Clinical research professionals (CRPs) are essential contributors to clinical and translational research endeavors, encompassing roles such as research nurses, research coordinators, data managers, and regulatory affairs specialists. This paper reports on the implementation of a novel training program for the CRPs, the Co-mentoring Circles Program, developed by the University of Florida Health Clinical Research Professionals Consortium, and proposes an initial logic model of CRP workforce development informed by the observations, participant feedback, and the established Translational Workforce Logic Model. The co-mentoring program was delivered through an online didactic curriculum and bi-monthly meetings over nine months, from January to September 2022. The formative evaluation identified the factors that support CRP workforce development through knowledge acquisition and professional relationship building. Finally, this paper proposes a logic model of CRP workforce development, including financial and human inputs, didactic and co-mentoring activities, workforce outputs, outputs related to workforce and clinical research study progress, and resulting impacts of increased national capacity for translational research and increased rate of research translation.

OBJECTIVES/GOALS: While the current management of single ventricle repairs has drastically prolonged life expectancy, the repair fails over time primarily through pathologic inflammation and fibrosis. Our goal is to demonstrate that cardio-omentopexy can decrease inflammation and fibrosis in swine after cryoinjury. METHODS/STUDY POPULATION: A cryoinjury is created using a liquid nitrogen cooled probe to the right ventricle of 15-20kg swine for three minutes. In half the groups the omentum is attached to the heart over the area of the injury. The swine are recovered and monitored for 4 or 8 weeks at which time they are euthanized. The injured area is evaluated via histological and immunohistochemical testing for markers of inflammation and scarring including collagen type, scar area, macrophage activity. RESULTS/ANTICIPATED RESULTS: Currently, we have successfully validated the animal model to create myocardial scar validated by histological testing. We anticipate that the addition of omentopexy to cryoinjury will decrease scar area, fibrosis and markers of chronic inflammation. Additionally, we expect an increase in myocytes in the area of injury. We expect that this will occur through the anti-inflammatory and protective mechanism of the omentum. DISCUSSION/SIGNIFICANCE: Cardio-omentopexy, if able to decrease fibrosis and preserve myocytes, may provide a useful adjunct to the treatment of single ventricle repair by prolonging the longevity of the repair. Additionally, as these repairs often require a ventriculotomy, decreasing the operative scar may preserve myocardial function.

OBJECTIVES/GOALS: Frequent utilizers of emergency departments (ED) make up a substantial share of overall ED use. Within pediatric emergency departments (PED), infants represent an age group that make up a disproportionate share of PED visits. The objective was to compare patterns of PED use for children less than 1 year of age by visit frequency and resource utilization. METHODS/STUDY POPULATION: Retrospective cohort study of infants less than 1 year presenting to 5 EDs in one health system over a 5-year period, with a 365-day follow-up after each index visit. Patient characteristics (age, sex, race/ethnicity, presence of chronic condition) and visit characteristics (arrival day/time, acuity level, disposition, testing (labs and radiographs, medications) were assessed. The relationship between patient and visit characteristics with utilization and repeat visits was assessed using multivariable regression. RESULTS/ANTICIPATED RESULTS: A total of 20,620 patients with 33,127 ED visits during study timeframe. Thirty three percent (n=6842) had more than one visit in a year; 3964 (19.2%) had two visits, 1542 (7.5%) had three visits, and 1336 (6.5%) had 4 or more visits. Across all visits, over half (52%) were low acuity. The most common diagnoses were respiratory diseases (27%), systemic states (including fever, viral illness, 23%), and gastrointestinal diseases (15%). These diagnoses remained the most common for those with 1, 2, 3, and ≥ 4 ED visits during follow up. As ED visit frequency increased, there was an increase in percentage of children who were older, non-Hispanic Black, and triaged as low acuity. Infants with ≥ 4 ED visits were more likely to be without a chronic condition, have no medications or testing ordered, and be discharged. DISCUSSION/SIGNIFICANCE: There was high ED utilization for those without chronic conditions who were least likely to need medications, testing, and hospital admission. With increasing attention paid to high-utilization in healthcare, it is important to assess why infants use the ED at high rates and develop systems to improve high value care while decreasing resource burden.

