OBJECTIVES/SPECIFIC AIMS: Our aim was to assess the feasibility and acceptability of a VW-based cardiac rehabilitation (CR) program (Destination Rehab) as an extension of a face-to-face conventional CR program. We hypothesized that a VW-based CR program could be successfully implemented as an extension of conventional CR and would have high acceptability among cardiac patients. METHODS/STUDY POPULATION: We recruited 30 adult cardiac patients (10/site) hospitalized at Mayo Clinic Hospitals in Rochester, MN, Jacksonville, FL or Scottsdale, AZ with a diagnosis for CR (eg, acute coronary syndrome (ACS), heart failure, elective percutaneous coronary intervention (PCI)). Other inclusion criteria included at least 1 modifiable, lifestyle risk factor target: sedentary lifestyle (< 3 hours physical activity (PA)/week), unhealthy diet (< 5 servings fruits and vegetables/day) or current smoking (>1 year). Patients participated in an 8-week, health education program using a VW platform from a prior proof-of-concept study and provided intervention usability, usefulness and satisfaction feedback. We assessed cardiovascular (CV) health behaviors (diet, PA) and risk factors (eg, blood pressure (BP), lipids) at baseline and immediate post-intervention. RESULTS/ANTICIPATED RESULTS: Among 30 patients enrolled (mean age; 59 years; 50% women; 65% <college graduate; 32% annual household income <$50,000), 28 (98%) completed the study. The majority (64%) were enrolled in conventional CR with a high session completion rate (median 36 sessions, interquartile range 8-36). The most common CR indication was PCI (68%). There were statistically significant improvements in PA from baseline to post-intervention: vigorous PA, +10.7 (SD 11.7) minutes/day (p = 0.05) and flexibility exercises +0.9 (SD 0.9) days/week for men (p=0.05). There were favorable trends in risk factors: systolic BP (−6.8 mmHg, SD 29.8), total cholesterol (−31.6 mg/dL, SD 46.2) and LDL (−26 mg/dL, SD 44.8) from baseline to post-intervention, although not statistically significant. The majority reported that they would continue to use VW as a resource (76%) and agreed/strongly agreed that the program improved their heart health knowledge (86%) and assisted with adapting healthier lifestyle (100%). Overall, the VW CR program received a rating of 8 (scale 0-10). DISCUSSION/SIGNIFICANCE OF IMPACT: VW-based CR program is a feasible, highly acceptable and innovative platform to influence health behaviors and CV risk and can increase accessibility to disadvantaged populations with higher CVD burdens.

Early in the COVID-19 pandemic, the World Health Organization stressed the importance of daily clinical assessments of infected patients, yet current approaches frequently consider cross-sectional timepoints, cumulative summary measures, or time-to-event analyses. Statistical methods are available that make use of the rich information content of longitudinal assessments. We demonstrate the use of a multistate transition model to assess the dynamic nature of COVID-19-associated critical illness using daily evaluations of COVID-19 patients from 9 academic hospitals. We describe the accessibility and utility of methods that consider the clinical trajectory of critically ill COVID-19 patients.

Pragmatic trials aim to generate timely evidence while ensuring feasibility, minimizing practice burden, and maintaining real-world conditions. We conducted rapid-cycle qualitative research in the preimplementation period of a trial evaluating a community paramedic program to shorten and prevent hospitalizations. Between December 2021 and March 2022, interviews (n = 30) and presentations/discussions (n = 17) were conducted with clinical and administrative stakeholders. Two investigators analyzed interview and presentation data to identify potential trial challenges, and team reflections were used to develop responsive strategies. Solutions were implemented prior to the commencement of trial enrollment and were aimed at bolstering feasibility and building ongoing practice feedback loops.

