OBJECTIVES/GOALS: Clinical and Translational Science Award (CTSA) hubs are launching D&I Science cores to provide resources and services to promote the translation of clinical evidence into practice. We developed a D&I Science Core strategic plan reflecting our research community’s needs by assessing Implementation Science (IS) competencies. METHODS/STUDY POPULATION: The Tufts CTSI D&I Science Core was launched in early 2023. To design services that meet research community needs, we conducted a survey and key informant interviews based on Padek etal.’s list of Implementation Science (IS) competencies. The competencies are organized into four domains (Definition, Background, and Rationale; Theory and Approaches; Design & Analysis; and Practice-Based Considerations) and categorized by expertise level (beginner, intermediate, advanced). Participants who had attended or expressed interest in a D&I interest group were asked via an email survey to rate their level of confidence in completing selected IS-related research activities, about their experience with IS research or practice, and the types of resources, services and training they desired. RESULTS/ANTICIPATED RESULTS: Twenty researchers (20/65, 31%) submitted survey responses and six researchers participated in in-depth interviews. Survey respondents felt most confident in engaging stakeholders in IS research and least confident selecting a model or framework for a study. Results suggest that researcher capacity building is needed to: • Understand IS models and frameworks and their approaches, strengths, and limitations • Select and use models and frameworks in studies • Assemble IS teams and prepare grant proposals Suggestions for resources, services, and training, include: • Customized education to address diverse needs, knowledge levels, and learning styles • Promotion of D&I Core consultations and grant support services • Sharing of successful proposals to help researchers learn how to apply IS methods DISCUSSION/SIGNIFICANCE: A strategic workplan for the D&I Science Core was developed and implemented to address the findings. Initial emphasis is on developing easily accessible resources and timely consultations for investigators new to IS needing to apply these methods in current grant proposals, while also providing training resources for deeper skill building.

OBJECTIVES/GOALS: Utilizing clinical electronic health record (eHR) data pulled en masse from data warehouses provides unique challenges when applying it to retrospective studies. Use of this data in conjunction with metabolomic and genomic results to predict response to lisinopril or ondansetron has been completed. METHODS/STUDY POPULATION: Study population consists of >2000 subjects recruited from the Emergency Medicine Specimen Bank at University of Colorado Denver (UCD). All patients presenting to the emergency department are approached to participate which significantly increases demographic diversity of our study populations. Clinical data is pulled from Health Data Compass (data warehouse at UCD that collects all electronic health record (EHR) data to be able to deliver de-identified). Effectiveness of lisinopril and ondansetron were investigated using metabolomic data collected via ultra-high performance liquid chromatography mass spectrometry and genomic data from Illumina chip technology to find relevant correlations. RESULTS/ANTICIPATED RESULTS: Obtaining retrospective clinical data from data warehouses comes with significant challenges to be addressed. Verifying all clinical variables from patient EHRs is a crucial step that requires extensive quality control steps. As well, ensuring data validity, appropriateness of data points pulled as relate to the study criteria and identifying alternate EHR data points is needed. Chart review is a critical step necessary to surmount these challenges. Additionally, use of retrospective EHR data often necessitates the development of novel definitions of clinical effectiveness that can be abstracted from the EHR– such as how to determine decrease in nausea without a visual analogue scale. DISCUSSION/SIGNIFICANCE OF IMPACT: Utilizing data warehouses to deliver EHR data provides a valuable tool for completing retrospective precision medicine projects. The validation of definitions for clinical outcomes identifiable retrospectively are necessary and provide novel guidance for future studies.

