Objectives/Goals: Our objective was to use human-centered design methods to co-develop an intervention that enhances postpartum management of hypertensive disorders of pregnancy and reduces long-term cardiovascular (CV) disease risk. Methods/Study Population: Human-centered design is a problem-solving approach that centers the end-user including patients, clinicians, and community members. We conducted six focus groups with people who experienced HDP, doulas, lactation consultants, perinatal community health workers, midwives, Ob/Gyns, and family physicians (n=26). Design activities included patient journey mapping, group discussion, mad lib creation, rapid solution brainstorming, dot voting, impact/difficulty matrix analysis, and pitch concept development. Focus group sessions explored the patient journey and identified major unmet needs. These results informed the co-design of solutions to address key facilitators and barriers to positive care pathways. Results/Anticipated Results: Participants identified a need for a community-embedded care model that promotes continued engagement after delivery, timely blood pressure (BP) monitoring and management, chronic stress reduction, and a smooth transition to primary care. These findings informed the co-design of a multi-level intervention that includes 1) midwife-led dyadic mom–baby visits that facilitate evidence-based strategies: BP surveillance, medication management, and lifestyle education; 2) remote BP monitoring with bi-directional communication; 3) community-based doula care; 4) a co-located family support specialist that addresses social determinants of health and chronic stress; and 5) facilitated primary care transition. Discussion/Significance of Impact: Using human-centered design enabled the integration of lived experiences, clinical insights, and community perspectives. This participatory process ensures that actionable solutions are responsive to real-world needs and have greater potential to improve CV health.

Objectives/Goals: To integrate proteomic and metabolomic profiling with genetic literacy and patient experience data to uncover biological mechanisms, community perceptions, and barriers to care in Puerto Ricans affected by Huntington’s disease. Methods/Study Population: We conducted a mixed-methods, multi-omic study combining quantitative proteomic and metabolomic analyses with surveys and interviews exploring genetic literacy and access to care. Participants included patients, first-degree relatives, and controls recruited through PR Huntington Foundation (Fundación Huntington Puerto Rico). Plasma samples were analyzed via mass spectrometry to identify differential protein and metabolite expression associated with CAG repeat length, clinical stage, and symptom burden. Qualitative data captured perceptions of genetics, stigma, and support networks. Results/Anticipated Results: Multi-omic analysis revealed disruptions in energy metabolism, oxidative stress response, and mitochondrial pathways, including altered creatine kinase, apolipoproteins, and kynurenine metabolites. These signatures correlated with CAG repeat length and disease severity. Qualitative findings showed limited genetic literacy, lack of formal counseling, and reliance on community organizations for support. Participants emphasized the need for accessible education and culturally adapted care models. Discussion/Significance of Impact: Integrating omics with community insights highlights both biological and social determinants of disease burden. The findings underscore the significance of equitable precision medicine, culturally grounded education, and community partnerships in enhancing care for underserved Huntington’s disease populations.

Objectives/Goals: This study evaluates the correlation between coronary artery calcium (CAC) scores and arteriosclerotic disease progression, determining if CAC scoring can predict high-risk individuals and guide early interventions to improve cardiovascular outcomes and disease prevention. Methods/Study Population: The retrospective descriptive study analyzed 800 coronary calcium scoring (CCS) reports to evaluate patterns of CAC scores and their relationship to arteriosclerotic disease progression. Data were collected from the Hospital Cardiovascular de Puerto Rico, focusing on CCS reports generated in 2024. The study population included patients aged 21 years and older who underwent CAC scoring during 2024. Instruments included radiology reports containing CAC scores and medical records detailing patient demographics, clinical history, and outcomes. Descriptive and correlation analyses were performed to explore associations between CAC scores and arteriosclerotic disease. Results/Anticipated Results: Preliminary findings from 800 CCS reports revealed that over half of the participants presented measurable coronary calcification, mainly among those aged 45–84 years with hypertension, diabetes, or hyperlipidemia. These results highlight the importance of CAC scoring as a noninvasive, cost-effective tool for early detection of subclinical atherosclerosis, enabling timely intervention and improved cardiovascular risk assessment. The study underscores its value in guiding prevention strategies and reducing disease burden. Discussion/Significance of Impact: This study highlights the calcium score as a precise, noninvasive tool for early detection of cardiovascular disease. It improves risk prediction and guides timely, targeted interventions to prevent complications and support effective, evidence-based cardiovascular prevention strategies.