OBJECTIVES/SPECIFIC AIMS: Responding to the need and interest of students and faculty of the UHSP in learning about CTR, the Title V Cooperative Project between UPR-MSC and UCC, developed and offered a training cycle (TC) in CTR. METHODS/STUDY POPULATION: Undergraduate students (US), undergraduate faculty (UF), and graduate students (GS) were invited to register in: Research Education Towards Opportunities (RETO) and Mentorship Offering Training Opportunities for Research (MOTOR), which consisted of 20 hours of training in CTR, with interdisciplinary sessions in: Introduction and preparation of a presentation in CTR; Identify, interview and share a presentation of a CT researcher; participation in conferences and a summer camp in CTR. At the end of the TC, surveys—satisfaction and needs assessment—for training in CTR were administered. RESULTS/ANTICIPATED RESULTS: Thirty-three (33) registered in the TC, distributed: 13 (39.39%) US in RETO, 12 (36.36%) GS and 8 (24.24%) UF in MOTOR. Of these, 25 (75.75%) answered and submitted the on-line surveys and received a completion certificate. All (100%) were satisfied with the TC, and for 96% of the respondents, their expectations were fulfilled, and will continue in the TC. They selected critical review, scientific communication, and cultural diversity as thematic areas of interest. In addition, 60% of them selected neuroscience, cancer and medical imaging as main research areas of interest. DISCUSSION/SIGNIFICANCE OF IMPACT: The TC demonstrated to be an effective strategy to provide new knowledge, experiences, and interest in CTR. It also established a pathway for future engagement in CTR.

OBJECTIVES/GOALS: Missed appointments (MAs) negatively impact the health outcomes of adults living with type 2 diabetes mellitus (T2DM), causing disruptions in clinic operation and added financial cost to healthcare providers and systems. This study aimed to identify risk factors for MAs in both in-person and telehealth settings among adults living with T2DM. METHODS/STUDY POPULATION: Using a sequential multi-method design guided by the modified Quality-Caring Model, the quantitative phase of this study used electronic health records (EHR) data in Calendar Years 2019 and 2020 with 7,276 encounters made by 2,235 patients with T2DM from four diabetes clinics within a tertiary academic medical center in Baltimore, MD. Multivariable random effect logistic regression were used to examine the association between MAs and included predictors (i.e., patient characteristics [e.g., age, race, health status], health provider factors [e.g., types of provider], and health system factors [e.g., scheduling lag]). Based on the results of the quantitative phase, a purposive sample of 23 adults with T2DM and 10 providers were then interviewed individually via phone or zoom. RESULTS/ANTICIPATED RESULTS: The EHR data found that the following variables decreased the odds of MAs: having an activated patient portal account, patients with age over 46 or with white race. Telehealth was associated with 50% decreased odds of MAs during COVID (after 3/23/2020). On the other hand, longer scheduling lag increased the odds of MAs. Qualitative interviews revealed that MAs were often related to social needs, such as lack of/limited health-related transportation and its associated financial burden. Telehealth helped break these barriers for some adults with T2DM, but technical challenges in telehealth persisted for those with low digital health literacy and people who did not have a digital device and/or with unstable internet connection. Providers worried that these challenges might undermine the quality of diabetes care. DISCUSSION/SIGNIFICANCE: Disparities in MAs by age and race were noted, which might reflect the impact of unmeasured social needs in EHR. Perceived convenient telehealth may reduce MAs in T2DM care. However, the persistent technical challenges of telehealth should be addressed to optimize the quality of diabetes care and to promote care continuity for underserved populations.