OBJECTIVES/GOALS: Cerebral palsy (CP) is the most common motor disability in childhood in the US1. Augmented reality (AR) has promise enhancing engagement of rehabilitation2. We developed adaptive games for children with CP using Augment Therapy™. The goal of this study was to obtain user experience in the orthopedic clinic to inform a home-based clinical trial. METHODS/STUDY POPULATION: Participants were recruited at a pediatric center from July 1 to September 20, 2023. Inclusion criteria werediagnosis of CP, ages 5-10 years, English/Spanish speaking. Exclusion criteria were cognitive delay, audio or visual impairment, seizures, or recent surgery. The Augment Therapy™ app was delivered through a clinic iPad. The electronic medical record was used to screen eligible patients. 22 patients were screened; 14 were not eligible based on exclusion criteria. 2 patients refused based on not having enough time to participate. Children played 5 games and their movements were tracked using augmented reality. To evaluate the quality of the app, participants were asked to complete a validated questionnaire, the modified Mobile App Rating Scale. Descriptive statistics were used to analyze responses. RESULTS/ANTICIPATED RESULTS: Six participants were eligible and completed phase I. Eighty-three percent (5/6) of participants reported the character was mostly matching their child’s movements and easy for their child to follow instructions. Thirty three percent (2/6) reported there were technical issues where the app did not track or froze. 100% reported being interested in participating in the home clinical trial. Parent reported their child’s favorite games were flying and obstacle course. The mean and median MARS score was 3.8/5 and 4/5, respectively. Regarding engagement, 66.7% (4/6) reported the app was fun to use. DISCUSSION/SIGNIFICANCE: Families of children with CP reported positive experiences overall with Augment Therapy™ mobile app. The technical issues will need to be addressed. Future studies will need to establish efficacy and dosing time of use of the app for adherence to a program using these modules and engagement with the app to increase habitual physical activity.

OBJECTIVES/GOALS: Hypermobile Ehlers-Danlos syndrome (hEDS) is a heritable connective tissue disorder with no known genetic etiology. Its complex phenotypic presentation with multi-system involvement delays proper diagnosis and treatment, especially for females. This study examines the risk for common hEDS comorbidities and medical service utilization. METHODS/STUDY POPULATION: Electronic health records from over 150 million patients across 92 American healthcare servers were queried using the TriNetX database to determine phenotypic presentation of hEDS and risk of receiving comorbid diagnoses. Contingency tables were created with hEDS as the condition and postural orthostatic tachycardia syndrome (POTS) or gastroparesis as the grouping variables. Advanced analytics were conducted to compare outcomes of two cohorts: (1) patients diagnosed with hEDS and both POTS and gastroparesis, and (2) patients with a sole diagnosis of hEDS. After propensity score matching, differences in medical service utilization and mental health diagnoses were assessed between these two cohorts. All analyses restricted age (12-70 years) and employed established exclusion criteria (e.g., diabetes). RESULTS/ANTICIPATED RESULTS: TriNetX national health records (N = 1,968) reveal that hEDS predominantly affects females (87%) and is diagnosed at a mean of 35 years of age. People diagnosed with hEDS have a high prevalence of comorbid nervous system (81%), mental health (76%), and digestive system (69%) disorders. They are 29.7 times more likely to be diagnosed with POTS [95% CI: 27.1, 32.6] and 66.3 times more likely to be diagnosed with gastroparesis [95% CI: 56.5, 77.9], compared to people without hEDS. After propensity score matching for sex, race, and ethnicity, people diagnosed with hEDS and both POTS and gastroparesis have significantly greater service utilization (72.2% vs. 56.7%; z = 2.18, p < .05) but not a greater incidence of mental health disorders (34.4% vs. 24.4%; z = 1.47, p = .14) than people diagnosed with hEDS alone. DISCUSSION/SIGNIFICANCE: This study reveals the phenotypic presentation of hEDS and the elevated risk of co-occurring POTS and/or gastroparesis diagnosis. hEDS and its comorbidities are associated with more frequent medical encounters but not with a greater incidence of mental illness. Findings have implications for both clinical practice guidelines and further research.