OBJECTIVES/SPECIFIC AIMS: Stakeholder and community engagement (SCE) is a national priority for the National Center for Advancing Translational Science (NCATS). An established framework for stakeholder engagement exists for the latter stages (T2-T4) of translational, but no such framework currently exists for early stages of translational science (T1). Four Clinical and Translational Science Award (CTSA) hubs launched a collaboration to develop a new framework for engaging communities and stakeholders in T1 research. METHODS/STUDY POPULATION: We led structured individual and group discussions with T1 investigators to learn about: (1) the health decisions they seek to inform with research evidence, (2) the actors who make those decisions, and (3) the individuals and organizations that are affected by those decisions. In total, 18 individuals connected to 4 CTSA hubs participated in the discussions. Participants came from the fields ranging from basic chemistry and drug development to infectious disease and pediatrics and represented both methodological and topical experts. Focus groups lasted, on average, 1 hour, were audio recorded. Interviews lasted ~30 minutes. Audio recordings were transcribed and deidentified, and transcripts were coded using Dedoose™. We used a deductive-inductive procedure to develop the framework for stakeholder engagement in T1 research. A deductive codebook was development from the focus group and interview guides; emergent themes were added and the codebook was revised after preliminary inductive analysis. Two coders analyzed all transcripts using a constant comparison approach. We used an inductive process to identify themes and form them into a framework that could be used by T1 researchers in their work. The framework was developed through sequential reviews with coauthors and research participants. RESULTS/ANTICIPATED RESULTS: Preliminary findings suggest that stakeholders in early stage translational research (T1) do not fit into the same framework as those further down the translational spectrum (T2-T4). Basic scientists can identify stakeholders, however, and would like more guidance on who, how, and when to engage them in their research. DISCUSSION/SIGNIFICANCE OF IMPACT: By showing T1 researchers how to identify and involve their stakeholders in (1) defining research questions, (2) carrying out research activities, and (3) disseminating research evidence, this work has the potential to improve the use of basic science evidence in latter stages of translation from bench to bedside.

Objectives/Goals: To generate actionable insights into the commercialization process in academic translational science by using comparative case studies to identify strategies, success factors, and challenges across CTSA hubs, informing best practices for innovators and institutions. Methods/Study Population: We will employ a comparative case study approach, engaging 11 CTSA hubs to document two or more product-specific commercialization case studies, including at least one successful and one unsuccessful example. To ensure the comprehensiveness and consistency of data collection and analysis across cases, a standardized framework developed by the TCSC WG is followed by all participating hubs for both quantitative data (e.g., milestones, funding) and qualitative insights (stakeholder interviews). Coding and downstream cross-case analysis is leveraged to identify unifying themes and discriminating factors in commercialization strategies and associations with success and failure. Results/Anticipated Results: We aim to identify patterns, barriers, and catalysts in academic commercialization, defining key resources along with effective practices and strategies. Findings will clarify the role of CTSA hubs and their collaboration with institutional partners such as Technology Transfer. Results will highlight best practices in IP management, funding, team dynamics, partnerships, and regulatory navigation. A comparative analysis across CTSA hubs will yield a case study repository, cross-case report, educational materials, and a peer-reviewed publication. Collectively, we expect findings to provide practical guidance to NCATS and academic institutions for accelerating biomedical innovation. Discussion/Significance of Impact: This study fills a critical gap by providing real-world, comparative insights into the commercialization process within academic medicine. Outcomes will support CTSA hubs, healthcare systems, innovators, and policymakers in improving translational efficiency and maximizing innovation impact.

We conducted a survey study of clinical research coordinators (CRCs) at the member institutions of the Pediatric Emergency Care Applied Research Network, to determine the demographic and linguistic characteristics of CRCs around the network, and any perceived impact of those characteristics on their duties. A total of 53/74 CRCs completed the survey. Most respondents identified as “female,” “white,” and “not Hispanic/Latino.” Most respondents felt that their race/ethnicity and their ability to speak a language other than English would positively impact recruitment. Four female respondents felt that their gender hindered their recruitment efforts and their sense of belonging within the research team.

OBJECTIVES/GOALS: This project aims to improve the design of medical technology for global health by addressing gaps in engineering education. Our primary goal is to develop open educational resource’curriculum boosters’ that can be added to existing BME curricula to build skills in transdisciplinary collaboration, practical ethics, and failure resilience. METHODS/STUDY POPULATION: A phasic mixed-method research strategy has been employed. The Needs Analysis includes a systematic review and meta-analysis of existing knowledge regarding the three conceptual pillars of Transdisciplinary Collaboration, Practical Ethics, and Integrated Resilience. The Behavioral Study includes surveys, interviews, observations, and biometric data collection from working engineers, engineering students, global health stakeholders, and clinicians. The Validation Study will be conducted via small group workshops, a semester-long engineering design course, and a summer study-abroad course. Data collected will be analyzed and used to refine the proposed educational strategies. RESULTS/ANTICIPATED RESULTS: The final educational strategies will be structured into 'curriculum boosters' and published as open educational resource materials. The boosters and their supporting data will be made available to other engineering education programs with the goal of promoting widespread adoption and integration of these methods. DISCUSSION/SIGNIFICANCE: The long-term outcome of this ongoing work is to train a new generation of engineers prepared to participate adeptly in the co-design of technological solutions for complex global healthcare challenges by working ‘with, not for,’ clinicians, communities, and other stakeholders in peripheral healthcare settings.