Objectives/Goals: Parenting programs overlook the needs of Latina mothers affected by intimate partner violence (IPV). To address this, we aim to adapt the Attachment and Biobehavioral Catch-up (ABC) parenting program. Objective: to understand core parenting challenges and strengths, identify implementation needs, and deliver a contextually responsive protocol. Methods/Study Population: Guided by the ADAPT-ITT framework, we are conducting semi-structured interviews with Latina mothers (n = 12–15) and service providers (n = 5-10) to inform the adaptation of ABC while maintaining its core components (10 dyadic sessions focused on following the child’s lead, nurturing children when distressed, and avoiding frightening behaviors). To date, we have interviewed four mothers in Spanish. Two bilingual coders are conducting the thematic analysis using Nvivo. The results presented here are preliminary, based on 80% inter-rater reliability, and derive from transcript review and interviewer memos; final themes will be confirmed through the planned coding process Results/Anticipated Results: We identified the following themes: parenting challenges: persistent safety worries after IPV; heavy caregiving responsibilities with limited time and money; custody/visitation disrupting children’s routine; immigration related stress and co-parent conflict; and symptoms of depression/anxiety. Parenting strengths include a strong commitment to protection, existing routines, and faith/community support. Anticipated adaptations include acknowledging mothers’ protective strengths while integrating brief, accessible content that normalizes stress responses and offers practical co-regulation tools (e.g., grounding breathing exercises) to strengthen parent–child connection. Discussion/Significance of Impact: Early insights suggest that pairing ABC with content that honors mothers’ protective strengths, normalizes stress responses, and offers accessible co-regulation tools could fill a critical gap in contextually responsive support for Latino families, potentially strengthening parent–child relationships and increasing service access.

Objectives/Goals: Our hub’s annual survey evaluates the impacts of our institute’s support on investigators’ research productivity and real-world impacts. We have piloted new measures to establish valid and reliable approaches to measuring short- and long-term translational science impacts of interest to the CTSAs. Methods/Study Population: SC CTSI developed an annual survey to assess our institute’s impact on investigators’ research productivity, sustained engagement in behaviors of translational scientists, and real-world impacts. In 2023, we piloted two versions of the TSBM 30-elements across four domains. In 2025, we piloted a 20-item hallmarks of a Translational Scientist scale covering collaboration, mindset, capacity building, and planning for D&I and real-world impact. After online administration to over 700 CTSI-supported USC and CHLA-affiliated researchers, data are analyzed using descriptive statistics and exploratory factor analysis, to assess factor structure, item loadings, validity, and reliability. Results/Anticipated Results: Prior analyses showed that 27/30 TSBM items aligned well with intended domains, with clinical/medical and policy benefits demonstrating strong internal consistency. Current analyses will establish the psychometric properties of the new Hallmarks of a Translational Scientist scale and sub-domains. Refinement of items and best practices will be shared. Anticipated outcomes include standardized tools for CTSA evaluators to assess short- and long-term translational science impacts. The survey aims to enable consistent measurement of translational science benefits, support longitudinal tracking, and strengthen cross-hub comparisons of real-world impact beyond research productivity. Discussion/Significance of Impact: The validated impact measures shared in this session advance translational science evaluation. Standardized items assessing translational science short- and long-term impacts are of interest to the CTSA community and any organization engaged in translational science capacity building.