The University of Michigan created the Practice-Oriented Research Training (PORT) program and implemented it between 2008 and 2018. The PORT program provided research training and funding opportunities for allied healthcare professionals. The program consisted of weekly didactics and group discussion related to topics relevant to developing specific research ideas into projects and funding for a mentored research project for those who submitted a competitive grant application. The goal of this evaluation was to assess the long-term impact of the PORT program on the research careers of the participants. Ninety-two participants (74 staff and 18 faculty) participated in both phases of the program. A mixed-methods approach to evaluation was used; 25 participants who received funding for their research completed surveys, and semi-structured interviews were conducted with eight program participants. In addition, data were collected on participants’ publication history. Fifteen out of the 74 staff participants published 31 first-authored papers after participating in PORT. Twelve out of 15 staff participants who published first-authored papers did so for the first time after participating in the PORT program. Results of quantitative and qualitative analyses suggest that the PORT program had positive impacts on both participants and the research community.

OBJECTIVES/GOALS: While most transgender and non-binary (TNB) youth experience improved mental health post-initiating gender-affirming hormones (GAH), some continue to experience persistent, significant depressive symptoms two years post-GAH. Importantly, few studies have examined this issue given the lack of existing longitudinal studies. METHODS/STUDY POPULATION: We aimed to identify intervenable factors predicting persistent clinical depressive symptoms (PD) among TNB youth two years post-initiation of GAH utilizing the Trans Youth Care U.S. Study, an ongoing, multisite, observational study of TNB youth from four major pediatric hospitals across the U.S. We compared TNB youth (ages 12-20 at baseline) with persisting depression symptoms (PD) two-years post-GAH (i.e., PD; N=59) and those youth without (non-PD; n=215). Logistic regression estimated the association between PD and risk (e.g., negative expectations) and protective factors (e.g., parental acceptance, self-efficacy), measured at baseline and longitudinally. A mixed-effects model compared the rate of change of these factors between PD and non-PD youth. Models controlled for birth sex. RESULTS/ANTICIPATED RESULTS: Participants (Mean age=16) identified as transmasculine, then transfeminine, followed by non-binary. PD youth had higher negative expectations at baseline and internalized transphobia by 2-years, while non-PD youth reported greater parental acceptance over 2-years. The odds of PD compared to non-PD decreased with increasing self-efficacy at baseline (OR=0.7, 95% CI:0.5-0.9), whereas negative expectation for the future was associated with increased odds (OR=1.3, 95% CI:0.9,1.8). Moreover, the odds of PD increased 50% with increased rate of change in negative expectations, and odds decreased 50% with increased rate of change in self-efficacy, after adjusting for baseline negative expectations and self-efficacy, respectively. DISCUSSION/SIGNIFICANCE: We identified key intervenable factors for mental health treatment for TNB youth with PD; specifically, negative expectations increased risk for PD while self-efficacy appeared to buffer against PD risk. These findings also support assessment of youth for negative expectations for the future conferring greater risk for later PD.

Strategies are needed to ensure greater participation of underrepresented groups in diabetes research. We examined the impact of a remote study protocol on enrollment in diabetes research, specifically the Pre-NDPP clinical trial. Recruitment was conducted among 2807 diverse patients in a safety-net healthcare system. Results indicated three-fold greater odds of enrolling in remote versus in-person protocols (AOR 2.90; P < 0.001 [95% CI 2.29–3.67]). Priority populations with significantly higher enrollment included Latinx and Black individuals, Spanish speakers, and individuals who had Medicaid or were uninsured. A remote study design may promote overall recruitment into clinical trials, while effectively supporting enrollment of underrepresented groups.

