OBJECTIVES/GOALS: Describe the pipeline of training, coaching, and council opportunities through the Partnerships of Academicians and Communities for Translation (PACT) and how it enhances Community-Based Participatory Research (CBPR) practices and increases community participation and capacity. METHODS/STUDY POPULATION: We conceptualized a pipeline for building capacity for community-based participatory research (CBPR). Key components include Colorado Immersion Training in Community Engagement which introduces academic investigators to specific geographic and demographic communities in Colorado, Partnership Development grants that fund time to building relationships between research and community, Joint Pilot Grants to provide subsequent funding for collaborative research, and the PACT, consisting of Community Research Liaisons (CRLs) and Community and Academic Council Members. RESULTS/ANTICIPATED RESULTS: The pilot grants program was created in 2008; to date has awarded 138 partnerships. In response to academic and community needs, our core developed CIT in 2010. 16 CIT Participants received Partnership Development pilot grant funding, six of whom went on to receive Joint Pilot funding, and an additional 8 who started with a Joint Pilot award. There have been 24 Partnership Development awardees who received subsequent Joint Pilot funding. Ten CIT participants have either become a PACT council member, pilot grants reviewer, or PACT trainer or coach. There has been one person to complete the entire pipeline from CIT, pilot grant awardee, to PACT council member. DISCUSSION/SIGNIFICANCE: The pipeline is a strong foundation for engaging with academic and community researchers who aim to improve CBPR in Colorado. Our signature programs, CIT and Pilot Grants, are unique opportunities to increase community engagement across sectors and improve research practices.

OBJECTIVES/SPECIFIC AIMS: Explain the difference between creative and critical thinking. Practice and enhance the critical thinking skills. Display innovative thinking through creative solutions and insights. Critically evaluate evidence in research. Think imaginatively, actively seeking out new points of view. METHODS/STUDY POPULATION: Offer an online course in Critical and Creative Thinking to junior researchers to improve their capacity to think and transforms their ideas in research questions and aims that bring new option to the field of clinical and translational research. Evaluate their improvement through evaluation forms and exercises that show their process to think imaginatively. RESULTS/ANTICIPATED RESULTS: The Scholars will understood the importance of critical and creative thinking in their careers, believed they could apply the insights and knowledge from the course in their grant and paper writing, recognized that they don’t always consider if they are being critical or creative in their thinking and actions. DISCUSSION/SIGNIFICANCE OF IMPACT: The course helped the participants to improve their capacity to think and saw a need to develop a more systematic thought processes in their life and work. The junior research will understand the difference between opinion, reasoned, judgment and fact and they will be able to judge the credibility of an information source using criteria such as authorship, currency and potential bias that can improve their grant submission and scientific writing skills.

OBJECTIVES/SPECIFIC AIMS:. This study aims to understand the effects of prenatal opioid exposure on structural and functional connectivity in the neonatal brain. Our central hypothesis is that infants with prenatal opioid exposure will have decreased structural and functional connectivity as compared to non-exposed controls. Our overarching goal is to improve neurodevelopmental and behavioral outcomes in infants with prenatal opioid exposure. METHODS/STUDY POPULATION:. Infants with prenatal opioid exposure were recruited from 2 birth hospitals in our area. Control infants were recruited from the larger community. Infants underwent MRI between 4-6 weeks of age in the Cincinnati Children’s Hospital Imaging Research Center. MRI sequences included 3D structural T1 and T2-weighted imaging, resting state functional connectivity MRI, and multi-shell DTI (36 directions at b=800 and 68 directions at b=2000). Tract-based spatial statistics (TBSS) was used to identify differences in fractional anisotropy (a measure of white matter integrity) between groups. Group independent component analysis was used to identify differences in resting-state networks between groups RESULTS/ANTICIPATED RESULTS:. There were 5 subjects enrolled in the study with evaluable imaging, 3 infants with prenatal opioid exposure and 2 unexposed controls. Structural MRI was normal in all cases. Infants with prenatal opioid exposure had reduced structural connectivity as measured by fractional anisotropy (FA) in the genu and splenium of the corpus callosum as compared with controls. The orange/red color represents areas in which the FA of the opioid-exposed group was lower than controls and green represents the white matter skeleton common to both groups. Infants with prenatal opioid exposure also had significantly reduced within-network functional connectivity strength (z-transformed partial correlation coefficient 0.358 vs 0.199, p = 0.03) in the sensorimotor network as compared with controls. DISCUSSION/SIGNIFICANCE OF IMPACT:. In this small pilot study, both structural and functional connectivity were reduced in opioid-exposed infants compared with controls. This data suggests that differences in structural and functional connectivity may underlie the later developmental and behavioral problems seen in opioid-exposed children. These findings must be validated in a larger population with correction for confounding factors such as maternal education