Objectives/Goals: Advance translational understanding of how families with young children from low SES backgrounds engage with music and how these experiences shape interest in music enrichment programs. By identifying family perceptions and barriers, this work will inform the design of responsive music interventions to promote developmental outcomes. Methods/Study Population: This is a qualitative study of semi-structured interviews. Families had at least one child who was ≤ 2-years old and an income which qualified for the Women, Infants, and Children’s (WIC) program. Exclusion criteria included children (≤ 2-years old) with chronic health diagnosis (e.g., cerebral palsy). Audio recordings were transcribed and coded using the inductive approach of thematic analysis. N = 15 included in the final analysis. The sample consisted of primarily black (53%) and multi-race (20%) families who reported an annual income below the 2023 poverty threshold for the number of family members living in the home (73%). Participating parents were mothers (94%), single (73%), and had a high school education or below (87%). Results/Anticipated Results: The home music environment: Parents’ own musical background influences decisions on music they select for their children. Parents prefer children’s songs that sound like the music they prefer to listen to (e.g., pop, hip-hop). Parent–child music interactions mostly include listening to and watching music shows vs. singing together. Parent interest/perception of community music programs: Parents have interest in community music programs and are interested in social and educational benefits to their child. Parent perceived barriers: Parents were not aware of music programs in their community. Social barriers include irregular work schedules, co-parenting, transportation, and balancing the demands of multiple children. Discussion/Significance of Impact: Understanding how families from low SES backgrounds engage with and access community-based music programs will inform equitable and scalable strategies to promote early developmental enrichment through music, bridging research and community impact.

Objectives/Goals: Cultivating authentic partnerships between community members and scholars requires significant time and effort. Scholars often encounter situations with insufficient time to build a mutually beneficial partnership. Our matchmaking events provide a space for researchers to connect with community members and begin their partnership journey. Methods/Study Population: UW-Madison Institute for Clinical and Translational Research (ICTR) partnered with UW-Madison Wisconsin Network for Research Support (WINRS) to invite scholars in ICTR Workforce Development Programs to attend a community advisory board meeting, share about their research, and invite feedback from community members. Each event was scheduled for 90 minutes in the evening at an accessible location in the community. Scholars met with WINRS in advance to share their intent for the meeting and receive guidance on how to best prepare. Each event allowed for a maximum of 3 scholars to attend. During these events, scholars shared either an overview of their area of research or a specific research project and invited feedback and guidance from community members. Results/Anticipated Results: Feedback from community members is a critical component of community-engaged research. Scholars across career stages have participated in matchmaking events, including PhD students, postdoctoral trainees, and faculty members. During the event, community members acknowledge the importance of the scholar’s research and suggest areas of improvement. Some community members offer to connect a scholar with a community organization that would be invested in their work, providing an opportunity to start building an authentic relationship. Scholars have subsequently participated in Community Advisory Board meetings, bringing their team members with them to advance their knowledge and skillsets related to community engagement. Discussion/Significance of Impact: After completing trainings on community-engaged research, scholars are unsure how to start connecting with community, demonstrating the utility of Matchmaking events. These events provide an opportunity to connect with community members and begin developing relationships with community members and organizations as part of their career.

Cathleen Kane, NYU Karen Cielo, UIC Paul Duguid, Arkansas Mendy Dunn, Florida Maryam Gholami, UCSD Kristi Holmes, Northwestern Joe Hunt, Indiana Patricia Moussatche, Stanford Christy Navarro, UC Davis Brittney Jackson Patterson, Wake Forest Alfred Vitale, Mayo Jennifer Croker, UAB – confirmed. Objectives/Goals: Over the past few years, there has been debate and confusion about the definition of Translational Science (TS) versus Translational Research (TR). The CTSA Administrators met in 2024 to discuss how to better define TS versus TR and create a useful product for the consortium. Methods/Study Population: The Administrators brainstormed best practices and discussed what products could be developed to clarify these concepts. A committee formed to create a useful product for the consortium. An editable document was shared by email and discussed at the December 2024 and February 2025 Administrators meeting to crowdsource existing assets. This process was repeated with the NCATS QA/QC Group, CTSA Evaluators, Workforce Development Enterprise Committee, and Communications Consortium Committee between May and July 2025. The team collects 87 entries from 31 CTSA hubs. Members of the committee reviewed and curated the entries for relevance, accuracy, duplication, and completeness. Results/Anticipated Results: The final work product will be deposited on the Coordination, Communication, and Operations Support (CCOS) website for long-term storage. This site provides a password-protected, stable home for this resource. To help improve the usefulness of this resource, documents available as pdfs are downloaded into a database, so they can be found even if their URLs change. In addition, the name of the institution, person, and email address contributing the resource was included with each item. Discussion/Significance of Impact: The authors’ hope this resource will provide the clinical and translational science community with materials to educate and clarify the meaning of TS and TR, and how each contributes to scientific advances that improve health for everyone.