OBJECTIVES/GOALS: Despite food pantries’ efforts to improve nutritional quality and encourage healthy cooking, limited evidence exists regarding pantry shoppers’ culinary preferences and kitchen equipment access. This project utilized pantry food demonstrations and samples to collect recipe and kitchen tool feedback. METHODS/STUDY POPULATION: For 4 months, a Culinary Medicine team delivered food demonstrations at Crossroads Community Services food market in Dallas, Texas, which serves primarily Hispanic and Black residents. Each demo provided a food sample, corresponding printed recipe in English or Spanish, and a survey. Part 1 of the survey measured shoppers’ hedonic liking of the sampled food and their likelihood of recreating it. Part 2 used the same scale for non-sampled recipes adapted from Health meets Food Community Culinary Medicine programming. Averages of appeal and likelihood to cook between sampled and unsampled groups were compared with a student’s T test. Part 3 contained a visual graphic of 24 kitchen appliances, and shoppers circled each item they owned. Investigators collected surveys from 207 shoppers across 12 demos. RESULTS/ANTICIPATED RESULTS: Preliminary analyses showed a positive response to the food demonstrations with a mean rating on a 5-point Likert scale of 4.58 for recipe appeal and 4.46 for likelihood of cooking the recipe at home. The Health meets Food recipes not demonstrated were also positively reviewed (4.40 for appeal and 4.32 for likelihood to cook). There was a statistically significant difference in appeal between sampled and non-sampled recipes (p = 0.03) while no significant difference was found for likelihood to cook (p = 0.08). On average, clients owned 75% of kitchen appliances with most clients owning a sauté pan (94%) but few having access to a food processor (27%). DISCUSSION/SIGNIFICANCE: An effective nutrition program for food pantry clients must be accessible, culturally relevant, nourishing, and enjoyable. Providing samples alongside recipes may increase appeal and engagement. Consideration of kitchen equipment access is essential to promote recipe recreation at home.

OBJECTIVES/GOALS: The Mayo Clinic Clinical and Translational Science (CTS) Predoctoral program aims to develop independent researchers capable of leading multi-disciplinary teams to accelerate the translation of discovery to application. Here, we detail the outcomes of our graduates over the past ten years (2010-2019). METHODS/STUDY POPULATION:): A survey was fielded with all CTS graduates whose degrees were conferred since the program’s inception to 2019. Items addressed their current position, whether they were still involved in research, what type of research they were involved in, and whether they stayed involved with education. They also submitted a recent CV, from which data were collected about publications and grants. A subset were then contacted for a semi-structured interview. Items included questions addressing motivation for pursuing a PhD in CTS, whether the program prepared them for their current work, gaps they felt they had in training, and whether they felt they were making a difference in the lives of patients. RESULTS/ANTICIPATED RESULTS: Of the 41 alumni, 34 responded (83% response rate). Of these, 19 (56%) are at Mayo Clinic, 9 (26%) work for other academic institutions, and 6 (21%) do not work for an academic institution. Most have remained in research (33/34, 97%). The majority (22/33, 67%) are involved in clinical research, 30% (10/33) in basic science, and 24% (8/33) in healthcare delivery research. Most (23/34, 68%) are engaged in educational activities. When asked about changes they have led, 67% (18/27) led quality improvement projects and 44% (12/27) designed a new research method. Several hold leadership positions either in their organization (12/16, 75%) or in a professional organization (10/16, 63%). DISCUSSION/SIGNIFICANCE OF IMPACT: The CTS Predoctoral program successfully prepares scholars for careers involving clinical and translational research; furthermore, alumni remain in research-oriented careers after graduation. We will continue to gather longitudinal data alumni move forward in their careers.

OBJECTIVES/GOALS: During the COVID-19 pandemic, translational scientists sought to provide scientific and data expertise to school districts serving diverse and disadvantaged students to enable equitable access to in-person learning. METHODS/STUDY POPULATION: We showcase two CTSA examples. One is a partnership with the second largest U.S. school district; the second is a national network of scientists and urban and rural school districts. In each example, CTSAs assembled expert science teams to support data-driven decision-making. The teams provided honest brokering of COVID-19 science, scientific interpretation that is sensitive to local context, and responses to community-driven questions. The teams collaborated with school district partners to design actionable data displays on key metrics including primary COVID-19 cases, school-acquired cases, quarantines, and missed school. The national ABC Science Collaborative) provided a platform for shared learning and reproducibility and credibility of science using district data. RESULTS/ANTICIPATED RESULTS: The CTSAs developed easily interpretable and actionable data displays. Partnered school districts observed data in real time to identify signals of change. Districts in the national network were able to learn in real time from variation across districts based on policies and procedures that they adopted, such as quarantine, masking, and physical distancing. DISCUSSION/SIGNIFICANCE: This scientific collaboration is a model of rapid CTSA response, informing science and real-time action. The data displays enable school districts to explain decisions regarding student and staff health and safety. These partnerships and data designs are infrastructure that can be quickly mobilized for emergent and for ongoing information needs.