OBJECTIVES/GOALS: Histopathological descriptions of kidney tissue provide more information about kidney disease severity and prognosis than serum measures, yet most patients with chronic kidney disease do not undergo kidney biopsy. We aim to develop a method to determine the degree of renal injury in patients with diabetes and hypertension without the need for biopsy. METHODS/STUDY POPULATION: Clinical data and renal tissue samples were collected from 864 patients undergoing tumor-associated nephrectomy in seven medical centers in the United States. Exclusion criteria included age < 18, presence of pyelonephritis or non-diabetic or hypertensive renal disease or incomplete clinical or histopathologic data. 19 histologic parameters were scored in a blinded manner by one renal pathologist. We examined the relationship between and functional variables (such as estimated glomerular filtration rate (eGFR)). Polynomial regression analysis was performed to model histopathologic variables and important clinical parameters such as eGFR RESULTS/ANTICIPATED RESULTS: 607 samples met inclusion criteria and were stratified as: control (no history of diabetes or hypertension, n = 160), hypertension alone (n = 224) and both diabetes and hypertension (n = 223). Interstitial fibrosis (IF) and glomerulosclerosis (GS) had the strongest correlations with eGFR. Regression analysis was used to model histopathologic score for a given eGFR. We found that diabetes and hypertension modified the relationship between tubulointerstitial fibrosis and eGFR. For example, while hypertensive patients without diabetes had 33% IF at an eGFR of 30 ml/min/1.73m2 (r2 = 0.64, p<0.01), hypertensive patients with diabetes had 32% IF at an eGFR of 30 ml/min/1.73m2 (r2 = .43, p<0.01) and control patients had approximately 23% IF at an eGFR of 30 ml/min/1.73m2 (r2 = 0.22, p<0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: Here, we describe the relationship between renal structural changes and renal function and show that hypertension significantly modifies the relationship at a given eGFR. These data can be used to reasonably predict renal structural changes given clinical information without the need for renal biopsy and may provide prognostic value.

Objectives/Goals: This initiative accelerates translational science by integrating infrastructure, engagement, and workforce development to overcome barriers and improve efficiency in building a new academic health center. The primary objective is to overcome translational roadblocks while fostering a culture of innovation and collaboration. Methods/Study Population: The Florida State University (FSU) Health Research Connections ticketing and navigation system serves as a centralized system for research support, data capture, and service coordination. Pilot projects include utilizing group model building, a systems science approach, to map barriers and facilitators in community clinics; and testing community-engaged, trustworthy recruitment strategies into FSU Health Research Link, a community facing research portal. The initiative engages academic researchers, community members, healthcare providers, and trainees across Florida, adapts existing UF/FSU hub resources, and develops new resources that capitalize on FSU’s strengths and needs. Evaluation applies the Translational Science Benefits Model to assess impact across domains. Results/Anticipated Results: Preliminary outcomes from CTSA-supported initiatives at FSU demonstrate measurable progress in breaking translational barriers and boosting efficiency. The HRC ticketing system has streamlined research support. Metrics to be presented include the number of individuals enrolled in the FSU Health Research Community Portal, use of HRC tools and services, engagement in training workshops, external funding and scholarly outputs, utilization of big data, and adoption of findings into clinical practice. Findings from community-engaged recruitment pilots and trust metrics will also be presented. Discussion/Significance of Impact: FSU Health offers a replicable model for new academic health centers, particularly relevant for newer CTSA hub partners. Embedding evaluation and engagement sets a new standard for community-partnered, efficient, and impactful translational science infrastructure and accelerates discovery into practice.