OBJECTIVES/GOALS: To develop and validate a tool to systematically identify benefits accruing to research within the Translational Science Benefits Model (TSBM) framework. We used a Delphi panel to reach consensus among a group of experts on criteria required for a clinical, community, economic, or policy benefit to be verified as coming from research. METHODS/STUDY POPULATION: A coding tool with proposed criteria to verify each of the 30 benefits was created at UCI to confirm the TSBM benefits resulting from funded research. We convened 11 experts from 8 CTSA hubs, who consisted of evaluators (faculty and staff) with experience using the TSBM. A web-based survey was used for Round 1, followed by a panel discussion of remaining unvalidated criteria, and a Round 2 survey as the final decision for inclusion of items in the tool. Response options for each criterion were “yes, required” or “no, not required”. Criteria that reached consensus (>70% agreement) were considered validated for inclusion in the final version. Panelist suggested criteria in Round 1 were also incorporated in the Round 2 survey for consideration by the experts. RESULTS/ANTICIPATED RESULTS: In the web-based survey for Round 1, all 11 experts participated and 92% of criteria reached the determined consensus level (N = 157). The remaining 8% of the criteria (N = 13) were discussed during the panel meeting. The discussion, in which 8 experts participated, was moderated by UCI and took place virtually via Zoom. All experts were sent a recording of the discussion and given the opportunity to post comments online about the remaining criteria before, during, and for a day after the discussion. Round 2 will include 50 newly proposed criteria from panelists and the 13 criteria that did not reach consensus in Round 1. Based on the results of Round 2, the criteria that reach consensus will be included in the final version of the coding tool that can be used across all TSBM benefits. DISCUSSION/SIGNIFICANCE: Using the Delphi Methodology, we will have a standardized set of criteria that may be applied to determine whether a TSBM benefit has resulted from a specific research project or program. This standardization will allow for aggregation and comparison of data across CTSA hubs and further multi-level evaluation of impact.

Objectives/Goals: To evaluate the incremental value of post-approval adverse event reporting and population exposure in characterizing a drug’s safety profile, using PD-1 inhibitors as a model class to assess how continued clinical experience enhances safety knowledge. Methods/Study Population: Using PD-1 inhibitors as a model, we are exploring FDA Adverse Event Reporting System (FAERS) database to capture real-world post-marketing safety information on drugs in this class approved by FDA since 2014. Findings from FAERS will be compared with the safety profile in the initial package insert used for FDA approval for each of the drugs. The nature of novel adverse events will be characterized and compared with the extent of exposure as determined through the use of marketing databases (e.g., IQVIA, Cortellis). We seek to identify relationships between the observation of novel adverse events and levels of population exposure. We will explore whether the safety experience with older products in this drug class could be predictive of safety outcomes in newer class candidates. Results/Anticipated Results: The findings would aim to inform the development of a “Goldilocks” approach (the value of incremental exposures), to explore how post-marketing exposure impacts changes in the safety profile of drugs in this class. Results will be used to explore whether a particular level of post-approval exposure is predictive of the occurrence of novel adverse events, excluding idiosyncratic events, among PD-1 inhibitors. Discussion/Significance of Impact: The study will guide the understanding of the incremental value of additional population exposure to refining the safety profile within a class of well-defined drugs and may inform a systematic approach towards consistent class labeling.