Objectives/Goals: This study sought to gather older adult feedback on UCHealth’s artificial intelligence (AI) based chatbot, Livi, to ensure it is accessible and easy to navigate for end users to access fall prevention resources near their homes after an emergency department (ED) visit. Methods/Study Population: UCHealth’s electronic health record and ED operations team implemented an automated process to provide high fall-risk patients access to Livi via a QR code in their after-visit summary. Patients can then access evidence-based free or low-cost fall prevention resources based on their location. TO gather older adult feedback, rapid iterative testing was conducted at 3 community events (a religious center, assisted living facility, and academic medical campus). Research team members introduced Livi using an iPad and invited participants to explore the tool. End user feedback was gathered through notes taken on one-on-one guided conversation emphasizing first impressions and suggestions regarding Livi. Results/Anticipated Results: Suggestions from 93 community members included increasing font size and the addition of languages. Further resource suggestions included the following: increased locations, home modifications, and self-fall risk assessment. Based on these recommendations, our team increased font size, implemented the ability to switch from English to Spanish, added additional resources for other Colorado regions, added the ability to self-screen for fall risk using the National Council on Aging’s 13-question Screener, and fall prevention tips. Discussion/Significance of Impact: Many older adults do not follow up with primary care after a fall, increasing risk for subsequent falls. While Livi offers a pragmatic solution to this, ensuring end users can navigate it is key, so gathering feedback was a critical step before assessing Livi’s impact via randomized trial.

Objectives/Goals: Community-engaged research (CER) emphasizes equitable partnerships between academic and community partners, yet many lack structured training opportunities to develop the necessary knowledge and skills to engage. Recognizing this gap, we launched a co-design process to develop a CER 101 course tailored for both community members and academics. Methods/Study Population: The CER101 design process is rooted in principles of co-design. CAB members, community partners, and academics meet as part of an iterative, interactive, facilitated process to share perspectives, exchange knowledge, and co-create course content. A 2-day workshop began with a process to align visions – define the audience of the course, identify barriers to engagement with the material, and define parameters of the final product. Activities included structured discussions, brainstorming sessions, and feedback cycles. Emphasis is placed on valuing first-hand experience alongside academic expertise to ensure accessibility and relevance. Results/Anticipated Results: The co-design process will produce a CER 101 training that reflects jointly developed foundational concepts, practical strategies for building equitable community–academic partnerships, and case studies highlighting effective CER practices. Participants are expected to demonstrate improved understanding of CER principles, enhanced ability to apply tools for collaboration, and greater appreciation for both lived and academic expertise. The training will strengthen mutual trust, expand shared capacity for CER, and inform iterative refinements to ensure sustained relevance and impact within the community of practice. Discussion/Significance of Impact: In addition to resulting in the development of a CER 101 course that includes foundational concepts and practical strategies for engaging in CER, the co-design process will lead to increased mutual understanding of CER principles, enhanced appreciation for diverse forms of expertise, and strengthen trust.

Objectives/Goals: Researchers have an ethical responsibility to disseminate their discoveries beyond the walls of academia, tailoring communications about their research to various audiences. Learning to articulate and convey the impact of their work is a critical skill for translational scientists to develop. Methods/Study Population: Trainings were developed to prepare investigators to describe the impact of their biomedical research to stakeholders. A one-credit class was designed for doctoral students and consisted of knowledge-based training and skill development. It included instruction in developing an impact statement and conveying research impact to various audiences. Then, students practiced engaging different stakeholders by developing and presenting tailored research presentations. Also, a seminar series on research impact, with a didactic curriculum similar to the class, was created for our wider research community, and the series will be offered in the spring. Results/Anticipated Results: Six graduate students participated in the class during its initial offering and completed a post-course survey that included quantitative and qualitative measures. All students strongly agreed or agreed that the course increased their interest in research dissemination, helped them become more competent in dissemination, and provided training that they plan to apply to their work. In response to open-ended questions, students stated that expert feedback about their presentations helped them better refine their impact messages for distinct audiences. Similar survey data will be collected from seminar participants when the series is offered in the spring. Discussion/Significance of Impact: Investigators must discuss research impact with non-academic audiences to bridge the scientific discovery to real-world application gap. Intentional training in articulating and disseminating impact helps investigators be competent and confident in discussing research implications with stakeholders.