OBJECTIVES/GOALS: To adapt and evaluate motivational interviewing (MI) as a tool for better understanding the beliefs that underlie vaccine hesitancy and effectively respond to these beliefs with emphasis on reaching underserved communities disproportionately impacted by COVID-19. METHODS/STUDY POPULATION: Our group reviewed the principals for motivational interviewing, rationale for vaccination, and likely beliefs underlying hesitancy and developed a guide for MI to address vaccine hesitancy. We recruited lay members of Black and Hispanic communities in Washington, DC and Baltimore, MD. 90-minute zoom facilitator training sessions included didactic material, questions and discussion, and role playing. We were not successful recruiting unvaccinated individuals to provide written consent to be followed re vaccination status. Facilitators indicated incorporating MI in their job-related and informal interactions. Surveys were developed to obtain feedback regarding beliefs underlying hesitancy, perceptions of MI effectiveness, and more recently (Oct 2022), evolving concerns regarding the pandemic. RESULTS/ANTICIPATED RESULTS: 67% of facilitators were Black, their average age was 39 years, and 67% had at least a high school education. All had received a COVID-19 vaccination. 82% endorsed utilizing MI in discussions receiving the COVID-19 vaccine. 46% of the facilitators endorsed that MI was moderately effective (46%) in clarifying objections and very effective (50%) in persuading friends, family, and co-workers to consider getting vaccinated. The most common elicited objections to the vaccine were side-effects (21%) and beliefs in government conspiracies (21%). In the second survey respondents indicated receiving another booster followed by getting their children vaccinated as the most common identified concerns. DISCUSSION/SIGNIFICANCE: MI can be adapted to address vaccine hesitancy in underserved minority groups and appears promising for identifying beliefs underlying hesitancy and possibly for increasing vaccination rates among these communities.

OBJECTIVES/GOALS: To develop the Adherence to Medications In Latinx adults with Depression and Anxiety (AMILDA) intervention using community engaged research principles, AMILDA will integrate culturally tailored messaging to improve depression and anxiety symptoms and adherence to antidepressant medications. METHODS/STUDY POPULATION: Bilingual steering committee members representing primary care and behavioral health professionals from 2 primary care clinics, and 1 lay community member met monthly for 1 year to develop the intervention. One clinic is an academic health center and the other is a federally qualified health center. Members identified, developed, and voted on the interventions components, therapeutic goals, and the mechanisms underlying its effectiveness that needed to be studied. To evaluate AMILDAs components, we conducted an observational study of health care providers (N=13) and Latinx adults with depression and/or anxiety (patients; N=26) from both clinics, and community pharmacists (N=9) from surrounding pharmacies to gather feedback. Based on their input, we revised the intervention. RESULTS/ANTICIPATED RESULTS: AMILDA consists of culturally tailored collaborative drug therapy management with a collaborative practice agreement between the physician and pharmacist. Patients recently started on an antidepressant receive language and culturally concordant motivational interviewing, teach back, and infographics; AMILDA is designed to improve symptoms, adherence, and health determinants. Most provider, pharmacist, and patient participants reported that AMILDA could be beneficial. Several participants indicated a lack of understanding about a US pharmacists scope of practice. Recommendations included ensuing language concordance, incorporating more statistics and scientific data, using images that are relatable, avoiding idioms and stereotypes, taking the time to build rapport, and being friendly. DISCUSSION/SIGNIFICANCE: AMILDA will be tested in a pilot effectiveness randomized controlled study to determine if it improves depression and anxiety symptoms and adherence to antidepressants among Latinx adults compared with enhanced usual care. The mechanisms to be assessed include self-efficacy, antidepressant knowledge, and personal health literacy.