OBJECTIVES/GOALS: Trigeminal Neuralgia (TN) is a debilitating neuropathic condition characterized by electric-shock-like pain attacks. TN is considered a clinical diagnosis, and few proposed objective markers exist. This work studies the ability of advanced MRI techniques to diagnose and classify TN. METHODS/STUDY POPULATION: Anatomical MRI data from patients undergoing radiosurgery to treat TN was collected. A custom deep-learning UNet algorithm was trained to segment trigeminal nerves from the pons to the anterior wall of Meckels cave using segments drawn by an expert in neuroanatomy. 108 radiomics features related to nerve shape, voxel intensity, and image texture were extracted from the segmented nerves. A 2 layer neural network was trained to distinguish TN affected nerves from the pain-free contralateral nerves. Feature selection was performed within a cross-validation scheme to prevent model overfitting. Mean model performance over the validation sets was used to estimate model generalizability. RESULTS/ANTICIPATED RESULTS: 134 patients and 268 nerves were included. The average number of years with TN was 8. The average validation set accuracy was 78% [range: 75-80%]. The average validation set sensitivity and specificity were 0.82 [range: 0.79-0.84] and 0.76 [range: 0.70-0.79]. 34% of patients had undergone a prior invasive procedure to treat their TN. To evaluate whether the model detected signal changes relating to the previous treatment, those patients were excluded and the model was retrained on the surgically naive patients. Model performance in a reduced cohort of patients was similar to the model trained on all the patients, with accuracy of 77% [range: 73-82%]. DISCUSSION/SIGNIFICANCE: This study suggests that radiomics features calculated from MRIs of trigeminal nerves correlate with anatomical changes in TN affected nerves. This technique will need to be verified in a larger, more heterogeneous cohort of TN patients with a range of MRI acquisition parameters.

OBJECTIVES/GOALS: Wheezing has been shown to be associated with use of cigarettes, and more recently, electronic nicotine delivery systems (ENDS). This study assessed the association of poly use of tobacco products with wheezing among a national representative sample of US adult current tobacco users. METHODS/STUDY POPULATION: Data from the Population Assessment of Tobacco and Health (PATH) Study Wave 3 (W3) were used. Weighted prevalences of self-reported wheezing and related respiratory symptoms for non-users compared to users of cigarettes, ENDS, cigars, and any combination of these products (poly use of tobacco products) were presented for 28,082 adults. The cross-sectional association of tobacco use with self-reported wheezing and other related respiratory symptoms was assessed using weighted multivariable and ordinal logistic regression with consideration of complex sampling design. RESULTS/ANTICIPATED RESULTS: Most adults who reported on wheezing symptoms did not currently use cigarettes, ENDS or cigars (79%), 15% used cigarettes, 3% used a combination of cigarettes, ENDS and cigars, 1% used ENDS, and 1% used cigars. Significantly higher odds of ever had wheezing or whistling in chest at any time in the past was observed among current cigarette (adjusted OR: 2.62, 95%CI: 2.35, 2.91), ENDS (1.49, 95%CI: 1.14, 1.95), and poly users (2.67, 95%CI: 2.26, 3.16) compared to non-users. No differences were seen for cigar use. Polytobacco use was associated with a higher odds of ever wheezing when compared to ENDS (1.61, 95%CI: 1.19, 2.17) and cigar use (2.87, 95%CI: 1.93, 4.26), but not cigarettes. DISCUSSION/SIGNIFICANCE OF IMPACT: Wheezing is associated with the use of cigarettes, ENDS, or any combination of cigarette, ENDS and cigars likely due to the inhalation of noxious chemicals and gases found in the smoke of cigarettes and ENDS that are likely to increase the odds of experiencing wheezing. CONFLICT OF INTEREST DESCRIPTION: MLG serves as a paid consultant for Johnson & Johnson and has received research grant from Pfizer, manufacturers of smoking cessation medications. The other authors have no conflicts to declare.

OBJECTIVES/SPECIFIC AIMS: Heart transplant (HTx) recipients are more likely to exhibit abnormal circadian blood pressure (BP) patterns (e.g., lack of nocturnal dip in BP) compared with the general population. Our goal was to assess the relationship between abnormal circadian BP patterns and end-organ damage in HTx recipients. METHODS/STUDY POPULATION: The retrospective study included 30 patients who were ≥ 6 months post-heart transplant and had 24-hour ambulatory BP data collected during a parent study. Nocturnal BP decline was categorized as: ≥10% decline, dipper; <10% decline, non-dipper. The primary end-organ damage outcomes we plan to analyze are left ventricular hypertrophy (LVH), chronic kidney disease (CKD), and proteinuria. The association between nocturnal BP decline and the primary outcomes will be analyzed using logistic regression. RESULTS/ANTICIPATED RESULTS: The study cohort consists of 83% men and 83% Caucasians (mean age=57±14 years; mean time post-transplant =9.0±6.6 years). Systolic and diastolic non-dippers represent 53.3% and 40% of the cohort, respectively. Data are currently being analyzed for the association between nocturnal BP dipping status and LVH, CKD, and proteinuria. These findings will be presented at the conference. DISCUSSION/SIGNIFICANCE OF IMPACT: An understanding of factors, such as abnormal circadian BP patterns, that contribute to the development of end-organ damage following HTx may provide opportunities to improve BP management and prevent adverse complications in this high-risk population.

