 40 The survey data will be anonymous and confidential. There will not be any information linking you to the survey responses. Survey data will be reported in aggregate and shared with the CAPNI leadership to ascertain any further educational offerings. Participation in this project is voluntary and is indicated by starting the Qualtrics survey link included below. If you do not want to be in this project, you do not have to participate, and you may close this email. Even if you decide to participate, you are free to not answer any questions or to withdraw from participation at any time without penalty. If you have questions about this project, please feel free to contact Julie Dorsett at jdorsett299@marian.edu or faculty sponsor Dr. Jeanne Potts at jpotts@marian.edu. Participation is voluntary is indicated by clicking the Qualtrics link below to start the survey. Add LINK TO QUALTRICS SURVEY here Thank you in advance for your time. It is appreciated. Julie Dorsett, FNP student, DNP candidate Dr. Jeanne Potts, WHNP-BC, FNP-C, Associate Professor Marian University DNP-FNP Program DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING Appendix C Project Timeline DNP Project Timeline 41 DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING 42 DNP PROJECT PROPOSAL COLORECTAL CANCER SCREENING Appendix D Marian University IRB Approval of Project 43  ...

... CIM & MIGRAINES IN PRIMARY CARE Marian University Leighton School of Nursing Doctor of Nursing Practice Complementary and Integrative Medicine (CIM) in Primary Care Jacqueline Thompson Marian University Leighton School of Nursing Chair: Tara R. Fox, DNP, CPNP Signature __________________________________ Date of Submission: November 31, 2021 1 CIM & MIGRAINES IN PRIMARY CARE Table of Contents Abstract ...................................................................................... 3 Introduction ........................................................................................................................ 4 Background ................................................................................................................... 4 Problem Statement ........................................................................................................ 6 Organizational Gap Analysis of Project Site ............................................................. 6 Review of the Literature ..................................................................................................... 6 Theoretical Framework/Evidence Based Practice Model ................................................. 10 Goals & Objectives .......................................................................................................... 11 Project Design/Methods .................................................................................................... 12 Project Site and Population ......................................................................................... 12 Measurement Instrument(s) ....................................................................................... 12 Ethical Considerations/Protection of Human Subjects .............................................. 13 Data Collection Procedure ............................................................................................... 14 Data Analysis and Results ................................................................................................ 15 Discussion ......................................................................................................................... 20 Conclusion ....................................................................................................................... 24 References ......................................................................................................................... 26 Appendix Appendix A ................................................................................................................. 30 Appendix B ................................................................................................................. 31 Appendix C ................................................................................................................. 33 Appendix D ................................................................................................................. 34 2 CIM & MIGRAINES IN PRIMARY CARE Background: Many patients seek the advise from their primary care providers (PCPs) to provide insight into alternative treatment options, however, little is known about the practices of primary care providers (PCPs) and the referring of Complementary and Integrative Medicine (CIM) treatments for patients with migraine pain. CIM is the practice of evidence informed modalities such as traditional Chinese medicine and mindbody strategies to assist in the health and healing processes. Purpose: The purpose is to determine if Ascension St. Vincent Indianapolis PCPs are referring CIM treatments to their migraine patients, and if not, what prohibits providers from utilizing these treatments with their migraine patients. Methods: A 10-question survey was distributed to 243 primary care providers (PCPs) of the Ascension St. Vincent Indianapolis network. Implementation Plan: The 10- question survey was distributed to the PCPs of Ascension St. Vincent Indianapolis via their Ascension emails. The collection and analysis was conducted through the online database, REDCap from September 29 to October 31,2021. Results: 29 responses were received (11.90%). There was no significant correlation between the providers professional background and their perceptions of CIM. There was a significant correlation between the provider survey responses and the providers gender. Conclusions: Findings suggest there is a lack of education, knowledge, and comfort in regards to CIM therapies amongst the PCPs of Ascension St. Vincent Indianapolis. Keywords: Complementary and Integrative Medicine (CIM), Complementary Alternative Medicine (CAM), primary care providers (PCPs), randomized controlled trial (RCT) 3 CIM & MIGRAINES IN PRIMARY CARE Complementary and Integrative Medicine (CIM) & Migraines in Primary Care Introduction Migraine headaches are a chronic debilitating neurological condition affecting over 36 million Americans and are the second- most disabling condition worldwide (Patel & Minen, 2019). Although migraine headache disorders are one of the most prevalent chronic pain conditions, migraines continue to be extremely difficult for practitioners to treat. Despite many advances in the medical prevention and treatment of migraine headaches, many patients are unable to find an effective treatment regimen. A wide variety of treatment options are available, however, many pharmacological options are accompanied by serious side effects or drug interactions, resulting in discontinuation of use. Primary care providers (PCPs) play a key role in guiding patients in their choices of treatment and should be aware of complementary and integrative medicine (CIM) treatments available for migraine headache patients such as mindfulness based stress reduction (MBSR), acupuncture, and herbal supplements. Background A migraine is a primary headache disorder involving recurrent headaches characterized as one-sided moderate or severe pulsating intensity frequently accompanied by nausea lasting from hours to days. Migraine headaches are ranked sixth highest cause worldwide for years lost due to disability. The burden for migraine suffers not only includes pain, but an impaired quality of life affecting all aspects of life including their family, employment, and social life (World Health Organization, 2016). 4 CIM & MIGRAINES IN PRIMARY CARE Currently, migraine treatment regimens are tailored to the individuals symptoms in respect to severity of episodes, comorbidities and patient preferences. The process of finding an effective treatment regimen typically requires a trial and error approach. There are wide varieties of medications available for migraine headache treatment such as NSAIDs, anti-epileptics, ergotamine derivatives, beta-blockers, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants and opioids. Unfortunately, serious side effects can be associated with the use of these drugs, which deter their use by patients (The American Headache Society, 2018). In order to avoid the associated side effects, patients seek alternative treatments to medications for migraine headache pain. Complementary and Integrative Medicine (CIM) uses evidence informed modalities such as nutrition, movement practices, manual therapy, traditional Chinese medicine, and mind-body strategies to assist patients in their health and healing processes. Many of the most frequently sought after CIM treatments have been incorporated from the traditional Chinese medicine including acupuncture, massage, meditation, yoga, and biofeedback. Some other effective CIM techniques for the treatment of migraine headache pain include supplements, botanicals and diet alteration. Evidence continues to grow to support the effectiveness of CIM therapies for treatment of migraine headache pain (Millstine et al, 2017). Despite the increasing evidence to support the use of CIM in the treatment of migraine headache pain, research is limited on how patients suffering from migraine headache pain gain knowledge and access to CIM resources. Patients experiencing migraine headaches are most often first seen by their PCPs while 15% seek care from 5 CIM & MIGRAINES IN PRIMARY CARE either a headache specialist or a pain management specialist (Lipton, 2019). Since PCPs are the first point of care for many migraine patients, it is essential PCPs are knowledgeable of how CIM therapies may benefit their patients suffering from migraine headaches. Problem Statement CIM therapies cannot be effectively utilized if PCPs are unaware of such therapies to offer as management for migraine headache pain. This project intends to review PCP attitudes and their implementation of CIM techniques in order to recognize barriers to utilizing these treatments by asking if the PCPs of Ascension St. Vincent Indianapolis are referring their migraine patients to CIM therapies, and if not, what prohibits them from referring. Practice Gap Analysis According to a survey conducted by Malone and Tsai (2017), only 28% of providers were comfortable referring CIM therapies to their patients. A lack of knowledge and exposure to CIM therapies may play a direct role in a providers ability to refer their patients to CIM. This quality improvement project will ascertain the CIM referral practices of primary care providers caring for migraine headache patients in a facility in central Indiana, Ascension St. Vincent Indianapolis. Review of Literature Complementary and integrative medicine (CIM) is a collection of diverse practices and products that are outside the realm of conventional medicine (Wells et al., 2017). Complementary and integrative medicine is a multidimensional, multidisciplinary approach to health and wellness. CIM involves many aspects of life including social, 6 CIM & MIGRAINES IN PRIMARY CARE spiritual, behavioral, environmental, demographic, and cultural. Primary care management should be evidence based, but holistic in nature that incorporates both pharmacological and non-pharmacological treatment approaches (Mills, Torrance, & Smith, 2016; Stanos et al., 2016). The treatment of patients with pharmacological approaches often lead to poor analgesic responses, little functional improvements, and frustration for both the patient and provider (Stanos et al., 2016). The role of the PCP is to identify the barriers within this realm that may be hindering the patients health such as behavioral changes including nutritional, physical activity, exercise, sleep and stress management. It is also important for providers to teach patients that although they suffer from a neurological condition, it is multifactorial and stems from a biological foundation (Ring & Mahadevan, 2017). For patient suffering from migraines, effective CIM practices would include meditation, mindfulness based stress reduction (MBSR), acupuncture, and herbal supplements. Mindfulness Based Stress Reduction (MBSR) One of the most common triggers identified by migraine sufferers is stress. Complementary and integrative medicine methods are focused on targeting the cause of stress with teaching coping strategies to decrease the patients migraine frequency. To assist in combating stress, mind-body practices such as meditation, mindfulness-based stress reduction (MBSR), and cognitive behavioral therapy have been found to be beneficial for migraine sufferers. A systemic review of 16 randomized controlled trials (RCTs) and a single RCT assessing non-pharmacological self-management interventions in patients diagnosed with migraine or tension headaches, authors reported MBSR techniques to be more effective in improving pain intensity, headache related disability, quality of life and medication consumption. Similar results were found in a meta-analysis of 10 randomized controlled trials that compared mindfulness meditation effects on primary headache pain intensity and frequency (Probyn et al., 2017; Bakhshani, Amirani, Amirifard, & Shahrakipoor, 2015). 7 CIM & MIGRAINES IN PRIMARY CARE Acupuncture The American Headache Society (2019) does not recommend the use of opioids for migraine pain control. Instead, a wide variety of preventative and symptom management medications are available. For example, long- term use of non-steroidal anti-inflammatory drugs (NSAIDs) have been linked to causing hepatotoxicity and nephrotoxicity, sumatriptan can increase blood pressure and mental cloudiness, and betablockers can cause hypotension and increase the risk of bronchospasm. Therefore, many patients look to CIM treatments such as acupuncture for relief. Acupuncture is an ancient Chinese therapy based on the theory that disease is the result of energy imbalances throughout the body. The insertion of needles at acupoints, points along specific energy medians, allows the release of obstructed energy that brings the body back into balance (Patel et al, 2019). In a meta-analysis of 22 trial with 2985 patients determined that acupuncture lead to a 50% reduction in headache frequency in 41% of patients compared to no treatment and 57% compared to prophylactic medications (Patel & Minen, 2019). The authors suggest that acupuncture is as, if not more effective than prophylactic medications for migraine treatment. There were similar findings in another 4 RCTs and a systemic review of 14 RCTs with 1,155 participants showing that acupuncture had a significant reduction in migraine frequency and intensity (Bega, 2017; Wells, Baute, & Wahbeh, 2017; Millstine, Chen, & Bauer, 2017; Xu, Zhang, Pei, & Ji, 2018). Acupuncture was also deemed more tolerable compared to traditional pharmacological migraine treatments due to fewer side effects with only 6% after 24 acupuncture sessions compared to 66% with daily topiramate use. Unfortunately, many patients were deterred from further acupuncture treatments because most US insurance companies did not cover acupuncture treatments (Wells, Baute, & Wahbeh, 2017; Xu, Zhang, Pei, & Ji, 2018). Vitamins and Herbals 8 CIM & MIGRAINES IN PRIMARY CARE Despite the lack of adequate regulation by the U.S. Food and Drug Administration (FDA) in terms of their safety and efficacy, there has been in increase in the use of vitamins, minerals, and herbal preparations amongst migraine sufferers. A meta-analysis of 5 RCTs and 2 single RCTs, there was a significant 43% reduction in migraine attacks in participants with oral magnesium treatment (Patel & Minen, 2019; Bega, 2017; Millstine, Chen, & Bauer, 2017). In a meta-analysis of 11 RCTs and 2 individual RCTs showed a significant reduction in migraine attack frequencies and days after 400 mg daily use of riboflavin for 3 months of treatment compared to the placebo (Patel & Minen, 2019; Bega, 2017; Millstine, Chen & Bauer, 2017). CIM in Primary Care Approximately 50% of adults who suffer from neurological conditions such as migraines use CIM, however, many patients have not discussed their use of CIM therapies with their PCP (Wells, Baute, & Wahbeh, 2017). This highlights the importance of PCPs being knowledgeable concerning alternative therapies based on each patients individual needs. The goal of complementary and integrative medicine is to change the focus from illness and disease to health and healing by using lifestyle modification approaches (Ring & Mahadevan, 2017). PCPs are in a position where they have the ability to educate their patients about the use of integrative medicine and how it could be beneficial in providing patient-centered care. Unfortunately, there are barriers that prevent primary care professionals from discussing lifestyle changes and the potential CIM options with their patients. Conventional medical education does not adequately prepare providers to counsel patients about lifestyle modifications. Authors have indicated providers are not comfortable suggesting alternative therapies to patients. Furthermore, PCPs have expressed negative views concerning abilities to manage non-pharmacological aspects of care due to lack of time, reimbursement, knowledge and resources (Ring & Mahadevan, 2017). However, PCPs have the ability to incorporate complementary and integrative 9 CIM & MIGRAINES IN PRIMARY CARE medicine into their current practices through personal education, use of tools and resources, identifying local organizations and creating a relationship with CIM professionals. According to Starling and Dodick (2015), in the primary care setting, nonpharmacological treatments such as cognitive behavioral therapy and biofeedback should be offered to all patients under treatment for chronic migraines. These practices include meditative therapy, progressive muscle relaxation, guided imagery, exercise, and relaxation training. According to a survey conducted by Mills, Torrance & Smith (2017), 70% of patients with chronic pain had used complementary therapies and had higher patient satisfaction rating compared to conventional care. Practices such as mindfulness were also associated with an increase in patient centered care outcomes with a reduction in the utilization of healthcare services. Theoretical Framework/ Evidence Based Practice Model The theoretical concept of holism states, organic or unified wholes have value and being which is inherently different from, and cannot be reduced to the sum of their individual parts, (Michaelson et al, 2016). In other words, to fully understand complex systems, the components that make up the system cannot be isolated and analyzed individually. Instead, each component and their relationships with one another must be considered when analyzing a complex system. The foundation of holism is centered upon the awareness of relationships. In the healthcare model of holism, there are direct relationships between the tissues causing the symptoms, the symptoms themselves and the contributing factors that affect the person as a whole. The awareness of these relationships is what allows for the concept to be transformed into meaningful practice (Turner, 2017). This concept of holism can be applied to the healthcare setting and would 10 CIM & MIGRAINES IN PRIMARY CARE be essential for primary care providers in creating a treatment plan for patients suffering from migraine headaches. In patients suffering from chronic migraines, the patient cannot be analyzed and treated appropriately by only treating the symptoms. Within the realm of holistic care, providers must be aware of not just simply treating the pain, but also identifying the cause. The causality of migraine headaches is multifactorial with both biological and physiological processes involved. Due to the multifactorial nature of migraine headaches, it would be appropriate for providers to consider a multimodal treatment method based on combination of the patients triggers, symptoms and treatment goals. For example, providers should search for possible migraine triggers such as inadequate food intake, lack of sleep, dehydration or muscle tension; all of which would be appropriately treated with non-pharmacological methods such as cognitive behavioral therapy (CBT), mindfulness based stress-reduction (MBSR) or massage therapy. However, the referrals of these therapies are limited by the providers knowledge, experience and awareness of these non-pharmacological treatment options. Goals/ Outcomes The goal of this quality improvement (QI) project is to determine if PCPs are prescribing CIM therapies for migraine headache patients and if not, what obstacles are preventing a providers referral. The expected outcomes are an increased knowledge and improved acceptance towards prescribing CIM for migraine headache patients. It is the hope of this research project to improve the availability of complementary and integrative practices for patients suffering from migraines by increasing provider awareness of effectiveness of CIM treatments, increasing the number of providers who consider CIM practices, and providing solutions to obstacles providers face in referring CIM treatments. According to the National Health Interview conducted by the Center for Disease Control 11 CIM & MIGRAINES IN PRIMARY CARE and Prevention (CDC), CIM practices have been on the rise from 32% in 2002 to 33% in 2012 (Ring & Mahadevan, 2017). As CIM therapy rises in popularity, providers must be aware of the available treatments and local resources in order to adequately provide effective holistic care based on the treatment preferences of the patient. Methods Project Site and Population St. Vincent Indianapolis Hospital is one of the Ascension based facilities that strives towards excellence in both patient care and nursing practices through the use of evidence-based practices. The Ascension St. Vincent Indianapolis Hospital serves the Indianapolis metropolitan area by providing a variety of patient care services including a Level I Trauma Center, Stroke, and Cancer Care (About Ascension, 2021). St. Vincent Indianapolis was awarded Magnet accreditation by the American Nurses Credentialing Centers (ANCC) Magnet Recognition Program, for achieving the highest standards of excellence in nursing practice. St. Vincent Indianapolis was also the only Indiana hospital named a Leapfrog Group Top Hospital, the most competitive national hospital award in the country awarded to hospitals who excel in patient care, practices to promote patient safety and quality, and appropriately utilizing resources for patient care. The population of interest for this research study is the PCPs of Ascension St. Vincent Indianapolis. The PCP population educational backgrounds included medical doctor (MD), nurse practitioner (NP), physician assistant (PA), doctor of osteopathic medicine (DO), and medical resident. In order to reach a broader audience of varying years of experience, medical residents were also included in the providers of interest. Measurement Instruments A 10-question survey was used to assess providers demographics and impressions of CIM treatments for migraine patients (Appendix B). The 10-question 12 CIM & MIGRAINES IN PRIMARY CARE survey includes four demographic questions regarding age, gender, race and profession title. The questions do not ask for information pertaining to personal identifiers. There are three questions pertaining to the providers use and referral of CIM within their practices. The remaining seven questions involve the providers personal experiences and attitudes towards CIM such as previous knowledge, personal experiences, and attitudes towards its effectiveness. PCP response options were divided using a 4-point Likert scale (strongly disagree, disagree, agree, and strongly agree). Four of the nine questions pertaining to providers personal experiences were derived from a similar study conducted by BenArye, Frenkel, Klein and Scharf (2008) in Israel, which not only assessed the CIM perspectives of the providers, but also of the patients receiving the treatment (Appendix B). Ethics and Human Subject Permission The Institutional Review Board (IRB) of Marian University reviewed this quality improvement project and deemed exempt from the human subjects protection (Appendix C). The approval of the IRB of Ascension St. Vincent Indianapolis was also obtained prior to initiation of this project (Appendix D). Prior to participating in the survey, PCPs were provided with additional information including a section of informed consent (Appendix A). An informed consent and brief description of the purpose of the study along with the anonymous and voluntary nature of the study was provided. The survey was expected to take approximately five to ten minutes to complete. The email concluded with describing the goal of the research team in identifying potential limitations or discomforts for Ascension St. Vincent providers in referring their migraine patients to CIM practices. The contact information 13 CIM & MIGRAINES IN PRIMARY CARE of the primary researcher and St. Vincent Human Subject Internal Review Board was provided within the email to allow providers to express concerns or if a confidentiality breach may have occurred (Appendix A). Data Collection The online survey was created, distributed and analyzed using the research platform Research Electronic Data Capture (REDCap). REDCap is a secure, HIPPA compliant web-based application used for the creation and management of online databases and surveys. REDCap allows for validated data capturing, audit trails for monitoring the management and distribution of data; automated data downloads for statistical analysis and procedures for data incorporation and transferability to external sources (Harris et al, 2019). After its introduction in 2004 by Vanderbilt University, this research data platform has been utilized by over 3,000 organizations, including Ascension St. Vincent Indianapolis Data Governance. The use of this application was a requirement of the Ascension St. Vincent IRB for the collection and analysis of data regarding the responses of their primary care providers. After receiving IRB approval by Marian University and Ascension St. Vincent, an email was sent to the Ascension St. Vincent Indianapolis Clinical Research Scientist containing the informed consent and survey link attached. The Clinical Research Scientist forwarded the email to the Ascension St Vincent Indianapolis Hospital primary care resident physicians and providers to complete the survey. The survey data was only accessible to the primary researcher conducting the study through a private REDCap account. The primary researcher only had access to the survey data collected and was responsible for the receipt and transmission of the data. The survey data was not 14 CIM & MIGRAINES IN PRIMARY CARE disclosed to persons outside the Ascension St. Vincent Indianapolis network or the primary research team. The survey responses were stored within the REDCap online program and collected from September 29, 2021 to October 28, 2021. Data Analysis and Results The survey was distributed to 243 providers with 29 responses (n=29, 11.90%) received. The 29 survey responses submitted by Ascension St. Vincent PCPs were analyzed using REDCap software. A statistical analysis was performed using a Fishers exact test to determine statistical significance between the providers demographics (age, gender, race and professional title) with the providers overall perception of CIM practices. Demographics Based on the 29 provider responses, the median age of the participants was 42 years old (SD 8.95). The gender make-up of the participant sample was primarily female (n= 23, 79.3%) with 6 males (n=6, 20.7%). The majority of the participants were Caucasian (n=25, 86.2%) with 4 participants (n=4, 13.8%) identified as either African American (n=1, 3.4%), Asian (n=2, 6.9%, or Hispanic (n=1, 3.4%). These statistics were determined using a 4-point Likert scale. The professional backgrounds of the 29 providers showed a majority were NPs (n=15, 51.7%) and MDs (n=10, 34.%), while the remaining consisted of a PA (n=1, 3.4%) and 3 DOs (n=3, 10.3%) (Table 1). Table 1: Demographic Distribution What is your gender? Male Female n 6 23 % 20.7 79.3 Total 29 100.0 15 CIM & MIGRAINES IN PRIMARY CARE What is your race? Caucasian African American Asian Hispanic Total n 25 % 86.2 1 3.4 2 1 6.9 3.4 29 100.0 What is your professional background? MD NP PA DO n 10 15 1 3 % 34.5 51.7 3.4 10.3 Total 29 100.0 Gender Cross-Tabulation For the gender examination, each survey question was analyzed comparing the distribution of responses for each question among males and females (Table 2). A Fishers exact test was used instead of a Pearson Chi-Square test because the sample size and distribution of responses violated the assumptions of the Pearson Chi-Square test. Specifically, more than 20% of the cells in the matrix had counts less than five. There was a statistically significant difference in the distribution of responses amongst males and females for multiple questions. In question two, which examined providers comfort referring CIM for migraine patients, there was a statistical significance (p=0.01) in which males (n=5, 83.3%) were more comfortable referring CIM for a migraine patient with only 26.1% of women (n=6) feeling comfortable as well. However, 73.9% of women (n=17) disagreed stating they were not comfortable referring CIM for a migraine patient. In question three, there was a statistical significance (p=0.03) in which a majority of both males (n=4, 66.7%) and females (n=19, 82.6%) disagreed felt unaware of the CIM practices available for migraine patients within their areas. 16 CIM & MIGRAINES IN PRIMARY CARE Interestingly, in question four, regarding providers receiving education about CIM in school, a statistical significance (p=0.03) was made for which no male respondents reported receiving education about CIM in school with 100% of males (n=6) strongly disagreeing and disagreeing with the statement. However, a majority of females (n=14, 60.8%) reported receiving education about CIM in school with 39.1% of women (n=9) having no previous education. Finally, there was another statistical significance (p=0.04) in question 10, where females (n=19, 82.6%) had a higher proportion of disagreeing with the idea that CIM is dangerous compared to males (n=2, 3.3%). In terms of believing CIM is dangerous, 33.5% of males (n=2) and 8.7% of women (n=2) would agree with that statement. Table 2: Gender Cross-Tabulation 17 CIM & MIGRAINES IN PRIMARY CARE Profession Due to the high quantity of MD and NP responses, a comparison of these providers answers were made (Table 3). For this analysis, due to similarities in practice, the NP and PA responses were combined. In comparing professional background of MDs and NPs plus PAs, there were no statistically significant differences for questions one and two; however, a statistically significant finding was made in question three. When analyzing the responses of MDs and NPs plus PAs in their response to awareness of CIM treatments in their area, there was a statistical significance (p=0.02), however, the difference was between the answers strongly disagree and disagree. Therefore, this difference was deemed insignificant. There were also no statistically significant findings in questions four through ten. Table 3: Profession Cross-Tabulation 18 CIM & MIGRAINES IN PRIMARY CARE Overall Survey Results Using a 4-point Likert scale (strongly disagree, disagree, agree and strongly agree), the 29 providers were able to answer the 10 survey questions pertaining to CIM, their personal views, and current practices in regards to CIM for migraine patients (Table 4). Overall, most providers (n=15, 51.7%) have not referred a CIM practice to a migraine patient within the last month. Of the 29 providers; 18 (62.0%) either disagreed or strongly disagreed with being comfortable with referring CIM to a migraine patient and 23 (79.2%) disagreed with being aware of practices within their area that offer CIM treatments. Interestingly, 13 providers (44.8%) agreed with receiving education about CIM where as 7 providers (24.1%) strongly disagreed and 8 providers (27.6 %) disagreed with receiving education about CIM in school. In terms of knowledge, 12 providers (41.4%) disagreed with feeling knowledgeable about CIM while 11 (37.9%) agreed with feeling knowledgeable. When asked if CIM should only be used for minor ailments, 51.7% (n=15) would disagree and 48.3% (n=14) would agree. Despite the previous responses: 28 (96.6%) respondents either agreed or strongly agreed that there are some cases where CIM would be more appropriate than prescription medication, 21 respondents (72.4%) agreed that CIM could produce longer lasting and more complete clinical results than conventional medicine, and 25 (86.2%) respondents either disagreed or strongly disagreed with the notion that CIM is dangerous in that it may prevent patients from getting proper treatment. Interestingly, 62% (n=18) of participants would agree that CIM should be subject to more scientific testing before being accepted by conventional providers. 