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/GOALS: Although there is ample evidence that environmental contaminants impact reproductive health, the exact mechanisms of action, for the most part, remains unclear. We sought to determine whether known contaminants in Puerto Rico can contribute to the selection of a bioassay to add granularity to geospatial contamination data at the cellular level. METHODS/STUDY POPULATION: A PubMed literature search was conducted: Puerto Rico AND Vieques AND Environmental Contaminants AND Heavy Metals OR Phthalates OR Metals OR PCB OR Air Pollution OR CVOC . Additional inclusion criteria were free full text, English language and year of publication between 2000 to 2022 (n = 244 studies). References that were not related to Puerto Rico and environmental contaminants in air, soil, water, or vegetation were excluded. A second PubMed literature search was conducted to determine whether a clinical link has been established between contaminant exposure and the male reproductive system. Search terms were: heavy metals AND hypospadias OR cryptorchidism NOT female NOT animal NOT review , heavy metals AND male infertility NOT female NOT animal NOT review . The same strategy was used for phthalates. RESULTS/ANTICIPATED RESULTS: We found that 12 out of 15 studies that were conducted in the Archipelago of Puerto Rico between 2000-2022 reported heavy metals- and/or phthalates- contamination in soil and water. We also found that there is a paucity of clinical studies that consider plausible relationships between a given contaminant and congenital conditions or male reproductive function. Specifically, we found that heavy metal exposure has been linked to hypospadias (n=1 study), comorbidity of hypospadias plus cryptorchidism (n= 1 study) or male infertility (n=14 studies). Phthalates exposure has been linked to comorbidity of hypospadias and cryptorchidism (n=1 study) or male infertility (n=1 study). Male subfertility has been overlooked so far. We noted that Sertoli cell dysfunction has been linked to all of these conditions. DISCUSSION/SIGNIFICANCE: The geography of Puerto Rico provides an opportunity to close the gap in knowledge between environmental contamination and male reproductive health. Based on our findings, we propose that the use of a bioassay with an immortalized Sertoli cell line can uncover the cellular processes that may be affected in male reproduction upon contaminant exposure.

OBJECTIVES/GOALS: Recent NCATS funding announcements emphasize pursuing domain-agnostic translational science projects that seek to transform the system of science. We aimed to articulate the social responsibility of translational science, defined as prioritizing improved health outcomes and decreased disparities. METHODS/STUDY POPULATION: We focused on the framing of social responsibilities of translational science and distinctions between (a) domain-agnostic translational science that aims to transform the system of science and (b) translational research that takes place within a specific therapeutic area. We reviewed CTSA funding calls, translational research ethics papers, and statements by leaders in the field of translational science. We integrated the social responsibilities of improving health outcomes and decreasing disparities with the values of translational science, which prioritize the relevance, usability, and sustainability of translational interventions. RESULTS/ANTICIPATED RESULTS: We drew on our review of the literature and case studies to offer guidance aimed at helping to ensure that differently positioned actors and entities within the translational ecology can advance the values of translational science while also fulfilling the social responsibilities of translational science. We specify how (a) Funders and policymaking institutions, (b) Organizations such as research universities and CTSA institutes, (c) Translational health science teams working on innovative translational science projects, and (d) Individual translational scientists can all contribute to ensuring that translational science fulfills its ethical obligations and social responsibilities. DISCUSSION/SIGNIFICANCE: The social responsibility of translational science can be fulfilled by centering its efforts to develop useful, sustainable, and relevant innovations. These criteria clarify how social responsibilities manifest in practice and can help funders shape and guide the next era of translational discovery.

A translational team (TT) is a specific type of interdisciplinary team that seeks to improve human health. Because high-performing TTs are critical to accomplishing CTSA goals, a greater understanding of how to promote TT performance is needed. Previous work by a CTSA Workgroup formulated a taxonomy of 5 interrelated team-emergent competency “domains” for successful translation: 1). affect, 2). communication, 3). management, 4). collaborative problem-solving, and 5). leadership. These Knowledge Skills and Attitudes (KSAs) develop within teams from the team’s interactions. However, understanding how practice in these domains enhance team performance was unaddressed. To fill this gap, we conducted a scoping literature review of empirical team studies from the broader Science of Team Science literature domains. We identified specific team-emergent KSAs that enhance TT performance, mapped these to the earlier “domain” taxonomy, and developed a rubric for their assessment. This work identifies important areas of intersection of practices in specific competencies across other competency domains. We find that inclusive environment, openness to transdisciplinary knowledge sharing, and situational leadership are a core triad of team-emergent competencies that reinforce each other and are highly linked to team performance. Finally, we identify strategies for enhancing these competencies. This work provides a grounded approach for training interventions in the CTSA context.