Objectives/Goals: Evaluate the impact of a community-engaged research (CEnR) training institute by assessing knowledge, skills, and sustained engagement and estimating societal value via logic-model guided surveys and social return on investment (sROI) utilizing a participatory evaluation approach. Methods/Study Population: We co-designed a logic model and evaluation plan with community partners for the Great Plains IDeA-CTR 2024 CEnR Institute. The day-long institute amplified community voices through sessions on trust building, co-creation of research, and equity in evaluation. The agenda for the institute was collaboratively developed with community and academic partners. Participants included 54 in-person and 29 virtual attendees representing researchers, community organizations, and practitioners. Using mixed methods, we administered a pre, post, and 6-month follow-up survey to assess knowledge, skills, and engagement; collected qualitative partner feedback; and conducted sROI analysis using stakeholder-defined indicators to estimate broader social impact. Results/Anticipated Results: Post-institute surveys showed significant gains in self-reported CEnR knowledge (+22.4%) and skills (+13.9%), along with the formation of 20 new partnerships among attendees. Six-month follow-up (n = 29) indicated 99.4% retention of knowledge and skills, as well as 3 newly funded community–academic collaborations averaging $135,000. Qualitative feedback highlighted strengthened partnerships and multidirectional learning between community and academic participants. sROI analysis estimated a social return of approximately ten dollars ($9.61) for every dollar invested in the training, demonstrating substantial social value generated relative to cost. Discussion/Significance of Impact: We present a scalable framework combining participatory methods, logic modeling, and sROI to capture the social impact of community-engaged programming. The institute generated a 9.61:1 social return, demonstrating that thoughtfully co-designed programming can measurably strengthen participant capacity and sustainable partnerships.

Objectives/Goals: Early identification of heart failure with reduced ejection fraction (rEF) by emergency medical service (EMS) providers is challenging, particularly in rural settings. We developed a rEF decision aid that addresses barriers to adoption using demographics, measurements, and computerized findings from ubiquitous EMS 12-lead defibrillators. Methods/Study Population: We identified all patients at Tufts Medical Center between Jan 1, 2012 and Apr 16, 2024 who had a 12-lead ECG taken within 30 days of an echocardiogram. Using the echocardiogram left ventricular ejection fraction (LVEF), each ECG-echo pair was classified as reduced EF (rEF – LVEF < 40) or non-rEF (LVEF >= 40%). The rEF is the outcome in a step-wise logistic regression model (LRM) to predict rEF. Variables of interest in the model were selected based on literature review in clinical assessment for heart failure with reduced ejection fraction (HFrEF) and what can be provided by a 12-lead ECG. We also included left ventricular damage score (e.g., Selvester Score) due to previous myocardial infarction (MI). Prior MI is a known risk factor in HFrEF. We used R 4.5 to perform the analysis and logistic regression modeling. Results/Anticipated Results: 2,289 patients were identified with a 12-lead ECG taken within 30-days of an echocardiogram. Our final regression model included demographic and ECG features: age, sex, myocardial scarring score, computerized interpretation of conduction defects (bundle branch block, early repolarization, and intraventricular conduction defect), and acute myocardial infarction findings. The rEF prediction model had an area under the curve of 0.684 and good calibration along the identity line up to predicted probability of 0.3. Discussion/Significance of Impact: A LRM to predict rEF using an ECG is computationally efficient and address important barriers of adoption in the EMS setting. It does not require additional EMS training or equipment. LRM transparency facilitates communication between paramedics and medical control clinicians to make shared decisions regarding treatment and transport decisions.