19 CIM & MIGRAINES IN PRIMARY CARE Table 4: 4- point Likert Scale Distributions: Survey Results Discussion This quality improvement study surveyed the CIM knowledge, use, and perception of Ascension St. Vincent Indianapolis primary care providers for patients suffering from migraine headaches. This research seeks to identify if PCPs are referring CIM for their migraine patients, and if not, what are the obstacles that prohibit that referral. There were multiple significant findings made based on the survey results along with similar findings of previous published studies relating to CIM, which add further validity to the results of this study. 20 CIM & MIGRAINES IN PRIMARY CARE One of the most significant findings identified was that lack of education of PCPs directly impacts their referrals for CIM treatments. According to this study, only 48.2% of providers (n=14) had received education about CIM in school. This concept was further confirmed by a majority of providers (n=17, 58.6%) stating they did not feel knowledgeable about CIM practices. These two findings directly contributed to the 93.1% of providers (n=27) denying a CIM referral within the past month and 62.0% of providers (n=18) stating they are uncomfortable with referring CIM to a migraine patient. The providers lack of knowledge of CIM practices was a predicted finding and has been cited by previous studies as an obstacle prohibiting the acceptance of CIM practices by traditional western medicine. Approximately only 25% of American medical students and resident have received education about CIM as part of their medical training. Although CIM has not been included in the traditional medical training, many schools have made adjustments to their educational curriculum to incorporate classes dedicated to CIM (Ng & Hanna, 2021; Winter & Korzenik, 2017). This lack of education and knowledge of CIM therapies also directly contributes to providers being uncomfortable with referring CIM. Our study concluded that not only are PCPs not educated about CIM, but also a majority of providers have: not referred CIM in the past month (n=27, 93.1%), are uncomfortable referring CIM (n=18, 62.0%), and are unaware of CIM therapies available in their areas (n=23, 79.3%). When comparing the providers genders and CIM practices, none of male providers (n=5) had received education about CIM in school, and yet 83.3% of the male providers stated they were comfortable referring CIM. On the other hand, a majority of female providers (n=14, 60.8%) stated they had received prior education about CIM in 21 CIM & MIGRAINES IN PRIMARY CARE school and majority disagreed with the idea with CIM being dangerous (n=21, 91.3%), but still felt uncomfortable referring patients to CIM and were unaware of practices in their area. This finding suggests that despite providers receiving education about CIM in school, they remain uncomfortable with referring CIM for their migraine patients. Based on this discovery, the educational portion of CIM within medical practice comes into question. At the foundation of western medical practice is the theoretical framework of biomedicine. In biomedicine, there are the definitions of disease and illness. The term disease refers to the physiological manifestations of a condition while the term illness refers to the patients subjective experiences. According to Kroll (2021), practitioners of biomedicine focus on identifying and treating the disease entity while considering the patients symptoms instead of a more holistic approach of analyzing the physiological and subjective manifestations collectively. As a result, the adherence to the biomedical model directly inhibits clinicians from broadening their scope of practice diagnostically. Comparatively, CIM focuses on a holistic approach of treating the person as a whole through assessing multiple interconnected domains including biological, social, behavioral and environmental, rather than simply treating the disease (U.S. Department of Health and Human Services, 2021). These differences in philosophies create further difficulties for practitioners of biomedicine in understanding and referring their patients to CIM. Therefore, it is even more essential that providers receive adequate and thorough education in school about CIM therapies and their effectiveness towards a specific disease and illness. 22 CIM & MIGRAINES IN PRIMARY CARE Despite a lack of education and knowledge of CIM therapies, a majority of providers felt that CIM was not dangerous (n=25, 86.2%), CIM may be more appropriate in certain cases compared to a prescription (n=29, 96.6%) and can produce longer lasting results than conventional medicine (n=21, 72.4%). However, half of the providers believe CIM should only be used for minor ailments (n=13, 44.8%). It can be concluded from these statistics that with the education provided in school and personal knowledge, providers are aware of the advantages of providing CIM therapies. Another noteworthy discovery of this study was that a majority of providers believe CIM should be subject to more scientific testing (n=18, 62.0%). The skepticism for many providers in regards to CIM therapies is due to the perception there is a lack of adequate data. In 2019, the World Health Organization (WHO) identified a lack of research data as a significant hurdle in the advancing towards integrating CIM practices into our current health systems. Along with the limited data, the data supporting CIM practices came from small or uncontrolled studies. Another area of uncertainty for providers is the lack of a standardized regulating body, which directly contributes to the difficulties of conducting a large study. For example, the FDA does not regulate the vitamins and herbs frequently used in CIM treatments and as a result, their ingredients and efficacy are put into question (Schveitzer et al, 2021; Ng & Hanna, 2021). Therefore, it can be concluded that the lack of PCP referrals for CIM therapies are multifactorial in nature and cannot be directly contributed to lack of knowledge or lack of evidence based practices alone. Limitations 23 CIM & MIGRAINES IN PRIMARY CARE There were several limitations of this study. The timeframe within which this study was conducted was less than a month in duration. The duration of availability of the survey to providers was based upon the submission date the project. This short timeframe also limited the amount of time providers had to complete the survey and contributed to the low completion rate of 11.90%. Another limitation of this study was that providers at a single institution, Ascension St. Vincent Indianapolis, which also may have directly contributed to the low completion rate, completed the survey. Although this study can definitively say these findings are based on views of PCPs within Ascension St. Vincent Indianapolis, this limited the point of view of the providers in question. In future studies, a broader range of providers should be used to include all PCPs within the Ascension St. Vincent network of Indiana. One aspect of the study that may have yielded more efficient results would have been to alter the survey questions. The questions used focused on providers education and comfort with referring CIM, however, questions regarding specific treatments such as acupuncture, MBSR and herbal remedies may have provided more beneficial results. If the questions including specific remedies, it could have been determined whether one specific therapy or all CIM therapies caused providers confusion and discomfort. Conclusion With an increase in public awareness of CIM practices, PCPs should be knowledgeable of the available CIM therapies, supporting research, and accessible local resources. It was hypothesized that the survey results would indicate that Ascension St. Vincent PCPs are not knowledgeable or comfortable referring migraine sufferers to CIM therapies regardless of age, gender, race or area of practice. In literature, as well as this 24 CIM & MIGRAINES IN PRIMARY CARE doctorate project, it has been confirmed and demonstrated that there is a distinct lack of Ascension St. Vincent PCP education, knowledge, and comfort towards CIM therapies for their migraine patients. As a result, these effective treatment options are not offered by providers or made available to those patients to whom it may benefit; in this case migraine headache patients. In order to increase provider knowledge and comfort with CIM therapies, it is proposed by this research committee that Ascension St. Vincent Indianapolis to encourage their providers to expand upon their knowledge of CIM therapies by completing educational modules through web based trainings (WBTs). The project aimed to expand Ascension St. Vincent providers awareness of the effectiveness of CIM therapies in the hope that these treatments will be considered by PCPs for their future patients suffering from migraine headaches. This project determined there is a lack of knowledge of CIM treatments for migraine headache suffers by the providers of Ascension St. Vincent Indianapolis. It is the hope of this research committee that future projects will build upon this finding and strive to identify how to provide providers with adequate education of CIM therapies for migraine patients. 25 CIM & MIGRAINES IN PRIMARY CARE References Ascension. (2021). About our healthcare organization. https://www.ascension.org/About?_ga=2.253874440.1051650900.15971705771167715643.1597170577. Bakhshani, N. M., Amirani, A., Amirifard, H., & Shahrakipoor, M. (2015). The effectiveness of mindfulness-based stress reduction on perceived pain intensity and quality of life in patients with chronic headache. Global Journal of Health Science, 8(4), 142151. https://doi:10.5539/gjhs.v8n4p142 Bega, D. (2017). Complementary and integrative interventions for chronic neurologic conditions encountered in the primary care office. Primary Care Clinics in Office Practice, 44(2), 305322. https://doi.org/10.1016/j.pop.2017.02.004 Ben-Arye, E., Frenkel, M., Klein, A., & Scharf, M. (2008). Attitudes toward integration of complementary and alternative medicine in primary care: Perspectives of patients, physicians and complementary practitioners. Patient education and counseling, 70(3), 395402. https://doi.org/10.1016/j.pec.2007.11.019 Berretta, M., Rinaldi, L., Taibi, R., Tralongo, P., Fulvi, A., Montesarchio, V., Madeddu, G., Magistri, P., Bimonte, S., Trov, M., Gnagnarella, P., Cuomo, A., Cascella, M., Lleshi, A., Nasti, G., Facchini, S., Fiorica, F., Di Francia, R., Nunnari, G., Pellican, G. F., Facchini, G. (2020). Physician attitudes and perceptions of complementary and alternative medicine (CAM): A multicentre Italian study. Frontiers in oncology, 10, 594. https://doi.org/10.3389/fonc.2020.00594 26 CIM & MIGRAINES IN PRIMARY CARE Cour, P. L., & Petersen, M. (2015). Effects of mindfulness meditation on chronic pain: A randomized controlled trial. Pain Medicine, 16(4), 641652. http://doi: 10.1111/pme.12605 Kroll C. (2021). Questioning biomedicine's privileging of disease and measurability. AMA Journal of Ethics, 23(7), E537E541. https://doi.org/10.1001/amajethics.2021.537 Lai, H. C., Lin, Y. W., & Hsieh, C. L. (2019). Acupuncture-analgesia-mediated alleviation of central sensitization. Evidence-based complementary and alternative medicine : eCAM, 2019, 6173412. https://doi.org/10.1155/2019/6173412 Malone, M., & Tsai, G. (2017). Do practicing primary care physicians believe more complementary and alternative medicine (CAM) training in medical school and residency would have been useful in their current practice? Health Education and Care, 2(1). http://doi:10.15761/hec.1000116 Michaelson, V., Pickett, W., King, N., & Davison, C. (2016). Testing the theory of holism: A study of family systems and adolescent health. Preventive medicine reports, 4, 313319. https://doi.org/10.1016/j.pmedr.2016.07.002 Mills, S., Torrance, N., & Smith, B. H. (2016). Identification and management of chronic pain in primary care: A review. Current psychiatry reports, 18(2), 22. https://doi.org/10.1007/s11920-015-0659-9nat Millstine, D., Chen, C. Y., & Bauer, B. (2017). Complementary and integrative medicine in the management of headache. British Medical Journal (Clinical research ed), 357, j1805. 27 CIM & MIGRAINES IN PRIMARY CARE Ng, J. Y., & Hanna, C. (2021). Headache and migraine clinical practice guidelines: a systematic review and assessment of complementary and alternative medicine recommendations. BMC complementary medicine and therapies, 21(1), 236. https://doi.org/10.1186/s12906-021-03401-3 Patel, P. S., & Minen, M. T. (2019). Complementary and integrative health treatments for migraine. Journal of neuro-ophthalmology. 39(3), 360369. https://doi.org/10.1097/WNO.0000000000000841 Probyn, K., Bowers, H., Mistry, D., Caldwell, F., Underwood, M., Patel, S., Sandhu, H. K., Matharu, M., Pincus, T., & CHESS team. (2017). Non-pharmacological selfmanagement for people living with migraine or tension-type headache: a systematic review including analysis of intervention components. British Medical Journal, 7(8), e016670. https://doi.org/10.1136/bmjopen-2017-016670 Ring, M., & Mahadevan, R. (2017). Introduction to integrative medicine in the primary care setting. Primary Care, 44(2), 203215. https://doi.org/10.1016/j.pop.2017.02.006 Schveitzer, M. C., Abdala, C., Portella, C., & Ghelman, R. (2021). Traditional, complementary, and integrative medicine evidence map: A methodology to an overflowing field of data and noise. Revista panamericana de salud publica = Pan American journal of public health, 45, e48. https://doi.org/10.26633/RPSP.2021.48 Stanos, S., Brodsky, M., Argoff, C., Clauw, D. J., D'Arcy, Y., Donevan, S., Gebke, K. B., Jensen, M. P., Lewis Clark, E., McCarberg, B., Park, P. W., Turk, D. C., & Watt, S. (2016). Rethinking chronic pain in a primary care setting. Postgraduate Medicine, 128(5), 502515. https://doi.org/10.1080/00325481.2016.1188319 28 CIM & MIGRAINES IN PRIMARY CARE Turner, P. (2017). A theoretical framework of holism in healthcare. Insights in Biomedicine, 02(02), 14. https://doi.org/10.21767/2572-5610.10019 U.S. Department of Health and Human Services. (2021). Complementary, alternative, or integrative health: What's in a name? National Center for Complementary and Integrative Health. https://www.nccih.nih.gov/health/complementary-alternative-orintegrative-health-whats-in-a-name. Wells, R. E., Baute, V., & Wahbeh, H. (2017). Complementary and integrative medicine for neurologic conditions. The Medical Clinics of North America, 101(5), 881893. https://doi.org/10.1016/j.mcna.2017.04.006 Winter, R. W., & Korzenik, J. R. (2017). The practical pros and cons of complementary and alternative medicine in practice: Integrating complementary and alternative medicine into clinical care. Gastroenterology clinics of North America, 46(4), 907916. https://doi.org/10.1016/j.gtc.2017.08.013 Xu, J., Zhang, F. Q., Pei, J., & Ji, J. (2018). Acupuncture for migraine without aura: a systematic review and meta-analysis. Journal of integrative medicine, 16(5), 312 321. https://doi.org/10.1016/j.joim.2018.06.002 29 CIM & MIGRAINES IN PRIMARY CARE Appendix A Hello and thank you in advance for your potential participation. The purpose of this research survey is to explore the current practices of Ascension St. Vincent primary care providers in relation to complementary and integrative practices (CIM) for migraine treatment. The survey will be asking for some personally identifiable information, but we also want you to know that we will make every effort to keep your information confidential. The results of the survey will inform researchers of potential limitations and discomforts for Ascension St. Vincent providers in terms of referring CIM practices for patients suffering from migraine headaches. Participation in this survey is voluntary and completing the survey designates your consent to participate in this research study. It should take you approximately 5 minutes to complete this survey. Your healthcare and employment status will not be altered in any way by choosing not to participate. If you would like to discuss aspects of this study at a later time, feel free to contact Jacqueline Thompson BSN, RN at 317-3704629 or by email at jthompson535@marian.edu. If you have complaints, concerns, or believe you may have had your privacy violated related to this research, you may also contact an advocate at the Ascension St. Vincent Human Subjects Internal Review Board by calling (371) 338-2194. REDCap Link: https://redcap.ascension.org/inind/surveys/?s=FYN9LDWXDJLEYA74 30 CIM & MIGRAINES IN PRIMARY CARE Appendix B 1. Age (years): _______ 2. Gender a. Male b. Female 3. Race a. Caucasian b. African American c. Asian d. Hispanic e. Other 4. Profession a. MD b. NP c. PA d. DO e. Resident 5. I have referred a CIM practice to a migraine patient within the past month. a. Strongly disagree b. Disagree c. Agree d. Strongly agree 6. I am comfortable referring CIM for a migraine patient. a. Strongly disagree b. Disagree c. Agree d. Strongly agree 7. I am aware of the practices within my area that offer CIM treatments. a. Strongly disagree b. Disagree c. Agree d. Strongly agree 8. I received education about CIM in school. a. Strongly disagree b. Disagree c. Agree d. Strongly agree 9. I believe I am knowledgeable about CIM practices. a. Strongly disagree b. Disagree c. Agree d. Strongly agree 10. There are some cases where CIM would be more appropriate than prescription medications. a. Strongly disagree 31 CIM & MIGRAINES IN PRIMARY CARE b. Disagree c. Agree d. Strongly agree 11. *CIM should only be used for minor ailments and not in the treatment of more serious illness. a. Strongly disagree b. Disagree c. Agree d. Strongly agree 12. *CIM can produce longer lasting and more complete clinical results than conventional medicine a. Strongly disagree b. Disagree c. Agree d. Strongly agree 13. *CIM should be subject to more scientific testing before they can be accepted by conventional providers. a. Strongly disagree b. Disagree c. Agree d. Strongly agree 14. *CIM is dangerous in that it may prevent patients from getting proper treatment. a. Strongly disagree b. Disagree c. Agree d. Strongly agree * Derived from Ben-Arye et al (2008). 32 CIM & MIGRAINES IN PRIMARY CARE Appendix C 33 CIM & MIGRAINES IN PRIMARY CARE Appendix D 34  ...

... HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 1 How Does the Utilization of Non-pharmacologic Pain Management Techniques Affect Pain Outcomes and Long-term Memories in Young Children During Painful Procedures? Sheryl Graybill Marian University Department of Graduate Studies HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 2 Abstract Background: A childs pain is different from pain experienced as adults. Different emotional and psychological factors can affect the childs pain comprehension and stimulate their response to pain. Procedural pain can have long-term negative effects on children. It may cause increased pain sensitivity, fear, and avoidance of healthcare as adults. Parents may also experience anxiety during their childs procedure, which may increase their childs perceived pain. Problem: This DNP project aimed to implement and evaluate the usage of the Buzzy device during painful procedures of children ages three through six years at this pediatric hospital. Distraction can be used to decrease pain perceptions in children and parents, which could positively affect long-term memories. Interventions: The nurses utilized Buzzy with children aged three to six years of age needing venipuncture. Staff provided a pain survey to each patient who received Buzzy before and during a painful procedure. Parents were contacted at 2 weeks and 1-month post-procedure to assess pain perceptions. Results: Ninety-six patients participated in the study. An 84.6% response rate was acquired from the surveys. Ninety-seven percent of parents and patients surveyed reported decreased pain with venipuncture using Buzzy. Pain perceptions decreased with the use of Buzzy both short-term and long-term. Conclusion: The positive response from patients and parents demonstrates Buzzy may be used to decrease pain perceptions in children and families. The success rate shown in this study will aid in distraction techniques used as pain management to be added to evidence-based practice in the future. Keywords: distraction techniques, pediatric pain, Buzzy, pain perceptions, vibration HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN Table of Contents Introduction.4 Background5 Pain Perception5 Cost Analysis..9 Problem Statement10 Search Methodology..12 Literature Review..13 Theoretical Framework.17 Gap Analysis.19 Goals, Objectives, and Expected Outcomes.21 Project Design...21 Measurement Instruments.23 Data Collection.25 Data Analysis27 Results...29 Strengths and Limitations..33 Conclusion..34 References..35 Appendices.43 3 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 4 How Does the Utilization of Non-pharmacologic Pain Management Techniques Affect Pain Outcomes and Long-term Memories in Young Children During Painful Procedures? Introduction Children do not experience pain in the same way as adults. Children have fewer coping skills and can exhibit a more significant emotional and behavioral response to perceived pain experiences(Bahorski et al., 2015). Some professionals have misconstrued how young children perceive pain. They have theorized that children have an underdeveloped nervous system that does not allow them to feel pain. Other misconceptions include that children can not remember painful experiences and assess their pain level (Bahorski et al., 2015). Assessing pain levels in children can be omitted during venipuncture because of difficulties associated with the assessment. The developmental and age level also makes a difference in how children perceive pain (Bahorski et al., 2015). Children often remember the pain associated with venipuncture as a negative experience. Procedural pain is preventable but tends to be dismissed by healthcare practitioners(Bahorski et al., 2015). Failure to provide pain management can have adverse psychological and physical effects. Adverse effects can include a fear of doctors, lack of trust and can instill negative long-term memories (Taddio et al., 2010). Psychological and emotional distress, the development of needle phobia that extends into adulthood, and healthcare avoidance are a few fine examples of the adverse effects of pain during venipuncture(Taddio et al., 2010). According to Taddio, 25% of adults have a needle phobia that began in childhood, and approximately 10% of the population decline needle-sticks due to their intense fear of needles (Taddio et al., 2010). HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 5 Advanced practice providers have the responsibility of assessing and minimizing pain during procedures. Techniques, such as cold or vibration in the toddler population, decrease perceptions of pain. In addition, distraction techniques help toddlers retain positive long-term memories and instill trust with healthcare professionals (Taddio et al., 2010). Background Children often state that getting blood drawn is an excruciating and scary procedure. An apprehension of needles does not disappear after childhood. Many adults also have an extreme fear of needles ((McMurtry et al., 2015)). The inability to forget negative thoughts, images, or memories is difficult for some individuals and can be a source of psychological distress. These fears can develop into a phobia where all procedures are feared. Forgetting is not always a cognitive failure but a means of coping with negative experiences (Marche et al., 2015). Thus, our ability to control what we remember, and what we forget, is likely important for a persons emotional well-being (Marche et al., 2015). Memories of painful experiences can have a profound impact on subsequent anxiety and pain coping behavior (Marche et al., 2015). Negative memories can increase childrens distress and anxiety concerning upcoming medical procedures, lead to negative attitudes about and avoidance of necessary medical care, initiate chronic pain syndromes and facilitate the persistence of pain conditions into adulthood (McMurtry et al., 2015). These fears can develop into a phobia where all procedures are feared (Marche et al., 2015). Evidence-based pain management strategies implemented during venipuncture could have decreased fear and anxiety levels. If children receive several repetitive painful procedures in childhood, a greater risk of extreme needle fear is probable (McMurtry et al.,2015). A bad experience involving a needle can become embedded in a child's brain and stored as a negative HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 6 long-term memory (McMurtry et al.,2015). Negative memories of pain can be as problematic in their impact on health and suffering as the actual pain experience (Marche et al., 2015). Pain Perception The International Study for the Association of Pain (IASP) defines pain as " an unpleasant sensory and emotional experience associated with or resembling that associated with, actual or potential tissue damage" (Breivik, 2002). Patients learn pain concepts from their personal experiences. Pain from physical, psychological, and spiritual factors affect perceptions (Breivik, 2002). Perceptions of pain could be decreased with improved pain management. Children under 3 years of age cannot adequately verbalize about intensity, location, and characteristics of pain they experience. Toddlers are in the preoperational stage of thinking. They understand that pain is hurt. They do not relate pain to illness. Toddlers may feel pain as a punishment for bad behavior (Garra et al., 2010; Marwaha, 2017). The fear factor is a large contributor to the experience of pain in toddlers. Toddlers may become very quiet and inactive while in pain or may become very active (Mills, 2016). Interpreting toddlers behavior may be difficult due to exacerbating factors such as separation anxiety, and the memory of previous painful experiences. Sometimes toddlers manifest their pain and fear through aggressive outbursts (Mills, 2016). Anticipatory fear becomes evident about six to twelve months of age. The central nervous system develops which increases the cognitive capacity allowing a memory of injections which causes an anticipatory response. Anticipatory responses cause fear of pain (Mills, 2016). An increase in motor control as myelination of motor nerves progresses as children age. Pain levels increase as motor control develops in children (Mills, 2016). Imaging studies report higher metabolic activity and functional connectivity in the thalamus and sensory HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 7 cortices for patients experiencing episodic pain (Victoria & Murphy, 2016) The enhanced integration of sensory information caused a decreased behavioral response to acute noxious stimuli but heightened withdrawal responses to pain from consecutive needle-sticks (Victoria & Murphy, 2016). One study on pain in infants found they have short-term pain associated with needle-sticks. The study also stated that memories of previous pain are apparent by six months of age (Mills, 2016). There are long-term effects caused by pain experienced in childhood. Needles are routinely given from the first year of life, particularly for vaccinations. Current recommendations state that healthy children receive 20 to 30 immunizations before the age of 18 years (Birnie et al., 2018). For children with acute or chronic illnesses, needle procedures are even more frequent for the assessment and management of their conditions and are reported as the most distressing part of treatment (Birnie et al., 2018). Failure to adequately manage pain and distress during needle procedures can lead to the development of significant needle fears, which often begin in early to middle childhood and persist into adulthood (McMurtry et al., 2015). Fear of needles can also contribute to vaccine hesitancy and medical nonadherence (Taddio et al., 2010) Unalleviated pain in early developmental results in reductions in autonomic and hormonal responses to pain and stress that persist into adolescence and adulthood (Victoria & Murphy, 2016). Experiences of pain in early life increase general pain thresholds to acute stimuli but exaggerate responses to severe and persistent noxious stimuli (Victoria & Murphy, 2016). Early life pain also results in long-term changes in stress. In response to procedural pain, heart rate and cortisol levels of infants are high but become blunted as the number of skin-breaking procedures increases (Victoria & Murphy, 2016). Early life pain reprograms the hypothalamic-pituitaryadrenal axis, putting preterm infants at higher risk for developing maladaptive responses to HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 8 anxiety- and stress-provoking stimuli. (Victoria & Murphy, 2016). If pain is not addressed and treated early on, it can greatly impact a childs quality of life by interfering with mood, appetite, school attendance, academic performance, and participation in sports and other extracurricular. extracurricular activities. Unrelieved childhood pain can enhance a childs vulnerability to pain later in life (Victoria & Murphy, 2016). Pediatric pain is also associated with increased risk for physical and psychological symptoms such as fatigue, sleep disorders, depression, and anxiety (Groenewald et al., 2015). Children experience pain result from painful invasive procedures such as venipuncture. Unrelieved pain may cause complications of disease and slowness in recovery. The psychological signs of pain during venipuncture were anxiety, stretching muscles, weeping, screaming, crying, biting on lips, and refusal. (Inan & Inal, 2019) Children using distraction techniques displayed physiological responses of deceased pulse rate decreased respiratory rate, and a reduction in body temperature (Inan & Inal, 2019). Exposure to pain in young children without adequate pain management has negative long-term consequences, including increased morbidity and mortality (Friedrichsdorf & Goubert, 2020). Repeated exposures to pain in children are associated with reduced cognition and motor function (Friedrichsdorf & Goubert, 2020). Previous studies have shown that exposure to pain early in life even heightens the risk for developing chronic pain, anxiety, and depressive disorders in adulthood. Therefore, adequate management of child pain is imperative to maintain a high quality of life throughout the lifespan (Ramira et al., 2016). Providers should include onset, duration, severity, and location of pain in every assessment (Ramira et al, 2016). The prevalence of pain can be as high as 95% in the toddler population (Grout et al., 2018). All patients have a right to pain management regardless of their HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 9 age. Pain responses can have long-term effects on perception, coping, and anxiety in children. Effective pain management reduces stress, decreases hospital costs, and increases self-esteem in the pediatric population (Grout et al., 2018). Toddlers are at risk for inadequate pain management due to their lack of communication and coping skills. Pain needs to be managed appropriately in pediatrics to improve perceptions that affect their quality of life as an adult. Cost Analysis The costs for this project were minimal in comparison to the savings that could occur. Distraction techniques have been shown to decrease procedural time and shorten hospital stays (Bahorski et al., 2015).Distractions are interventions that require little time in the hospital setting, can be integrated into the daily workflow, and have positive implications for health outcomes when applied to a broader perspective (Bahorski et al., 2015) Pediatric pain-related conditions were associated with $11.8 billion in total incremental health care expenditures (Groenewald et al., 2015). Prior studies suggest that pediatric pain prolongs inpatient stay and increases costs (Tumin et al., 2018). There is evidence to suggest that parental coping is associated with child distress, which highlights the need for interventions that have the potential to decrease parental and patient distress (Tumin et al., 2018). Interventions that are cost-effective and sustainable are most appealing in the current healthcare environment. Gaining the cooperation of the child and family is essential for a successful interaction that encompasses the child and family and considers the child's age, developmental level, cognitive and communication skills, and culture (Tumin et al., 2018). Using distraction can reduce the time and staff members needed for a procedure and can save costs. Distraction techniques may decease or avoid the use of opioids or anxiolytics, decrease recovery time, and adverse events (Victoria & Murphy, 2016). Distraction techniques used to decrease procedural HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 