Objectives/Goals: This study aims to gather user feedback from clinical research professionals on the usefulness and relevance of regulatory resources found on a new regulatory web portal, OpenRegSource, to enhance its usability, thereby advancing this project from the initial to the full implementation phase of the implementation science framework. Methods/Study Population: The Regulatory Knowledge and Support core of the Southern California Clinical and Translational Science Institute developed a regulatory web portal called OpenRegSource to help researchers gain basic regulatory information prior to professional and/or paid consultation. Before publicly launching, a virtual focus group (FG) composed of 21 members of the local clinical research workforce was given two weeks to explore the web portal and answer three surveys. Two other research professionals also gave feedback outside of the focus group. The user feedback data was analyzed and discussed by the web portal project team. Updates were then made accordingly. Once the portal was launched, a plan was implemented to collect usage metrics and additional feedback for continuous improvement. Results/Anticipated Results: Of the 21 FG participants, 20 completed the feedback survey specifically for their experience with the web portal. 65% (13/20) said the number of resources was just right. 90% (18/20) found the resources to be very relevant to their respective topics. 85% (17/20) found the resources very useful and somewhat useful to their daily work activities. 75% (15/20) found the organization of the portal to be good or very good. 85% (17/20) found it very easy and somewhat easy to navigate the web portal. 90% (18/20) found the portal to be effective in providing its audience with a basic understanding of regulatory requirements. 95% (19/20) found the portal useful for novice research professionals. 85% (17/20) found the web portal useful overall. Participants were also able to provide commentary feedback for specific pages. Discussion/Significance of Impact: Obtaining stakeholder input during the development of a resource or tool is essential to ensure the final product meets user needs and is effectively utilized. In this case, involving the feedback of clinical researchers will help improve OpenRegSource to better facilitate the advancement of their work.

Objectives/Goals: To assess the effect on the immune response to COVID-19 in children exposed to pesticides. The hypothesis is that increased pesticide exposure results in different immunological response to COVID-19. The goal of the proposal is to improve scientific knowledge on factors affecting COVID-19 and identify a modifiable factor to reduce these disparities. Methods/Study Population: A cross-sectional analysis of children (aged 5–17 years) with asthma to assess pesticide exposure and immune markers of SARS-CoV-2. SARS-CoV-2 infection or vaccination was determined with blood exposome RNA analyses assessed from blood samples taken at baseline. Immunological response was measured using neutralizing, phagocytizing, and NK-activating antibody responses biomarkers using plasma antibody isotyping, effector functions, T-cell activation-induced marker (AIM), and recall cytokine secretion assays on lysed, whole blood. Pesticide exposure was assessed as concentration of four urinary metabolites in a spot urine sample adjusted for creatinine. Unadjusted regression models were created to assess the effect of 3-phenoxy benzoic acid, a common pyrethroid pesticide, on immune markers. Results/Anticipated Results: Children’s (N = 30) average age was 10 years (interquartile range: 8–11) A majority of children were male (63%) and Non-Hispanic Black (73%). The majority of children had markers of SARS-CoV-2 infection (77%). Of the 4 pesticide metabolites assessed, only 3-PBA was commonly found (77% of samples > LOQ). Higher urinary concentrations of 3-PBA are associated with a significant (p Discussion/Significance of Impact: Significant associations in cytokine and inflammatory marker may indicate a Th2-skewed response, and dysregulated cytokine responses can lead to severe disease. A suggested increase in T-cell activation markers (e.g., CD4, CD8) may indicate potential exhaustion if excessively activated.