OBJECTIVES/GOALS: The objective of this presentation is to describe different recruitment tools implemented by the Miami Clinical and Translational Science Institute (CTSI) to facilitate participant recruitment into research studies. METHODS/STUDY POPULATION: Participant recruitment is critical to the success of all research studies. In the effort of advancing clinical and translational science and to help investigators recruit volunteers for research studies, the University of Miami has two recruitment tools: 1) Consent to Contact (CTC), an opt-in research registry where University of Miami Health System patients are asked for permission to be contacted about studies matching their demographic and/or health profiles; and 2) UMiamiHealthResearch.org (UMHR), implemented with the Michigan CTSA, a community-based registry for volunteers to sign up and be contacted about studies. Study investigators can use these tools once they have obtained IRB approval for their research. RESULTS/ANTICIPATED RESULTS: The CTC was launched in 2016; to date, over 130,000 patients have enrolled in CTC; 69 studies have been approved with over 75,000 patients’contact information released to study teams. UMHR was launched in 2020. To date, the site lists 237 studies. A total of 2,727 portal visitors have expressed interest in participating in specific studies. Study team members were successful in engaging interested participants, and enrolling participants into studies. Overall, teams reported a positive impact on recruitment. Data collection on utilization and satisfaction of these recruitments tools is ongoing. In addition, focus groups of study team members are being conducted to identify best practices for using these tools, and findings will be presented. DISCUSSION/SIGNIFICANCE: The CTC and UMHR recruitment tools have demonstrated positive impact in helping study teams identify potentially eligible research volunteers. The continued promotion of these tools at the University of Miami Health System and in the community will be crucial to the recruitment process and execution of research studies.

The potential utilization of a cold-contact approach to research recruitment, where members of the research team are unknown to the patient, has grown with the expanded use of electronic health records (EHRs) and affiliated patient portals. Institutions that permit this strategy vary in their implementation and management of it but tend to lean towards more conservative approaches. This process paper describes the Medical University of South Carolina’s transition to an opt-out model of “cold-contact” recruitment (known as patient outreach recruitment or POR), wherein patients can be contacted so long as they do not express an unwillingness to receive such communication. The work highlights the benefits of this model by explaining how it, in many ways, supports and protects autonomy, beneficence, and justice for patients. The paper then describes the process of standing up the recruitment strategy, communicating the change to patients and the community, and documenting study team contact and patient research preference. Data supporting increased access to potentially eligible patients of greater diversity as well as initial researcher feedback on perceived success of POR is also shared. The paper ends with a discussion of next steps to enhance the POR process via more detailed data collection and reengagement with community stakeholders.

OBJECTIVES/GOALS: Current clinical practice recommends occlusive dressings (e.g., film and hydrocolloid) for wounds with variable regenerative capacities. However, clinical evidence suggests that occlusion may hinder regeneration. Our objective was to test the impact of occlusion on regeneration using animal models. METHODS/STUDY POPULATION: The murine wound-induced hair neogenesis (WIHN) is a well-established model of regeneration characterized by de novo hair follicle (HF) formation in the center of large full-thickness wounds. The quantity of neogenic HFs depends on the robustness of Wnt signaling. Optimal tissue mechanics is also required for WIHN. Utilizing the murine WIHN model, we tested the hypothesis that wound occlusion impedes regeneration. We determined how (i) the timing and duration of wound occlusion impacts WIHN, (ii) Wnt signaling influences the occlusion-induced effects on regeneration and (iii) occlusion alters the tissue mechanics of the wound, which establishes the morphogenetic field needed for WIHN. RESULTS/ANTICIPATED RESULTS: Occlusion completely eliminated WIHN. Only a brief period of occlusion between post-wound days 0-3 or 4-7 was sufficient to abrogate WIHN. Microarray and qPCR of open and occluded wounds demonstrated that occlusion promotes fibrosis by upregulating TGF-β2 and mechanotransduction, a mechanosensitive profibrotic pathway. Recruitment of these potent profibrotic pathways generated a symmetrically rigid wound incapable of de novo HF regeneration. Using transgenic animal models with enhanced Wnt signaling, we determined that the ligand-dependent Wnt signaling protected against the occlusion-induced inhibition of WIHN, as well as the occlusion-induced upregulation of both profibrotic pathways. DISCUSSION/SIGNIFICANCE: In animal models, occlusion promoted fibrosis at the expense of regeneration during acute wound healing. Augmented Wnt signaling protected against this effect. Occluding wounds may reduce regeneration. Further studies are warranted to validate these findings.