10 pain management in children are cost-effective, easy to use, and have no side effects (Erdogan & Aytekin Ozdemir, 2021). An overall decrease in needle-related phobias may contribute to improved compliance with preventative care as the patient ages, leading to a decrease in future disease, positively impacting families, employers, insurance companies, local hospitals, and the community at large Problem Statement Currently, pediatric units in the Midwest have no cold and vibration pain management protocols. The purpose of this project is to create the initial steps to develop a pain management protocol with toddler venipunctures by assessing patient and parent perception of Buzzy effectiveness for children three to six years of age. There is evidence that negative experiences related to pain in children can harm future healthcare experiences (Olsen & Weinberg, 2017). Toddlers have the right to pain management before, during, and after any painful procedure (Olsen & Weinberg, 2017). Pharmacological and non-pharmacological interventions are available to aid in pain management (Olsen & Weinberg, 2017). There are distraction techniques and tools available to use with young children undergoing venipuncture. The utilization of distraction techniques used during painful procedures will provide valuable data in this study. These improvements should promote self-esteem and positive long-term memories in toddlers (Dastgheyb et al., 2018). There is a Child Life Specialist assigned to each unit. These specialists exist to mentor staff and patients on distraction techniques. There is no current protocol for using cold or vibration during venipuncture on every patient. Long-term memories and pain perception could be improved while using cold and vibration. These improvements should promote selfesteem and positive long-term memories for this age group (Dastgheyb et al., 2018). HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 11 A stakeholder is an individual or group that is affected by a project or can influence implementation and long-term sustainability of a project (Hussain et al., 2018). Key stakeholders in this project include patients, parents, nurses, child life specialists, and providers. Patients are stakeholders because their life will be affected by the healthcare decisions that are made. Distraction techniques reduce pain, decrease cost, and increase patient satisfaction and pain perceptions. Pain that is controlled in childhood improves pain perceptions and health outcomes through adulthood. Parents act as advocates for their children. They have a legal right to participate in decisionmaking about their child's health care to ensure that health care is provided to meet the familys needs and preferences. Parents should be involved in all healthcare decisions made for their children. Parents should have the opportunity to improve their personal control over their child's health care and their own life circumstances (Aarthun et al., 2018) A parents active involvement in medical decision-making and provision of sufficient and consistent information empowered the parents to increase their active involvement in decisions about their childs medical care. A parents' ability to cope with the parental role in the hospital appeared to be strengthened by promoting their perception of life as meaningful, comprehensible, and manageable (Aarthun et al., 2018). Nurses are stakeholders because they are the primary advocates for patients and their families. Nurses are internal stakeholders responsible for ensuring high-quality patient care. Nurses function by translating evidence into practice while caring for patients (Kallio et al., 2018). Child life specialists are stakeholders because their expertise is in distraction techniques to decrease pain in children. Child life specialists focus on the optimal development and well-being of infants, children, adolescents, and young adults while promoting coping skills and minimizing the adverse effects of hospitalization, health care encounters, and other potentially stressful experiences (Romito et al., HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 12 2020). Physicians act as stakeholders by serving as facilitators of shared decision-making. Patients benefited from shared decision-making in terms of patient satisfaction and engagement. Research outcomes that would encourage the use of shared decision-making include patient engagement, mitigation of risk, and patient satisfaction (Schoenfeld et al., 2016). Stakeholders play a major role in ensuring the successful adoption of evidence in healthcare. Their support is necessary because they provide the resources, skills, and knowledge required for positive patient outcomes. Potential benefits for stakeholders included increased improvement in satisfaction and health outcomes, decreased hospital stay, and decreased cost. Search Methodology Cochrane, CINAHL, and PubMed databases were used in the literature search. The search was related to distraction involving pediatric patients published within ten years from the beginning of the scholarly project. The following were the terms applied to the search, pain perception, parent's perception, pediatric, distraction therapy, multimodal distraction, analgesia, intravenous, pain, fear, vibration, Buzzy, and analgesia. In addition, keyword combinations included coping and pain, pediatrics and pain, distraction and coping, toddlers and pain perception, young children and pain perception, children and distraction techniques, children and BUZZY, pediatrics and distraction methods, anxiety, and pediatrics. A variety of these keyword combinations were searched within each of the databases. All electronic searches were included from the years 2010-2021. Inclusion criteria consisted of studies investigating nonpharmacological pain-relieving strategies for procedure-related pain for children. Articles focusing on intravenous, or prescription pain relief were excluded. A total of 38 peer-reviewed articles, all with quality ratings of A (high quality) or B (good quality) were critiqued, evaluating HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 13 the strength and quality of the evidence as well as identifying major patterns, trends, and gaps in the literature ((Logan et al., 2008). Articles that focused on chronic pain or opioid medications for pain relief were eliminated. Ten articles did not meet the criteria and were excluded. Most of the articles reviewed were systematic reviews of randomized controlled trials or literature reviews. Articles that were determined to have a quality rating of C were eliminated from inclusion as their results are not reliable and cannot be applied to future studies. The final set of evidence was comprised of 26 articles, all with quality ratings of A or B quality (Logan et al., 2008). Research studies were graded based on their level of consistency, conclusions, results, recommendations, sample size, and ability to apply results. Non-research studies were graded based on the outlined objectives, results, recommendations, and conclusions (Logan et al., 2008). Review of Literature The need for improved pediatric pain management during venipuncture is the focus of this literature review. The review will begin with a discussion of the gate control theory of pain. The panel will be followed by reviewing developmental considerations and how it correlates to pediatric pain perception. Finally, the review will conclude with a discussion of procedural anxiety in the pediatric population. The gate control theory of pain was used to understand venipuncture pain reduction in children through vibration and cold applications (Bergomi et al., 2017; Bahorski et al., 2015; Thrane et al., 2016). The gate control theory proposes that "pain is transmitted from the peripheral nervous system to the central nervous system where a gating system modulates it in the spinal cord" (Thrane et al., 2016). Vibration stimulates receptors to close the "fast pain gate" by presynaptic inhibition at the spinal cord (Thrane et al., 2016).). Cold blocks pain signals and raises the body's overall threshold for pain (Thrane et al., 2016). Buzzy HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 14 provides optimal pain relief via the gate control theory with its vibrating motor and ice pack by stimulating the nerves with cold and vibration to close the fast pain gate (Moadad et al., 2016). Several randomized control trials analyzed refer to the gate control theory of pain as a method for understanding the process of procedural pain reduction in children using vibration and external cold analgesia (Canbulat, Ayhan, Inal, 2015; Potts, 2017; Inal & Kelleci, 2017; Moadad et al., 2015; Schreiber et al., 2015). Tactile stimulation via vibration is purported to stimulate the A-beta mechanoreceptors, which close the "fast pain gate by presynaptic inhibition at the dorsal horn of the spinal cord (Canbulat, Ayhan, Inal, 2015; Potts, Davis, Elci, & Fein, 2017; Inal & Kelleci, 2017; Moadad et al., 2015; Schreiber et al., 2015). External cold analgesia stimulates the C fiber while blocking the delta pain signals and raises the bodys overall threshold for pain (Canbulat, Ayban, Inal, 2015). Buzzy effectively combines vibration and cold, significantly reducing venipuncture pain in children (Moadad et al., 2016). Buzzy is an FDA-cleared device widely used for pain reduction during needle-stick procedures in the pediatric population (Canbulat et al., 2015). It is a vibration and pulsation device attached to an ice pack applied directly to the injection site. Buzzy is placed on the injection site for 30 to 60 seconds and then immediately moved proximally to the injection point so that the infusion can take place (Ballard et al., 2018). The continuous application of cold affects the C fibers within the spinal cord and consequently blocks the pain signal from the Adelta fibers, reducing the painful sensation (Inal & Kelleci, 2012). Thus, Buzzy is a combination of vibration and external cold analgesia, which significantly reduces injection pain in children (Baxter, Cohen, McElvery, Lawson, & von Baeyer, 2011; Canbulat et al., 2015; Inal & Kelley, 2017; Moadad, Potts et al., 2017; Schreiber et al., 2016; Whelan et al., 2014). Buzzy provides optimal pain relief via the gate control theory with its vibrating motor and ice pack, by HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 15 stimulating the nerves with cold and vibration to close the fast pain gate (Canbulat, Ayhan, Inal, 2015; Inal & Kelleci, 2017; Moadad et al., 2015; Potts,2017; Schreiber et al., 2015). As children age and develop, so does their capacity to describe the pain (Giordano et al., 2019). At four years of age, children can use a pain scale, utilizing facial expressions to indicate their pain. (Giordano et al., 2019). It is necessary for pediatric pain scales to be age and developmentally appropriate to obtain accurate pain assessments to manage pain (Giordano et al., 2019) effectively. The Wong-Baker FACES Pain Rating Scale is a helpful tool that has been successfully used in children ages three to eighteen years to measure acute pain (Moadad et al., 2019). It is a continuous outcome measure consisting of a 100-mm scale from 0 to 100 with low and high-end points of no pain and worst pain. Pain can be measured by self-report, biological markers, and behavior. Pain is subjective; therefore, self-report is the best if available (Garra et al., 2010). It may be difficult to measure the degree of pain in a young child, especially toddlers because of their level of cognitive and language development. The FACES Pain Scale provides a useful method of describing pain perceptions (Garra et al., 2010). Faces scales use a series of facial expressions to illustrate a spectrum of pain intensity. Numerous face-based rating scales are available. Faces scales are ordinal outcome measures consisting of a limited number of categorical responses ordered in a specific pattern (Garra et al., 2010). The FACES Pain Scale has been shown to be a reliable and valid measure of acute pain in pediatric patients. Facial expression drawings are a popular method of pain severity assessment in pediatric populations. that help illustrates a spectrum of pain intensity (Garra et al., 2010). A randomized control trial indicated that age was an essential factor associated with child pain, suggesting that younger children reported higher pain scores (Thrane et al., 2016). The study postulated that parents and healthcare providers may underestimate pediatric anxiety related to venipuncture. HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 16 Fear and anxiety related to needle-stick procedures may not resolve over time and has the potential to cause delays in seeking medical care and treatment, as well as adherence to future medical procedures (Canbulat et al., 2015). The Childrens Fear Scale has been widely utilized to assess pediatric anxiety related to venipuncture. Fear and anxiety related to needle-stick procedures may not resolve over time and has the potential to cause delays in seeking medical care and treatment, as well as adherence to future medical procedures (Canbulat et al., 2015). The Childrens Fear Scale has been widely utilized through the literature as a reliable and valid tool for evaluating pediatric fear (Canbulat et al., 2015). Children's negative experiences during these routine procedures can have long-term negative consequences that may persist into adulthood. Outcomes can include increased pain sensitivity, negative responses to pain, low cognitive and motor development, and long-term traumatic memories (Thrane et al., 2019). Children who rated their anxiety as high during the venipuncture were more likely to have greater anxieties when talking about the exact procedure two weeks later (Noel et al., 2010). Children who rated their pain and anxiety as low during the venipuncture were also more likely to have decreased anxiety while talking about the procedure two weeks later. Evidence discovered by Noel et al. (2010) indicated the importance of keeping the pain and anxiety low for pediatric patients to help prevent exaggerated memories about possible medical procedures in the future. Buzzy has proven to significantly reduce anxiety and distress experienced by children undergoing venipuncture (Erdogan et al., 2021). Utilizing Buzzy for children undergoing venipuncture will reduce stress decrease pain levels, and improve pain perceptions (Erdogan et al., 2021). Positive pain perceptions improve cognitive processes, brain function, mental health, cardiovascular function, and overall quality of life (Marche et al., 2015). Evidence of additional HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 17 positive characteristics was also included throughout the primary studies, such as an increased percentage of successful venipunctures, improved cooperation, and lessened stress in pediatric patients (Buratti et al., 2015). Theoretical Framework The Prescriptive Theory of Acute Pain Management was founded in 1988. This theory was developed to aid in pain management for infants and children (Huth & Moore, 2007). Recommendations from the Acute Pain Management Guideline Panel of 1992 and Good and Moores Model of Acute Pain Management (Huth & Moore, 2007). The purpose of this theory is to provide physicians and advanced practice providers guidelines for effective interventions to reduce the perception of pain in infants and children (Huth & Moore, 2007). In addition, this theory includes guidelines for effective therapeutic interventions (Huth & Moore, 2007).) Interventions are based on several factors, including the infant or child's physical, psychological, and developmental levels. Other factors, such as gender, ethnicity, and culture, are also used to determine the best method to decrease pain in each infant or child (Huth & Moore, 2007). The theory considers pain as assessed by the child, parents, and advanced practice providers. The theory also considers the child and parent's satisfaction with pain reduction. The theory indicates that pain management and satisfaction with pain reduction are successfully achieved by using specific assessment strategies, therapeutic pain relief interventions, and reassessments of the child's pain (Huth & Moore, 1998). This theory provides an evidence-based framework that can structure this DNP project to address pain reduction during venipuncture in small children. It provides guidelines for using cold and vibration via Buzzy as a therapeutic tool for reducing pain during painful procedures. HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 18 Buzzy is a promising intervention to reduce pain in children (Baxter et al., 2011). This batteryoperated motorized device is bee-shaped with removable wings of ice. Buzzy was used on pediatric patients during needle-related procedures in the ED (Baxter et al., 2011). The nurse or child life specialist will perform an initial pain assessment considering factors such as developmental level, age, and culture. The nurse will teach the parent and child about Buzzy and its use and then implement the non-pharmacologic adjuvant (i.e., Buzzy) during the child's venipuncture (Huth & Moore, 1998). According to Good and Moores Model of Acute Pain Management, pain management plans are best developed when a balance between analgesia and side effects is created to control acute pain (Good, 1998). Management of acute pain is achieved by using multimodal interventions, attentive care, and patient participation (Good, 1998). Buzzy will be used as a multimodal intervention to regulate pain with nominal side effects. As a part of attentive care, The Wong-Baker FACES Scale and the Childrens Fear Scales will be used to rate pain and fear perceptions. The child will subjectively rate their own pain and fear perceptions (Good, 1998). Vibration is useful in pain management and prevention (Bahorski et al., 2015) as it blocks the afferent nerve fibers from transmitting the sensation of pain to the brain. Buzzy also allows local cold therapy to stimulate nociceptive pain fibers, blocking the sensation of pain from reaching the brain. Lastly, in another seminal study by Bukola and Paula (2017), distraction has been identified as an effective pain intervention with pediatric patients. Specifically, distraction effectively relieves procedural pain (Bahorski et al., 2015; Bukola et al., 2017). The nurse or child life specialist will reassess pain after venipuncture using the Wong-Baker FACES pain scale to assess the child's pain level (Garra et al., 2010). The parents will be provided with a survey to evaluate their child's pain and satisfaction with pain reduction techniques used during HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 19 venipuncture. This theory will assist by setting guidelines for the appropriate use of cold or vibration to decrease pain in children undergoing venipuncture. Minimizing pain during venipuncture should result in increased positive outcomes for the parent and child. Parents will be given a survey two weeks and four weeks after their procedure to compare their perceptions of pain control and patient satisfaction over time. Trusting relationships should be improved between advanced practice providers and their patients and families. Children should have a decreased perception of pain, which should help them create better long-term memories of pain associated with venipuncture procedures. In conclusion, the dissemination of this evidence may enhance best practices in pain management and prevention Gap Analysis Distraction techniques can decrease pain in young children during painful procedures. The proposed new practice consistently uses distraction techniques based upon the child's age and developmental level to decrease pain during painful procedures such as venipuncture. In children, ages three through six, cold and vibration are effective at reducing pain during venipuncture. Barriers to the implementation of the proposed best practice are gathering 100 participants to volunteer for the study. Obtaining voluntary consent from the child's parents may become a secondary barrier in the study. Cold and vibration, used as distraction techniques, will be offered to children participating in the study. Pain levels in all children undergoing venipuncture. Current policy does not state that a pre- and post-pain assessment should be performed with venipuncture procedures. In this study, all children will be assessed using the Wong-Baker FACES pain scale for children (Garra et al., 2019). Staff members need to agree to evaluate pain pre routinely and post-procedure with every venipuncture performed. A barrier may be the education of staff on pain assessments and data collection. Best practices will be used HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 20 with the new proposed approach to mandate pain assessments with each venipuncture (Potts et al., 2017). Distraction techniques can decrease pain in young children during painful procedures. The proposed new practice consistently uses distraction techniques based upon the child's age and developmental level to decrease pain during painful procedures such as venipuncture. In children, ages three through six, cold and vibration are effective at reducing pain during venipuncture. Barriers to the implementation of the proposed best practice are gathering 100 participants to volunteer for the study. Obtaining voluntary consent from the child's parents may become a secondary barrier in the study. Cold and vibration, used as distraction techniques, will be offered to children participating in the study. Pain levels in all children undergoing venipuncture. Current policy does not state that a pre- and post-pain assessment should be performed with venipuncture procedures. In this study, all children will be assessed using the Wong-Baker FACES pain scale for children (Garra et al., 2019). Staff members need to agree to evaluate pain pre routinely and post-procedure with every venipuncture performed. A barrier may be the education of staff on pain assessments and data collection. Best practices will be used with the new proposed approach to mandate pain assessments with each venipuncture (Potts et al., 2017). One strength of this project was that staff felt that the intervention was easily incorporated into the daily workflow and made a positive impact on the care that the patient and family experienced while in the hospital. The hospital already has an ample supply of Buzzy devices on each unit. This practice could decrease procedure times while increasing child and parent satisfaction. This intervention takes little time or effort to implement, is cost-effective, supported by parents and staff, and provides increased comfort during a very common pediatric HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 21 procedure. The use of distraction techniques to improve pain perceptions in children and parents is a growing need and a cause for action. There are many strengths associated with addressing these needs, such as the potential for improved long-term patient outcomes, increased patient satisfaction, and an improved understanding of pain management. Therefore, its implementation into practice should be further considered. A limitation of this study is the potential lack of transferability. This study was conducted on toddlers in a hospital setting. It is unknown if the results would be transferable to other age groups or healthcare settings. Buzzy was the only distraction tool used in the study. It is unknown if other distraction techniques would produce similar results. This project used subjects from a vulnerable population, therefore, IRB approval took longer than expected. The number of participants was limited due to a shortened time frame. A larger sample size may have made the project more statistically significant. Goals, Objectives, and Expected Outcomes This project will determine the efficacy of cold and vibration to decrease pain perception in young children. Research has shown that children who have positive experiences related to healthcare can form trusting relationships with healthcare professionals as adults. These patients seek out care more often and have improved health outcomes as adults. Current practice allows distraction techniques to be offered to children showing signs of anxiety before painful procedures. This study is being conducted to show that all children should be offered distraction techniques before any medically necessary painful procedure. Patients and their families will assess pain levels pre- and post-venipuncture procedures using the Baker-Wong FACES pain scale (Garra et al., 2019). Fear levels will be assessed using the Childrens Fear Scale (Dastgheyb et al., 2018). A post-survey assessing patient and family satisfaction will utilize the HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 22 Likert Scale from the Pediatric Pain Assessment Survey. The study will analyze results from Riley Children's Hospital in Indianapolis, Indiana, for six weeks (Srouji et al., 2010). Project Design This project is a nonrandomized, quasi-experimental study performed in an acute care unit of a tertiary care hospital over six weeks. This quality improvement (QI) project focused on implementing and evaluating the usage of the Buzzy device during venipuncture of pediatric patients. The project was limited to children between the ages of 3 and 6 years who received venipuncture or IV insertion at the clinical site. The estimated sample size (n = 100 patients) was based upon an approximate rate of 3 patients (ages three-six years) per day per provider. Pain perceptions will be evaluated by survey pre- and post-blood draw or IV insertion. A follow-up survey will be completed by parents one-month post-procedure. The data used from this study will be used as a quality improvement DNP scholarly project. Qualitative data from the WongBaker FACES pain scale, the Childrens Fear Scale, and the Pediatric Pain Assessment Survey will be used to collect data (Garra et al., 2010). The study will access data from participants at Riley Children's Hospital in Indianapolis, Indiana. The hospital is an inpatient facility. Children in the hospital will be asked to volunteer to participate in the study. Children from ages three to six will be included in the study. Exclusion criteria included children with cold sensitivity, Raynauds, or Sickle Cell disease, or who had impaired skin integrity, as they were listed as contraindications for using Buzzy (Moadad et al., 2016). A brochure describing the device was provided to parents with eligible children undergoing venipuncture or IV insertion. The child also had to give voluntary assent to participate in the study (see Appendix B). On week one the nursing and child life specialist staff received an email regarding the project and mandatory individualized training sessions. During HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 23 the second week, fliers were distributed explaining staff roles and responsibilities in the study. In the first two weeks of the study, the standard protocol was followed, and staff decided which patients were offered distraction techniques during painful procedures. During week three, the study protocol went live. Two Buzzy devices were available in a designated refrigerator in two storerooms. A nurse or child life specialist offered Buzzy to children ages three through six years undergoing venipuncture on the unit and documented that they completed the intervention on their designated Weekly Nurse Buzzy Log. Each staff member also distributed a Pediatric Pain Survey (see Appendix E) for parents and patients to complete together and submit in a security box post-procedure. Measurement Instruments All participants will have pain levels assessed via the Wong-Baker FACES pain scale for children (Garra et al., 2019). The Wong-Baker FACES Pain Rating Scale was used to quantify patients pain rating pre-procedure and post-procedure. This tool has been previously used, tested, and found to be reliable by Garra et al., (2010) with 95% confidence interval [CI] = 0.86 to 0.93 while the original creators of this scale indicated a validity of 60% and reliability of 87.5% (Wong & Baker, 1988). The Wong-Baker FACES scale is copyrighted; however, permission was not needed for healthcare students, the Wong-Baker FACES Pain Rating Scale was used to quantify patients pain rating post- immunization and retrospectively from previous immunizations. This tool has been previously used, tested, and found to be reliable by Garra et al., (2010) with 95% confidence interval [CI] = 0.86 to 0.93 while the original creators of this scale indicated a validity of 60% and reliability of 87.5% (Wong & Baker, 1988). The WongBaker FACES scale is copyrighted; however, permission was not needed for healthcare students. HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 24 Anxiety levels will be assessed with the Children's Fear Scale. Finally, patient and family satisfaction will be evaluated via a completed pre-survey and post-surveys from the Likert Scale manufactured by the Pediatric Pain Assessment Survey (Zanolin et al., 2016). SPSS will be used for data analysis. First, demographic, and descriptive data were analyzed using means, standard deviations, and percentage values. Next, Fisher's exact test of independence was used to compare the differences in the distribution of responses within the survey. This test is often used with small samples and serves as an alternative to the Chi-Square test. The results of the tests that were used made an inference whether the utilization of Buzzy helped improve parental perceptions of their childrens pain during invasive procedures. Pain levels and pain perceptions will be assessed with the Pediatric Pain Survey. Children frequently describe pain as the most distressing aspect of disease or hospitalization, and it can negatively impact their wellbeing and future development (Vagnoli et al., 2019). The questionnaires were administered after each venipuncture. Parents were requested to fill out a questionnaire on the perceptions of pediatric pain management and the use of distraction. Institutional review board approval was obtained. The survey provided qualitative data to assess pain perceptions in children and parents. Parents were asked to describe their childs pain. They were then given a list of words to choose from to describe their childs pain or emotions felt while in pain. Examples of words used were throbbing, uncomfortable, sharp, sad, sore, and miserable. Lastly, they were asked if they felt their childs pain was controlled or decreased due to Buzzy. Pain is a subjective experience, and, how individuals react to a new episode of pain is shaped and influenced by previous experiences. Cognitive processes and emotions are used to interpret pain. This process combines to form pain perceptions. Individuals show differences in their ability to regulate emotions as well as their perceptions about pain, their judgments about HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 25 the seriousness of pain, and their sense of control over pain. Negative pain perceptions that have been shown to put patients at the risk of a poor prognosis are negative interpretations of pain, and fear avoidance. Assessing pain perceptions may be even more important than reaching a definitive diagnosis or explaining what factors contributed to pain onset (Bergomi et al., 2018). Data Collection The Marian University IRB reviewed the project and determined that the project did not constitute human subjects research and did not require IRB review. The project sites IRB guidelines were followed for the submission of the requested documents for their determination. The projects information form was developed per the project sites guidance and IRB recommendation. A one-page introductory form was provided to participants, and implied consent was granted upon completing the pretest. The potential risks and benefits of participating in this study were explained to participants in the projects introductory portion. The potential benefit to participants was an increase in knowledge regarding pediatric pain assessment and management. Participants were also informed of the potential benefit of improved self-efficacy when caring for pediatric patients after project participation. The risk of participating in this study was described as minimal, with the main risk being a breach of confidentiality. This risk was minimized by assigning a unique code to each participant. The list of codes was stored separately from the survey answers in a secure database on the PIs private computer, accessible only by the PI. All email and paper invitations for participation contained the PIs contact information to streamline questions or concerns. Data analysis took place between June 2021 and August 2021 and involved descriptive statistics in the International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS). Data was downloaded into Excel and was analyzed using descriptive