OBJECTIVES/GOALS: Due to clinical advances, cancer survivors are living longer but have an increased risk of a second primary cancer (SPC). This cross-sectional study aims to examine SPC prevalence in immigrant women and compare healthcare use (HCU) and cancer screening in immigrants with SPC versus (1) immigrants with a single cancer and (2) US-born women with SPC. METHODS/STUDY POPULATION: The study population will include adult women with breast/gynecologic primary cancer (PC) from the 2005, 2008, 2010, 2013, and 2015 National Health Interview Survey. First-generation immigrant or US-born status will be defined by region of birth. SPC includes diagnosis with a second cancer type ≥1 year after the initial PC diagnosis. We will compare the prevalence of ≥1 SPC in immigrant and US-born women. To evaluate HCU and cancer screening differences, we will assess sociodemographic and socioeconomic factors, risk behaviors, length of US residence, and citizenship status with descriptive statistics. In regression analyses, we will compare number of provider visits and cancer screening rates in immigrant women with SPC versus immigrants with PC alone and US-born women with SPC after matching by age and PC type. RESULTS/ANTICIPATED RESULTS: Disparities in cancer diagnosis, quality of care, receipt of recommended treatment, and screening rates among immigrants in the US are well documented. Therefore, we hypothesize that immigrant cancer survivors will have similar or higher rates of SPC compared to women born in the US with variations based on health status. We further hypothesize that immigrants with SPC will report lower rates of HCU after diagnosis of their first cancer and cancer screening compared to US-born women. However, we expect that immigrants with SPC will report similar or higher rates of HCU and cancer screening compared to immigrant women with PC alone. DISCUSSION/SIGNIFICANCE: To our knowledge, this study will be the first to describe SPC among immigrant cancer survivors in the US. This research will inform interventions to improve cancer care delivery and ultimately reduce SPC in immigrants with cancer.

OBJECTIVES/GOALS: Total-body symptom surveys among patients with idiopathic orthostatic intolerance (OI) at our referral center suggest that non-conventional OI symptoms, such as pelvic pain, impact quality of life. We seek to identify additional common yet unconventional symptoms reported during clinic visits to improve targeted symptom management. METHODS/STUDY POPULATION: Pelvic pain symptom surveys were completed by 178 patients age 18 and over with a chief complaint of OI. Pelvic pain prevalence was assessed using the International Pelvic Pain Society (IPPS) and Pelvic Congestion Syndrome (PCS) surveys. Expanding on this work, surveys will be distributed to a population with the same inclusion criteria but with a broader symptom scope, chosen based on patient reports during clinical encounters—including presence of migraines, cold digits (Raynaud’s phenomenon), anxiety and depression. The Migraine Disability Assessment Test (MIDAS), modified Assessment of Systemic Sclerosis–Associated Raynaud’s Phenomenon (ASRAP), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9) surveys, respectively, will be used to obtain symptom prevalence. RESULTS/ANTICIPATED RESULTS: Of the pelvic pain survey participants, pelvic pain was endorsed by 144/178 (80.9%) of respondents. Prevalence of the additional surveyed symptoms—migraines, cold digits, anxiety, and depression—will similarly be assessed. Given that in our referral clinic we have observed a trend of patients reporting these additional symptoms, we anticipate that at least some of them will be prevalent in a majority of the patient population formally surveyed, similar to the trend observed with pelvic pain prevalence. In particular, we anticipate many patients will report significant migraines, as migraine pain severity on a scale of 0-10 with 0 being no migraine pain and 10 being the most severe migraine pain imaginable is one of the elements of the IPSS survey, and 106/178 (59.6%) reported migraine pain of 5 or higher. DISCUSSION/SIGNIFICANCE: Novel treatment approaches for OI are needed, as lifestyle management is the current treatment paradigm. Several patients reporting pelvic pain have undergone targeted workup and subsequent symptomatic treatment that has improved their quality of life. Other targeted symptom approaches to prevalent symptoms could have the same effect.