OBJECTIVES/SPECIFIC AIMS: Translational research involves researchers’ teams working together to address health issues. However, successful translational researchers in health disparities require a set of competencies and skills. In order to increase the number of new minority investigators in translational research focused on health disparities, the Hispanics-in-Research Capability: SoHP & SoM Partnership and the Puerto Rico Clinical and Translational Research Consortium designed and implemented a webinar series “Fostering the Next Generation of Researchers in Health Disparities.” METHODS/STUDY POPULATION: From March 31 to July 14, 2017, this webinar series offered the theoretical perspectives of health disparities, research methodology specific to its study, and intervention strategies to address health disparities in communities through minority investigators. National and local interdisciplinary experts were the presenters. Participants’ experience and impact were assessed through a self-administrated questionnaire. RESULTS/ANTICIPATED RESULTS: A total of 78 minority investigators participated in this webinar. Overall, participants indicated that the webinar improved their knowledge and skills about health disparities research. DISCUSSION/SIGNIFICANCE OF IMPACT: Results guide the programs actions plans to enhance and support the translational researchers’ capacity. Diverse capacity building initiatives including peer-to-peer education, online course, tailored coaching, and other interventions have been designed to address researchers’ needs. This webinar was a pathway to build the next generation of translational researchers in health disparities.

Objectives/Goals: To evaluate an undergraduate nursing externship revised to integrate the updated International Association for Clinical Research Nursing (IACRN) curriculum, designed to strengthen knowledge, skills, and career readiness for the specialty of clinical research nursing (CRN). Methods/Study Population: A 192-hour, 8-week summer externship was conducted at the Rockefeller University (2022–2025), accepting two rising junior nursing students annually. The curriculum included lectures on clinical research principles and processes, IRB observation, informed consent simulation, a mock IRB, and rotations in bionutrition, pharmacy, bioinformatics, and laboratory processing. Externs also completed the Collaborative Institutional Training Initiative on Good Laboratory Practice and lab safety modules. Program evaluations included a pre- and post-test, a 30-item knowledge exam to assess understanding of clinical research concepts, as well as ratings by the mentors across professional competencies, and open-ended questions to obtain feedback from the externs. Results/Anticipated Results: Externs’ knowledge scores rose from pretest averages of 58–70% to post-test scores of 73–86%, a gain of ~20 points. Surveys revealed an improved understanding of research processes, particularly in areas such as informed consent and protocol design. Hands-on activities, lab processing, dietary simulation, and pharmacy were most valued. Mentors consistently rated externs as “Good” to “Excellent” in terms of professionalism, adaptability, and teamwork. Externs reported a greater interest in CRN careers and a deeper appreciation for the specialty’s breadth. Discussion/Significance of Impact: This externship, which embedded updated IACRN competencies at the undergraduate level, successfully enhanced knowledge and understanding of the field. Its innovative, replicable model demonstrates how early exposure can expand the clinical research nursing pipeline and prepare future CRN leaders.