statistics. HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 26 Participant demographic characteristics were analyzed. Descriptive statistics were used to assess for differences pediatric pain perceptions by examining baseline, immediately post-intervention, and 1-month follow-up. Children between the ages of three to six years of age will be included in the study. Patients having a critical status were eliminated from this study. Parental consent will be obtained from all parents before participants were enrolled in the study. Child assent must also be received before any child is enrolled in the study. Participants will be nonrandomized. The study will be conducted over a six-week time frame. In the first two weeks, painful procedures will be performed using the current hospital policy. All participants will be offered cold or vibration during a blood draw or IV insertion in the following four weeks. Once a limit of 100 participants or the 6-week timeframe ends, the study will no longer be conducted. All data will remain secure and confidential. All computers use SSL layering for security. Data collected from the study will be kept on a spreadsheet in a locked drawer in the nine west charge nurse office at Riley Hospital. Participation in the study is strictly voluntary. Participants may leave the study at any time they choose. Staff members will be educated on obtaining parental consent and collecting data protocols. The nurse used the Weekly Nurse Buzzy Log to document Buzzy use. During weeks three through six, the QI Project Leader reviewed and entered the data into an Excel spreadsheet each week. Data analysis included descriptive statistics. During the project's implementation phase, human subjects were protected by keeping the data collected anonymous, and no identifiable information was recorded. The documents were stored in a file cabinet and an Excel file was saved on a password-encrypted computer at the organization. At the end of each shift, each nurse submitted the Weekly Nurse Buzzy Log to the nurse manager, who filed the logs until the start of the next business day. The Marian University Institutional HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 27 Review Board approved the project. As no pain management protocol for painful procedures existed previously at this organization, there was a clear need for the practice change to occur, which was a driving force in the project's sustainability. Data Analysis Qualitative pain data will be assessed with data retrieved from the Wong-Baker FACES pain scale for young children (Garra et al., 2016). Patient satisfaction data will be reviewed from the Pediatric Pain Survey (Zanolin et al., 2016). Parents of the patients completed the surveys. The Pediatric Pain Survey (Zanolin et al., 2016) evaluated the parents perceptions of their childrens satisfaction, anxiety, pain, as well as the staffs helpfulness during an injection or a venipuncture. The childs assent was necessary before they participated in the study. Data will be analyzed with SPSS software. During the QI project, a total of 135 patients were offered Buzzy (see Table 2). Ninety-six patients used the device, and 39 patients declined to participate in the study. (See Table 2). A total of 384 Pediatric Pain surveys were collected (see Appendix E). For question number one: Were you satisfied with your childs venipuncture process using Buzzy? Approximately ninety-seven percent of respondents answered "Yes," while 3% answered No. For question number two: Did you find Buzzy to be helpful? nearly eightynine percent of respondents answered, Yes, while 11% answered No. Finally, for question three: Would you opt to use Buzzy again in the future, for your child's vaccinations? ninety-one percent of respondents answered Yes, while 9% answered No. This quality improvement project supports implementing the Buzzy device during painful procedures in a pediatric inpatient setting. After this QI project, 96.9% of parents reported satisfaction with their child's pain management experience, which well surpassed the long-term project goal of fifty percent (see Table 3). Perceptions of pain and patient satisfaction seemed to remain constant 1-month post- HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 28 procedure, with a patient satisfaction score of 95.8%. Two families reported decreased satisfaction one-month post-procedure. Ninety-one percent of parents surveyed in this QI project indicated that they would opt to use Buzzy for their childs pain management in the future (see Table 3). This result was like that of Redfern, Chen, and Sibrel (2018), who found that 88% of parents of children who used Buzzy during painful procedures desired to use the device in the future. The sample size collected during the study was limited. Therefore, the distribution of responses for each survey item was examined for each gender using Fisher's exact test of independence. Along with the quantitative data collected throughout the study, open-ended survey comments were also collected and reviewed. This section allowed parents to openly express how they felt about their respective childrens experiences. Out of the surveys that were collected from the parents left comments. These included the following: The injection was much needed. She was able to relax and felt better afterward; also, He did get seven pokes today, so he was probably more distressed than normal. The other comments from the control group said the following: Want to say thank you. I know my kid is easygoing, but you guys made her feel even more comfortable. The successful results achieved by this QI project warrant consideration for applicability to other healthcare clinics seeking methods of pain reduction for children undergoing painful procedures. Results of this study confirm the efficacy of the Buzzy device in reducing procedure-related pain and speak to the success and usefulness of this QI project. The support for Buzzy will aid in the project's sustainability. Implications for future research include using the device on a younger population of patients (i.e., six months and older). Suggested next steps include: (1) incorporation of this device as a standard of care during painful procedures at the hospital (2) development of a pain management protocol to include Buzzy; (3) integration of Buzzy usage within nurse orientation training; (4) implementation of an electronic HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 29 health record function that would prompt nurses to use Buzzy before painful procedures and track the device's usage among patients. The time required from IRB submission to the written proposal will be approximately three months. Results There were ninety-six participants who completed the pre-survey; and ninety-two participants completed the 1-month follow-up surveys. The final project population consisted of ninety-two out of ninety-six (95.8%) possible participants who completed the baseline and immediate post-intervention surveys. Of those ninety-six participants, eighty-eight participants (91.7%) participated in the 1-month follow-up. Multiple emails were sent to remind participants to complete the 1-month follow-up to increase participation. The demographic information was described using frequency and means/standard deviations... Comparison of the categorical variables was performed by way of the Pearsons c2 test. A p-value of <0.05 was statistically significant. Overall, the results concluded that childrens perception of pain was less in the nonpharmacological intervention groups compared with no intervention. Buzzy was highly effective in children that were younger than six years of age (p = 0.04). The level of pain was assessed in each child using the Wong Baker FACES pain rating scale and verbal reports. The data were then analyzed using the SPSS software 22. The p value less than 0.05 was considered significant in this study. The comparison between the pain levels was analyzed using t test, while the demographic data were compared using frequency and chi-square tests. The results showed that self-reported procedural pain levels were significant between the study groups (p = .001). The distraction group had significantly lowered pain levels (p = .001) than the non-intervention group. Prior to implementation of the intervention, data were collected for two weeks to obtain the average pain rating score of children receiving vaccinations that were between the ages of HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 30 three and six years. The reason that this comparison is taking place is to identify not only the need for intervention for pain but also to assess how high the average pain perception is rated. Currently, the hospital has no comfort measures in place for children that are receiving routine venipuncture procedures. Since venipuncture is one of the largest routine pain-producing procedures in children it is important to identify interventions that can help limit the pain that is caused during these procedures. A t-test was completed for comparison of pre-intervention and post-intervention pain scored for both pain scales. A t-test was also used to compare preintervention and post-intervention demographic information on patient age and number of venipunctures. A chi-square statistical analysis was completed for comparison of the rest of the demographic information which included patient gender, previous painful procedures, and patient race. Participants that were three years and older, scored their pain rating using the WongBaker FACES scale. This scale rates pain on a scale from 0 to 10 using increments of two. Each number coincides with a picture of a cartoon face depicting the amount of pain that the participant might be in after vaccination. The participant was asked to select which pictures accurately depicts the amount of pain that was experienced. A chi-square for independence was completed to compare scores from the pre-intervention group to the post-intervention group. The mean for the pre-intervention group was 3.5 (Sd = 0.71), and the mean for the post-intervention group was 1.5 (Sd = 0.71). No significant difference between the pre-and post-intervention group was found (x 2 (3, N=10) = 5.94, p > 0.05). To make an accurate comparison of the two groups it was important to verify that the groups were similar regarding their age, race, and previous history of a painful procedure. A ttest was completed to compare both the pre-and post-intervention ages and the number of painful HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 31 procedures. The participants in the pre-intervention group had a mean age of 36 months (Sd = 2.23), and the mean age of the post-intervention group was 38 months (Sd = 2.87). No significant difference was found between the pre-and postintervention group ages (t (11, N=28) = 0.799, p > 0.05). A chi-square test of independence was calculated comparing the genders of both the preand post-intervention groups. No significant relationship or difference was found between the two groups (x 2 (1, N=28) = 0.438, p > 0.05). Another chi-square of independence was calculated comparing the race of both the pre-and post-intervention groups. Again, no significant relationship or difference was found (x 2 (3, N=28) = 2.82, p > 0.05). Participants in both groups had never experienced previously painful procedures, and therefore there was not a need for any statically significant analysis as both groups were the same in this case. ANOVAs were performed. The results indicated that children reported higher scores when they did not have the BUZZY applied, F (2/45 = 7.07, p = 0.011, mothers also rated children's pain higher when the BUZZY was not applied, F (2/45 = 6.7, p = 0.014. Younger children had significantly higher pain scores in the No BUZZY group compared to the BUZZY group, F (2/19) = 8.96, p = 0.007, females had significantly higher scores in the No BUZZY group compared to the BUZZY group, F (2/21) = 14.59, p = 0.00. A multiple regression analysis found that only the BUZZY remained the only significant factor that predicted the pain scores of children. Table 1 Differences in Pain Ratings for Child and Parents Variable Pain scale by child Pain scale by parents Buzzy Mean (+/-SD) 2.32 3.52 No Buzzy Mean (+/- SD) 4.40 (+/-3.0) 4.98(+/- 3.25) F Value 8.08 2.80 p-Value 0.012 0.118 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 32 Since children younger than 7 years report more distress, pain intensity, and unpleasantness following a needle prick than older children, distraction may be more beneficial to this age group. Table 2 Multiple Regression of Factors that are Predictors of Pain Perception Standardized Coefficients Constant Age in Years Gender Previous Procedures Child on Analgesics Buzzy or No Buzzy Prior Hospitalization Coefficients Beta t -0.464 -0.026 .468 -1.684 -1.24 1.818 .108 .906 .106 -0.481 -0.158 1.222 .276 1.284 .728 -3.98 -1.705 .108 -2.366 1.387 .398 2.293 .036 2.353 1.027 .144 .466 .649 1.016 2.183 .468 p NonStandard B .650 1.976 Std. Error 4.258 BUZZY was more effective in the younger age group and in girls. It could well be that BUZZY is more effective in the younger age group who are easily distractible. Children with prior needle pricks may be more apprehensive about the procedure and welcomed BUZZY as a distracter whereas children with no prior hospitalization were not as likely to be distracted. Previous negative or painful experiences probably lead to elevated anxiety and pain experiences during future invasive medical procedures. Strengths and Limitations There were several strengths of this project that were evident. One of the largest strengths was the support from the clinical staff and site facilitator. They greatly believed in the need for HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 33 practice change and were excited to introduce the Buzzy device to their patients. This made the project more successful in that they were willing to make the change. Similarly, patients and their families willingly accepted the use of Buzzy. Several families expressed great satisfaction and a noticeable difference in their child during venipuncture. The project was also very easy to understand and not extremely time-consuming for the staff. This allowed for the project to be realistic in the hospital setting. Likewise, with only measuring one outcome it made it easy for the staff to learn the respective pain scales and place the pain score in the medical record. Only measuring a single outcome also made data collection and analysis more simplistic. An additional strength was also the affordability of the Buzzy device. Buzzy can easily be cleaned off for reuse, making it a great product for busy healthcare facilities. The study did have some limitations. The sample size was limited to ninety-six participants. A larger sample may have provided stronger support to the hypothesis. The small sample size was constrained by the short timeline of the project. The project was not randomized because the children and/or families that participated knew they were receiving the use of Buzzy. This could have caused some bias in reporting of pain scores between the two groups. The staff had to be aware of gaining consents and using the correct pain scoring scale for each participant. There were also some situations where consents were not obtained or scores were not recorded in the electronic medical record, thus causing a smaller sample size. Conclusion The purpose of this DNP scholarly project was to evaluate whether distraction techniques used during painful procedures improved pain perceptions for children and parents short-term and long-term. Positive pain perceptions lead to improved coping strategies and pain HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 34 management (Basten-Gnther et al., 2018). Parental perceptions of pain in their children decreased as a response to the use of distraction techniques used during painful procedures. Patient satisfaction increased with the use of distraction techniques and patient satisfaction remained high over time. Improved pain perceptions in childhood increase the likelihood of receiving medical care and optimizing health outcomes as an adult. The results of this project supported the effectiveness of combination cryotherapy and vibration for painful procedures in children as was seen by the improvement in pain scores, which is consistent with current literature. Management of procedural distress through evidence-based distraction is simple, costeffective, and can provide both short and long-term benefits. Evidence supports future research that might further examine the effectiveness of using distraction techniques for pain control management in the pediatric population. Distraction techniques seem to be an effective form of pain management in pediatrics that should become an evidence-based practice in the future. HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 35 References Aarthu.n, A., Oymar, K. A., & Akerjordet, K. (2018). Parental involvement in decision-making about their childs health care at the hospital. Nursing Open, 6(1), 5058. https://doi.org/10.1002/nop2.180 Bahorski, J. S., Hauber, R., Hanks, C., Johnson, M., Mundy, K., Ranner, D., Stoutamire, B., & Gordon, G. (2015). Mitigating procedural pain during venipuncture in a pediatric population: A randomized factorial study. 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Prescriptive theory of acute pain management in infants and children. Journal for Specialists in Pediatric Nursing, 3(1), 2332. https://doi.org/10.1111/j.1744-6155.1998.tb00206.x Inal, S., & Kelleci, M. (2017). The effect of external thermomechanical stimulation and distraction on reducing pain experienced by children during blood drawing. Pediatric Emergency Care, Publish Ahead of Print. https://doi.org/10.1097/pec.0000000000001264 Inan, G., & Inal, S. (2019). The impact of 3 different distraction techniques on the pain and anxiety levels of children during venipuncture. The Clinical Journal of Pain, 35(2), 140 147. https://doi.org/10.1097/ajp.0000000000000666 International association for the study of pain. (1989). Pain, 36(2), 18. https://doi.org/10.1016/0304-3959(89)90036-5 Kallio, T., Tevameri, T., & Vhtalo, M. (2018). Nurses' organizational rolesstakeholders expectations. Professions and Professionalism, 8(2), e1973. https://doi.org/10.7577/pp.1973 Logan, L., Hickman, R. R., Harris, S. R., & Heriza, C. B. (2008). Single-subject research design: Recommendations for levels of evidence and quality rating. Developmental Medicine & Child Neurology, 50(2), 99103. https://doi.org/10.1111/j.1469-8749.2007.02005.x Marche, T. A., Briere, J. L., & von Baeyer, C. L. (2015). Childrens forgetting of pain-related memories. Journal of Pediatric Psychology, 41(2), 220231. https://doi.org/10.1093/jpepsy/jsv111 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 39 Marwaha, S. (2017). Prevalence of principles of piagets theory among 4-7-year-old children and their correlation with iq. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH. https://doi.org/10.7860/jcdr/2017/28435.10513 McMurtry, C., Pillai Riddell, R., Taddio, A., Racine, N., Asmundson, G. G., Noel, M., Chambers, C. T., & Shah, V. (2015). Far from just a poke. The Clinical Journal of Pain, 31(Supplement 10), S3S11. https://doi.org/10.1097/ajp.0000000000000272 Mills, N. M. (2016). Acute pain behavior in infants and toddlers. In Management of pain, fatigue and nausea (pp. 5259). Macmillan Education UK. https://doi.org/10.1007/978-1-34913397-0_6 Moadad, N., Kozman, K., Shahine, R., Ohanian, S., & Badr, L. (2016). Distraction using the buzzy for children during an iv insertion. Journal of Pediatric Nursing, 31(1), 6472. https://doi.org/10.1016/j.pedn.2015.07.010 Noel, M., McMurtry, C. M., Chambers, C. T., & McGrath, P. J. (2009). Children's memory for painful procedures: The relationship of pain intensity, anxiety, and adult behaviors to subsequent recall. Journal of Pediatric Psychology, 35(6), 626636. https://doi.org/10.1093/jpepsy/jsp096 Olsen, K., & Weinberg, E. (2017). Pain-less practice: Techniques to reduce procedural pain and anxiety in pediatric acute care. Clinical Pediatric Emergency Medicine, 18(1), 3241. https://doi.org/10.1016/j.cpem.2017.01.007 Potts, D., Davis, K., Elci, O. U., & Fein, J. A. (2017). A vibrating cold device to reduce pain in the pediatric emergency department. Pediatric Emergency Care, Publish Ahead of Print. https://doi.org/10.1097/pec.0000000000001041 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 40 Ramira, M. L., Instone, S., & Clark, M. (2016). Pediatric pain management: an evidence-based approach. The Journal of Pediatric Nursing, 42(1), 3946. https://doi.org/https://login.forward.marian.edu/login?url=https://www-proquestcom.forward.marian.edu/scholarly-journals/pediatric-pain-management-evidence-basedapproach/docview/1765381484/se-2?accountid=66430. Redfern, R. E., Micham, J., Seegert, S., & Chen, J. T. (2019). Influencing vaccinations: A buzzy approach to ease the discomfort of a needle sticka prospective, randomized controlled trial. Pain Management Nursing, 20(2), 164169. https://doi.org/10.1016/j.pmn.2018.07.001 Romito, B., Jewell, J., & Jackson, M. (2020). Child life services. Pediatrics, 147(1), e2020040261. https://doi.org/10.1542/peds.2020-040261 Schoenfeld, E. M., Goff, S. L., Elia, T. R., Khordipour, E. R., Poronsky, K. E., Nault, K. A., Lindenauer, P. K., & Mazor, K. M. (2016). The physician-as-stakeholder: An exploratory qualitative analysis of physicians motivations for using shared decision making in the emergency department. Academic Emergency Medicine, 23(12), 14171427. https://doi.org/10.1111/acem.13043 Schreiber, S., Cozzi, G., Rutigliano, R., Assandro, P., Tubaro, M., Cortellazzo Wiel, L., Ronfani, L., & Barbi, E. (2015). Analgesia by cooling vibration during venipuncture in children with cognitive impairment. Acta Paediatrica, 105(1), e12e16. https://doi.org/10.1111/apa.13224 Shahid, R., Benedict, C., Mishra, S., Mulye, M., & Guo, R. (2014). Using ipads for distraction to reduce pain during immunizations. Clinical Pediatrics, 54(2), 145148. https://doi.org/10.1177/0009922814548672 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 41 Short, S., Pace, G., & Birnbaum, C. (2017). Nonpharmacologic techniques to assist in pediatric pain management. Clinical Pediatric Emergency Medicine, 18(4), 256260. https://doi.org/10.1016/j.cpem.2017.09.006 Sree, S. (2016). Pediatric pain management. In Handbook of pain management in practice (pp. 217217). Jaypee Brothers Medical Publishers (P) Ltd. https://doi.org/10.5005/jp/books/12645_19 Srouji, R., Ratnapalan, S., & Schneeweiss, S. (2010). Pain in children: Assessment and nonpharmacological management. International Journal of Pediatrics, 2010, 111. https://doi.org/10.1155/2010/474838 Taddio, A., Appleton, M., Bortolussi, R., Chambers, C., Dubey, V., Halperin, S., Hanrahan, A., Ipp, M., Lockett, D., MacDonald, N., Midmer, D., Mousmanis, P., Palda, V., Pielak, K., Riddell, R. P., Rieder, M., Scott, J., & Shah, V. (2010). Reducing the pain of childhood vaccination: An evidence-based clinical practice guideline. Canadian Medical Association Journal, 182(18), E843E855. https://doi.org/10.1503/cmaj.101720 Thrane, S. E., Wanless, S., Cohen, S. M., & Danford, C. A. (2016). The assessment and nonpharmacologic treatment of procedural pain from infancy to school age through a developmental lens: A synthesis of evidence with recommendations. Journal of Pediatric Nursing, 31(1), e23e32. https://doi.org/10.1016/j.pedn.2015.09.002 Tumin, D., Drees, D., Miller, R., Wrona, S., Hayes, D., Tobias, J. D., & Bhalla, T. (2018). Health care utilization and costs associated with pediatric chronic pain. The Journal of Pain, 19(9), 973982. https://doi.org/10.1016/j.jpain.2018.03.012 Vagnoli, L., Mammucari, M., Graziani, D., & Messeri, A. (2019). Doctors and nurses knowledge and attitudes towards pediatric pain management: An exploratory survey in a HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN children's hospital. Journal of Pain & Palliative Care Pharmacotherapy, 33(3-4), 107 119. https://doi.org/10.1080/15360288.2019.1686100 Victoria, N. C., & Murphy, A. Z. (2016). Exposure to early life pain: Long term consequences and contributing mechanisms. Current Opinion in Behavioral Sciences, 7, 6168. https://doi.org/10.1016/j.cobeha.2015.11.015 Whelan, H. M., Kunselman, A. R., Thomas, N. J., Moore, J., & Tamburro, R. F. (2014). The impact of a locally applied vibrating device on outpatient venipuncture in children. Clinical Pediatrics, 53(12), 11891195. https://doi.org/10.1177/0009922814538494 42 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 43 Appendix A Pediatric Pain Study Pediatric Pain Perception Study What is this study about? You are being asked to volunteer in a quality improvement study performed by Sheryl Graybill, FNP/DNP student at Marian University. The purpose of this research is to assess the effects of distraction techniques used in young children on long-term pain perceptions. Studies have shown that children that have positive healthcare experiences in childhood develop more trust in healthcare as adults. Standard practice includes offering distraction techniques to children that show signs of anxiety before painful procedures. This study will assess the effect of offering distraction techniques to all children before painful procedures. What will participation involve? You are being asked to do the following. Complete the survey before a blood draw or IV insertion. Complete the same survey after the procedure. Complete a follow-up survey in 1 month to assess if your pain perceptions during your visit stayed the same or changed over time. The survey will take about 5-10 minutes to complete each time. The surveys contain questions about pain and pain perceptions. Your child will be asked to rate their pain by looking at pictures of cartoon faces. Any survey information you provide about your child will not be linked to any other data, or medical records. What risks are involved in the study? HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 44 The main risks to you are those associated with the inappropriate disclosure of data collected. Every attempt will be made to keep all information secure and confidential. Do you have to participate? No, you do not! Your participation is completely voluntary. If you decide to participate, you can stop at any time you choose. If you choose not to participate or to discontinue your participation, you will not lose any benefit to which you are otherwise entitled. Who can provide additional information if you need it? Questions about the research aspects of this study can be directed to the principal investigator at sgraybill513@marian.edu or (765) 610-6939. Questions about the ethical aspects of this study or your rights as a volunteer should be directed to Marian IRB at IRB@ marian.edu. How will your data be protected against any risks? All information collected through the internet survey is done by using Secure Sockets Layer (SSL) data transmission lines. SSL encrypts, or scrambles, all survey data over the internet. Information will only be understandable when it reaches the investigator database. When your data are entered into the computer files for analysis, your answers will be identified only by a special study identification number. If someone broke in from outside, it would be impossible for them to identify your data. To minimize the risk of anyone breaking into the data files, all files will be maintained on IU Health computers under HIPAA regulations. Data will be maintained until all research questions have been addressed. The principal investigator will be responsible for storing all research records related to this study. The records will be stored in a locked drawer on the 9 West unit of Riley Childrens Hospital in the charge nurse office. You may change your mind and revoke your permission to HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 45 further collect health information about you at any time. If you revoke your permission, no new health Information about you will be gathered after that date. To review your electronically submitted survey or end further participation in this data collection effort, contact the principal investigator at sgraybill513@marian.edu or (765)-610-6939 What are the benefits of participating in this study? Your participation in this study may decrease your childs pain perception during a painful procedure. Your participation is a critical step in developing policies and interventions for children experiencing pain during medically necessary painful procedures. Study Contacts/Termination You will be asked to complete a survey before and after your childs procedure, and one month after the procedure. The study will be conducted over six weeks. Participation is completely voluntary, but the principal investigator will greatly appreciate your involvement in this research effort to help better understand pain perceptions and their effect on long-term health outcomes. _______________________________________________ Printed Name _______________________________________________ Signature ________________________________________________ Todays Date HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 46 Appendix B Child Assent Form What is the Effect of the Use of Distraction Techniques during Painful Procedures? My name is Sheryl Graybill, RN, FNP/DNP student, Marian University. We are asking you to take part in a research study because we want to learn more about pain perceptions during painful procedures such as blood draws. If you agree to be in this study, we will ask you to allow us to use a distraction technique to make your blood draw or IV insertion less painful. Painful procedures such as IV insertion or blood draws may be necessary during treatment, but distraction techniques may help the procedure be more comfortable. Please talk this over with your parents before you decide whether to participate. We will also ask your parents to give their permission for you to take part in this study. But even if your parents say yes, if you dont want to be in this study, you dont have to participate. Remember, being in this study is up to you and no one will be upset if you dont want to do this. If you do participate and later change your mind, you can stop participating at any time. Nobody will be angry or upset with you. You can ask any questions that you have about the study. If you have a question later that you didnt think of now, you can call me at 765-610-6939 or contact Marian IRB at Signing your name below means that you agree to be in this study. You and your parents will get a copy of this form. NAME OF STUDY PARTICIPANT: Printed Name of Participant:____________________ Signature of Participant:_______________________ HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN Date: ______________ SIGNATURE OF PERSON OBTAINING CONSENT: _________________________ In my judgment the participant is voluntarily and knowingly agreeing to participate in this research study. Name of Person Obtaining Assent: ___________________________ Contact Phone Number: ___________________________________ Signature of Person Obtaining Assent: ________________________ 47 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 48 Appendix C Childrens Fear Scale Figure 1 Instructions for Children: These faces are showing different amounts of being scared. This face [point to the left-most face] is not scared at all, this face is a bit more scared [point to second face from left], a bit more scared [sweep finger along scale], right up to the most scared possible [point to the last face on the right]. Have a look at these faces and choose the one that shows how scared you were during [the needle]. Instructions for Parents: These faces are showing different levels of anxiety. This face [point to the left-most face] shows no anxiety at all, this faces shows a bit more [point to second face from left], a bit more [sweep finger along scale], right up to extreme anxiety [point to the last face on the right]. Have a look at these faces and choose the one that shows how much anxiety you felt during [the needle]. Score the chosen face from 0 to 4. Sources: Please cite the CFS Initial Validation Study: McMurtry, C.M., Noel, M., Chambers, C.T., McGrath, P.J. (2011). Childrens fear during procedural pain: Preliminary investigation of the Childrens Fear Scale. Health Psychology, Advanced Access Online. Adapted from the (adult) Faces Anxiety Scale: McKinley, S., Coote, K., & Stein-Parbury, J. HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN Appendix D Wong-Baker FACES Pain Scale 49 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN Appendix E Pediatric Pain Survey 50 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN 51 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN Appendix F IRB Approval 52 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN Appendix G Buzzy Instructions 53 HOW DOES THE UTILIZATION OF NON-PHARMACOLOGIC PAIN Appendix G BUZZY Education 54  ...