Objectives/Goals: To explore how generative AI and chatbot technologies can transform clinical research administration by improving operational efficiency, reducing administrative burden, and thereby enhancing overall productivity and accuracy in clinical research environments. Methods/Study Population: This explores AI’s application in enhancing clinical research administration. We specifically address AI’s role in QCT/MCA activities, charge master data cleaning, and generating IRB consent forms from award documents. AI algorithms optimize charge master data for accuracy and compliance. Generative AI models are employed to produce IRB consent forms efficiently, incorporating key grant documents. AI also conducts thematic analyses of historical CTSA aims to identify trends and recurring themes. Furthermore, AI-assisted tools enhance study design through innovative approaches to hypothesis generation, sample size calculation, and protocol development. Integrating these AI methods aims to significantly improve efficiency, accuracy, and overall quality in clinical research administration. Results/Anticipated Results: Incorporating AI into clinical research administration will yield improvements in efficiency and accuracy. AI-driven QCT/MCA steps are expected to reduce human error and enhance data integrity. Chargemaster data cleaning via AI prompts will likely result in optimized, error-free data, ensuring compliance with regulations. The use of genAI for creating IRB consent forms from grant documents should significantly streamline the IRB approval process, reducing preparation time and administrative burdens. Thematic analysis of CTSA aims by AI will provide deep insights into historical trends and recurring themes, aiding in strategic planning. AI-assisted study design tools are anticipated to optimize sample estimation, protocol development, and advance the quality of clinical research administration. Discussion/Significance of Impact: The significance lies in enhancing efficiency, accuracy, and quality in clinical research administration. By streamlining processes, reducing errors, and providing strategic insights, AI supports the CTSA mission to accelerate translational research, thus improving public health outcomes and scientific innovation.

Objectives/Goals: This study aimed to explore Puerto Rican adolescents’ mental health experiences, focusing on risk and protective factors, and cultural perspectives on mental health. Methods/Study Population: Three focus groups were conducted: two with 20 adolescents aged 12 to 18 years of both genders and one with five adults who work with adolescents. Data were analyzed using interpretative phenomenological analysis. Results/Anticipated Results: The majority of participants in both groups of adolescents identified five key themes: social pressures, barriers to discussing mental health, the impact of social media, coping strategies, and institutional interventions. The adult focus group highlighted adolescent mental health problems, support systems, family and social factors, the church’s role, and recommended interventions. Discussion/Significance of Impact: The findings emphasize that social and familial pressures, mental health stigma, and social media significantly impact adolescent mental health. Coping strategies, such as sports, art, and nature, were also identified. These themes underscore the need for safe, supportive spaces, and targeted approaches to address youth mental health.

Objectives/Goals: Our goal for this project is to develop a metric that integrates the intersectional social and structural determinants of health and well-being into the existing policy development framework to impact the integration of such considerations on population mental health. Methods/Study Population: This project was developed from a case study module offered by the Translational Research Program at the University of Toronto. This course was designed to sharpen contextual inquiry skills and further develop a case through employing strategies, including outreach engagement with stakeholders, conducting informational interviews and formulating potential pathways forward based on the integration of insights from interdisciplinary perspectives. Results/Anticipated Results: The anticipated outcome would be improved mental health outcomes as measured by the Mental Health Commission of Canada’s Mental Health Indicators (Mental Health Commission of Canada, 2015) Discussion/Significance of Impact: Although there are established mental health indicators and policy development framework the two operate independently of each other. Our proposal bridge the gap between the sectors so that one may inform the other, and they can collectively formulate reflective and representative policies.

Objectives/Goals: We aim to explore the associations of race/ethnicity and socioeconomic status (SES): 1) with grip strength, walking speed, and comorbidity index cross-sectionally and 2) with the change in comorbidity index and mortality risk over four years of follow-up in cancer survivors. Both aims will examine the potential mediating role of cytomegalovirus (CMV) infection. Methods/Study Population: This study includes 1,602 cancer survivors (mean age = 72 years, 10% Black, 54% female) from the Health and Retirement Study (HRS), a nationally representative U.S. sample followed for health outcomes until 2020. HRS measured CMV immunoglobulin G (IgG) antibody levels (from blood samples), grip strength, and walking speed in 2016. We will apply linear regression to examine the associations of race/ethnicity and SES with grip strength, walking speed, and comorbidity index cross-sectionally and with the change in comorbidity index over four years of follow-up. We will apply Cox proportional hazard regression to examine the associations of race/ethnicity and SES with mortality over four years of follow-up. In all models, we will investigate the potential mediating role of CMV infection in these associations. Results/Anticipated Results: We expect that CMV infection mediates the associations of race/ethnicity and SES with age-related health outcomes, including muscle weakness (measured by grip strength), decreased functional performance (measured by walking speed), comorbidity index, and mortality in elderly cancer survivors. Discussion/Significance of Impact: If our hypothesis is confirmed, the findings may inform physicians to closely monitor CMV infection among cancer survivors from socially disadvantaged groups and apply treatment if needed. Several oral medications for CMV exist, and CMV vaccines are currently undergoing testing in clinical trials. This will make the treatment for CMV more accessible.