ABSTRACT IMPACT: The Summer Foundation on Research gave undergraduate students the opportunity to do research despite the new normal - COVID-19 pandemic. OBJECTIVES/GOALS: The COVID-19 pandemic prevented domestic and international undergraduate students from attending in-person Mayo Clinic Summer Undergraduate Research Programs. Mayo decided to redesign this program as a virtual, 4-week Summer Foundations in Research (SFIR) program. The goal of this program was to give students a scientific research experience. METHODS/STUDY POPULATION: The SFIR included an Introduction to Experimental Design, Dialogue methodology for communicating science, scientific mentoring, asynchronous online modules and a Resiliency component. Evaluations of the program were undertaken to gather feedback for program improvement and to assess the educational and mental health impact on participants. These evaluations asked student to rate each section of the program. Additionally, students were encouraged to provide their own comments and feedback. Statistical analysis of quantitative data was performed using excel. The qualitative data was studied using the identification, analysis and interpretation of patterns method per the student’s comments on each of the questions addressed in the survey. RESULTS/ANTICIPATED RESULTS: These evaluations revealed positive outcomes across program components: 66% of the participants found the Resiliency component extremely worthwhile, 80% of participants liked the experimental design and 70% liked the educational courses. Qualitative data showed that mentor/mentee interactions were highly valued, and both participants and faculty suggested increasing the amount of time devoted to these interactions. Small group discussions gave students the opportunity to get to know other peers and encouraged further discussions about science and the community. Participants suggested minor improvements to the program, such as re-creating the online modules specific for undergraduate students, increasing 1-to-1 and small group’s discussion, and increasing the length of the program. DISCUSSION/SIGNIFICANCE OF FINDINGS: Despite the quick pivot of the SFIR program, the re-design and new format supported the development of participants’ resilience skills and training as future scientists during a particularly challenging time. Mayo is committed to continuing this program as an early step in a pathway to careers in research.

OBJECTIVES/SPECIFIC AIMS: This study will elucidate what percent of unnecessary ED visits for chronic conditions can be reduced by extant telemedicine devices, and which telemedicine devices can yield the greatest reduction in unnecessary ED visits for chronic conditions. METHODS/STUDY POPULATION: We intend to use the Nationwide Emergency Department Sample (NEDS) to estimate the percent of ED visits, with a chronic condition as the principal diagnosis, were only evaluation and management services were rendered. The NEDS is the largest publicly available, all-payer ED database, providing national estimates of ED visits. The NEDS contains information on patient demographics, principal diagnosis (captured by ICD-9-CM codes and defined as the main reason for bringing the patient to the hospital), and procedure codes using Current Procedural Terminology, Fourth Edition (CPT-4). Patients with a chronic condition will be identified using Chronic Condition Indicator developed by the Agency for Healthcare Research and Quality and, from them, patients who only received “evaluation and management” services will be extracted using the CPT-4 codes 99281–99283 and G0380–G0383. Then using our previously developed database, wherein FDA-approved OTC medical devices were allied to chronic conditions by applying the transitive property of equality between telemedicine devices – measurement and measurement – conditions pairs, we will elucidate what percent of unnecessary ED visits for chronic conditions which can be reduced by extant telemedicine devices. RESULTS/ANTICIPATED RESULTS: We anticipate multiple OTC telemedicine devices will be necessary to evaluate and manage common principal conditions. DISCUSSION/SIGNIFICANCE OF IMPACT: Telemedicine is seen as a potentially powerful tool for improving healthcare and reducing cost. UnitedHealthcare, the largest US insurance provider, has partnered with Doctors on Demand, the largest players in the telemedicine app space, and other app-based telemedicine services to provide on-demand access to physicians. However, to reach the full potential of telemedicine, and more specifically towards reducing unnecessary ED visits for chronic conditions, telemedicine services need to include capabilities that will allow for the evaluation and management of chronic conditions. This study is a pragmatic first step towards understanding what telemedicine devices would best augment existing telemedicine services to reduce unnecessary ED utilization.