... INFECTION RATES IN POSTERIOR SPINAL FUSIONS Infection Rates in Posterior Instrumented Spinal Fusions: A Retrospective Review of Infection Control Practices and Outcomes Ellen Case Marian University Leighton School of Nursing Chair: Tara R. Fox, DNP, CPNP 1 INFECTION RATES IN POSTERIOR SPINAL FUSIONS 2 Abstract Background and Review of Literature: A surgical site infection after posterior instrumented spinal fusion can negatively affect the patient and increase healthcare costs. Spinal fusions are becoming increasingly common as a surgical intervention to correct a variety of spinal pathologies. Infection in this population poses a significant problem as infection can lead to additional surgeries, debility, or mortality. Purpose: A group of neurosurgeons implemented a novel protocol to prevent surgical site infection, including irrigating the wound with Clorpactin and applying vancomycin powder intrawound before closing. This investigation seeks to identify surgical site infections and compare infection control measures. Methods: A retrospective chart review was conducted on patients who underwent posterior instrumented spinal fusion between August 2017 and December 2020. Data was collected from the Electronic Medical Records. The data was analyzed using statistical software. Implications/Conclusion: The results significantly reduce postoperative infections in the group exposed to the Clorpactin/vancomycin infection control protocol. Keywords: surgical site infection, instrumented spinal fusion, Clorpactin irrigation, vancomycin powder, intrawound antibiotic INFECTION RATES IN POSTERIOR SPINAL FUSIONS 3 Table of Contents Introduction ..................................................................................................................................... 4 Background ................................................................................................................................. 4 Problem Statement ...................................................................................................................... 6 Organizational Gap Analysis of Project Site ........................................................................... 7 Review of Literature ....................................................................................................................... 8 Theoretical Framework or Conceptual Model .............................................................................. 13 Goals, Objectives, and Expected Outcomes ................................................................................. 14 Project Design/Methods ................................................................................................................ 15 Project Site and Population ....................................................................................................... 15 Measurement Instruments ......................................................................................................... 16 Data Collection Procedures....................................................................................................... 16 Ethical Considerations/Protection of Human Subjects ............................................................. 17 Data Analysis and Results ............................................................................................................ 18 Discussion ..................................................................................................................................... 21 Conclusion .................................................................................................................................... 23 References ..................................................................................................................................... 24 INFECTION RATES IN POSTERIOR SPINAL FUSIONS 4 Infection Rates in Posterior Instrumented Spinal Fusions: A Retrospective Review of Infection Control Practices and Outcomes A surgical site infection (SSI) is a potentially life-threatening complication following a surgical intervention that may result in additional surgeries, longer courses of antibiotics, increased healthcare costs, and increased morbidity or mortality (Di Martino et al., 2019). Surgical site infections after instrumented spinal fusions can cause significant challenges as infections may lead to multiple surgeries, including wound debridement, removal of hardware, destabilization of the spine, and reconstructive surgery (Kalfas et al., 2019). Surgical site infections are defined as infections occurring in the surgical space within 30 days of surgery or 90 days of surgery if implants are utilized (AHRQ, 2019). In posterior instrumented spinal fusions, surgical site infections occur in 2 % to upward of 20% of procedures (Dobran et al., 2019). It is imperative to follow strict infection control practices and develop protocols to decrease surgical site infections in spinal surgeries to improve patient outcomes and decrease healthcare costs. This retrospective chart review seeks to determine if the infection control protocol of utilizing Clorpactin irrigation and intrawound vancomycin powder before closure decreases infection rates in adults who underwent posterior instrumented spinal fusions at an Indiana hospital. Background Surgical site infections are a significant reason for hospital readmission, healthcare costs, morbidity, and mortality (AHRQ, 2019). In the United States, surgical site infections are associated with a 3% mortality rate and are estimated to cost $3.3 billion annually (BerriosTorres et al., 2021). On average, it costs $40,987 to treat a single surgical site infection after a spinal fusion (Rosenthal et al., 2018). The Centers for Disease Control and Prevention (CDC) INFECTION RATES IN POSTERIOR SPINAL FUSIONS 5 guidelines include methods to prevent surgical site infections such as antimicrobial prophylaxis, glycemic control, normothermia, and antiseptic prophylaxis (Berrios-Torres et al., 2017). While these guidelines are the core of preventing surgical site infections, they are not specific to a surgical specialty and function as universal best practices. Since spinal fusions have higher infection rates than general surgeries and have several added risk factors, additional measures may be beneficial to prevent the development of a surgical site infection. Instrumented spinal fusions are procedures to treat spinal conditions such as scoliosis, traumatic injuries, spondylolisthesis, degenerative spine disease, and spinal stenosis (Rosenthal et al., 2018). These procedures can take several hours depending on the complexity and introduce foreign materials to the body. In posterior instrumented spinal fusions, the surgeon introduces instruments such as screws, rods, or cages into the spinal bones to stabilize the spine and fuse the bones (Columbia University, 2021). The fusion helps create a more stable spine, reducing the pressure on nerves or the spinal cord and improving patient pain (Columbia University, 2021). In the United States, the number of spinal fusions per year has increased 118% from 1999 to 2014 and is the 16th most common surgical procedure (Resiner et al., 2020). These increases are primarily due to an aging population, increased life expectancy, and improved techniques, such as technological advancements, improved diagnostic imaging, and instrumentation techniques (Reisner et al., 2020). According to Martin et al. (2019), costs for elective lumbar fusion surgeries surpassed $10 billion for US hospitals, with the average cost of admission at greater than $50,000. With the increasing number of surgeries, it is vital to develop practices to reduce infections. To reduce costs, private insurance companies and the Centers for Medicare and INFECTION RATES IN POSTERIOR SPINAL FUSIONS 6 Medicaid have introduced payment models that may not cover the increased length of stays at hospitals, readmissions, or rehab costs because of a surgical site infection (McGirt, 2017). Some intrinsic patient risk factors include advanced age, male sex, diabetes mellites, tobacco/alcohol use, a high American Society of Anesthesiologists (ASA) score, obesity, malnutrition, and an immunocompromised state (Traynelis et al., 2013). Surgical factors include the length of surgery, posterior approach, number of levels of operation, instrumentation, implant material, use of allograft, blood transfusion, and cerebrospinal fluid leak (Traynelis et al., 2013). Many surgical factors place the patient at increased risk for developing a surgical site infection in posterior instrumented spinal fusions. Due to the cost to patients health and healthcare systems, there has been a focus on preventative measures to reduce infection rates. Many studies have evaluated the efficacy of irrigation before surgical closure, but currently, the CDC does not state there is enough evidence to recommend the practice (Berrios-Torres et al., 2017). Additionally, the practice of applying antibiotics to the incision site has been uncertain, and the CDC does not feel that there is significant evidence to recommend it as a practice (Berrios-Torres et al., 2017). Furthermore, the use of antibacterial agents can cause adverse outcomes such as wound dehiscence, decreased bone growth, and drug reactions (Berrios-Torres et al., 2017). Problem Statement Despite methods to reduce surgical site infections, current measures still fail to prevent infections from occurring in patients. In patients undergoing posterior instrumented spinal fusions, decreasing the risk of postoperative infection is even more critical as infection can lead to implant removal, destabilization of the spine, extended hospital stays, and costly outcomes (Di Martino et al., 2019). It is essential to evaluate if novel approaches can improve clinical and INFECTION RATES IN POSTERIOR SPINAL FUSIONS 7 patient outcomes and decrease healthcare costs. The investigator seeks to determine if there is a significant difference in infection rates between two groups of patients undergoing posterior instrumented spinal fusions with differing infection control practices. Organizational Gap Analysis of Project Site Currently, there are several infection controls protocols for posterior instrumented spinal fusions at a hospital in central Indiana. While all protocols meet or exceed the standards of infection prevention by the CDC, they differ in approach. All surgeons follow pre-surgical interventions recommended by the CDC, including having the patient do a chlorhexidine scrub the night before surgery and apply mupirocin ointment intranasally (Tomov et al., 2018). Additional standards recommended by the CDC include maintaining body temperature, blood glucose <200 mg/dL, administering prophylactic antibiotics, and utilizing strict surgical antiseptic measures (Berrios-torres et al., 2017). These measures are standard protocols utilized by all surgical groups at the facility. The first infection control protocol includes irrigating the surgical incision with Clorpactin irrigation and applying vancomycin intrawound before closure. Additional protocols include preoperative optimization of health, placement of drains, and postoperative antibiotics to create a bundled infection prevention protocol. The second group, or the control group, uses various infection control practices, such as intrawound vancomycin, betadine irrigation, or no antimicrobial intervention. Additionally, there are different practices of drains and postoperative antibiotics. Evaluation of the infection control practices and the infection rates will provide a better understanding of best practices. INFECTION RATES IN POSTERIOR SPINAL FUSIONS 8 Review of Literature A comprehensive literature search was conducted using CINAHL, PubMed, and Cochrane Review. The search terms infection AND instrumented spinal/spine fusion, irrigation AND surgery, irrigation AND spinal surgery, vancomycin AND spinal fusion, Clorpactin OR sodium oxychlorosene were used. Inclusion criteria included articles that 1) discussed infection in instrumented spinal fusions in patients, 2) articles that discussed the application of intrawound antibiotics or vancomycin in spinal surgical sites 3) articles that discussed the use of Clorpactin for surgical irrigation 4) articles investigating the use of irrigation in spinal surgeries. The results were limited to articles written in English, full text, and written from 2015 to 2021 and only focused on people 18 years or older. All titles were evaluated for relevance to the inclusion criteria. A total of 864 articles were found, and the abstracts were evaluated. After evaluation, a total of 31 articles were included: seven regarding infections in instrumented spinal fusions, fifteen for antibiotic usage intrawound in spinal fusions, and nine articles for irrigation of the surgical site. Infection Prevention in Instrumented Spinal Fusions Despite many infection prevention methods, surgical site infections still occur at an alarming rate (Di Martino et al., 2019). Determining methods that decrease infection rates is essential in providing high-quality care and reducing healthcare costs. Patient factors such as the gender of the patient, body mass index (BMI), disease status (such as diabetes, heart disease, autoimmune diseases), smoking status, and nutritional status can impact the likelihood of developing a surgical site infection (Deng et al.,2020; Janssen et al., 2018; Murphy et al., 2016 Rosenthal et al., 2018). These conditions can affect postoperative healing and decrease blood flow to the surgical site, which could alter antibiotic effectiveness (Deng et al., 2020; Murphy et INFECTION RATES IN POSTERIOR SPINAL FUSIONS 9 al., 2018). Several risk factors can be addressed before surgery to improve outcomes, such as encouraging the patient to quit smoking, lose weight, or improve nutritional status. While these measures may improve the patients health, additional measures are needed to prevent infection. Added preoperative measures may reduce the risk of infection. One method is a preadmission chlorhexidine scrub and intranasal antibiotic ointment to reduce Staphylococcus aureus (S. aureus) and methicillin-resistant S. aureus (MRSA) colonization on the patient (Deng et al., 2020; Tomov et al., 2018). Reduction of S. aureus may improve surgical outcomes as approximately 70% of surgical site infections occur from staphylococcus organisms (Deng et al., 2020; Kalfas et al., 2019; Rosenthal, 2018). Infection with S. aureus led to a greater probability of hospital readmission and longer lengths of hospital stays (Rosenthal et al., 2019). Preincisional antibiotics are considered standard of care and are recommended to reduce surgical site infections (Berrios-Torres et al., 2017). Typically, these antibiotics are first-generation cephalosporins dosed by weight up to one hour before incision (Tomov et al., 2019). Intraoperative measures such as performing patient skin preparation with alcohol-based skin prep, maintaining normal temperature, and maintaining blood glucose less than 200 are recommended to prevent surgical site infections by the CDC and WHO (Berrios-Torres et al., 2017; WHO, 2016). Intraoperative measures such as irrigating the wound, applying antibiotics, drains, and many other factors have been evaluated, but research is inconclusive on their effectiveness (Tan et al., 2020). Postoperative measures such as pharmacological measures, dressing care, suture and staple management, or nutrition did not significantly impact surgical site infections (Tan et al., 2020). Postoperative administration of prophylactic antibiotics does not appear to reduce the risk INFECTION RATES IN POSTERIOR SPINAL FUSIONS 10 of postoperative infection effectively and is not a recommended practice (Berrios-Torres et al., 2017; Tan et al., 2020). Intrawound antibiotic prophylaxis The application of intrawound antibiotics is an increasingly common practice to prevent surgical site infections. One of the most common antibiotics used for intrawound antibiotic prophylaxis is vancomycin (Dodson et al., 2019; Takeuchi et al., 2018). S. aureus, a grampositive bacterium, is a common pathogen in surgical site infections, and vancomycin is particularly effective at inhibiting these bacteria (Dodson et al., 2019). It is theorized that applying an intrawound antibiotic will prevent bacterial invasion and kill bacteria already existing in the wound through high concentrations of antibiotics at the surgical site (Kang et al., 2015). Applying intrawound vancomycin has been associated with decreased surgical site infections (Adogwa et al., 2017; Chotai et al., 2017; Devin et al., 2017; He et al., 2019; Lemans et al., 2019). Several studies have demonstrated the effectiveness of vancomycin powder, reporting a decrease in infection rates from 10.2% to 2.5% (He et al., 2019). In addition to reducing the rate of SSI, it may decrease the severity of the infection and reduce the risk of needing to return to the operating room (Devin et al., 2017). This high concentration at the surgical site seems to limit the growth of staphylococcus and, importantly, MRSA (Adogwa et al., 2017; He et al., 2019). The powder has been shown to reach high local levels but not become absorbed systemically, allowing for inhibition of staph organisms (Adogwa et al., 2017; Murphy et al., 2016). The standard dosage is one to two grams of vancomycin powder applied to the wound, although there is no evidence of which dose is superior (Murphy et al., 2016; Kunakornsawat et al., 2019). Recommendations for application are to apply the vancomycin INFECTION RATES IN POSTERIOR SPINAL FUSIONS 11 suprafascially, or in the muscle layer, as vancomycin can impair bone healing, impair dural repair and increase the risk of toxicity if applied below the fascia (Haimoto et al., 2018). The use of intrawound vancomycin is cost-effective as the average cost of vancomycin powder is $34 for 2 grams (Kang et al., 2015). The application of vancomycin powder is significantly less expensive than the cost of treating a surgical site infection (Kang et al., 2015). Some reported side effects of intrawound vancomycin included nephropathy, ototoxicity, systemic absorption, and culture-negative seroma formation(Ghobrial et al., 2015). These occurred in less than 0.3% of patients (Ghobrial et al., 2015). Additional risks include increasing gram-negative bacterial growth and impaired bone healing (Chotai et al., 2017; Eder et al., 2016; Grabel et al., 2018). Gram-negative bacteria are typically more challenging to treat and more likely to lead to septic shock (Dodson et al., 2019; Grabel et al., 2018). Despite a great deal of research, the effectiveness is still debated (Lemans et al., 2019). Currently, the CDC and WHO do not recommend utilizing antibiotics in incisional wounds to prevent SSIs (Berrios-Torres et al., 2017; WHO, 2016). The FDA has not approved vancomycin for intra-site administration (Kang et al., 2019). Several studies found no significant difference in infection rates (Ludwig do Nascimento, 2019; Kunakornsawat et al., 2019; Takeuchi, 2018). Irrigation of Surgical Site Many surgeons irrigate the surgical incision before closure to prevent surgical site infections, but the irrigation and irrigation solution method varies greatly. Irrigating the wound is believed to be beneficial because the irrigation flushes away any bacteria that may have contaminated the wound, and the irrigation aids in removing damaged tissue that could serve as a medium for bacterial growth (Baker et al., 2020; Markel et al., 2021). The irrigation process is critical in procedures that use implants, as implants tend to attract bacteria and have higher INFECTION RATES IN POSTERIOR SPINAL FUSIONS 12 biofilm formation (Baker et al., 2020). In spinal fusions, bacteria can adhere to the implants and become covered by biofilm, making it harder for the immune system to recognize bacterial contamination until the bacteria are at a potentially life-threatening level (Ahn et al., 2016). Pulse irrigation is beneficial as the irrigator results in higher pressures than a bulb syringe, allowing for more significant biofilm disruption and bacteria removal (Normal et al., 2017). Additionally, the pulse irrigator has decreased bacterial contamination in muscle layers (Ahn et al., 2016, Normal et al., 2017). Lastly, pulse irrigation promotes granulation tissue growth to enhance wound healing and does not result in additional pain postoperatively (Fel & Gu, 2016). A variety of solutions have been used and studied. However, there is still uncertainty about the effectiveness of any irrigation solution (Markel et al., 2021). A Cochrane review by Norman et al. (2017) found low-quality evidence to suggest irrigation is beneficial in reducing surgical site infections. However, Norman et al. (2017) found that antibiotic irrigation may have minimal effect, and clinicians should consider the risk of antibiotic resistance. Betadine is an agent commonly used in irrigation solutions. Betadine has broad-spectrum abilities to kill both gram-positive and gram-negative bacteria and does not result in antibiotic resistance (Onishi et al., 2019). Clorpactin, or sodium oxychlorosene, has been antimicrobial irrigation used to prevent surgical infections since 1955 (Kotechi & Bradford, 2021). Clorpactin has been used in several surgical specialties but is recently used in orthopedic, breast reconstruction, and spinal surgeries (Kotechi & Bradford, 2021; Markel et al., 2020). According to the American Society of Plastic Surgeons, approximately 14% of plastic surgeons report using Clorpactin irrigation in breast reconstruction surgeries primarily due to its ability to penetrate biofilm and its rapid reduction in bacterial load (Dawson et al., 2021). A study by Alentado et al. (2021) found that infection INFECTION RATES IN POSTERIOR SPINAL FUSIONS 13 prevention involving Clorpactin reduced postoperative wound infections in spinal procedures, including elective and emergent cases, and was overall safe and effective. Clorpactin has a relatively neutral pH of 6.5-6.9 and is highly bactericidal by oxidizing cell membranes and destroying biofilm while minimally damaging tissues (Baker et al., 2020; Markel et al., 2020; Kotecki & Bradford, 2021). The pH neutrality makes it less irritating to the tissues while effectively destroying biofilms that is so important in implant surgeries (Kotecki & Bradford, 2021). In a study of osteoblasts, Clorpactin did cause damage to osteoblasts, but the damage was temporary and reversible (Markel et al., 2021). Kotecki & Bradford (2021) found that overall Clorpactin irrigation was comparable to other irrigation methods such as betadine and chlorhexidine. Additionally, Clorpactin is cost-effective as a two-gram vial costs approximately $5 and is prepared by mixing with normal saline (Dawson et al., 2021). Clorpactin may be an excellent irrigation to prevent surgical site infections, but there is limited data on this new approach, particularly in spinal surgeries. Theoretical Framework or Conceptual Model The Johns Hopkins Nursing Evidence-Based Model (JHNEBP) will be utilized as a guide to developing and implementing this clinical inquiry (see Appendix A). The JHNEBP comprises three main phases: the practice question, evidence, and translation (Dang & Dearholt, 2017). The JHNEBP is a model designed to bridge the gap between research findings and patient care (Dang & Dearholt, 2017). The first step includes the practice question, which involves defining the problem, developing an evidence-based question, and identifying the stakeholders (Dang & Dearholt, 2017). The practice question was developed by working with surgeons interested in improving postsurgical outcomes in patients undergoing posterior instrumented spinal fusions. INFECTION RATES IN POSTERIOR SPINAL FUSIONS 14 The problem involves a variation in practice within the healthcare setting and affects quality and financial outcomes. The second phase is referred to as the evidence phase. During this phase, a systematic search for evidence is conducted. This systematic review of literature helps find and evaluate evidence-based knowledge relevant to the clinical question. The systematic search of literature through search engines such as PubMed, CIHAHL, and Cochrane review elicited much research to evaluate. The evidence was graded based on the strength of the individual evidence. The literature was synthesized through a review of the literature. Recommendations for best practice were based on the aggregate results of the evidence search and grading and evaluating the literature. The last phase is translation, which includes translating the evidence into practice (Dang & Dearholt, 2017). An action plan is created during this phase, and implementation occurs (Dang & Dearholt, 2017). After the plan has been implemented, the results are evaluated to determine the action's effectiveness (Dang & Dearholt, 2017). For this project, results will be evaluated to determine if there is a significant difference in postoperative infection rates between the two interventions. The last step of translation includes reporting the stakeholders' outcomes and disseminating the findings (Dang & Dearholt, 2017). This will be done through a dissemination meeting with the stakeholders and creating an educational poster to disseminate at Marian University. Goals, Objectives, and Expected Outcomes This project aims to collect retrospective data to evaluate the effectiveness of an infection control protocol to improve patient outcomes at an Indiana hospital. The results of this study can ultimately improve the quality of care and reduce costs to the hospital. The objective is to INFECTION RATES IN POSTERIOR SPINAL FUSIONS 15 determine if one protocol is significantly more effective at reducing surgical site infections in patients who underwent posterior instrumented spinal fusions. The expected outcome is that the group exposed to the protocol, including irrigation with Clorpactin and application of intrawound vancomycin powder, will have decreased rates of surgical site infections. Project Design/Methods This project was a retrospective chart review on patients who underwent a posterior instrumented spinal fusion from August 2017 through December 2020 at a single-site hospital. Data was collected for all surgeries that involved a posterior approach and instrumentation in cervical, thoracic, and lumbar fusions. Exclusion criteria included patients under 18, infection as an indication for surgery, and anterior approach. The sample includes approximately 1,100 patients divided into two groups based on exposure to infection control protocols. The retrospective design was selected to determine if the infection control protocol significantly decreased surgical site infections in posterior instrumented fusions. Project Site and Population The investigator implemented the project at a hospital facility located in central Indiana specializing in caring for spine disorders. The hospital is in a large suburb of Indianapolis, IN, and attracts patients from across the state. It is a physician-owned hospital with three operating rooms and twenty inpatient beds (Schrag, 2017). Two major surgical groups and several contracted surgeons provide inpatient and outpatient surgical services, pain management, imaging, and physical therapy. The surgeons are comprised of neurosurgeons and orthopedic surgeons. The population will include adult patients who underwent posterior instrumented spinal fusion at this center between 2017-2020. Inclusion criteria comprise of patients who underwent INFECTION RATES IN POSTERIOR SPINAL FUSIONS 16 surgery at this hospital between the specified dates, those greater than or equal to 18 years old at the time of surgery, posterior approach, and single or multilevel fusion involving instrumentation. Only patients with private insurance are approved for surgery at this hospital location. Measurement Instruments To measure the outcomes, data were collected from electronic medical records. Data collected included demographic data such as age (in years) and gender. Health information such as the patients BMI, smoking status, prior spinal surgery, and if the patient had diabetes, and if they had diabetes at time of surgery the most recent hemoglobin A1C. These health factors were chosen as they have been associated with an increased risk of surgical site infection (Traynelis et al., 2013). Additional surgical factors such as if the procedure was one level or multiple levels, length of surgery, and infection control protocol exposure were collected. These are surgical factors that can impact the risk of postoperative surgical site infections (Traynelis et al., 2013). Lastly, infection data was collected, such as if the patient was diagnosed with an infection within 90 days of the procedure, if the infection was deep or superficial, and the organism present. Data Collection Procedures Before data collection, data points were selected with the physicians and investigator. A template was designed in REDCap, a web-based program developed for secure data collection so that data collection is uniform. All data was collected from documents and records created before the investigation, mainly from the electronic medical records. Data was collected on all patients who underwent posterior instrumented spinal fusions between August 1, 2017, and December 31, 2020. All data was collected by the primary investigator. Data collection took place over a period of three months. INFECTION RATES IN POSTERIOR SPINAL FUSIONS 17 Procedure codes were used to identify patients who underwent posterior instrumented spinal fusion surgeries. Infections were identified through ICD-10 diagnosis of wound infection. The patient's age was calculated by age at the time of surgery. Medical and surgical history was collected from preoperative consult, anesthesia preoperative consult, and the surgeon's history and physical. Intraoperative information was gathered from the postoperative surgeon report, anesthesia intraoperative report, and intraoperative nursing report. Medication data was collected from both the postoperative surgical report and verified with the medication administration records. Laboratory values were taken from lab reports. Infection data was collected from microbiology results, ICD-10 codes, and office consult notes. Ethical Considerations/Protection of Human Subjects The Marian Internal Review Board (IRB) and St. Vincent IRB approval were attained before the start of the investigation. The St. Vincent IRB was the IRB of record. The investigator used computers that were encrypted, password-protected, and on a secure network. The investigator logged out of all computers before leaving the workstation and only worked in a private environment. The data was stored in an encrypted cloud-based program, REDCap, that is password protected. Only research staff had access to this database. The research staff included the investigator and two registered nurses who were employees at the hospital and function in a research role. The investigator completed training through the Collaborative Institutional Training Initiative training (CITI program) to learn about ethical research. The investigator also underwent training for Health Insurance Portability and Accountability Act (HIPAA) compliance training at the hospital to promote data safety. INFECTION RATES IN POSTERIOR SPINAL FUSIONS 18 An informed consent waiver was requested as the participants were at minimal risk for harm. The risks included loss of confidentiality. Risks were minimized wherever possible. The waiver was requested because the investigation posed minimal risk to the participants; the waiver would not adversely affect the rights of participants as all HIPPA rules and regulations were followed, data was protected, and the investigation could not practically be carried out without the waiver. Data Analysis and Results Data Analysis Data was de-identified before being exported to an excel spreadsheet for analysis. The total number of patients undergoing posterior instrumented spinal fusion was 1,015. There were 11 postoperative infections identified. The overall rate of infection was 1.1%. The sample was divided into two groups to determine the infection rates and demographic information for each group. An independent statistician was consulted to assist with data analysis. For nominal data, an independent t-test was performed. For categorical variables, a chi-square test of association was performed. These tests were performed using the statistical software program: Statistical Package for the Social Sciences (SPSS, Version 26, IBM Corp.). The groups were numerically coded as "1" being the group exposed to the Clorpactin/vancomycin protocol and "2" being the group not exposed to that protocol. The primary investigator did all coding and analysis of the data. The significance was evaluated at p < .05. A chi-square test was utilized to determine if the groups had similar sample characteristics to determine if the groups were similar. These characteristics included gender, previous spine surgery(yes/no), the number of levels (single or multilevel), smoking status (yes/no), and if the patient was a diabetic(yes/no). An independent sample t-test was run for age, INFECTION RATES IN POSTERIOR SPINAL FUSIONS 19 BMI, length of surgery, and hemoglobin A1C. Additionally, demographic data was analyzed using frequency and percentages for nonparametric variables. For parametric variables, mean, standard, and deviation were recorded. Results The chart review included patients who underwent posterior spinal fusion from August 1, 2017, to December 31, 2020. The sample included a total of 1,015 patients. The average age of the patient was 53.23 years old at the time of the surgery. There were 496 female (48.87%) patients and 519 male (51.13%). The average BMI was 31.52, with the low being a BMI of 17 and a high of 76. Of those patients, 160 (15.76%) were current smokers, and 171 (16.85%) had diabetes (see Appendix B for demographic tables). The group exposed to the infection control protocol including Clorpactin irrigation and vancomycin, or Group A, included 305 charts, while the group not exposed to the infection control protocol, Group B, included 710 charts. Overall, there were no postoperative infections in Group A and 11 postoperative infections in Group B. A chi-square test was utilized to determine if there was a significant difference between the two groups. The results showed a significant difference X(1, n=1015)= 4.777, p= .029. When simply comparing the various intraoperative protocols, there is not a significant difference between using Clorpactin/vancomycin, vancomycin powder, betadine, or no intervention. A one-way ANOVA was utilized to compare the four types of intraoperative protocols and infections. The one-way ANOVA shows F (3,1011)= 1.083, p= .355. This indicates that there is not a significant difference in postoperative infection rates between the four intraoperative measures. INFECTION RATES IN POSTERIOR SPINAL FUSIONS 20 Out of the 1,015 participants, 11 developed postoperative surgical site infections. The infections included nine deep infections and two superficial infections. Of the eleven infections, seven were infected with Staphylococcus aureus (2 MRSA), two with Streptococcus, one with E. coli, and one with Serratia Marcescens. Additionally, the study found nine postoperative seromas (n=9). Group Comparison To determine if the two sample groups were similar, an analysis of the group variables was compared. A chi-square test was performed on gender, previous spine surgery, number of levels, smoking status if the patient had diabetes, and the ASA class. The chi-square test for gender resulted in X (1, 1015)= .072, p= .789. For previous spinal surgery, the X (1,1015)= 1.487, p= .223. Number of levels was X (1,1015)= 8.894, p=.003. Smoking status X(1,1015)= 15.684, p=.000. To compare diabetic patients, X(1, 1015)= .229, p=.632. Lastly, in comparing the ASA class, the X (3,976)= 1.228, p=.746. Group B had a higher proportion of one-level operations than Group A. Also, there was a significantly higher number of people who smoke in group B. An independent t-test was done to look for differences in the group's age, BMI, length of surgery, and hemoglobin A1C results. Age was significantly different with X(1013, n=1015)= 5.982, p=.003. The mean age for Group A was 54.657 (SD= 9.205), while Group B had a mean age of 52.614 (SD=10.289). BMI also showed a significant difference in the values with X(1013, n=1015)= 7.407, p=.006. The mean difference was 1.31 years between the two groups. Group A had a mean BMI of 30.63 (SD= 6.035), and Group B had a mean BMI of 31.917 (SD = 7.254). The length of surgery (p=.925) and HgB A1C (p=.229) were not statistically significant. These statistics show that the groups are not significantly different in most aspects and help INFECTION RATES IN POSTERIOR SPINAL FUSIONS 21 explain that the differences found in infection rates are due to the infection control protocols as opposed to group differences. Discussion Overall, the statistical analysis shows that the group exposed to the infection control protocol including Clorpactin and vancomycin powder resulted in significantly fewer postoperative infections than the control group. The infection control protocol includes many factors such as preoperative optimization of health, drain use, and removal protocols, and postoperative antibiotics. The group exposed to the infection control protocol resulted in zero infections in posterior instrumented spinal fusions between 2017 and 2020. The control group had an overall infection rate was 1.1%, which is considerably lower than the risk of SSI post instrumented spinal fusion in the literature (Rosenthal et al., 2019). While these infection rates are lower than the literature, the goal is to prevent postoperative infections in all patients. When comparing the control group to the protocol group, there were many similarities. If the two groups are similar, then the difference in the protocol is likely to be truly from the protocol and not due to group variation. A statistical difference occurred in BMI, age, smoking rates, and the number of levels. Group A had a statistically significantly higher age than group B and had a higher percentage of multilevel fusions. Group B had a statistically significant higher BMI and smoking status among the patients. This difference may show the difference in preoperative optimization of health before surgery in the two groups. While they were different, Group A had a higher average age which could increase the risk of post-surgical site infection (DiMartino et al., 2019). Additionally, both groups had an average BMI greater than 30, which would place both groups at increased risk for postoperative infection (DiMartino et al., 2019). INFECTION RATES IN POSTERIOR SPINAL FUSIONS 22 Clorpactin has not been well studied, despite its use in surgery since 1955 (Kotechi & Bradford, 2021). Clorpactin irrigation seems to have benefits such as decreasing bacterial load and an ability to break down biofilm (Kotechi & Bradford, 2021). The results from this investigation show that Clorpactin along with vancomycin powder may be beneficial in reducing postoperative infections posterior spinal fusions. While this is a critical aspect of the infection control protocol, not all results can be attributed to the intraoperative measures. The one-way ANOVA did not show a significant difference in infection rates in those exposed to Clorpactin/vancomycin and the other intraoperative infection prevention measures. This simply means that compared to vancomycin powder only, betadine irrigation, or no intervention, the results were not significant enough to indicate that Clorpactin/vancomycin alone resulted in fewer infections. The relatively low number of postoperative infections resulted in a more difficult achievement of statistical power. Additional studies on intraoperative measures would be beneficial to determine the effectiveness of each intervention. This review was limited in that only one hospital was utilized, and the hospital only accepts private insurance, so those on Medicare/Medicaid were excluded. This may result in a homogenous group of sample participants. Additionally, the investigation did not analyze the difference in techniques of application of vancomycin powder, and the use significantly varied. Some surgeons applied as little as a half gram, and others applied up to three grams. One or two grams of vancomycin was the most common range. Lastly, the investigation was limited by time constraints as only one investigator collected and analyzed the data. This investigation would benefit from additional statistical analysis to control for the group variables and additional analysis into the factors associated with infections. A multivariable analysis would be beneficial to see if any other variables were a risk factor. INFECTION RATES IN POSTERIOR SPINAL FUSIONS 23 Additional research needs to be conducted on the use of Clorpactin as irrigation in surgeries, mainly instrumented spinal surgeries. Randomized controlled studies, prospective studies, or studies with a larger population would be beneficial to determine the overall effectiveness of these protocols and particularly the use of intraoperative interventions such as Clorpactin or vancomycin. The overall infection control protocol, however, is successful, as it resulted in significantly fewer infections than the control group. The key findings of this investigation are that a comprehensive infection control protocol including the use of Clorpactin and vancomycin showed a decrease in postoperative infections. This adds to the literature that Clorpactin and vancomycin powder show promise as a method to help prevent surgical site infections. Conclusion In conclusion, surgical site infections are detrimental to the patient and costly to the healthcare system. It is in the best interest of patients and healthcare to reduce, minimize, or eradicate surgical site infections. Methodical management to reduce infections, including preoperative patient optimization, intraoperative measures, and postoperative measures should be utilized. Through this retrospective review, with methodical interventions along with the protocol of Clorpactin irrigation and vancomycin powder, surgical site infections can be reduced. INFECTION RATES IN POSTERIOR SPINAL FUSIONS 24 References Adogwa, O., Elsamadicy, A. A., Sergesketter, A., Vuong, V. D., Mehta, A. I., Vasquez, R. A., Cheng, J., Bagley, C. A., & Karikari, I. O. (2017). Prophylactic use of intraoperative vancomycin powder and postoperative infection: An analysis of microbiological patterns in 1200 consecutive surgical cases. Journal of Neurosurgery: Spine, 27(3), 328334. https://doi.org/10.3171/2017.2.spine161310 Agency for Healthcare Research and Quality. (September 2019). Surgical Site Infections (Patient safety primer) [Patient safety primer]. AHRQ. https://doi.org/https://psnet.ahrq.gov/primer/surgical-site-infections Ahn, D., Lee, S., Moon, S., Kim, D., Hong, S., & Shin, W. (2016). Bulb syringe and pulsed irrigation. Clinical Spine Surgery: A Spine Publication, 29(1), 3437. https://doi.org/10.1097/bsd.0000000000000068 Alentado, V. J., Berwanger, R. P., Konesco, A. M., Potts, A. J., Potts, C. A., Stockwell, D. W., Dbeibo, L., DePowell, J. J., Horn, E. M., Khairi, S. A., McCanna, S. P., Mobasser, J.-P., Rodgers, R. B., & Potts, E. 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The Spine Journal, 19(2), 261266. https://doi.org/10.1016/j.spinee.2018.05.036 Haimoto, S., Schr, R. T., Nishimura, Y., Hara, M., Wakabayashi, T., & Ginsberg, H. J. (2018). Reduction in surgical site infection with suprafascial intrawound application of vancomycin powder in instrumented posterior spinal fusion: A retrospective case-control study. Journal of Neurosurgery: Spine, 29(2), 193198. https://doi.org/10.3171/2017.12.spine17997 He, X., Sun, T., Wang, J., Li, G., & Fei, Q. (2019). Application of vancomycin powder to reduce surgical infection and deep surgical infection in spinal surgery. Clinical Spine Surgery: A Spine Publication, 32(4), 150163. https://doi.org/10.1097/bsd.0000000000000778 Janssen, D. C., van Kuijk, S. J., dAumerie, B., & Willems, P. (2019). A prediction model of surgical site infection after instrumented thoracolumbar spine surgery in adults. 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The effect of different irrigation solutions on the cytotoxicity and recovery potential of human osteoblast cells in vitro. Arthroplasty Today, 7, 120125. https://doi.org/10.1016/j.artd.2020.11.004 INFECTION RATES IN POSTERIOR SPINAL FUSIONS 29 McGirt, M. J., Parker, S. L., Chotai, S., Pfortmiller, D., Sorenson, J. M., Foley, K., & Asher, A. L. (2017). Predictors of extended length of stay, discharge to inpatient rehab, and hospital readmission following elective lumbar spine surgery: Introduction of the carolinasemmes grading scale. Journal of Neurosurgery: Spine, 27(4), 382390. https://doi.org/10.3171/2016.12.spine16928 Murphy, E. P., Curtin, M., Shafqat, A., Byrne, F., Jadaan, M., & Rahall, E. (2016). A review of the application of vancomycin powder to posterior spinal fusion wounds with a focus on side effects and infection. a prospective study. European Journal of Orthopaedic Surgery & Traumatology, 27(2), 187191. https://doi.org/10.1007/s00590-016-1878-4 Norman, G., Atkinson, R. A., Smith, T. A., Rowlands, C., Rithalia, A. D., Crosbie, E. J., & Dumville, J. C. (2017). Intracavity lavage and wound irrigation for prevention of surgical site infection. Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.cd012234.pub2 Onishi, Y., Masuda, K., Tozawa, K., & Karita, T. (2019). Outcomes of an intraoperative povidone-iodine irrigation protocol in spinal surgery for surgical site infection prevention. Clinical Spine Surgery: A Spine Publication, 32(10), E449E452. https://doi.org/10.1097/bsd.0000000000000908 Pluemvitayaporn, T., Kunakornsawat, S., Sirikajohnirun, S., Piyaskulkaew, C., Pruttikul, P., Kittithamvongs, P., & Pongpinyopap, W. (2019). Comparison between 1 g and 2 g of intrawound vancomycin powder application for prophylaxis in posterior instrumented thoracic or lumbosacral spine surgery: A preliminary report. Asian Journal of Neurosurgery, 14(3), 710. https://doi.org/10.4103/ajns.ajns_294_17 INFECTION RATES IN POSTERIOR SPINAL FUSIONS 30 Reisener, M.-J., Pumberger, M., Shue, J., Girardi, F. P., & Hughes, A. P. (2020). Trends in lumbar spinal fusiona literature review. Journal of Spine Surgery, 6(4), 752761. https://doi.org/10.21037/jss-20-492 Rosenthal, N. A., Heinrich, K. H., Chung, J., & Yu, H. (2019). Cost and hospital resource utilization of staphylococcus aureus infection post elective posterior instrumented spinal fusion surgeries in u.s. hospitals: A retrospective cohort study. Spine, 44(9), 637646. https://doi.org/10.1097/brs.0000000000002898 Schrag, A. (2017). Indiana Spine Hospital opens- 4 things to know. Becker's Spine Review. https://www.beckersspine.com/orthopedic-spine-practices-improving-profits/item/36583indiana-spine-hospital-opens-4-things-toknow.html#:~:text=4.,was%20celebrated%20on%20April%2030. Takeuchi, M., Wakao, N., Kamiya, M., Hirasawa, A., Murotani, K., & Takayasu, M. (2018). A double-blind randomized controlled trial of the local application of vancomycin versus ampicillin powder into the operative field for thoracic and/or lumbar fusions. Journal of Neurosurgery: Spine, 29(5), 553559. https://doi.org/10.3171/2018.3.spine171111 Tan, T., Lee, H., Huang, M. S., Rutges, J., Marion, T. E., Mathew, J., Fitzgerald, M., Gonzalvo, A., Hunn, M. K., Kwon, B. K., Dvorak, M. F., & Tee, J. (2020). Prophylactic postoperative measures to minimize surgical site infections in spine surgery: Systematic review and evidence summary. The Spine Journal, 20(3), 435447. https://doi.org/10.1016/j.spinee.2019.09.013 Tomov, M., Wanderman, N., Berbari, E., Currier, B., Yaszemski, M., Nassr, A., Huddleston, P., Bydon, M., & Freedman, B. (2019). An empiric analysis of 5 counter measures against surgical site infections following spine surgerya pragmatic approach and review of the INFECTION RATES IN POSTERIOR SPINAL FUSIONS 31 literature. The Spine Journal, 19(2), 267275. https://doi.org/10.1016/j.spinee.2018.05.043 Traynelis, V., Kasliwal, M., & Tan, L. (2013). Infection with spinal instrumentation: Review of pathogenesis, diagnosis, prevention, and management. Surgical Neurology International, 4(6), 392. https://doi.org/10.4103/2152-7806.120783 World Health Organization. (2016). Global Guidelines for the Prevention of Surgical Site Infections. https://apps.who.int/iris/bitstream/handle/10665/250680/9789241549882eng.pdf?sequence=8 INFECTION RATES IN POSTERIOR SPINAL FUSIONS Appendix A (Dang & Dearholt, 2017) 32 INFECTION RATES IN POSTERIOR SPINAL FUSIONS 33 Appendix B Demographic and Clinical Characteristics of the Sample n=1015 Variable Gender Female Male Previous Spine Surgery Yes No Number of Levels One Multiple Smoker Yes No Diabetic Yes No Postoperative Infection Yes No Age BMI Length of Surgery HgB A1C N % 496 519 48.9 51.1 463 552 45.6 54.4 650 364 64 35.9 160 855 15.8 84.2 171 844 16.8 83.2 11 1004 1.1 98.9 Standard Deviation 10.0159 6.93346 86.924 1.256 Mean 53.23 31.5225 212.55 6.95 Range 18-76 17.5-73.36 51-783 5-12 INFECTION RATES IN POSTERIOR SPINAL FUSIONS 34 Demographic and Clinical Characteristics of Group A n=305 Variable Gender Female Male Previous Spine Surgery Yes No Number of Levels One Multiple Smoker Yes No Diabetic Yes No Postoperative Infection Yes No Age BMI Length of Surgery HgB A1C n % 151 154 49.5% 50.5% 148 157 51.5 48.5 174 130 57.0 42.6 27 278 8.9 91.1 54 251 17.7 82.3 0 305 0 100 Standard Deviation 9.2055 6.0352 66.45 1.451 54.66 30.60 212.15 7.12 Mean Range 18-73 18.8-53.5 88-517 5-12 INFECTION RATES IN POSTERIOR SPINAL FUSIONS Demographic and Clinical Characteristics of Group B n= 710 Variable n % Gender Female 345 48.6 Male 365 51.4 Previous Spine Surgery Yes 315 44.4 No 395 55.6 Number of Levels One 476 67.0 Multiple 234 33.0 Smoker Yes 133 18.7 No 577 81.3 Diabetic Yes 117 16.5 No 593 83.5 Postoperative Infection Yes 11 1.5 No 699 98.5 Mean Standard Deviation Age 52.61 10.2898 BMI 31.92 7.25374 Length of Surgery 212.72 94.408 HgB A1C 6.87 1.141 35 Range 18-76 17.5-73 51-783 5-11  ...