Objectives/Goals: Personalized cancer therapy based on genomic testing is advancing patient care. Genomic alterations in fibroblast growth factor receptor (FGFR) predict response to FGFR inhibitors; however, the role of RNA expression and protein activation is not known. We propose to examine the phospho-proteomic signature in FGFR-altered cancers to identify new candidates for FGFR-targeted therapies. Methods/Study Population: In our preliminary study, we have curated a cohort of FGFR2 mutants (13 FGFR2-fusions and 4 FGFR2 point mutations) with known clinical outcomes to FGFR inhibitors and 8 FGFR2 wild-type (WT) cholangiocarcinoma tumor samples to investigate the phospho-proteomic fingerprint using a clinical grade reverse phase protein array (RPPA). RPPAs are high throughput quantitative antibody-based proteomics assays that can quantify hundreds of proteins in thousands of patient tissues providing a high degree of sensitivity through laser tumor microdissection (LCM). We have selected proteins in the FGFR signaling pathway including FGFR2, AKT, ERK1.2, STAT1/3, FRS2, and PLCg to define the range of phospho-proteomic signal between FGFR2 WT and mutant cancers. All samples will undergo evaluation with RNASeq for gene expression. Results/Anticipated Results: Our initial analysis defined the range of RNA expression of FGFR2 and pFGFR2 protein signal (Y653/654 and Y769) between FGFR2 WT and FGFR2 mutant samples. On average, the FGFR2 mutant cohort displayed higher FGFR2 RNA expression compared to the FGFR2 WT cohort. There is no apparent correlation between RNA expression and clinical response to FGFR-targeted therapy. However, in this small cohort, there is no significant difference in FGFR2 phosphorylation between FGFR2 WT and mutant cancers. RPPA analysis of FGFR downstream signaling proteins reveals a wide range of phosphorylation, but no significant difference between FGFR2 WT and mutant cancers. Discussion/Significance of Impact: These findings illustrate the complexities of FGFR signaling between FGFR2 WT and mutant cancers. These data suggest that tumors with genomically WT FGFR may display increased pFGFR2 and downstream signaling phospho-proteins. We propose a larger study of cholangiocarcinoma to evaluate evidence of FGFR pathway activation in WT tumors.

Objectives/Goals: Understanding systematic review results help prioritise more valuable studies. However, evaluating whether a systematic review has conclusively answered a question is difficult, and it is unclear which tools are available for such assessments. Thus, we mapped the extent of methods for determining the conclusiveness of systematic review results. Methods/Study Population: We searched Medline (Ovid), EMBASE (Ovid), and Web of Science to find papers with methods to determine whether systematic review results were conclusive or should be updated. The characteristics of primary references for included methods are presented. We classified and summarized available methods. Results/Anticipated Results: A total of 58 unique methods were identified. Many have been published since 2010 and often did not include a worked example. We found 25 mathematical methods for the conclusiveness of meta-analyses, which included cumulative meta-analysis, fail-safe number, fragility index, prediction and machine learning model, simulation-based power, conditional power, and graphical approaches. There were 15 methods for the conclusiveness of cumulative meta-analyses, such as quality control approach, trial sequential analysis, sequential meta-analysis, and law of iterated logarithm. And, 18 methods assessed the conclusiveness of systematic reviews: GRADE framework, the strength of a body of evidence approach, methods for assessing the need to update a systematic review, and methods for specific clinical domains. Discussion/Significance of Impact: We found a wide range of methods that can be used to determine the conclusiveness of systematic review results. End-users of systematic reviews can review our results to find the most appropriate methods for their contexts and decisions.