Objectives/Goals: Goals for this work include identifying areas for continuous curricular improvement as well as documenting best practices in multidimensional mentoring in innovation. Programmatic goals include pivoting early career scientists toward translational science solutions that are commercially viable. Methods/Study Population: Using Likert-scaled perception surveys of fellowship participants, preliminary pre- and post-fellowship responses are presented. Preliminary regression analyses are used to identify trends in participants’ ratings across innovation pathways and customer-focused design. Results/Anticipated Results: Focusing on the initial cohort of fellows’ perceptions of their competencies in the areas of technology propositions and industry networking, we observed a near twofold improvement reported competency, suggesting a key strength area for the Fellowship program. Discussion/Significance of Impact: First of its kind at Penn State College of Medicine, the Center for Medical Innovation’s partnership with Clinical and Translational Science Institutesignals enhanced commitment to developing early career fundamental scientists in the areas of intellectual property, customer-focused design, and commercialization. Significance of this work includes capturing best practices.

OBJECTIVES/SPECIFIC AIMS: The purpose of this study was to summarize the existing literature on clinical research competencies and determine what competency assessments currently exist. We also wished to assess which competencies should be included in a research competency assessment tool and to evaluate the validity of current competency assessments. We also examined whether these competency assessments can be used for the purposes of formative and summative evaluation. METHODS/STUDY POPULATION: Prior to conducting our search of the literature, we first compiled a list of search terms (e.g., clinical, research, training, competencies) that could be used to locate articles. We then entered these search terms, in various combinations, on several relevant databases. We evaluated abstracts of the articles revealed by this search to determine whether they met three criteria. The first criterion was that the subjects of the article must be clinical investigators or clinical investigators in training. Relevant disciplines included medicine, public health, nursing, pharmacy, dentistry, and other related fields. The second criterion was that articles should focus on research-based (as opposed to clinical) skills. The last criterion was that research-based competencies (or related terms like skills, abilities, mastery, knowledge) must be assessed in some way. If the abstract suggested that the article met all three criteria, the full article was retrieved and analyzed in-depth. To identify articles that eluded literature search, we then examined the reference section of these articles and examined articles that cited these articles. When no additional articles could be located, the search for articles stopped. Once a pool of potentially eligible articles was identified, the articles underwent peer review by several researchers experienced with clinical research and competency-based education and assessment. Articles that were unanimously judged to meet the criteria were included in the systematic review. RESULTS/ANTICIPATED RESULTS: Approximately 75 articles were selected and reviewed for eligibility. After peer review, we found that only a small fraction of these articles met our criteria for inclusion in the systematic literature review. Our preliminary findings suggest that there are few assessments of clinical research competency and that many of these assessments are poorly validated. DISCUSSION/SIGNIFICANCE OF IMPACT: The findings of the present study suggest that the validation methods used thus far are limited and so the validity of many of these assessments is effectively unproven. Future research on assessments of clinical research competency ought to address these limitations by sampling clinical researchers, using more rigorous validation methods, and by confirming hypothesized factor structures in new samples. The use of better-validated instruments may enhance measurement of trainees’ knowledge and skill levels for the purposes of formative and summative assessment.