OBJECTIVES/GOALS: This study evaluates the impact of an updated and expanded training for social and behavioral health researchers. Participants’ experience with training modules focused on community engagement is a focus of this evaluation as is the application of this training by participants in teams. METHODS/STUDY POPULATION: The Social and Behavioral Research training series for health researchers and team members was first created by faculty and staff of the Michigan Institute for Clinical and Health Research in 2018. This training was updated and expanded in 2021 with support from the National Institutes of Health to include new material regarding community-engaged health research as well as updates concerning technology and new federal regulations. Past participants of the training were invited to retake the training, as were clinical and translational researchers at University of Michigan who were new to the training. Surveys were sent to all participants after completing the training and a focus group of research staff was conducted to identify how they utilized the training in support of their teams. RESULTS/ANTICIPATED RESULTS: It is anticipated that at least 100 individuals will participate in the evaluation of the Social and Behavioral Research training between October 2022 and February 2023. Data extracted from U-M’s learning management platform will demonstrate how well participants performed on key knowledge checks embedded in the modules and how quickly they progressed through the sections of the training. These results will be compared to benchmarks derived from evaluations of the prior course which were conducted in 2018. A focus group of at least 10 individuals will demonstrate how health research staff utilized the training and associated resources to advance the scientific work of their study teams. DISCUSSION/SIGNIFICANCE: Comprehensive training programs for research best practices in social and behavioral health need to have tailored and up-to-date information for this group of researchers and staff. The results of this evaluation will demonstrate how this program contributed to the professional development of the health research workforce.

OBJECTIVES/GOALS: To increase the diversity of the health sciences research workforce, students from a variety of backgrounds must have the opportunity to participate in hands-on research experiences that highlight translating science to treating human disease. We developed a mentored translational research program for students from VCU and central Virginia HBCUs. METHODS/STUDY POPULATION: The Wright Regional Center for Clinical and Translational Science collaborated with the existing VCU Honors’ Summer Undergraduate Research Program (HSURP) to expand their summer research experience to URM students from our partner HBCUs. For 10 weeks, students worked with faculty mentors to learn research techniques and engage in research projects. Students also participated in career development sessions like developing a CV and choosing graduate programs, and at the end of HSURP, they shared formal presentations of their research with peers and mentors. HSURP students were provided housing and a stipend, and mentors were provided a stipend. A post-program assessment gathered feedback on research and personal skills gained, the program’s influence on their career goals, and overall experiences with HSURP. RESULTS/ANTICIPATED RESULTS: Nine students, 7 from VCU and 2 from Virginia State University participated in HSURP. Students were rising sophomores, juniors, and seniors, and 5 had previous research experience. Students worked on projects ranging from basic to social behavioral, community-placed research. All students rated the program as good or excellent. Post-program assessments showed all students believed they had a better understanding of ethical responsibilities of researchers, relevance of community-engaged and clinical/translational research, and interpreting journal articles after participating in the program. Four students reported they plan to continue working on their research projects during the academic year, and all students strongly agreed or agreed that HSURP prepared them for graduate or professional schools. DISCUSSION/SIGNIFICANCE: A program that combines hands-on research training and career development opportunities provides a robust research foundation for URM students, which can increase their participation in the translational science workforce. Future program development will include preprogram training modules to better prepare students for research experiences.

OBJECTIVES/GOALS: [email protected] METHODS/STUDY POPULATION: Michelle Odonkor RESULTS/ANTICIPATED RESULTS: I accept DISCUSSION/SIGNIFICANCE: No, I do not want my poster published JCTS.

OBJECTIVES/GOALS: The Building Up Study tests the effectiveness of an intervention aimed to diversify the workforce using a two-arm cluster randomized trial. We examined how underrepresented (UR) participants’ perceptions of institutional inclusion affected burnout, intent to continue training, and perceived stress. METHODS/STUDY POPULATION: Building Up was conducted at 25 institutions with 225 UR post-doctoral fellow or early-career faculty participants. To assess perceived institutional inclusion, participants completed a 28-item survey in the first year of follow-up. We used descriptive statistics to describe age, race/ethnicity, and gender. We used exploratory factor analysis to extract factors or domains (survey questions that grouped together). We calculated mean domain scores and used correlations to assess associations between each domain and each dependent variable (burnout, intent to continue training, and perceived stress). Demographics, correlation coefficients and associated p-values are presented. RESULTS/ANTICIPATED RESULTS: 130 of 144 eligible participants completed all questions. The mean age was 39 years (SD = 6), 83% were female, 35% identified as non-Hispanic Black, and 36% identified as Hispanic. Greater inclusivity was associated with lower burnout across 5/6 identified domains: policies (-0.3, p DISCUSSION/SIGNIFICANCE: These findings suggest that institutional inclusion is associated with differences in capacity to function among UR postdocs and early-career faculty. Inclusivity of leaders was only associated with intent to continue training. Inclusion coupled with employee support and development are important for positive outcomes.