Objectives/Goals: To develop a personalized computational framework integrating computational fluid dynamics (CFD) and topology optimization for designing intracranial aneurysm implants. The primary objective is to reduce intra-aneurysmal blood flow velocity and enhance thrombus formation for improved treatment outcomes. Methods/Study Population: Patient-specific aneurysm geometries were extracted from pre-treatment rotational angiograms. A CFD-driven topology optimization framework was employed to design implants that reduce intra-aneurysmal flow velocity. The fluid dynamics were modeled using Navier–Stokes equations and the structural integrity of the implants was ensured by linear elasticity equations. The solid isotropic material with penalization (SIMP) method was applied to optimize the implant’s porous architecture, balancing flow reduction with structural support. COMSOL Multiphysics software was used to implement the optimization. Results/Anticipated Results: The optimized implants demonstrated significant reductions in intra-aneurysmal blood flow velocity and improved hemodynamic conditions. Flow velocity within the aneurysm was reduced by 77%, and the fluid energy dissipation ratio showed a 78.9% improvement compared to pretreatment conditions. The optimized porous structures were tailored to the aneurysm’s specific geometry, providing personalized designs that improve flow stasis and thrombus formation. Further validation of the implants will be performed in vitro and in vivo to assess their effectiveness and biocompatibility. Discussion/Significance of Impact: This personalized implant design framework could lead to better treatment outcomes by reducing aneurysm recurrence and complications compared to current devices. It provides a pathway for improved occlusion rates and patient-specific solutions for intracranial aneurysms.

Objectives/Goals: Present a framework for hosting Community Grand Rounds, where community and academic partners showcase completed community-engaged research (CEnR) projects. This highlights innovative dissemination methods, engages diverse audiences, elicits community responses, and advances the translational science of CEnR. Methods/Study Population: Our approach involves planning and outreach to collaborate with promotion of academic and community engaged grantees to develop community dissemination events that translate the science of CE into accessible, relatable, culturally relevant formats for diverse audiences. These events incorporate interactive presentations that encourage active participation and feedback from attendees. Following each event, an evaluation is completed to assess community impact. Key strategies for hosting, facilitating, and utilizing diverse marketing to ensure that events are tailored to culturally diverse community groups, including regional implementation when practical. This collaborative approach meets a critical need and strengthens the bond between researchers and the communities they aim to serve. Results/Anticipated Results: These events create a feedback loop between the community and academic researchers. It was not just about telling people what was found. We created opportunities for community members and academics to build trust, give us feedback, ask questions, and discuss how findings could be practically applied. By presenting the findings in an accessible way within the community, community members are more informed and empowered to make decisions or advocate for changes in their own lives based on the research. Academics also benefited from community feedback, which provided new insights to help refine future research questions and methods. The goal is for shared conversation and understanding between community members and academics to inspire real-world applications and policy change directly informed by the research. Discussion/Significance of Impact: Community Grand Rounds are one dissemination strategy to leverage community–academic collaboration to present tailored research, fostering engagement, understanding, and action between researchers and community members. This approach effectively enhances the translational science of CEnR by involving and benefiting the community.

Objectives/Goals: The operation of a clinical trials unit involves multifaceted tasks and stakeholders. A competent information system is critical to daily operations while ensuring smooth conduct of clinical research. We share 15 years of experience in the design and implementation of such a system at Mayo Clinic to inform other institutions with similar interests. Methods/Study Population: The Informatics team collaborated closely with nurse leaders and elicited input from additional stakeholders including nurse unit coordinators, lab managers, schedulers, investigators, study coordinators, and regulatory specialists throughout the phases of system design, development and continuous enhancements, and expansion. The stakeholders offered insights on the corresponding requirements throughout the study life cycle, from engaging with the study sponsor, operational review for protocol execution, development of study budgets, human subject protection and risk mitigation, data management and integration, to outcome monitoring, and regulatory reporting. The activities were then translated into functional components and implemented as a seamless and effective solution. Results/Anticipated Results: Patient safety, scientific rigor, operation automation, efficiency, and regulatory requirements were all considered in developing an integrated system, or the clinical research trials unit (CRTU) Tools. Our institution has leveraged the system for essential tasks from the study start-up, visit scheduling and execution, specimen collection and tracking, to individual protocol metrics and billing. We adopted a measure-as-we-go methodology so that data such as visit census, resource usage, and protocol deviation are tracked and collected during routine use of the system. Specifically, an issues/concerns/exceptions (ICE) tool is used for quality control and patient safety. Moreover, data quality greatly benefits from a task dictionary, standardizing the study activities that can be ordered and executed. Discussion/Significance of Impact: The implementation of a well-rounded clinical trials unit information system not only improves the operation efficiency and team productivity but also ensures scientific rigor and contributes to patient safety. We believe the experience can be informative to other institutions. More details will be shared in the poster.