Historically underrepresented groups in biomedical research have continued to experience low representation despite shifting demographics. Diversity fosters inclusive, higher quality, and innovative team science. One avenue for diversifying research teams is integrating diversity-focused initiatives into Clinical and Translational Science Award (CTSA) Programs, such as the integrated Translational Health Research Institute of Virginia (iTHRIV). In 2020, iTHRIV participated in Building Up, developed by the University of Pittsburgh CTSA, and intended to increase representation and improve career support for underrepresented groups in the biomedical workforce. Drawing lessons from this study, iTHRIV implemented the “inspiring Diverse Researchers in Virginia” (iDRIV) program. This yearlong program provided education, coaching, mentoring, and sponsorship for underrepresented early career investigators in the biomedical workforce. To date, 24 participants have participated in the program across three cohorts. Participants have been predominantly female (92%), with 33% identifying as Hispanic/Latinx, 29% as Black, and 13% as Asian. Notably, 38% of scholars have subsequently achieved at least one accomplishment, such as receiving a local research honor or award and an extramural funding award from a foundation or federal agency. The iTHRIV iDRIV program serves as a model for providing career support to developing investigators from underrepresented backgrounds, with the overall goal of improving patient health.

OBJECTIVES/GOALS: Our overarching aim is to examine, in an African American population, cognitive, affective, and neurophysiological processes, as well as risk-taking behavior, in response to racial stigma cues. While accounting for individual differences, we aim to see how these processes and drug-cue reactivity are impacted or altered by exposure to racial cues. METHODS/STUDY POPULATION: Participants will be African Americans between 18 and 25 years of age, equally distributed across genders. We will recruit 75 participants in order to have adequate power to conduct our intended analyses—particularly pertaining to individual differences in risk behavior outcomes. Participants will be asked to complete demographic and self-report questionnaires. Participants will also be asked to complete computerized tasks while their physiological responses (heart rate, skin conductance, and electroencephalographic (EEG) data) are recorded. The tasks are as follow: resting, gambling, go/no-go, picture viewing (positive, negative, and neutral images), and a drug cue image set. These tasks will be repeated after the participant views a racial stigma image set to evaluate the impact of discrimination. RESULTS/ANTICIPATED RESULTS: Data from 18 participants has been collected. Data will be periodically preprocessed and validated (e.g., 1 participant was removed due to data recording errors, so the current valid Nis 17). Generally, we anticipate that behaviors and neural activity will be modulated across all tasks after viewing the racial stigma image set. Specifically, (a) cognitive and affective processing of singular events of racial stigma may indicate a stress response, (b) modulation from chronic experiences of racial stigma render neural systems increasingly sensitive to stigma cues, and thereby less equipped to regulate stress response, (c) the impact of these processes on altering risk behavior (may increase such behaviors), and (d) the impact of these modulations on altering drug-cue reactivity (may amplify reactivity). DISCUSSION/SIGNIFICANCE: The study will identify factors that contribute to stress and risk behavior among African Americans. A substantial gap continues to exist regarding the nature of risk behavior among African Americans, despite the fact that African Americans represent a health disparity population with unique vulnerabilities to health-relevant risk behavior.