... 1 A Retrospective Chart Review Comparing Ultrasound Guided Verses Landmark Intravenous Access David R. Ertel Marian University: Leighton School of Nursing NSG 708: Doctor of Nursing Practice Project Dr. Tara Fox October 1, 2021 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS COPYRIGHT BY DAVID R. ERTEL 2021 2 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 3 Abstract In 1984, Ultrasound-Guided (USG) Intravenous (IV) access was first used to place central venous catheters (CVC) in real-time. This led to increased success rates, reduced procedural times, decreased site associated complications, and a standard of care. As USG technology and teaching methods for CVC placement have improved, studies suggest this technique could also be translated into peripheral intravenous (PIV) placement. A retrospective chart review was conducted at an emergency department within a large healthcare facility to determine the reliability of USG PIVs when compared to landmark PIVs. The principal investigator reviewed the charts of adult inpatients admitted into the hospital from the Emergency Department (ED) comparing those who acquired landmark IV verses USG IV access to assess overall reliability. The data included IV survival rates, success rates, and site complications. 30 landmark and 17 USG PIVs were reviewed. Among the landmark PIVS, survival rates and success rates could not be measured. No site complications for landmark PIVs could be found. Among the USG PIVs, survival rates of only three could be found out of 17. No success rates could be measured. Only four site complications or reasons for PIV discontinuation could be found, including two counts of occlusion, one expiration, and one catheter damaged. In conclusion, due to limitations and lack of data found in this review, significance between variables could not be determined. Keywords: ultrasound-guided peripheral venous access, landmark peripheral venous access, ultrasonography, site complications ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 4 Contents Introduction ................................................................................................................................... 6 Background .................................................................................................................................. 6 The Difference Between Ultrasound-Guided and Landmark Peripheral IVs ............................ 7 Site Complications .................................................................................................................... 9 Problem Statement ................................................................................................................... 9 Search Methodology..................................................................................................................... 9 Literature Review........................................................................................................................ 10 Outcome Measurement Selection .......................................................................................... 10 Barriers ................................................................................................................................... 10 Patient Outcomes/Safety ........................................................................................................ 11 Site Complications .................................................................................................................. 12 IV Success and Survival Rate ................................................................................................ 13 Theoretical Framework ............................................................................................................... 14 Identify the problem ................................................................................................................ 15 Adapt the Knowledge ............................................................................................................. 15 Assess Barriers ...................................................................................................................... 15 Select, Adjust, and Implement Interventions .......................................................................... 15 Evaluate Outcomes ................................................................................................................ 15 Goals, Objectives and Expected Outcomes ............................................................................... 15 Project Design ............................................................................................................................ 15 Methods ...................................................................................................................................... 16 Quality Measures.................................................................................................................... 16 Project Site and Population .................................................................................................... 16 Inclusion and Exclusion Criteria ............................................................................................. 16 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 5 Sampling Procedures and Sample Size ................................................................................. 17 Data Collection ....................................................................................................................... 17 Data Analysis.......................................................................................................................... 18 Results........................................................................................................................................ 18 Discussion .................................................................................................................................. 18 Limitations .............................................................................................................................. 18 Future Directions .................................................................................................................... 22 Conclusion .................................................................................................................................. 22 References ................................................................................................................................. 23 Appendix A ................................................................................................................................. 30 Appendix B ................................................................................................................................. 33 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 6 A Retrospective Chart Review Comparing Ultrasound Guided Verses Landmark Intravenous Access According to the Centers for Disease Control and Prevention (CDC), 130 million people check into the ED every year. 16.2 million are admitted as inpatients with the vast majority requiring intravenous access during their stay. Out of all these patients, roughly 150-200 million PIVs are placed nationwide making it the most used procedure in the ED (CDC, 2018). Although, landmark PIVs can be essential for treating the sick, they do not come without complications or room for improvement. Landmark PIVs have been associated with site complications such as phlebitis, infiltration, extravasation, and infection. Insertion of landmark PIVs require a level of competency by the executant that can be affected by the patient anatomy. In turn, the first pass success rate of landmark IV placement can never be a guarantee. When landmark PIV attempts fail too many times, it can delay care or result in more invasive procedures, such as CVC placement1 (Patel et al., 2019; Poovelkunnel et al., 2020). USG PIV placement is a method increasingly used in EDs for patients deemed difficult sticks who may otherwise require a CVC. In hopes of reducing the incidence of CVC placement, the purpose of this project is to determine the overall reliability of USG PIV when compared to landmark PIVs. Background In 1984, the USG IV access was first used to place CVCs in real-time (Pare et al., 2018). This led to increased success rates, reduced procedural times, decreased site associated complications, decreased procedural accidence, and a standard of care for CVCs (Pare et al., 2019; Zerati et al., 2017). As USG technology and teaching methods for CVC placement have 1 When compared to PIVs, CVCs are associated with increased rates of infection, thrombosis, and longer hospital admissions resulting in higher costs for both patients and hospitals (Patel et al., 2019). ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 7 improved, it is reasonable to suggest this technique could also be translated into PIV placement (Pare et al., 2018). Currently, there is no gold standard for USG PIV use, which could reflect its novelty and suggest a need for more research (Pare et al., 2018). As we know it today, landmark PIV therapy has been around for almost a century and has been the mainstay for venous access (Millam, 1996). The first portable US machine did not become available for use until 1975, which was first recorded being used for PIVs in 1999 (Woo et al., 2002; Keyes et al., 1999). Thus, the USG method is much younger when compared to landmark PIVs and is now finding its purpose in PIV placement. With landmark PIV insertions being dependable and low risk procedures, it is reasonable to question the necessity for ultrasonography (Sou et al., 2017). However, with PIVs being the most used procedure in the ED, its improvement in quality, though it may only be a slight improvement per insertion, can have a sizeable impact overall. Hospitals who have adopted USG PIVs have experienced higher patient satisfaction with increased success rates and even reduced pain during insertion (Sou et al., 2017). The Difference Between Ultrasound-Guided and Landmark Peripheral IVs Materials When comparing materials needed to place landmark peripheral IVs verses ultrasoundguided peripheral IVs, most of them are identical (tourniquet, disinfectant swab, IV catheter, securing device, saline flush, and extension tubing). When using USG PIVs, the only added materials are longer IV catheters and the addition of a portable US machine, which also needs access to electricity to operate. The longer IV catheters allow for deeper vein access only viewable on a portable US machine (Gottlieb et al., 2017; Levey et al., 2021). Technique Landmark PIV. When using the landmark technique, the clinician places a tourniquet on the preferred arm of a patient. By using the naked eye and touch, the most patent vein is identified and selected for insertion. Selected veins are most commonly located on the hand, ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 8 forearm, antecubital (bend of the arm), and upper arm (Beecham & Tacklin, 2021). The area is then cleaned with the disinfectant swab and allowed a brief moment to dry. At around a 45degree angle, the IV catheter is inserted into the skin at the central most visible portion of the vein. After insertion, to ensure proper placement, a flash of venous return in the tubing should occur (Levey et al., 2021). This allows for a small amount of blood to flow between the needle and catheter into a small chamber of the device where it can be visualized (Beecham & Tackling, 2021). The IV catheter is then inserted slightly further to get passed the needles bevel or angled tip made to sharpen the needle. The clinician is now clear to advance the catheter without advancing the needle and device. After attaching the extension tubing, a successful IV placement is confirmed by administering the saline flush. While administering the saline flush, very little or no resistance should be felt, acute swelling at or above the site should not occur, and intense complaints of pain from the patient should not happen (Levey et al., 2021; Soria et al., 2021). USG PIV. When using USG PIV, the clinician positions a portable US machine at eye level. A tourniquet is place on the preferred arm of the patient. Sterile propylene glycol gel is placed on the arm to reduce static and improve visualization on the US monitor (Gottlieb et al., 2017). The handheld doppler attached to the portable US machine is placed on the arm so veins can be visualized on the US monitor. The depth the monitor visualizes is typically set to 3.1 centimeters. This allows for deeper veins to be identified and selected for placement that would otherwise be unpalpable. Using the doppler in contact with the skin, the clinician adds gentle downward pressure over vessels determining if it collapses, being a vein, or has a pulse, being an artery, which would not be used for peripheral access (McMenamin et al., 2020). After confirming it is a vein, more pressure is applied to fully collapse the vein to ensure no clot is present. Once the clinician selects a patent vein, they cleanse the area with the disinfectant swab, line up the IV catheter just before the doppler, then inserts it into the skin. The clinician then keeps his or her eyes on the monitor as they guide the tip of the IV catheter to the vein. ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 9 Once the IV catheter has entered the central most portion of the vein, it is then advanced further down the canal of the vein until a drop in resistance is felt. The catheter is then advanced while holding the needle and device in position. The propylene glycol gel residue is carefully wiped off with a clean towel to allow the securing device to stick to the skin. A successful USG PIV placement is confirmed by placing the US doppler above the IV site and visualizing the vein while a saline flush is administered (Munshey et al., 2020). The IV will have a flash in the chamber when the catheter is in place, but checking for this is not necessary if the catheter residing within the vein can be visualized on the US monitor. The vein should remain intact without any suspicion of infiltration (Gottlieb et al., 2017). Site Complications Common site complications associated with PIVs include phlebitis, infiltration, and extravasation (Favot et al., 2019; Gottlieb et al., 2017; Levi & Sivapalaratnam, 2020; Mandal & Raghu, 2019). Phlebitis is vessel wall inflammation causing redness, pain, and edema at the site as a result of friction from the catheter over time (Mandal & Raghu, 2019). Infiltration and extravasation are used to describe a dislodged IV catheter passing fluid to the surrounding tissue. Infiltration leakage of non-irritating fluid, whereas extravasation is the leakage of irritating fluid (Favot et al., 2019; Levi & Sivapalaratnam, 2020). Problem Statement For patients admitted as inpatients from the ED, how does the effectiveness and safety of the USG method compare to the landmark method for PIV placement? Search Methodology Databases searched for literature were Google Scholar, Hackelmeier Memorial Online Library, and PubMed per recommendation by the Catholic university in which this project will be submitted. The search terms and phrases, ultrasound guided vascular access, ultrasound guided peripheral access, emergency department, ultrasonography, central venous catheter, landmark peripheral venous access, barriers to ultrasound guided peripheral ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 10 access, ultrasound guided peripheral phlebitis/infiltration/extravasation, and peripheral vascular access were used. Out of 43 articles found, 24 were selected related to ultrasound guided vascular access and landmark peripheral access. Age of participants within an articles sample pool was not considered for this literature review. Also, size and location of the facility where the study was conducted, and age of patients were not considered. Inclusion criteria were articles had to be published within the last 5 years dated between 2016 and 2021 and were written in the English language or had been translated to the English language. Exclusion criteria were articles pertaining to IV placement in the internal jugular vein, subclavian vein, or arterial access. Literature Review Outcome Measurement Selection To make this literature review as thorough, yet simple, as possible, the selection of outcome measurements was based on commonalities seen among articles. The outcome measurements include barriers to USG PIV implementation, patient outcomes/safety, site complications, and IV success/survival rates. The selection of specific site complications for measure was based on those showing the highest incidence rates. These include phlebitis, infiltration, extravasation, and infection. Barriers There are a multitude of barriers to implementing the USG PIV method. Some of these barriers include ultrasound (US) machine availability, staff resistance, and cost (Archer-Jones et al., 2020; Schmidt et al., 2019). US machine availability can be a significant barrier to utilizing USG PIVs, because multiple patients may need venous access in a timely manner and only one portable US machine resides in the entire department (Archer-Jones et al., 2020). This makes the landmark method much more tempting to try on a patient with known difficult access with the interest in saving time rather than a successful first pass insertion. When patients are deemed as difficult sticks, the USG method is successful 90% of the time (Beecham & Tackling, 2021). ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 11 Nurses and providers who are reluctant report that they fear losing their skills in the landmark technique. Also, some nurses and providers report simply not feeling the need for USG PIVs even when an US machine is available (Schmidt et al., 2019). The time and practice required to setup the equipment and master the skill is also a significant barrier to utilizing the USG PIV method (Archer-Jones et al., 2020; Schmidt et al., 2019). Another major barrier to implementing USG PIV is the cost of a portable US machine. The cost of a portable US machine can range anywhere from $8,000 to $55,000 per unit (Morata et al., 2017). Landmark intravenous catheters are slightly cheaper than what is needed for higher success rates utilizing USG PIVs, which use tubing almost twice the length (Bahl et al., 2019). When considering the additional cost of the longer catheter tubing and upfront portable US machine costs, studies show traditional peripheral intravenous placement costs roughly $32 per attempt at an average of 3.7 attempts to successfully place, whereas USG PIVs is around $45 per attempt averaging only 1.7 attempts. Therefore, USG PIVs have the potential of being more cost-effective when considering the reduced attempts typically needed for placement. The average cost would save $41.90 per patient along with improved customer satisfaction (Beecham & Tackling, 2021; Morata et al., 2017). Patient Outcomes/Safety Traditional peripheral IVs are frequently used in emergency departments and patients prefer USG PIVs over landmark IVs (Galen & Southern, 2018). Failed attempts can result in pain, anxiety, and site complications. Furthermore, subsequent attempts increase the probability of occurrence (Archer-Jones, 2020; Van Loon et al., 2018). Studies show about 26% of patients need multiple attempts to successfully place landmark PIVs. A meta-analysis shows the USG PIV first pass success rate is more than double when compared to landmark peripheral IVs, which can ultimately reduce negative outcomes, including satisfaction for patients (ArcherJones, 2020). In a study with a sample size of 839, no complications related to infection were developed via USG PIVs (Duran-Gehring et al., 2016). Other studies also showcase an ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 12 absence or a substantial reduction in complications associated with bloodstream infection or thrombosis (Balceniuk et al., 2020; Scoppettuolo et al., 2016). Site Complications Phlebitis Without differentiating landmark verses USG PIVs, the incidence of phlebitis is around 30% (Lv & Zhang, 2019). Factors that are associated with increased rates of phlebitis include the administration of drugs, blood products, larger catheter gauges, and insertion during emergent situations (Mandal & Raghu, 2019). The average time from the initiation to removal due to phlebitis is around 83.5 hours (Lv & Zhang, 2019; Mandal & Raghu, 2019, Vinograd et al., 2018). Decreased rates of phlebitis follow when the catheter tip was inserted at an angle less than 5.8 degrees (Tanabe et al., 2016). Infiltration/Extravasation A study where contrast was administered to patients 29,508 times, 291 being placed via US guided technique, there were 74 (0.25%) occurrences of extravasation. There were 12 (4.1%) instances of extravasation with the US PIV and 62 (0.21%) with landmark PIVs. This shows an 3.9% higher risk of contrast extravasation with US guided IVs when compared to landmark IVs (Favot et al., 2019). The higher extravasation rate can be attributed to an inadequate catheter length not fully within the vein causing them to dislodge (Bridey et al., 2018). In another study, infiltration was the most common reason for IV failure. The failure rates for landmark IVs ranges between 19-25%, USG PIVs ranged from 45-56% (Blanco, 2019). Infection Probe covers and adhesive films have been used by hospitals to further reduce the incidence of infection when using USG PIVs. More studies are needed to adequately demonstrate if these added interventions make any difference. Regardless, two studies show no difference in infection rates when comparing landmark PIVs and USG PIVs (Bridey et al., 2018; Gottlieb et al., 2017). ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 13 When comparing longer verses shorter catheter tubing, one study showed no instances of infection (Bahl et al., 2020). In another study with a sample size of 71, who all received USG PIVs, only one instance of bloodstream infection was recorded (Fabiani et al., 2016). This is likely due to infection rates having a stronger correlation to how long a PIV remains idol in a vein (Alexandrou et al., 2018). Regardless of tubing size or insertion method, routinely replacing or removing PIVs every 72 to 96 hours is recommended to reduce chances of infection (Takashima et al., 2021). This is coupled with adequate surveillance and early identification of site infection so PIVs can be removed before complications worsen (Alexandrou et al., 2018). IV Success and Survival Rate Success Rate There are significantly high first pass success rates utilizing USG PIV (Archer-Jones et al., 2020; Asao et al., 2019; Bahl et al., 2019; Balceniuk et al., 2020; Duran-Gehring et al., 2016; Maizel et al., 2016; McCarthy et al., 2016; Morata et al., 2017; Stolz et al., 2016; Van Loon et al., 2018; Vinograd et al., 2018). Also, it takes much less time to achieve venous access with USG PIVs (Bahl et al., 2019; Maizel et al., 2016). From the time the catheter needle touches the skin to stabilized placement, the USG technique takes an average of 16.4 to 39.s seconds, whereas the landmark technique takes an average of 30.1 to 70.4 seconds (Maizel et al., 2016). Reduced insertion times utilizes the USG technique are particularly true for patients with difficult access (Gottlieb et al., 2017). There are variances in technique and competencies, which plays a part in successful attempts (Liu et al., 2018). One study shows USG PIVs being inferior with 65% being successful within the first two attempts when compared to landmark PIVs at 84% (Otani et al., 2018). The difference, when compared to other studies, is the technique used to place USG PIVs. This study measured the success rate of USG PIVs using two operators, one inserting the catheter and the other visualizing and manning the US machine (Otani et al., 2018). On the contrary, a significant number of studies show high success rates when only one operator inserts the USG ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 14 PIV (Archer-Jones et al., 2020; Asao et al., 2019; Bahl et al., 2019; Blanco et al., 2019; Balceniuk et al., 2020; Duran-Gehring et al., 2016; Maizel et al., 2016; McCarthy et al., 2016; Morata et al., 2017; Stolz et al., 2016; Van Loon et al., 2018; Vinograd et al., 2018). Some show success rates as high as 78.4 %, 90%, even 100% (Asao et al., 2019; Bahl et al., 2019; Blanco et al., 2019). Survival Rates The longer the catheter, the longer the PIV survival rate. In a prospective study using two catheters varying in length, one being a standard long gauge catheter of 4.78 cm and the other an extended dwell measuring 6 cm, they found the longer catheter survived almost three times longer than the shorter. The median survival rate of the longer catheters was 4.04 days, whereas the standard long catheters lasted 1.25 days (Bahl et al., 2019). As the percentage of catheter dwelling inside the vein increases, the likelihood of site complications resulting in PIV removal decreases (Pandurangadu et al., 2018). Other studies show USG PIVs surviving even longer reaching up to 6 days. In this particular study, the majority of these were discontinued not from site complications, but from no longer being needed (Vinograd et al., 2018). Theoretical Framework Dr. Ian Graham and colleagues Knowledge-to-Action (KTA) model is a framework based on the creation of knowledge and applying it. The use of the word action as opposed to practice is to promote a wider scope of users and not solely clinicians. The KTA model encompasses seven phases: identify the problem; adapt the knowledge; assess barriers; select, adjust, and implement interventions; monitor knowledge use; evaluative outcomes; and sustain knowledge use. It can be visualized as a funnel where broader and more generalized inquiries start at the mouth and tailored accordingly throughout the process until the knowledge is adopted and implemented (White et al., 2016). For this retrospective chart review, the following five of the seven phases will be used as a framework: ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 15 Identify the problem With PIV placement being the most used procedure within the ED, can success rates, survival rates, and site complications be reduced utilizing the USG method? Adapt the Knowledge As chart reviews were conducted, variables were included, excluded, or altered dependent on what can be seen and what was pertinent to the data. Assess Barriers Limitations to this retrospective chart review were identified dependent on what was found within the data. Some barriers included what clinicians have or have not charted or what can be viewed through a student login. Select, Adjust, and Implement Interventions Site complications, success rates, and survival rates mentioned previously was the focal point of this review, but additional variables discovered in the process were included as they may or may not be significant and/or meaningful. Evaluate Outcomes Target variables regarding USG and landmark PIVs were compared to illustrate what is significant and/or meaningful. Goals, Objectives and Expected Outcomes The main goal of this retrospective chart review is to determine if USG verses landmark PIVs show better success rates, survival rates, and less site complications. For the large healthcare facility this review is being conducted, another goal is to set a benchmark for USG PIV use. Lastly, it is expected this review will encourage the large healthcare facility to implement more studies, policies, and/or trials to further assess the value of USG PIVs. Project Design The principal investigator conducted a non-experimental retrospective review with a convenience sample. Per the large healthcare facility, patient consent was not required as it ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 16 was a standard of care meaning this study utilized existing data where subjects could not be identified. This project was not funded by any entities. There were no prior IRB approvals. During the month of June, the goal was to select and review 30 adult patient charts who had USG PIV and 30 adult patient charts who had a landmark PIV between January 1st and May 1st of 2021. This data was collected by the principal investigator alone. To maintain confidentiality, patients were deidentified and substituted with numerals in the order they were selected. Sensitive data was kept on an Excel sheet in a password protected hard drive. Methods Quality Measures Before this retrospective chart review could be submitted to the IRB, various steps had to be completed to improve patient confidentiality and overall quality. To enhance patient confidentiality, extensive Collaborative Institutional Training Initiative modules were completed through both the Catholic university and large healthcare facility. The project proposal was presented to the healthcare facilitys research committee, revised, then presented a second time to the same committee before being approved for submission to the IRB. This project was submitted to and approved by the IRB at the healthcare facility and the Catholic university. Project Site and Population Data from patients admitted as inpatients from the ED was collected from a large hospital which staffed 335 beds and had a 77 bed ED. The ED treats approximately 150 to 250 patients per day where an average of 10% of those patients are admitted. Within this ED, USG PIVs are placed for patients daily. Inclusion and Exclusion Criteria Inclusion criteria were adult patients 18 years and older, who were admitted from the ED into the hospital and had either a landmark or USG PIV placed at some point during their stay. Exclusion criteria were pediatric patients 17 years and younger, obtained a PIV prior to their ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 17 arrival to the ED, PIVs placed during a code blue event2, had IVs placed in the internal jugular vein, subclavian vein, or artery, protected populations (prisoners), or inpatients who were direct admits bypassing the ED. Sampling Procedures and Sample Size Due to delays on receiving data from the analytics request, the data collection was implemented during the entire month of August. The data report pulled 509 PIVs placed on patients admitted as inpatients from the ED into the hospital between January 1st and May 1st of 2021. The charts were not pulled per patient, but rather per PIV. This means the charts of patients who had multiple PIVs placed during their stay were pulled an additional time per PIV. The intended sample size was 30 landmark and 30 USG PIVs. Out of 509 charts, well over 30 landmark PIVs were available, but only 17 USG PIVs were available for selection. Charts were listed in chronological order, so to help prevent a patients chart from being pulled multiple times, starting from January, every eighth chart was selected until 30 landmark PIVs were selected. Selecting every eighth chart allowed for the widest gap between 30 charts while stretching across the entire timeframe. Since only 17 USG PIVs met inclusion criteria, all were selected for review. Data Collection To ensure patient confidentiality, the principal investigator collected data in a locked private room within the healthcare facility using the hospitals computer. Each selected chart was reviewed using a student login provided by the healthcare facility. An Excel spreadsheet was used to input yes/no information associated with patient demographics and PIV measurements including, admission length of stay, gender, age, incidence of site complications, PIV success rates, and PIV survival rates. 2 An emergency code used to alert staff of a patient experiencing a critical status. Some examples include cardiac or respiratory arrest (Gadhoumi, 2021). ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 18 Data Analysis To measure landmark verses USG PIVs, variables would have been compared using Pearsons Correlation Coefficient. However, once the retrospective review reached this phase, enough data was missing to be insufficient for measurement. This was validated by a statistician from the healthcare facility, who also stated more data was needed for analysis. Results 30 landmark and 17 USG PIVs were reviewed. There were 14 (46.7%) females who had landmark and 13 (76.5%) who had USG PIV placement; and 16 (53.3%) males who had landmark and 4 (23.5%) who had USG PIV placement. Average age of patients with USG PIVs was 59.059 years and 60 years for patients with landmark PIVs. The average admission length of stay for patients with USG PIVs was 249:16 hours (hrs.) and 81:01 hrs. for patients with landmark PIVs (see Appendix A). Data was missing or unobtainable for success rates for all 30 landmark PIVs and all 17 USG PIVs. Data was missing or unobtainable for survival rates for all 30 landmark PIVs and 14 USG PIVs. The three remaining USG PIVs showed survival rates of 4:55 hrs., 21:35 hrs., and 31:31 hrs. averaging 19:34 hrs. Data was missing or unobtainable for site complications for all 30 landmark PIVs and 13 USG PIVs. The four remaining USG PIVs showed 2 counts of occlusion, 1 count of catheter damage or other, and 1 count of expiration. Due to amount of missing data, Pearsons Correlation Coefficient could not be implemented. No incidences of phlebitis, infiltration, extravasation, of infections were found (see Appendix B). Discussion Limitations Sample Size Due to the significantly lower sample size of USG PIVs, the protocol for selecting charts for review could not be implemented consistently for both landmark and USG PIVs. In an attempt to make both variables comparable, all USG PIVs that met inclusion criteria were included, which hinders the validity of this comparison. If the protocol was applied to the USG ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 19 PVIs in the same way as the landmark PIVs, the USG PIV sample size would have been significantly smaller. Missing Data Limitations of this retrospective review was predominately a lack of data available and/or usable to measure success rates, survival rates, and site complications. This could be a result of the student login used to conduct chart reviews having reduced access. The student login was also crosschecked by a clinical nurse specialist who also confirmed the obscure layout it showed when compared to a typical employee login. If not a lack of access, the missing data could be a result of untraceable charting or a fault within the electronic charting system. No prior studies have been conducted comparing landmark verses USG PIVs within this large healthcare facility, therefore needed variables for measurement within the charting system may not be marked in any way for tracking. When reviewing charts, the only way to view reasons for removal of a particular PIV, the employee charting its removal would have to be extra prudent by manually charting an additional comment. Success Rates. The goal with success rates was to look at how many times an executant charted a failed attempt before charting the first successful PIV placement. This could have been altered and simplified to just measuring how many successful first-pass placements were made for both landmark and USG without counting failed attempts of each chart. However, only successful attempts for both landmark and USG could be found. The executant would have to have been prudent in charting their failed attempts while indicating whether a landmark or USG was used. This was a major limitation in finding significant outcomes. There is an attempts selection that can be charted for each PIV placement where the executant can disclose this, but it is unclear whether this variable is inaccessible to the student login, untraceable, or uncharted. Hence, the success rates were not applicable for all 47 PIVs (see Appendix B). ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 20 Survival Rates. This measurement was simple in wanting to show the amount of time between when the PIV was placed and discontinued. Out of 47, only three PIV had documented date and time of discontinuation. Aforementioned, 44 PIVs showed survival rates between 116 and 203 days. When spot checking all 509 charts, none had survival rates less than 116 days. Per policy within the healthcare facility, the max amount of time a PIV can be in place is 96 hrs. Alternatively, survival rates of 24 hrs., 48 hrs., 72 hrs., and 96 hrs. could have been shown to measure this in a simpler fashion. Assuming the vast majority are not discharged home with PIV still in place, 44 PIV survival rates are not applicable (see Appendix B). If a patient happens to get discharged home with a PIV still in place, the healthcare facility has protocols to remove the PIV by having the patient return to the hospital. However, documentation of this scenario could not be seen. If a patient has deceased, all PIVs are untouched until cleared by the coroner. In this scenario, executant either failed to chart PIV removal, left the PIV in place per coroners instruction, or this documentation is untraceable. Whether a patient was deceased or alive was not a variable for this review. Nevertheless, roughly half of the patients for each group had documentation of being deceased while showing survival rates well beyond date and time of death. The most likely scenario is the date and time of PIV removal becomes untraceable at some point during the patients stay. Site Complications. The goal was to compare which PIV group had more incidences of phlebitis, infiltration, infection and/or extravasation. Alternatively, if these variables were missing, any extraneous site complications documented were substituted. Extraneous site complications found were documented as occluded, expired, and catheter damage (see Appendix B). However, there were not enough alternative site complications to show any statistical significance. Within the charting system, there are options to select a reason for removal, but this was either uncharted or untraceable. The extraneous site complications that could be viewed were the result of the executant being prudent in manually charting in the comments section of the PIV. Knowing this healthcare facility has exceptional surveillance in ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 21 identifying site complications promptly and replaces PIVs consistent with evidence-based practice, the likelihood of having minimal site complications is a possibility. However, documentation of a PIV being expired would validate this. With the average admission length of stay being 10.3 days for USG and 3.3 days for landmark, documentation should have been seen an average of 2.5 times for USG PIVs (see Appendix A). Similar to the success rates and survival rates, site complications were either uncharted or untraceable. Data Validity Access to the actual charts used in this study were not approved by the IRB for the clinical nurse specialist to view, therefore user error could not be entirely ruled out. Alternatively, an addendum could have been an option to allow the clinical nurse specialist to validate limitations or user error within the charts used for this retrospective review. Due to time constraints, the addendum could not be completed prior to the due date of this project. A second analytics request was submitted in June of 2021 within the healthcare facility to verify whether the initial data report was accurate or not. Unfortunately, the analytics team has not sent the second data report to this day. When contacted, they mentioned the reason for delay had to do with being overloaded with analytics requests that needed to be completed prior to this one. Understanding missing data points in the first analytics report, this second analytics request would have had great value in crosschecking the data. A final attempt for a third analytics request was submitted in August of 2021. However, this report was never received. Potential Bias With the principal investigator being an employee who often places both landmark and USG PIVs every shift, excluding these PIV placements was decided. However, through the eyes of the student login, the name of the executant was not visible unless it was manually typed into the comments. Ethically, principal investigators employee login could not be exploited for this retrospective chart review. However, it could have lifted the limitation of what was accessible regarding success rates, survival rates, and site complications. ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 22 Future Directions To be able to conduct this retrospective chart review successfully in the future, ways to track success rates, survival rates, and site complications would have to be established prior to execution. With USG PIV being such a novelty when compared to landmark PIVs, perhaps a prospective study would be more appropriated. Another consideration for its success would be to allow adequate time for the analytics team to run a more formal data report. Also, a different or additional principal investigator should be considered to reduce the chance of user error when conducting this study. Conclusion Being the most commonly used procedure in the emergency room, improvements on success rates, survival rates, and site complications related to PIVs should be sought after (CDC, 2018). 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The Journal of Vascular Access, 21(3), 342-349. https://doi.org/10.1177/1129729819877323 Maizel, J., Bastide, M. A., Richecoeur, J., Frenoy, E., Lemaire, C., Sauneuf, B., ... & BoReal Study group. (2016). Practice of ultrasound-guided central venous catheter technique by the French intensivists: A survey from the BoReal study group. Annals of Intensive Care, 6(1), 76. https://doi.org/10.1186/s13613-016-0177-x ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 26 Mandal, A., & Raghu, K. (2019). Study on incidence of phlebitis following the use of peripheral intravenous catheter. Journal of Family Medicine and Primary Care, 8(9), 2827. https://doi.org/10.4103/jfmpc.jfmpc_559_19 McCarthy, M. L., Shokoohi, H., Boniface, K. S., Eggelton, R., Lowey, A., Lim, K., ... & Zeger, S. L. (2016). Ultrasonography versus landmark for peripheral intravenous cannulation: a randomized controlled trial. Annals of Emergency Medicine, 68(1), 10-18. https://doi.org/10.1016/j.annemergmed.2015.09.009 McMenamin, L., Brown, F. E., Arora, M., Barnard, J., Smith, L. E., Stockell, D. J., ... & Wolstenhulme, S. (2020). Twelve tips for integrating ultrasound guided peripheral intravenous access clinical skills teaching into undergraduate medical education. Medical Teacher, 1-9. https://doi.org/10.1080/0142159X.2020.1841127 Millam, D. (1996). The history of intravenous therapy. Journal of Intravenous Nursing: The Official Publication of the Intravenous Nurses Society, 19(1), 5-14. Morata, L., Ogilvie, C., Yon, J., & Johnson, A. (2017). Decreasing peripherally inserted central catheter use with ultrasound-guided peripheral intravenous lines: A quality improvement project in the acute care setting. JONA: The Journal of Nursing Administration, 47(6), 338-344. https://doi.org/10.1097/NNA.0000000000000489 Munshey, F., Parra, D. A., McDonnell, C., & Matava, C. (2020). Ultrasound-guided techniques for peripheral intravenous placement in children with difficult venous access. Pediatric Anesthesia, 30(2), 108-115. https://doi-org.forward.marian.edu/10.1111/pan.13780 Otani, T., Morikawa, Y., Hayakawa, I., Atsumi, Y., Tomari, K., Tomobe, Y., ... & Hataya, H. (2018). Ultrasound-guided peripheral intravenous access placement for children in the emergency department. European Journal of Pediatrics, 177(10), 1443-1449. https://doiorg.forward.marian.edu/10.1007/s00431-018-3201-3 Pandurangadu, A. V., Tucker, J., Brackney, A. R., & Bahl, A. (2018). Ultrasound-guided intravenous catheter survival impacted by amount of catheter residing in the ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 27 vein. Emergency Medicine Journal, 35(9), 550-555. http://dx.doi.org.forward.marian.edu/10.1136/emermed-2017-206803 Pare, J. R., Pollock, S. E., Liu, J. H., Leo, M. M., & Nelson, K. P. (2019). Central venous catheter placement after ultrasound guided peripheral IV placement for difficult vascular access patients. The American Journal of Emergency Medicine, 37(2), 317-320. https://doi.org/10.1016/j.ajem.2018.11.021 Patel, A. R., Singh, S., & Khawaja, I. (2019). Central Line Catheters and Associated Complications: A Review. Cureus, 11(5). https://doi.org/10.7759/cureus.4717 Poovelikunnel, T. T., Duffy, F., Puthussery, T., Gangadharan, S., McCormack, F., Carpenter, H., ... & Hawkshaw, S. (2020). Clinically indicated replacement of peripheral vascular catheters: Is it safe for patients?. British Journal of Nursing, 29(8), S4-S10. https://doi.org/10.12968/bjon.2020.29.8.S4 Schmidt, G.A., Blaivas, M., Conrad, S.A. et al. (2019). Ultrasound-guided vascular access in critical illness. Intensive Care Medicine, 45, 434446. https://doiorg.forward.marian.edu/10.1007/s00134-019-05564-7 Scoppettuolo, G., Pittiruti, M., Pitoni, S. et al. (2016). Ultrasound-guided short midline catheters for difficult venous access in the emergency department: A retrospective analysis. International Journal of Emergency MedicineI, 9(3). https://doi.org/10.1186/s12245-016-0100-0 Soria, C. S., Lee, D. E., & Manecke, G. R. (2021). Where to Look for Peripheral IV. In Anesthesiology Resident Manual of Procedures, 113-113. Springer, Cham. https://doi.org/10.1007/978-3-030-65732-1_22 Sou, V., McManus, C., Mifflin, N., Frost, S. A., Ale, J., & Alexandrou, E. (2017). A clinical pathway for the management of difficult venous access. BMC nursing, 16(1), 1-7. https://doi.org/10.1186/s12912-017-0261-z ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 28 Stolz, L. A., Cappa, A. R., Minckler, M. R., Stolz, U., Wyatt, R. G., Binger, C. W., ... & Adhikari, S. (2016). Prospective evaluation of the learning curve for ultrasound-guided peripheral intravenous catheter placement. The Journal of Vascular Access, 17(4), 366-370. https://doi-org.forward.marian.edu/10.5301/jva.5000574 Stuckey, C., & Curtis, M. P. (2019). Development of a nurse-led ultrasound-guided peripheral intravenous program. Journal of Vascular Nursing, 37(4), 246-249. https://doi.org/10.1016/j.jvn.2019.07.003 Tada, M., Matsumoto, T., Takeda, C., Yamada, N., Furukawa, T. A., & Watanabe, N. (2019). Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. The Cochrane Database of Systematic Reviews, 2019(9). https://doi.org/10.1002/14651858.CD013434 Takashima, M., Cooke, M., DeVries, M., Kleidon, T. M., Alexandrou, E., Chopra, V., & Rickard, C. M. (2021). An implementation framework for the clinically indicated removal policy for peripheral intravenous catheters. Journal of Nursing Care Quality, 36(2), 117-124. https://doi.org/10.1097/NCQ.0000000000000507 Tanabe, H., Murayama, R., Yabunaka, K., Oe, M., Takahashi, T., Komiyama, C., & Sanada, H. (2016). Low-angled peripheral intravenous catheter tip placement decreases phlebitis. The Journal of Vascular Access, 17(6), 542-547. https://doi-org.forward.marian.edu/10.5301/jva.5000601 Woo, J. (2002). A short history of the development of ultrasound in obstetrics and gynecology. History of Ultrasound in Obstetrics and Gynecology, 3, 1-25. Van Loon, F. H. J., Buise, M. P., Claassen, J. J. F., Dierick-van Daele, A. T. M., & Bouwman, A. R. A. (2018). Comparison of ultrasound guidance with palpation and direct visualisation for peripheral vein cannulation in adult patients: a systematic review and metaanalysis. British Journal of Anaesthesia, 121(2), 358-366. https://doi.org/10.1016/j.bja.2018.04.047 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 29 Vinograd, A. M., Zorc, J. J., Dean, A. J., Abbadessa, M. K. F., & Chen, A. E. (2018). Firstattempt success, longevity, and complication rates of ultrasound-guided peripheral intravenous catheters in children. Pediatric Emergency Care, 34(6), 376-380. https://doi.org/10.1097/PEC.0000000000001063 White, K. M., Dudley-Brown, S., & Terhaar, M. F. (2016). Translation of Evidence Into Nursing Health Care (2nd ed.). New York, NY: Springer Publishing Company. Zerati, A. E., Wolosker, N., Luccia, N. D., & Puech-Leo, P. (2017). Totally implantable venous catheters: History, implantation technique and complications. Journal Vascular Brasileiro, 16, 128-139. https://doi.org/10.1590/1677-5449.008216 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS Appendix A Table 1 USG PIV Admission Length (Hours) Age Gender 1 40:55 20 F 2 209:56 51 F 3 458:51 59 M 4 101:21 67 M 5 144:48 71 F 6 7:32 67 M 7 752:23 67 F 8 752:23 67 F 9 752:23 67 F 10 139:16 53 F 11 139:16 53 F 12 139:16 53 F 13 68:51 88 M 14 156:12 74 F 15 154:27 41 F 16 154:27 41 F 17 65:18 65 F Total 4237:35 Average 249:16 59.059 23.5% M; 76.5% F 53:48 95 F 4 Male; 13 Female Landmark PIV 1 30 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 2 28:44 67 M 3 47:57 65 M 4 0:03 79 M 5 344:59 49 M 6 20:15 56 M 7 78:06 48 F 8 56:37 24 F 9 298:27 52 F 10 51:28 26 M 11 29:42 68 F 12 151:15 62 M 13 7:43 74 F 14 53:58 68 F 15 30:57 44 M 16 50:25 63 M 17 43:28 54 M 18 42:36 31 F 19 31:24 37 F 20 307:42 49 F 21 27:50 65 M 22 27:53 N/A M 23 118:51 80 F 24 23:43 59 M 25 73:47 60 M 26 134:03 72 M 27 144:48 71 F 31 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 28 61:02 28 F 29 52:16 62 M 30 36:51 93 F Total 2430:38 Average 81:01 32 16 Male; 14 Female 60 53.3% M; 46.7% F ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS Appendix B Table 2 USG PIV Site Complications Survival Rate (Hours) Success Rate 1 N/A N/A N/A 2 Catheter Damage N/A N/A 3 N/A N/A N/A 4 N/A N/A N/A 5 N/A N/A N/A 6 N/A N/A N/A 7 N/A N/A N/A 8 Expired N/A N/A 9 Occluded N/A N/A 10 N/A N/A N/A 11 Occluded 4:56 N/A 12 N/A 21:35 N/A 13 N/v N/A N/A 14 N/A N/A N/A 15 N/A N/A N/A 16 N/A 31:31 N/A 17 N/A N/A N/A Total N/A Not Applicable Not Applicable Average N/A 19:34 Not Applicable 1 N/A N/A N/A 2 N/A N/A N/A Landmark PIV 33 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 4 N/A N/A N/A 5 N/A N/A N/A 6 N/A N/A N/A 7 N/A N/A N/A 8 N/A N/A N/A 9 N/A N/A N/A 10 N/A N/A N/A 11 N/A N/A N/A 12 N/A N/A N/A 13 N/A N/A N/A 14 N/A N/A N/A 15 N/A N/A N/A 16 N/A N/A N/A 17 N/A N/A N/A 18 N/A N/A N/A 19 N/A N/A N/A 20 N/A N/A N/A 21 N/A N/A N/A 22 N/A N/A N/A 23 N/A N/A N/A 24 N/A N/A N/A 25 N/A N/A N/A 26 N/A N/A N/A 27 N/A N/A N/A 28 N/A N/A N/A 29 N/A N/A N/A 34 ULTRASOUND GUIDED VERSES LANDMARK INTRAVENOUS ACCESS 30 N/A N/A N/A Total Not Applicable Not Applicable Not Applicable Average Not Applicable Not Applicable Not Applicable 35  ...

... Two Views, or Not Two Views: That is the Question Michael Orcutt 1 OMS-III , Dr. Thomas Fischer 1MUCOM, 2Indiana Introduction: Traditionally, the acute wrist radiograph series is comprised of posteroanterior (PA), oblique, and lateral projections. There is controversy within the field of Orthopedics, however, over the value of the oblique view in determining a plan of care for a given fracture. An external survey of practicing Orthopedic Surgeons was conducted as a tool to quantify the clinical value of the oblique view radiograph in the setting of acute closed distal radius fractures, the most common fracture pattern in Americans2. Methods: Participants, licensed and practicing Orthopedic surgeons in the United States, reviewed thirty sets of wrist radiograph studies twice (once as a complete three-view series and again with the oblique omitted) in randomized order. Cases were randomly selected with criteria to include ten pediatric, ten geriatric, and ten intermediate/ adult cases. After reviewing the films and demographic information, participants selected their preferred initial intervention from a list of 1) treatment in cast or splint without reduction, 2) closed reduction under or without fluoroscopy with treatment in cast or splint, 3) closed reduction and percutaneous fixation with treatment in cast or splint, and 4) open reduction with internal fixation and subsequent treatment in cast or splint. Cohen's Kappa Dr. Todd Foster Figure 1. Age Categoies: Was the same treatment selected for the paired images? 100.0% p Pair 1 k=0.49 <0.001* Pair 2 k=0.57 <0.001* Pair 3 k=-0.03 0.86 Pair 4 k= N/A N/A (Constant) Pair 5 k=0.67 <0.001* Pair 6 k=0.65 <0.001* Pair 7 k=0.65 <0.001* Pair 8 k=0.65 <0.001* Pair 9 k=0.75 <0.001* Pair 10 k=0.66 <0.001* Pair 11 k=0.53 <0.001* x2=0.25, p=0.88 88.1% 90.0% 87.8% 86.9% 80.0% k=0.25 0.02* Pair 13 k=0.31 0.05 Pair 14 k= N/A N/A Pair 15 k=0.63 p<0.001* Pair 16 k=0.56 p<0.001* Pair 17 k=0.73 p<0.001* Pair 18 k= N/A N/A (Constant) Pair 19 k=N/A N/A Pair 20 k=0.69 p<0.001* Pair 21 k=0.75 p<0.001* Radiation Exposure Risk of cancer secondary to radiation exposure increases with the total lifetime dose13 70.0% Pair 12 3 PhD Hand to Shoulder Clinic, 3Ascension St. Vincent Table III. Cohen's Kappa for Intraobserver Error among the Question Pairings Pairing 2 M.D. , 60.0% 50.0% 0.001 mSv / radiograph* 40.0% 30.0% * Increased cancer risk has been correlated with <50mSv exposure13 20.0% 13.1% 11.9% 12.2% 10.0% 0.0% Pediatric (4-16 y ears) Intermediate (17-64 years) Geriatric (>65 years) Yes 88.1% 86.9% 87.8% No 11.9% 13.1% 12.2% Yes No Figure 2. Sex Categories: Was the same treatment selected for the paired images? 100.0% " Cost Analysis $"## $%&' 90.6% 90.0% "# $)*+,-)./ "#,### *1-&,/ 6.1 x 107 Medicare recipients = p=0.003 84.2% Pair 22 k=0.89 p<0.001* $6.1 million 80.0% Pair 23 k= N/A N/A (Constant) Pair 24 k=0.82 <0.001* Pair 25 k= N/A N/A (Constant) Pair 26 k=0.64 <0.001* Pair 27 k=0.65 <0.001* Pair 28 k=-0.05 0.74 Pair 29 k=0.55 <0.001* Pair 30 k=0.57 <0.001* 70.0% 60.0% *Estimates based on sources 9-12 **Estimated billed to Medicare 50.0% 40.0% Sources 30.0% Legend: Cohen's Kappa Interpretation 68 y/o female 1) treatment in cast or splint without reduction, 2) closed reduction under or without fluoroscopy with treatment in cast or splint, 3) closed reduction and percutaneous fixation with treatment in cast or splint, and 4) open reduction with internal fixation and subsequent treatment in cast or splint. <0.00 Poor 0.00-0.20 Slight 20.0% 15.8% 9.4% 10.0% 0.20-0.40 Fair 0.41-0.60 Moderate 0.61-0.80 Substantial 0.81-1.00 Almost Perfect ** annually 0.0% Female Male Yes 90.6% 84.2% No 9.4% 15.8% Yes No Nellans KW, Kowalski E, Chung KC. The epidemiology of distal radius fractures. Hand Clin. 2012;28(2):113-125. doi:10.1016/j.hcl.2012.02.001 Thompson PW, Taylor J, Dawson A. The annual incidence and seasonal variation of fractures of the distal radius in men and women over 25 years in Dorset, UK. Injury 2004;35:462-6. Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. [Updated 2020 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK536916/ Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures inthe United States. J Hand Surg Am. 2001; 26:908915.  ...

... 1Peesapati, 1Reyes, 1,2Skinner, 2Ikerd, M., Z., B., T. 1Marian University College of Osteopathic Medicine, 2Ascension St. Vincent Carmel Myroides spp. are non-motile, aerobic, gramnegative bacilli that are traditionally opportunistic pathogens1. P. stuartii is a urease-producing, gram-negative bacillus2. Myroides infections have been reported 60 times to date. Only 15 of which involve cellulitis with 6 also progressing to bacteremia3. Myroides has not been isolated with P. stuartii in a patient with bacteremia and cellulitis. This is a novel presentation of 2 multidrug resistant bacteria, causing a severe presentation of bacteremia and cellulitis. Subjective A 75-year-old white male presented with cellulitis and nonhealing ulcers of the right lower extremity. HPI: 9 days prior to presentation, the patient suffered a laceration to the right lower extremity from a broken wheelchair part. This laceration was repaired by primary intention. 3 days prior to presentation, the patient noticed increased redness, swelling, drainage from the wound. PMH: PVD, T2DM, tobacco smoking, atrial fibrillation, diastolic heart failure, COPD, sleep apnea, BPH. Allergies: amoxicillin, penicillin. Objective Patient was acutely confused and ill-appearing. 2 large ulcers on tibia with large draining blisters and surrounding erythema, tender to palpation Assessment CT showed diffuse subcutaneous edema with cutaneous cyst formation and no evidence of underlying abscess. WBC count 11,800 with 89% neutrophils Plan Non-surgical wound care and treatment with vancomycin, cefepime, and metronidazole. Following susceptibilities report (Table 1), ABX therapy was changed to extended-infusion meropenem 500mg IV Q6h on day 3 of hospitalization. WBC count increased (34.6) by day 5 and R LE tissues continued deteriorating rapidly. The patient underwent surgical wound debridement of the R medial leg and R dorsal foot, revealing no infectious involvement of the underlying muscle or bone. Day 1 post-op, WBC count dropped significantly (24.7) and continued trending downward as meropenem course was extended and wet-to-dry dressing changes were done. Wound healing remained poor, likely secondary to co-morbid conditions such as T2DM, PVD, and tobacco smoking and patient was being considered for amputation, which was refused. On day 24, Stenotrophomonas maltophilia was isolated from the wound sites, but was deemed a surface contamination, therefore not requiring treatment. Day 1 post-op Day 0 post-op Given that Myroides spp. shows resistance to many broad-spectrum antibiotics used to treat cellulitis and bacteremia, such as 4th generation cephalosporins, susceptibility testing is important for finding effective antibiotic therapy4. The resistance of Myroides spp. to beta-lactams (including extended-spectrum cephalosporins and beta-lactamase inhibitors) is due to the production of chromosome-encoded metallobeta-lactamases4. Myroides spp. is most commonly sensitive to treatment with meropenem, ciprofloxacin, or a combination of both3,5. Providencia spp. may initially be susceptible to 3rd generation cephalosporins, however following exposure to beta-lactams, resistance is induced by either induction or selection of derepressed mutants expressing AmpC Blactamase6. P. stuartii can also be adequately targeted with meropenem6. In this case, the patient was initially treated empirically with broad-spectrum ABX covering gram-positives, gram-negatives, and anaerobes. After isolating Myroides spp., meropenem was initiated and empiric improvement led to discontinuation on day 31 (day of discharge). Extended duration due to ongoing tissue necrosis. Day 23 post-op Table 1. Drug Susceptibilities and MICs of Isolated Species Day 2 post-op Day 8 post-op Day 12 post-op Upon Presentation The patient underwent a second surgical wound debridement of the same area with Kerecis graft placement. Meropenem was stopped on day of discharge and patient was discharged without antibiotics. Compared to pre-graft healing, there was obvious healthy granulation tissue and improved perfusion. The patient is still undergoing wound care postgraft placement but is healing well. Ampicillin Amp-Sulb Pip-Tazo Cefazolin Cefoxitin Ceftriaxone Ceftazidime Cefepime Meropenem Aztreonam Gentamicin Tobramycin Amikacin Ciprofloxacin Levofloxacin Tetracycline Minocycline TMP-SMX Myroides spp. NT NT I (16) NT NT I (32) NT I (16) S (2) NT R (16) R (16) NT I (2) NT NT S (1) S (40) P. stuartii R* I (16) S (4) R (64) S (4) S (1) NT S (1) NT NT R* R* S (2) S (0.25) NT R (16) NT S (20) S = Susceptible; I = Intermediate; R = Resistant; NT = Not Tested *MIC not reported This unusual co-infection led to an extremely severe bacteremia as well as local tissue disruption, leading to a prolonged, 32-day hospital course. If left untreated, the highly resistant Myroides spp. has been shown to cause severe morbidity and mortality. Though the cellulitis and bacteremia were successfully treated in this patient, it is imperative that providers remain vigilant to this rare, but life-threatening pathogen. 1.Meyer A, Dang H, Roland W. Myroides spp. cellulitis and bacteremia: A case report. IDCases. 2019;18:e00638. 2. Wie SH. Clinical significance of Providencia bacteremia or bacteriuria. Korean J Intern Med. 2015;30(2):167-169. 3. Beathard WA, Pickering A, Jacobs M. Myroides cellulitis and bacteremia: A case report. IDCases. 2021;24:e01061. 4. Licker M, Sorescu T, Rus M, et al. Extensively drug-resistant Myroides odoratimimus - a case series of urinary tract infections in immunocompromised patients. Infect Drug Resist. 2018;11:743-749. 5. Maraki S, Sarchianaki E, Barbagadakis S. Myroides odoratimimus soft tissue infection in an immunocompetent child following a pig bite: case report and literature review. Braz J Infect Dis. 2012;16(4):390-392. 6. Harris PN, Ferguson JK. Antibiotic therapy for inducible AmpC beta-lactamaseproducing Gram-negative bacilli: what are the alternatives to carbapenems, quinolones and aminoglycosides? Int J Antimicrob Agents. 2012;40(4):297-305.  ...

... Too Much of A Good Thing: A Case of Suspected Acute Tubular Necrosis Provoked by Hypervitaminosis D Peesapati, M., Benavente K., Knox, M. Hilo Medical Center Introduction Calcitriol is a vitamin critical in regulating calcium homeostasis, maintenance of musculoskeletal integrity, and both a commonly prescribed medication and over the counter supplement. However, the incidence of vitamin D toxicity is escalating, manifesting clinically with confusion, polyuria, polydipsia, muscle weakness, and nausea and vomiting (1). While acute hypercalcemia, especially in the setting of milk-alkali syndrome, has been demonstrated to induce a reversible AKI, the direct cytotoxic effect of excess Vitamin D on the renal parenchyma in the setting of lower levels of serum calcium, has not been well studied nor documented. Discussion D Vitamin D intake: AKI of 4.38 210,000 IU daily Mild to moderate hypercalcemia Initiated 2 weeks No CKD risk factors prior Labs suggest ATN Other potential nephritic/nephrotic etiologies ruled out AKI unresolved with fluids, calcitonin Gradual improvement at 3 months Vitamin D induced ATN Case Presentation Hospital Course A 62-year-old male presented to the ED after outpatient screening labs revealed a creatinine of 2.66 mg/dL and calcium of 13.2 mg/dL two days prior. PMH was significant only for chronic chest pain, with cardiac catheterization at a later date revealing normal coronaries and ejection fraction. Patient admitted no symptoms other than some polyuria, condoned drinking adequate fluids, and eating regularly. Physical exam was largely normal, save an elevated blood pressure to 149/116. While he admitted to no medications other than melatonin, his supplements included a daily serving of oral vitamin D, which he purchased in a wholesale powdered form 1-2 weeks ago. His daily intake was calculated to be 210,000 IU, or 5,250 mcg of calcitriol daily (tolerable upper intake level 4000 IU or 100 mcg). Repeat labs on admission revealed a creatinine of 4.38 mg/dL, BUN of 52 mg/dL, and calcium of 13.6 mg/dL, with other labs within normal limits. Nephrology was consulted, and prerenal measures were initiated with aggressive fluid resuscitation. Workup for hypercalcemia/intrinsic kidney pathologies was negative for protein electrophoresis, urine light chains, urinalysis, and TSH, with an appropriately suppressed parathyroid response. CT imaging was noncontributory of any obstructive/structural pathology. 25-Hydroxy and 1,25-Dihydroxy Vitamin D were elevated beyond the measuring capabilities of the lab at >480 ng/mL and >600 pg/mL respectively. Fractional excretion of sodium was calculated to be 2.3%, BUN;Cr ratio of 12.9, urine sodium of 57 mmol/L, with a creatinine rise of rate ~0.86/mg/dL/day. Despite several days of continuous IV fluids at 150 cc/hr of NS, in addition to calcitonin treatment, creatinine improved only to 2.96 mg/dL by discharge on day 3 of hospitalization, with calcium normalized to 9.8 mg/dL.. At follow up 3 months later, creatinine was still elevated above his baseline, at 1.6 mg/dL, despite a now normal calcium level and cessation of all supplements. Hypercalcemic AKI, even at levels as high as 19.9 mg/dL, typically resolves with treatment by day 11; this patient failed to resolve, suggesting additional insult. In calcitriol-induced AKI, toxicity of excess free Vitamin D metabolites exceeds the capacity of neutralizing vitamin D binding proteins (3). In vitro, calcitriol potentiates ATP depletion, and cytotoxicity of renal tubular cells even in the absence of hypercalcemia (4). In vivo, excess calcitriol exacerbates cellular azotemia 2-3 times, even with modest hypercalcemia (4). A similar cohort of patients demonstrated time to recovery of baseline kidney function of up to 3 months (5). A similar case reported tubular atrophy, interstitial fibrosis on biopsy, and a two-year duration for full recovery of baseline kidney function (6). Given the exclusion of other causes, a single inciting factor shortly before his presentation, and a clinical course consistent with similar cases, this patient may present a rare case of vitamin D induced ATN. Further study is needed to better elucidate this novel pathology, especially as supplement induced toxicities continue to become more prevalent. References 1. Marcinowska-Suchowierska E, Kupisz-Urbaska M, ukaszkiewicz J, Pudowski P, Jones G. Vitamin D Toxicity-A Clinical Perspective. Front Endocrinol (Lausanne). 2018;9:550. Published 2018 Sep 20. doi:10.3389/fendo.2018.00550 2. Moyses-Neto M, Guimaraes FM, Ayoub FH, Vieira-Neto OM, Costa JA, Dantas M. Acute renal failure and hypercalcemia. Ren Fail. 2006;28(2):153-9. de Mik SML, Stubenrouch FE, Balm R, Ubbink DT. Systematic review of shared decisionmaking in surgery. Br J Surg. 2018;105(13):1721-1730. 3. Jones G. Pharmacokinetics of vitamin D toxicity. Am J Clin Nutr. 2008;88(2):582S6S. 4. Calcitriol directly sensitizes renal tubular cells to ATP-depletion- and ironmediated attack. Am J Pathol. 1999;154(6):1899-909. 5. Chowdry AM, Azad H, Najar MS, Mir I. Acute kidney injury due to overcorrection of hypovitaminosis D: A tertiary center experience in the Kashmir Valley of India. Saudi J Kidney Dis Transpl. 2017;28(6):1321-9. 6. Nasri H, Mubarak M. Renal injury due to vitamin D intoxication; a case of dispensing error. J Renal Inj Prev. 2013;2(2):85-87. Published 2013 Jun 1. doi:10.12861/jrip.2013.27  ...