Objectives/Goals: A history of criminal incarceration in prison or jail is rarely considered in planning health services for individuals with mental illness. We estimate the impact of a history of incarceration on access to health care when needed among adults with mental illness. Methods/Study Population: Cross-sectional data from n=3,796 adults ages 32 to 42 who had been diagnosed with a mental illness were drawn from Wave 5 of the National Longitudinal Study of Adolescent to Adult Health database. Access to health care when needed was measured by answering the question “In the past 12 months, has there been any time when you thought you should get medical care, but you did not?” Regression-adjusted inverse probability of treatment weighting was used to adjust analyses of use of health care when needed for measured differences between individuals with prior incarceration (n=536) and those with no prior incarceration (n=3,260). Interaction terms were used to assess whether insurance, health and social status, chronic illness, and social support moderate the association between incarceration and unmet healthcare need. Results/Anticipated Results: After balancing group characteristics, individuals with a prior incarceration were 7 percentage-points (20%) more likely to have not received health care when needed during the past year (42% in those with prior incarceration versus 35% in those without prior incarceration; p<0.015). Weighted logistic regression models confirmed that incarceration history was significantly associated with unmet healthcare need (p<.05). Predicted probabilities ranged from 28-52% among those never incarcerated to 32-66% among those with incarceration histories. Marginal effects revealed that poor self-rated health, low self-rated social standing, and social support from family or friends amplified this association (p<.05). Discussion/Significance of Impact: A history of incarceration was associated with decreased access to healthcare when needed. Translational efforts to reduce disparities in healthcare access among adults with mental illness should include tailored models of care for individuals with incarceration histories.

Objectives/Goals: The relationship between factors that strain a healthcare system and delays in antimicrobial dosing for patients with sepsis is unclear – including redosing after first administration. The objective of this study is to define elements of capacity strain that impact timely second antimicrobial administration using electronic health record data. Methods/Study Population: In our planned retrospective cohort study, patients are eligible for inclusion if they present to one of 19 Atrium Health hospitals’ emergency department (ED) between 2022 and 2024, meet 2 or more Systemic Inflammatory Response Syndrome criteria within 6 hours, and are subsequently admitted to an intensive care unit (ICU). Capacity strain is defined using multiple measures including ED and ICU census, ED acuity, patient turnover, and ED wait times. The primary outcome is time between first and second doses of antimicrobials. Secondary outcomes are hospital length of stay (LOS), ICU LOS, days free of mechanical ventilation, and 90-day hospital re-admission. Association between variables will be assessed using univariate and multivariable regression models. Fit statistics will compare model performance. Results/Anticipated Results: Based on prior literature, we anticipate finding high rates of antimicrobial dosing delays (>10% incidence). We hypothesize that higher census, higher ED acuity, higher turnover, and wait times will each be associated with increased risk for delay in antimicrobial administration. This association will hold true when exposures are assessed in the ED, as well as in the ICU. We also expect that a model containing a combination of our proposed exposures will outperform each individual measure. Discussion/Significance of Impact: Gaps remain in understanding how system pressures interact with sepsis care delivery and outcomes. Health system strain may contribute to poor adherence to evidence-based practices. Identifying key strain measures can help direct the design and implementation of targeted interventions to improve care delivery and resource allocation.

Objectives/Goals: Since clinical trial participation is a key translational research initiative, the objectiveis to characterize research participants within a health system using electronic health record (EHR) data and evaluate how community-level factors influence research participation rates. Methods/Study Population: Retrospective, cross-sectional study of patients with ICD-10 research encounter codes (Z00.6) from 2016 to 2024 using Rush EHR data organized in the CAPriCORN Common Data Model. Research participation prevalence was the main outcome, calculated by geographic area (3-digit zip codes, Chicago community areas) and linked to Census data for neighborhood factor analysis. Variables include Area Deprivation Index (ADI), Social Vulnerability Index (SVI), education, occupation, and income. The Chi-square test compared demographics and t-tests compared mean SDOH variables between high- and low-participation community areas. Results/Anticipated Results: Of the 1,069,226 patients seen from 2016 to 2024, 11,937 patients had research visits. Of these patients, 45.4% lived in Chicago, 65 years or above is the largest age group (29%), 62% female, 58% White, 82% non-Hispanic, and 9% non-English preferred language. Overall, the research participation prevalence was 1.12%, higher outside of Chicago (1.21%) than within (1.03%). Within Chicago community areas, prevalence ranged from 0.34% to 2.8% (mean: 1.03%, SD: 0.44%). Higher-participating communities (above median) had significantly lower ADI (39.9 vs 61.9), lower SVI (0.51 vs 0.80), lower unemployment (8.0% vs 15.3%), higher bachelor’s degree attainment (43.6% vs 19.6%), higher income ($69,859 vs $36,376), and lower uninsured rates (7.4% vs 11.5%). Discussion/Significance of Impact: This work is the first local exploration of community factors and research participation using curated EHR data. Although limited by single-center data and required entry of EHR codes, it is a step into understanding factors that may influence research participation. Local estimates could be improved by utilizing data from all CAPriCORN sites.