OBJECTIVES/GOALS: The COVID-19 pandemic disrupted HIV care, though it prompted preventive measures for respiratory pathogens, particularly among PWH. We therefore quantified trends in respiratory ADE incidence during vs. before the COVID-19 pandemic to assess effects of these measures on non-COVID-19 illnesses. METHODS/STUDY POPULATION: We included PWH aged ≥18 years in care at the Vanderbilt Comprehensive Care Clinic in Nashville, Tennessee from 2017-2023. Individuals contributed time from the last of March 31, 2017 or clinic enrollment until the first of death, March 31, 2023 (study close), or final clinic visit (if there was no visit ≤12 months before study close). We described respiratory ADE incidences (per 1,000 person-years) in each year of the study; we used Poisson regression with robust variance to estimate the incidence rate ratio (IRR) and 95% confidence interval (CI) for respiratory ADEs in the three years following vs. before the World Health Organization’s pandemic designation for COVID-19 (March 2020). RESULTS/ANTICIPATED RESULTS: Among 4,880 persons contributing 19,510 person-years, 69 (1.4%) developed ≥1 respiratory ADE. Median age at cohort entry was 42.6 (interquartile range [IQR]: 32.1, 52.3) years and at first respiratory ADE was 43.6 (IQR: 36.1, 51.2) years. The overall average respiratory ADE incidence in the pre-pandemic period (March 2017-March 2020) was 4.5 (95% CI: 3.3-6.3) per 1,000 person-years and during the post-pandemic period (April 2020-March 2023) was 4.1 (95% CI: 1.8-9.0) per 1,000 person-years. When accounting for repeated outcomes and annual variation, the modeled respiratory ADE incidence was 10% lower (IRR=0.9, 95% CI: 0.6-1.4) during vs. before the COVID-19 pandemic. DISCUSSION/SIGNIFICANCE: Respiratory ADE incidence dropped 10% following the COVID-19 pandemic declaration, though the confidence interval for this change contains the null. It is plausible that nonpharmaceutical COVID-19 mitigation measures drove a brief but impermanent decline, though further research is needed to assess whether diagnostic biases also played a role.

OBJECTIVES/GOALS: Chronic kidney disease (CKD) affects nearly 40% of adults with diabetes. Our objective is to assess trends in risk factor control and use of 2022 ADA and KDIGO guideline-recommended medications. METHODS/STUDY POPULATION: Using data from 1988 to 2020 from the National Health and Nutrition Examination Survey, we will examine trends in sociodemographic risk factors and glycemic, blood pressure, and lipid control among adults with CKD and diabetes. Glycemic control will be defined as a hemoglobin A1c (HbA1c)<7%, blood pressure control will be examined at cutoffs of 130/80 and 120/80 mmHg, and lipid control will be defined as a fasting triglyceride level ≥150 mg/dL, a low-density lipoprotein (LDL) <100 mg/dL without atherosclerotic cardiovascular disease (ASCVD), or LDL<70 mg/dL if they have ASCVD. We will assess changes in the use of commonly used antidiabetic, antihypertensive, and lipid-lowering medications. RESULTS/ANTICIPATED RESULTS: We hypothesize that from 1988-2020, blood pressure control has improved while glycemic and lipid control has not improved among adults with diabetes and CKD. We expect decreases in sulfonylurea use and increases in DPP-4 inhibitor, metformin, ACE inhibitor, angiotensin receptor blocker, statin, and insulin use over time among those with diabetes and CKD. In addition, there is likely a significant gap between those who are eligible to use newer medications like SGLT2 inhibitors or GLP-1 receptor agonists and who are currently using them within this subpopulation. DISCUSSION/SIGNIFICANCE: This study will examine adherence to guideline-recommended management and identify gaps in care for adults with CKD and diabetes, which may inform how best to optimize medication use for cardiorenal protection in this high-risk patient population.

Telemedicine enables critical human communication and interaction between researchers and participants in decentralized research studies. There is a need to better understand the overall scope of telemedicine applications in clinical research as the basis for further research. This narrative, nonsystematic review of the literature sought to review and discuss applications of telemedicine, in the form of synchronous videoconferencing, in clinical research. We searched PubMed to identify relevant literature published between January 1, 2013, and June 30, 2023. Two independent screeners assessed titles and abstracts for inclusion, followed by single-reviewer full-text screening, and we organized the literature into core themes through consensus discussion. We screened 1044 publications for inclusion. Forty-eight publications met our inclusion and exclusion criteria. We identified six core themes to serve as the structure for the narrative review: infrastructure and training, recruitment, informed consent, assessment, monitoring, and engagement. Telemedicine applications span all stages of clinical research from initial planning and recruitment to informed consent and data collection. While the evidence base for using telemedicine in clinical research is not well-developed, existing evidence suggests that telemedicine is a potentially powerful tool in clinical research.