Objectives/Goals: Diffusion of innovations (DoI) posits that new health-related ideas spread through communities over time and across stages of adoption. We will apply DoI to understand a paradigm shift toward seeing participants as partners in clinical research, specifically through delivery of plain language summaries of results. Methods/Study Population: The return of results in lay language (plain language) to clinical trial participants represents a paradigm shift in the EU and now the USA. We will conduct a systematic review of the implementation of “lay summaries” or “plain language summaries” in different jurisdictions to understand current regulatory influence. We will then review PLS samples and published studies to determine the rate of adoption by industry and non-pharmaceutical company sponsors. Using the DoI framework, groups will be placed in an adopter category. Finally, we will employ an implementation science approach to understand the diffusion process and the translation to participants, laying the groundwork for a culture of change in medical product development. Results/Anticipated Results: Our search on PubMed using key terms “Diffusion of Innovation” and “Plain Language Summary” did not produce any relevant results in the context of clinical trials in the USA, which illustrates a gap in the literature and application of this theory in this context. In the future analyses, we will examine factors influencing the adoption stage and outcomes, such as regulatory action, what best practices have been defined/implemented (if any), culture shifts in the context of clinical research, health communications, and inclusion of patient voices in clinical research. Our analysis will include a network analysis to evaluate characteristics that influence adoption of PLS in clinical research. We hope to identify who is at the forefront of innovation and why. Discussion/Significance of Impact: Novel application of DoI theory will help lay the groundwork for a culture of change in patient-focused drug development, specifically for the dissemination of results to patients. In future studies, we plan to develop a tailored framework for the inclusion of PLS as part of a paradigm shift in the patient-focused drug development process.

Objectives/Goals: Urinary tract infections (UTIs) cause significant morbidity, and many patients require multiple courses of antibiotics increasing the risk of antibiotic resistance. We determined the prevalence of urinary antibiotic heteroresistance (HR), which has been associated with treatment failures in vivo, to three first-line antibiotics for UTIs. Methods/Study Population: Clinical urine Escherichia coli isolates from patients in metropolitan Atlanta, Georgia in August 2023 were collected as part of public health surveillance performed by the CDC-funded, Georgia Emerging Infections Program (EIP). Only the first E. coli isolate collected for each patient was included in this study. Antibiotic susceptibility was determined through medical record review. HR to nitrofurantoin, trimethoprim-sulfamethoxazole, and fosfomycin was determined by population analysis profiling (PAP), where broth dilutions of E. coli were plated on increasing concentrations of the antibiotic. HR was defined as survival of >1 in 106 cfu but fewer than 50% survival at 1X antibiotic breakpoint (bp), resistant as > 50% survival at 1X bp and susceptible as survival of Results/Anticipated Results: Among 355 patients, 21 (5.9%) were resistant or intermediate to nitrofurantoin and 92 (26%) were resistant to trimethoprim-sulfamethoxazole. Antibiotic susceptibility data were missing from 5(1.4%) and 11(3%) of isolates for nitrofurantoin and trimethoprim-sulfamethoxazole, respectively. Susceptibility testing was not routinely performed nor reported for fosfomycin, thus excluded. PAP revealed that of the total 355 isolates, 3(0.84%) were heteroresistant to nitrofurantoin, 17(4.8%) were heteroresistant to trimethoprim-sulfamethoxazole, and 27(7.6%) were heteroresistant to fosfomycin. Of the isolates found to be susceptible by standard testing, 1(0.3%) and 9(3.6%) were heteroresistant to nitrofurantoin and trimethoprim-sulfamethoxazole by PAP, respectively. Discussion/Significance of Impact: Despite low rates of HR to nitrofurantoin and trimethoprim-sulfamethoxazole (0.84%, 4.8%), HR to fosfomycin was more frequent (7.6%). Given that susceptibility is not generally performed for fosfomycin, this could have implications for including fosfomycin as a first-line treatment for E. coli UTIs.