Objectives/Goals: UW-Madison Institute for Clinical and Translational Research (ICTR) and Clinical Trials Institute (CTI) has teamed to develop a novel Clinical Investigator Training Program providing training modules to meet the demands of today’s translational researchers and study coordinators and improve trial design and analysis for greater impact. Methods/Study Population: In a novel transdisciplinary model, we have teamed to address the current needs of both investigators and study coordinators to develop a translational Clinical Investigator Training Program. Development activities include constructing a needs assessment with input from early stage, junior and senior faculty, as well as KL2 trainees and study coordinator staff. Needs assessment will inform development of “stackable” modules aiming to directly benefit investigators toward improved trial design. Incorporating perspectives of both study coordinators and principal investigators will allow for a more robust assessment of knowledge gaps and provide another method for tracking progress. Results/Anticipated Results: The curriculum in the training modules will be evaluated by a select group of new investigators in the UW Madison Pediatrics department and refined using their feedback. We will also examine if the training modules paired with individualized research planning assistance improves perceived competence for research study planning and execution. Integration of this investigator-driven, multidisciplinary training program will facilitate development of informed clinical trials and improve protocol development and execution. Discussion/Significance of Impact: This module-based training will be assessed for capability to prepare investigators to develop and execute clinical trials. With an early training program, accessible through ICTR and CTI, for both investigators and study coordinators, improvements in both trial development and impact are anticipated.

Objectives/Goals: Dietary variation can compromise metabolic control in phenylketonuria (PKU), yet the impact of improved management on within-subject dietary variation has not been explored. We examined the effect of a 5-day nutrition education camp on dietary variation and metabolic control in females with PKU. Methods/Study Population: Females with PKU (n=103; ages 12–59 years, median=18) who attended the Emory Metabolic Camp from 2014 to 2025 were included in the analysis. Pre- and post-camp 3-day diet records (3DDR) and blood samples (camp day 1 and day 5) were collected. Within-subject coefficients of variation (CVw) in energy, total protein, medical food protein, intact protein, and Phe were calculated from pre- and post-camp 3DDR. Wilcoxon signed-rank tests were used to assess pre- and post-camp dietary variation, and linear mixed models adjusted for age and energy intake were used to examine the relationship between changes in dietary variation and blood Phe concentrations. Results/Anticipated Results: Median (IQR) pre- to post-camp energy intake increased from 1475 (1207–1832) to 1733 (1459–2054) kcal, medical food protein intake increased from 36 (13–54) to 40 (18–54) g, intact protein intake decreased from 17 (10–29) to 12 (7–26) g, and Phe intake decreased from 641 (409–1152) to 527 (332–1015) mg. Blood Phe decreased from 529 (290–895) to 385 (196–721) μmol/L. CVw significantly decreased from pre- to post-camp for energy (p<0.001), intact protein (p<0.05), and Phe (p <0.05), and a reduction in energy CVw was associated with lower blood Phe (p <0.05). Notably, greater dietary variation in energy, total protein, and intact protein intake was associated with higher blood Phe at pre-camp but not at post-camp, suggesting improved metabolic stability after intervention. Discussion/Significance of Impact: These findings demonstrate that a 5-day nutrition education intervention in a large PKU cohort optimized dietary stability and resulted in improved metabolic control, providing strong evidence to support recent FDA guidance on optimizing and standardizing diet prior to and throughout inherited metabolic disorder clinical trials.