Funding for large research initiatives, such as those funded through the National Institutes of Health U mechanism, has increased since 2010; however, there is little published research on how to evaluate the success of such initiatives. Here, we describe the collaborative evaluation planning process undertaken by the Interactions Core of the Collaborating for the Advancement of Interdisciplinary Research in Benign Urology (CAIRIBU) research community, a clinical and translational research initiative funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Evaluation is necessary to measure the impact of our work and to allow for continuous improvement efforts of CAIRIBU activities and initiatives. We developed and implemented an iterative seven-step process that engaged the Interactions Core, NIDDK program staff, and grantees at each step of the planning process. Challenges faced in planning and implementing the evaluation plan included the time burden on investigators to submit new data for evaluations, finite time and resources for evaluation work, and the development of infrastructure for the evaluation plan. We call on funding agencies to include more explicit requirements for evaluation participation from grantees, as well as dedicated funding to support the evaluation process, in future funding opportunity announcements for large research consortia.

OBJECTIVES/GOALS: Computational pathology is an emerging discipline that resides at the intersection of engineering, computer science, and pathology. There is a growing need to develop innovative pedagogical approaches to train future computational pathologists who have diverse educational backgrounds. METHODS/STUDY POPULATION: Our work proposes an iterative approach toward teaching master’s and Ph.D. students from various backgrounds, such as electrical engineering, biomedical engineering, and cell biology the basics of cell-type identification. This approach is grounded in the active learning framework to allow for observation, reflection, and independent application. The learners are trained by a team of an electrical engineer and pathologist and provided with eight images containing a glomerulus. They must then classify nuclei in each of the glomeruli as either a podocyte (blue), endothelial cell (green), or mesangial cell (red). RESULTS/ANTICIPATED RESULTS: A simple web application was built to calculate agreement, measured using Cohen’s kappa, between annotators for both individual glomeruli and across all eight images. Automating the process of providing feedback from an expert renal pathologist to the learner allows for learners to quickly determine where they can improve. After initial training, agreement scores for cells scored by both the learner and the expert were high (0.75), however, when including cells not scored by both the agreement was relatively low (0.45). This indicates that learners needed more instruction on identifying unique cells within each image. This low-stakes approach encourages exploratory and generative learning. DISCUSSION/SIGNIFICANCE: Computation medical sciences require interdisciplinary training methods. We report on a robust approach for team-based mentoring and skill development. Future implementations will include undergraduate learners and provide opportunities for graduate students to engage in near-peer mentoring.

Enterprise data warehouses for research (EDW4R) is a critical component of National Institutes of Health Clinical and Translational Science Award (CTSA) hubs. EDW4R operations have unique needs that require specialized skills and collaborations across multiple domains which limit the ability to apply existing models of information technology (IT) performance. Because of this uniqueness, we developed a new EDW4R maturity model based on prior qualitative study of operational practices for supporting EDW4Rs at CTSA hubs. In a pilot study, respondents from fifteen CTSA hubs completed the novel EDW4R maturity index survey by rating 33 maturity statements across 6 categories using a 5-point Likert scale. Of the six categories, respondents rated workforce as most mature (4.17 [3.67–4.42]) and relationship with enterprise IT as the least mature (3.00 [2.80–3.80]). Our pilot of a novel maturity index shows a baseline quantitative measure of EDW4R functions across fifteen CTSA hubs. The maturity index may be useful to faculty and staff currently leading an EDW4R by creating opportunities to explore the index in local context and comparison to other institutions.

OBJECTIVES/GOALS: The design and phased roll-out of a CTSA competency-based longitudinal Clinical and Translational Research (CTR) curriculum pathway that can be integrated into the training of health sciences professional degree programs at three regional institutions. The outcome will be an increased number of health science professionals participating in CTR. METHODS/STUDY POPULATION: Based on an environmental scan, student surveys to assess interest, and feedback from regional stakeholders, a CTR pathway program was developed. The pathway curriculum will be grounded in 6 key focus areas derived from the Core Competencies in Clinical and Translational Research and prioritized based on regional need. The CTR pathway is currently being developed for the University of Washington School of Medicine, with additional implementations at the Washington State University School of Pharmacy and the Montana State University School of Nursing. Students will complete training modules and a mentored research project that is integrated into their specific course of study. RESULTS/ANTICIPATED RESULTS: In addition to the initial assessments and curriculum, an Advisory Committee will be established. Mentors, site leads, and research project partnerships across the region will be identified. Modifications will be made according to the local needs at both Montana State University and Washington State University. After the pilot launch and roll-out, the pathway curriculum will be adapted for other disciplines based on input from content experts and pathway evaluation data. Student retention in CTR fields will be tracked, with a goal to increase the number of CTR investigators and professionals across WWAMI in the next decade. CTR pathway processes and training resources will be shared with the CTSA consortium and other health sciences professional training sites. DISCUSSION/SIGNIFICANCE: Development of the CTR workforce is a priority to increase national capabilities in clinical and translational science. Building on a recognized need for targeted and longitudinal engagement, a CTR pathway is being established for health sciences students in the WWAMI region.