OBJECTIVES/GOALS: Multivariate regression is used for surgical outcomes analyses; but does not allow for evaluation of all variables. Machine learning could be the perfect alternative to address this issue. Our aim was to evaluate whether machine learning is a feasible alternative to evaluate surgical outcomes. METHODS/STUDY POPULATION: H-CUP National Inpatient Sample database was queried for adult patients with colorectal cancer who underwent colorectal resection, while the NSQIP database was queried for adult patients with rectal cancer who underwent proctectomy. A multivariate regression analysis was performed to assess risk factors associated with 30-day complications following those procedures. Subsequently, machine learning techniques of under-sampling and oversampling were applied to the same datasets for the evaluation of risk factors for the same outcome. These techniques were used to achieve a larger population sample size and to detect statistical significance. Results between the two methodologies were compared. RESULTS/ANTICIPATED RESULTS: Multivariate regression revealed that open approach, gender, race, geographic location, number of comorbidities, and type of insurance was associated with increased 30-day mortality in colorectal resection patients. Conversely, the use of machine learning revealed that preoperative weight loss, preexistent chest heart failure, renal failure or perivascular disease were strongly associated with 30-day mortality. For proctectomy patients, multivariate regression found no association between surgical approach and 30-day mortality. However, machine learning revealed gender, hypertension, and reoperation to be strongly associated with 30-day mortality. DISCUSSION/SIGNIFICANCE OF IMPACT: Machine learning enabled multiple combinations that were not possible to examine in a conventional multivariate regression analysis. Machine learning compared to traditional multivariate regression produced significantly different outcomes, highlighting the need for in depth of these methodologies.

ABSTRACT IMPACT: Optimizing the use of endotracheal aspirate cultures (EACs) has the potential to improve the care of complex mechanically ventilated children by improving testing practices and avoiding unnecessary antibiotic treatment for false-positive results. OBJECTIVES/GOALS: An electronic survey has previously been employed to characterize the practices and attitudes around blood cultures among critically ill children. The objective of this work was to develop and pilot a new survey as a tool to understand practices and attitudes that could inform quality improvement initiatives to optimize EAC practices. METHODS/STUDY POPULATION: Informed by prior experience of diagnostic stewardship of EAC in other settings and using a similar structure to the blood culture practice survey, we developed an electronic self-administered survey sent to respiratory therapists, advanced practice providers, and physicians at the Johns Hopkins All Children’s pediatric intensive care unit. RESULTS/ANTICIPATED RESULTS: A total of 27 of 87 clinicians (37%) responded to the survey (22 respiratory therapists, 9 attending physicians and 1 advanced practice provider). Responses indicated samples are typically collected by respiratory therapists via in-line (endotracheal) or open suctioning (tracheostomy). Most respondents did not feel EACs could lead to unintended negative consequences (71%), agreed practices vary between people (89%), and felt an algorithm would help align the clinical team (79%). Most respondents agreed some clinicians may be reluctant to change practice (82%) and may not change practice due to concern for missing diagnosis of ventilator-associated pneumonia or tracheitis (78%). Surveillance cultures were not used in this unit and there were no prior EAC diagnostic stewardship efforts. DISCUSSION/SIGNIFICANCE OF FINDINGS: This survey captured practices, perceptions and barriers to changes that will inform the implementation of quality improvement initiatives to optimize EAC use in this unit. Future studies can consider utilizing an electronic survey to describe practice variation, clinician believes and attitudes about EAC testing in ventilated patients.

OBJECTIVES/GOALS: The Community Engagement Forum (CEF), a quarterly series hosted by the Colorado Clinical and Translational Science Institute (CCTSI) and the ACCORDS Education program, provides seminars from leading academic and community research partners. Our goal is to share the process and outcomes so others may implement a similar forum in their institution. METHODS/STUDY POPULATION: In 2019, CCTSI and the ACCORDS Education Program partnered to offer a forum to exchange best practices for investigators and study teams conducting community-engaged research. Each forum features presenters from community and academic partnerships. Initially this series was offered in-person; during the COVID-19 Pandemic the Forum moved online. At registration we collect data on current position, school/department or organization, and how they heard about the forum. Post session evaluations are also collected. Various topics have been covered including: community engagement foundations, creating advisory boards, responding appropriately to community needs in a pandemic, data equity, and community dissemination. RESULTS/ANTICIPATED RESULTS: Between October 2019 and October 2022, we hosted twelve Community Engagement Forums. A total of 442 people have attended the forums, with the School of Medicine having the highest representation. Among attendees, university research staff are the highest represented position in attendance, with 115 attendees over the 12 forums. 133 people have completed evaluation questions since the start of the forum series. High percentages of agreement were seen from the question, will you use this information to make adjustments/improvements or continue the conversation . Additionally, most respondents agreed that the presentations were useful to their current or future work. DISCUSSION/SIGNIFICANCE: The CEF series has filled a gap for desired resources related to best practices for community-engaged research. CCTSI CE&HC and ACCORDS Education have created a learning community for investigators and study teams to share lessons learned and provide opportunities for trouble-shooting research ideas as they arise.