Objectives/Goals: The objective is to study the association of subjective tinnitus, hearing status, clinical symptoms and the psychosocial effects on Puerto Rican adults with the condition. A specific aim is to describe auditory status, tinnitus characteristics and subject’s performance on the Tinnitus Handicap Inventory (THI). Methods/Study Population: This is a Transversal Descriptive pilot study, where 30 clinical records of adult Puerto Rican subjects diagnosed with Tinnitus on the Intramural Audiology Clinic of the Medical Sciences Campus, located at the University of Puerto Rico, during 2022 to 2024 were analyzed to establish a profile. Subjects between 21 and 64 years old from both genders were studied. This research was conducted after the Office of Research Participant’s Protection-IRB of the Medical Sciences Campus of the University of Puerto Rico gave the approval. Results/Anticipated Results: The study found that Tinnitus can have a significant impact in the individual’s life. The effects were registered mainly in the following areas: •Emotional Area: Subjects reported anxiety associated to experiencing Tinnitus. •Mental Health: Subjects reported being stressed due to their Tinnitus •Cognitive Functioning: Subjects reported difficulties to concentrate, think with clarity o recall information. Also subjects indicated that Tinnitus interferes with their sleep patterns affecting rest and having negative synergic effects resulting in confusion and fatigue. The condition impacts daily living productivity as well as occupational tasks. Eighty-three percent of research participants reported that their Tinnitus interfere with household tasks. Discussion/Significance of Impact: This pilot study adds to the body of evidence that validates the need to address Tinnitus in an integral manner treating its effects in all the physical and mental health dimensions affected by the condition. Also, the results of this study can be used to promote health plans coverage in Puerto Rico for Tinnitus assessment and rehabilitation.

Objectives/Goals: To support the growing number of clinical research professionals (CRP) working in behavioral and social science contexts, relevant formative assessments of research skills are needed. This study examines the development of an objective formative assessment designed to assess skills relevant to conducting social and behavioral research. Methods/Study Population: A multidisciplinary group at the University of Michigan was convened to develop the assessment. Case studies depicting clinical and translational research conducted in behavioral and social science contexts were used to measure proficiency in seven of the eight ECRPTQ competencies: Scientific Concepts & Research Design, Ethical & Participant Safety Concerns, Clinical Trial Operations (Good Clinical Practice), Study & Site Management, Data Management & Informatics, Leadership & Professionalism, Communication, and Teamwork & Team Science. Three difficulty levels of questions were developed: basic, intermediate, and advanced. To reinforce knowledge and skill development, the assessment was designed to give respondents formative feedback after responding to each question. Results/Anticipated Results: A preliminary “pre-pilot” test was conducted with three postdoctoral scholars to ensure that the assessment items were understandable. The assessment was then pilot tested with a larger group of 40 clinical research professionals (CRP) to test for the clarity and difficulty level of the items. A smaller group of 20 of these CRPs agreed to participate in focus groups to obtain feedback on their user experience. Data regarding years of experience as a CRP, types of studies engaged with, and information regarding professional certification were collected and used in the analyses. Demographic data collected were not connected to user responses. Results of the pilot test and focus groups were used to revise the questions on the final version of the assessment. Discussion/Significance of Impact: To our knowledge, this is the first objective assessment of research skills for CRP working in behavioral and social science contexts. We will discuss how other institutions can use this instrument to evaluate the training needs of their social and behavioral research workforce.

OBJECTIVES/GOALS: Scientists are increasingly confronted with 'science critical' #_msocom_1 belief systems. The politicization of science fuels hesitancy towards evidence-based therapies. To overcome these barriers, we aim to devise strategies to communicate clinical translational science (CTS) through art. METHODS/STUDY POPULATION: A two-year pilot artist-in-residency (AIR) program embedded in the Translational Research Immersion Program (TRIP). Since 2009, TRIP contributes to CTS Workforce Development (WD) through a 10-week mentored, curriculum-rich summer undergraduate research experience. Students are recruited from 5 regional institutions, 6 HBCUs, and the University of Puerto Rico. AIR is composed of 3 phases: the “Immersive Phase” where the artist gains intensive exposure to the scientific process through the lived experience of TRIP students, the “Productive Phase” where the artist conceptualizes the process of CTS into works of art, and the “Engagement Phase” where the CTS workforce, artists, and community members coalesce around science-to-art materializations. RESULTS/ANTICIPATED RESULTS: In 2022 & 2023 the AIR participated in ~35hrs of CTS research seminars, panel discussions, and professional skills workshops. Additional TRIP student-AIR interaction occurred in focus groups including visits to mentor’s labs. An AIR-led workshop culminated in an Empowering CTS Communication event where TRIP students engaged with community members through elevator pitches of their CTS summer project on a speed-rotating basis. A month-long art-CTS exhibition planned for 3/2024 will feature contributions from AIR, TRIP students, and ITMAT community members. Qualitative insights were that TRIP is an effective art-science incubator, students strengthened their CTS communication skills, art functions as an icebreaker between science and communities with an ocean of opportunities for science education. DISCUSSION/SIGNIFICANCE: AIR embedded into existing CTS WD programs is proposed as creative approach to strengthen the reputation of science in the public. CTS-informed art functions as connective tissue between public and CTS workforce. The hands-on experience to adopt art as a science communication tool is a powerful soft skill for the next generation of CTS investigators.