OBJECTIVES/GOALS: Lymphedema is a chronic, debilitating disease characterized by progressive swelling due to lymphatic dysfunction. Lymphedema affects 5+ million people in the US, commonly as a consequence of cancer treatment. We identified the most relevant needs within lymphedema based on clinical impact, commercial viability, and technological feasibility. METHODS/STUDY POPULATION: A narrative review of lymphedema management was performed through a combination of literature review via English language PubMed, landscape determination for current solutions and primary ethnography. Lymphedema-focused physicians, patients, physical therapists and researchers were interviewed on Needs were identified and clustered based on common themes. These clusters were further refined through an iterative process of systematic scoring and expert evaluation. Clusters were evaluated on their potential for clinical and commercial impact as well as technical feasibility. RESULTS/ANTICIPATED RESULTS: General clusters identified included improved diagnostic modalities, curative treatment, disease knowledge among non-specialized clinicians and increased insurance coverage. 3 primary needs were determined to represent the best opportunities for technological innovation. There is a need for a quantitative method of evaluating lymphedema. This would allow for both improved tracking of progression for patients undergoing conservative management, and for better evaluation of surgical outcomes. Oncologists and surgeons need a method of prophylaxis in order to decrease the rate of lymphedema development following cancer treatment. Physicians need a method for early diagnosis of subclinical lymphedema to enable early intervention through proactive screening rather than reactive management. DISCUSSION/SIGNIFICANCE: Increasingly medical device design has moved towards a “bedside to benchtop” model where technology development is targeted based on critical needs within the clinical environment. Identification of these critical needs will serve as to guide future technological innovation in creating clinically impactful advancements.

OBJECTIVES/SPECIFIC AIMS: Upper-extremity (UE) impairment affects 88% of stroke survivors due to dysfunctional shoulder-hand coordination. Patients may be able to grasp with the arm at rest, but unable to grasp in a functional context (eg, from a high shelf) because shoulder use elicits involuntary hand muscle activity. Further, much rehabilitation research is directed at unsuccessful stroke recovery (patients with persistent UE impairment) but very little towards patients who show successful clinical recovery (such as those with mild UE impairment) even though these patients have attained the desired rehabilitation outcome. We examined the neurophysiological trajectory of successful compared to unsuccessful post-stroke recovery in the context of functional UE movements to clearly identify what factors are necessary for successful recovery of functional UE movements after stroke. METHODS/STUDY POPULATION: We studied 3 populations: (1) mildly-impaired patients, early (at <17 d, 30 d, 90 d, and 180 d) after stroke as a model of successful post-stroke recovery, (2) moderately-impaired, chronic patients (>6-months post stroke) with persistent hand function impairment, as a model of incomplete post-stroke recovery (unsuccessful recovery), and (3) Healthy age-range matched controls. We used transcranial magnetic stimulation (TMS) in all 3 groups at the given time points to measure corticomotor excitability (motor evoked potentials, recruitment curve), corticomotor inhibition (short-interval intracortical inhibition, long-interval intracortical inhibition), and intracortical facilitation of hand muscles with the shoulder positioned in different degrees of flexion or abduction (these shoulder positions are known to elicit involuntary, undesired hand muscle activation, which leads to UE dysfunction and impairment in individuals with stroke). RESULTS/ANTICIPATED RESULTS: Data collection are in process and will be presented. Preliminary data from controls shows that corticomotor excitability of selected hand muscles is affected by changes in shoulder position. Preliminary findings in controls are consistent with clinical findings in stroke that certain shoulder positions elicit involuntary and undesired hand muscle activation, leading to UE dysfunction and disability. Findings from the stroke groups will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: We hypothesize that this centrally-facilitated coupling between shoulder and hand muscles is disrupted after stroke, which may play a central role in the inability of patients to perform functional UE movements. By comparing the TMS metrics in mildly-impaired Versus moderately-impaired chronic patients, we will be able to identify the longitudinal change in neurophysiology underlying shoulder-hand coordination that is associated with successful or unsuccessful clinical recovery of UE function after stroke. Thus, these findings will help us distinguish between the neurophysiology underlying successful from unsuccessful UE recovery leading to more mechanism-based interventions for UE dysfunction post stroke in the future.