OBJECTIVES/SPECIFIC AIMS: The NIH states, “The training of the biomedical workforce has always been an integral part of the NIH mission… It takes just one good mentor to influence the career of a new investigator; it takes a robust culture of mentorship across the research community to strengthen, sustain and diversify the entire biomedical research enterprise.” The University of Minnesota’s CTSI-Education core strives to build and maintain a strong culture of mentoring by providing CTSI KL2 scholars an opportunity to mentor an undergraduate student participating in the Pathways to Research Program (PReP). Using this mentoring model, participants gain valuable benefits and CTSI’s culture of mentoring is strengthened. METHODS/STUDY POPULATION: Participating KL2 scholars are matched with a promising PReP scholar for a 12-week mentored research project. The PReP program selects top candidates through a highly competitive application process. Students work in their mentor’s lab full-time, funded by CTSI-Ed. They engage in additional activities together including a mentor/mentee, an interview activity and 2 social events. Junior faculty scholars are asked to participate as judges at CTSI’s Poster Session and are invited to present at PReP seminars. The program culminates with the announcement of the Junior Mentor of the Year, in which scholars nominate their mentors for the award. Junior faculty mentors receive support through a training course, Optimizing the Practice of Mentoring, mentor orientation and a roundtable discussion with the program director and other mentors. The program’s infrastructure is designed to foster mentee/mentor relationships through faculty and staff support. Junior faculty receive one-on-one coaching when faced with difficult mentoring situations and are recognized for their mentoring successes. RESULTS/ANTICIPATED RESULTS: Junior faculty mentors highly rate the program on the following points; the experience was a good use of time, I am satisfied with my experience, I would recommend this program to faculty colleagues and students. Undergraduates and Professional students rated their mentoring relationship as 1 of 3 best outcomes of the program. In exit surveys, their highly rated program successes include having a network that helps move their career forward, and confidence to persist through training to become a successful researcher. DISCUSSION/SIGNIFICANCE OF IMPACT: Creating a culture of mentoring is important to the strengthen, sustain and diversify the biomedical research workforce. This mentoring model contributes to the mission while vertically integrating CTSI-Ed’s KL2 and PReP programs. On an individual level, junior faculty improve communication and management skills, develop leadership qualities, increase their network, provide a sense of fulfilment and personal growth, and reinforce their own skills and knowledge of subject. They are also provided a top undergraduate student worker fully funded by the program.

ABSTRACT IMPACT: We review our strategy to use live community events on Facebook to share health and clinical research information and share further steps to increase engagement. OBJECTIVES/GOALS: To describe the use of live community events to enhance communication about clinical and health research through a Facebook platform (MN Research Link) with diverse social media users. The project identified variables associated with video engagement and strategic implications. METHODS/STUDY POPULATION: From June 2019 to November 2020 we streamed 31 events on the MN Research Link Facebook public page. Events highlighted different investigators’ clinical and health research in the areas of mental health, health and wellness, chronic diseases and immunology/infectious diseases. Facebook analytics were used to determine the number of views, total minutes viewed, average video watch time, and audience retention. Engagement score was calculated as the total number of interactions (likes, shares, and comments) divided by total number of followers (N=1437), expressed as a percentage RESULTS/ANTICIPATED RESULTS: Events averaged 24secs/16 min (SD=0.4). A mean of 1.61 (SD=1.28) followers viewed the events live but an average of 417.52 (SD=793.50) followers viewed after the event posted. The average engagement score was 1.1%. Mean total minutes viewed for all 31 videos was 253.5 (SD= 437.6). Viewers spent an average of 17 seconds (SD=0.01) watching each piece of video content. On average 28 followers viewed the events for at least 1-minute event (SD= 48.7). Audience retention at the halfway point for each video was 15.74% (SD=0.19). DISCUSSION/SIGNIFICANCE OF FINDINGS: Results suggest that novel approaches are necessary for active engagement. Promotion of live events is recommended to increase participation and length of engagement. Prior length of engagement (average 17 seconds), suggests refining video introduction will increase engagement.