OBJECTIVES/GOALS: Currently physicians are able to order CT Chest/Abd/Pelvis images as STAT or Routine. STAT images denote an emergency and are done immediately. We aim to determine the percentage of CT images that are inappropriately ordered as STAT, determine physician image ordering habits, and develop targeted interventions to encourage appropriate STAT image ordering. METHODS/STUDY POPULATION: A fishbone diagram helped reveal possible causes of inappropriate STAT image ordering. Based on the fishbone diagram, a survey was created to assess CT image ordering habits amongst radiology and internal medicine residents and attending physicians. All CT Chest/Abd/Pelvis images ordered over a 3 month period of time (July-Oct 2017) was obtained. The dataset included whether the image was ordered Stat vs Routine, time of image order, physician name and location, and reason for the imaging study.The STAT images were evaluated based on the explanation provided in the CT image order. Currently 2 radiology residents, 2 internal medicine residents, and 2 internal medicine hospitalists are evaluating all STAT CT images to determine appropriateness and how long they are willing to wait for the image to result in a read. RESULTS/ANTICIPATED RESULTS: Analysis of all CT Chest/Abd/Pelvis imaging orders revealed that 51% (1710/3345) of them were ordered as STAT. The preliminary analysis of 227 STAT images showed that 6% were inappropriate. We anticipate results of our survey to show differences in how long a STAT vs Routine image orders should take amongst Radiology and Internal Medicine clinicians. We also anticipate our survey to show differences in factors that warrant STAT imaging amongst the different medical fields. We anticipate that the clinician manual evaluation of all STAT CT image will reveal a large percentage of imaging orders to be inappropriate. All STAT imaging that were flagged as inappropriate will be characterized by the department who ordered the image and the reason provided for the imaging to assess for common themes. DISCUSSION/SIGNIFICANCE OF IMPACT: STAT images are the new routine with more images ordered STAT than Routine. Inappropriate STAT imaging results in truly urgent patients not getting the medical care they need. Many images ordered stat could potentially be switched to routine. By evaluating why clinicians are ordering STAT CT image inappropriately, we will be able to develop targeted interventions to decrease inappropriate STAT CT imaging.

OBJECTIVES/GOALS: Heart failure (HF) is a clinical condition that notably affects the lives of patients in rural areas. The partnering of a rural satellite hospital with an urban academic medical center may provide geographically underrepresented populations with HF an opportunity to access controlled clinical trials (CCTs). METHODS/STUDY POPULATION: We report our experience in screening, consenting and enrolling subjects at the VCU Health Community Memorial Hospital (VCU-CMH) in rural South Hill, Virginia, that is part of the larger VCU Health network, with the lead institution being VCU Health Medical College of Virginia Hospitals (VCU-MCV), Richmond, VA. Subjects were enrolled in a clinical trial sponsored by the National Institutes of Health (ClinicalTrials.gov: NCT03797001) and assigned to treatment with an anti-inflammatory drug for HF or placebo. We used the electronic health record and remote guidance and oversight from the VCU-MCV resources using a closed-loop communication network to work with local resources at the facility to perform screening, consenting and enrollment. RESULTS/ANTICIPATED RESULTS: One hundred subjects with recently decompensated HF were screened between January 2019 and August 2021, of these 61 are enrolled to date: 52 (85 %) at VCU-MCV and 9 (15%) at VCU-CMH. Of the subjects enrolled at VCU-CMH, 33% were female, 77% Black, with a mean age of 5210 years. DISCUSSION/SIGNIFICANCE: The use of a combination of virtual/remote monitoring and guidance of local resources in this trial provides an opportunity for decentralization and access of CCTs for potential novel treatment of HF to underrepresented individuals from rural areas.