OBJECTIVES/SPECIFIC AIMS: The TL1 Team approach aims to train translational investigators capable of tackling complex and multifaceted diseases, such as hypertension, by beginning multidisciplinary, team-based training early in their graduate programs. METHODS/STUDY POPULATION: Leanne Dumeny is a graduate student in Genetics and Genomics studying how pharmacogenomics can be applied to improve clinical care and cardiovascular outcomes. Chu Hsiao is a graduate student in Anthropology studying how sociocultural experiences become biologically embodied. Both are in the Ph.D. phase of M.D.-Ph.D. training. Joining the seemingly disparate but complementary fields of anthropology and genomics facilitates understanding of the intersection between socially driven experiences and genetics on nocturnal blood pressure. Understanding both social determinants, such as racial discrimination, and biological determinants, such as genetics, is important because an interplay of gene-environment interactions influences many complex diseases. Rarely can 1 individual, or 1 discipline, tackle all the perspectives necessary to answer these types of complex questions. The TL1 Team curriculum teaches students to navigate the spectrum of translational research as a team, reflect on disciplinary limitations, and embrace collaborative research. RESULTS/ANTICIPATED RESULTS: This team project will investigate the relationship between racial discrimination and genetics using a large epidemiological cohort of African Americans in Mississippi. The data request application is currently under review. By the project’s end, the team anticipates their investigation will reveal novel associations between racial discrimination, genetic polymorphisms, and nocturnal blood pressure measurements. The investigators will have gained experience obtaining and analyzing large external data sets, working in diverse team settings, collaborating across state-lines, and publishing articles. Through this team approach, the students will also understand the barriers to working in multidisciplinary groups, and develop a foundation for approaching future collaborations. DISCUSSION/SIGNIFICANCE OF IMPACT: By joining anthropology with genomics, it becomes possible to understand the intersection between socially driven experiences of racial discrimination and genetics on nocturnal blood pressure. The successful training of this first cohort of team-applicants to the TL1 funding mechanism can impact how graduate education will be structured and could reframe graduate education to emphasize a team-based approach.

Objectives/Goals: Competencies of a principal investigator (PI) in clinical research are crucial for ensuring the success, integrity, and ethical conduct of a study. This protocol aims to assess training offerings focused on improving clinical investigator competency and build a set of best practices for training. Methods/Study Population: The authors have started by creating a committed group of key opinion leaders at Rutgers Health and across industry to advise on the process. A mixed-method assessment of the current state of clinical investigator training/education in the conduct of T1-T4 clinical trials is currently being conducted to identify existing practices. An evaluation and assessment of key competencies will be initiated. Education and training objectives and modules will subsequently be developed from this process. The program will be piloted to early career clinicians, faculty, fellows, investigators within NJACTS, and other CTSAs and later assessed for efficacy. Results/Anticipated Results: A summary and descriptive statistics of the landscape of training opportunities and the variabilities of these offerings to address the needs of these investigators is projected to exhibit the gaps in knowledge and skill set required for a PI to effectively conduct a clinical trial. This will serve as the basis for developing a micro-credential (PI Badge) by the NJACTS’ Workforce Development group. Variability across educational offerings from academic institutions, sponsor/CRO protocol/study training, and online courses may not foster applicable skills. This badge is focused on addressing a clinician’s understanding of the roles and responsibilities as they align to the Principal Investigator commitments listed in the FDA form 1572. Discussion/Significance of Impact: Whether or not micro credentialing will enhance principal investigator competency, this mixed-method assessment is poised to identify a common benchmark for success. The ability to deal with increasing protocol complexity requires investigators to be more adept at implementation and compliance to sustain their ability to conduct clinical trials.