OBJECTIVES/SPECIFIC AIMS: (1) To discuss key differences of behavioral clinical trials from trials involving drugs, devices, and biologics and (2) to discuss NIH efforts to provide a study protocol template for use by investigators conducting behavioral clinical trials. METHODS/STUDY POPULATION: A working group was convened by NIH to refine the commonly used protocol template required for investigators conducting Phase 2 or 3 NIH-funded clinical trials. The committee met by phone regularly for 4 months to review, discuss, and refine each section of the template as needed to include aspects relevant to behavioral trials. RESULTS/ANTICIPATED RESULTS: The behavioral trial protocol template draft has been created and is being further modified by feedback from the research community. DISCUSSION/SIGNIFICANCE OF IMPACT: Use of the NIH behavioral trial protocol template is expected to enhance the quality of any behavioral study, because the template and supporting materials were developed with the unique aspects of behavioral research in mind.

OBJECTIVES/SPECIFIC AIMS: Innovation in healthcare is increasingly dependent on technology and teamwork, requiring effective collaboration among diverse disciplines. However, large knowledge barriers exist between these diverse disciplines which hinders effective communication and the innovation processes. We organized an intensive team-based competition event, Sinai MedMaker Challenge, that engaged individuals with a wide range of backgrounds in medicine, biomedical research, computers science, and engineering to collaborate in solving medical problems with technology-based solutions. The learning objectives were to: enable participants to identify healthcare problems which lend themselves to technology-based solutions; delineate key behaviors critical to multidisciplinary team success; identify optimal strategies for communicating in teams; engage and inspire participants to apply knowledge of technology to meaningfully impact clinical care and well-being. METHODS/STUDY POPULATION: The Sinai MedMaker Challenge was a 48-hour team-based competition, modeled after previously held health “hackathons.” Adapting from guidelines provided by MIT Hacking Medicine, the event gathered participants from diverse backgrounds (clinicians, medical students, graduate students in biomedical science and humanities, software developers, engineers, and others), for the purpose of utilizing technology to address pressing problems in the diagnosis, management and/or treatment of pain and/or fatigue. The event flow can be outlined as follows: Phase 1—pre-event brainstorming via Slack and Sparkboard online platforms; Phase 2—problem review with clinical experts; Phase 3—solution pitches, formation of teams, development of prototype solutions; Phase 4—presentations and prizes awarded. The event was sponsored by ISMMS Institutes and Technology Companies. Mentors roamed throughout the event to support the teams in the technical, clinical, and business development aspects of their solutions. RESULTS/ANTICIPATED RESULTS: In total, 78 participants forming 14 teams, worked on the development of software and hardware prototypes (apps/websites, devices, wearables) to address a variety of pain and fatigue problems, culminating in final pitch presentations to a panel of judges comprised of academic experts; innovators and entrepreneurs in the technology start up space. Award recipients were: (1) PT partners, a wearable device for monitoring physical therapy post knee replacement; (2) SickleMeNot, an interactive, multimodal website/app for children designed to assess, monitor and manage pain; and (3) Biolumen, a functional biofeedback system, to treat chronic back pain. Evaluations revealed a high-degree of satisfaction with the event. Several teams continue to develop their prototypes. DISCUSSION/SIGNIFICANCE OF IMPACT: The Sinai MedMaker Challenge (1) was a compelling and productive forum to bring together students, trainees, faculty and other stakeholders to explore tech-based solutions for management, monitoring, and treatment of pain and fatigue; and (2) can be repeated annually, fostering a “Community of Practice,” and expanded to offer pre and post event opportunities to encourage iterative learning and ongoing creative output.

Objectives/Goals: Collaborations between translational science programs and academic health sciences libraries can enhance research impact by improving efficiency, leveraging diverse professional expertise, and expanding opportunities for collaboration between librarians and translational science programs. Methods/Study Population: A team science approach was utilized, integrating findings from a literature review, practical experiences of health sciences librarians, and collaborative writing. An analysis of case studies from institutions with successful partnerships explored the roles of libraries in partnering with translational science programs. The data collected were mapped to the Clinical and Translational Science Award Program’s five functional areas outlined in the Notice of Funding Opportunity PAR-24–272. Librarians from 21 institutions engaged in discussions and collaborative writing to share insights and identify key factors driving successful partnerships. Results/Anticipated Results: Academic health sciences libraries play a crucial role in enhancing translational science programs through expert knowledge management, facilitation of research dissemination, and support for interdisciplinary collaboration. Results from this project include a table outlining 16 specific opportunities mapped across five functional areas and six topical categories for translational science programs and libraries to collaborate effectively.Successful partnerships demonstrate improved research workflows, increased interactions between researchers and libraries, and accelerated translation of discoveries into clinical settings. These collaborations illustrate opportunities for other institutions to adopt as they consider best practices in supporting translational science. Discussion/Significance of Impact: By combining resources and expertise between libraries and translational science programs, these partnerships enhance the ability to transform scientific discoveries into real-world clinical applications, drive innovation, and amplify the contributions of both libraries and translational science programs.

OBJECTIVES/GOALS: In a previous genome-wide association study of European Americans, rs12772424, a variant in the gene encoding transcription factor 7-like 2 (TCF7L2), was shown to have a SNP-BMI interaction association with bipolar disorder (BD). The objective of this study was to replicate this finding in an African American (AA) sample. METHODS/STUDY POPULATION: Using a sample of 659 controls and 323 BD cases from the Genetic Association Information (GAIN) Study of BD, we conducted analyses to assess association between BD and the interaction of BMI with genetic variation in TCF7L2. For this study we identified 4572 single nucleotide polymorphisms (SNPs) in a 1Mb region around the candidate SNP rs1272424. Based on variants identified in the prior analysis of the larger European American dataset we selected SNPs for analysis in the AA data. This allowed for a smaller AA sample, and still maintained adequate power for statistical significance. RESULTS/ANTICIPATED RESULTS: We anticipate observing an effect of TCF7L2 variation on the relationship between BD and BMI in the AA data. We also anticipate that combining results from the European and African American patients may help narrow down potentially functional variants in TCF7L2 that influence the association between BD and BMI. DISCUSSION/SIGNIFICANCE OF IMPACT: Psychiatric genetics studies lack ancestral diversity among participants, decreasing their generalizability, and possibly increasing health disparities, especially for diseases like BD, which is often misdiagnosed and untreated in AAs. This work propels us towards understanding the genetics of BD and obesity in this underrepresented population.

OBJECTIVES/GOALS: Dietary approach to stop hypertension (DASH) is a proven intervention to treat hypertension. Despite years of research the immediate physiologic response to its implementation was never characterized.This translational trial describes the biological pathway from nutrition through hormons, urine electrolytes and blood pressure reduction. METHODS/STUDY POPULATION: A single center interventional trial. Stage 1 hypertensive otherwise healthy volunteers were admitted for 14-days, transitioning from American style diet to DASH diet. Nutritional habits were assessed with food frequency questionnaires, and menus designed according to the guidelines of the National Heart Blood and Lung Institute (NHBLI) of the National Institute of Health (NIH). Data were collected daily for vital signs, blood and urine. Participants completed two 24-hour ABPM on days 1,10, and two 24-hour urine collections in parallel. We conducted a follow up visit two weeks after discharge. RESULTS/ANTICIPATED RESULTS: 9 volunteers (78% male, 89% Black individuals) completed the protocol. During an inpatient stay, they consumed a mean daily potassium intake of 5.6 g (±0.7g) and 2.6 g (±0.3g) of Sodium. Serum Aldosterone increased from day 0 (mean 8.3, range 2.8-18.9) to day 5 (mean 17.8, range 10.2-27.2) after intervention, and decreased on day 11 (mean 11.5, range 4.8-18.2) despite continuous exposure (p-value=0.002). The urine electrolyte ratio of ([Na]/[K]) decreased from a mean of 3.5 before intervention to 1.16 on day 4, creating a statistically significant slope (p-value<0.001). Blood pressure by 24-hour ABPM decreased by 3.7 mmHg systolic BP and 2.3 mmHg diastolic BP from day 1 to 10 for the entire period, and for measures taken during sleep or awake time, assessed separately. DISCUSSION/SIGNIFICANCE: Shifting from a high-sodium low-potassium diet to the opposite composition leads to serial physiological changes that are governed by aldosterone and result in blood pressure reduction. Urine electrolyte ratio reflects nutritional changes within 4 days of transition and should guide clinicians in assessing lifestyle modification adherence.