Objectives/Goals: We investigate how the gut microbiome protects against arsenic toxicity, showing antibiotic perturbation increases toxicity and causes interindividual susceptibility to a sepsis-like disease state in mice. Here, we aim to understand how baseline microbiomes from various mouse vendors impact these outcomes and characterize the observed disease. Methods/Study Population: We developed a novel mouse model where mice are exposed to an antibiotic (cefoperazone) for 2 days, followed by co-exposure to the antibiotic and 100 ppm arsenate. So far, we have evaluated C57BL/6N mice from MSU’s in-house colony, Taconic Biosciences (TAC), and Jackson Labs (JAX), along with C57BL/6J mice from JAX. To determine if the baseline microbiome drives inter-vivarium differences, we established in-house breeding colonies of TAC- and JAX-origin mice at MSU. This allowed us to assess whether, when housed under identical conditions, these mice still show differences in mortality based on their original microbiomes. To characterize the arsenic-induced sepsis-like disease, we performed blood biochemistry assays to quantify the white blood cell populations, and sepsis biomarkers used in clinical settings. Results/Anticipated Results: We observed differences in survival rates between genetically identical mice from MSU (45%), TAC (30%), and JAX (2.5%) in our model. From this, we characterized the baseline composition of the gut microbiomes of these mice and found they were significantly different from each other. We are still awaiting results from our in-house TAC and JAX experiments but expect them to have similar gut microbiome compositions to those directly purchased from TAC and JAX and respond similarly. In our blood biochemistry analysis, we found sick mice presented with low WBC counts and notable biomarkers indicative of liver, heart, and kidney distress. We also anticipate that 16S sequencing results of cecal contents will further support findings by providing evidence of a bacterial infection in the ceca of sick mice. Discussion/Significance of Impact: Collectively, our work demonstrates that antibiotic perturbation of the gut microbiome induces an inter-individual and inter-vivarium susceptibility to an arsenic-induced sepsis-like disease state. This work highlights the importance of considering antibiotic use in the risk assessment of arsenic to better protect the health of those exposed.

Objectives/Goals: To determine the acceptability of a mobile/school-based diabetes and prevention clinic to overcome transportation barriers and improve attendance at endocrinology appointments for youth with type 1 diabetes, type 2 diabetes, MODY diabetes, and obesity living in socially vulnerable communities Methods/Study Population: This study utilized a 3-phase implementation process focused on feasibility, demand, and acceptability. Phase 1: identified high-need areas using patient volume and disease control metrics. Collaborated with school districts to define needs, enrolled them through a memorandum of understanding, and subsequently recruited and consented existing patients attending these schools. Phase 2 piloted the program to refine logistics and workflows. Semi-structured interviews and surveys were conducted with caregivers to assess program acceptability and satisfaction. Phase 3 is ongoing and will track clinical outcomes including glycemic control, appointment attendance, hospital admissions, emergency department visits, and self-management metrics. Results/Anticipated Results: Demand for the program was high with 91% (10/11) of approached districts agreeing to participate. District enrollment was staggered, starting with 1 district in August 2023, expanding to 5 in September, 7 in October, and reaching 8 districts by May 2024. From August 2023 to July 2024, the school-based mobile clinic conducted 355 individual clinical encounters addressing diabetes and obesity. The encounters included 180 for type 1 diabetes, 69 for type 2 diabetes, 8 for MODY diabetes, and 98 for obesity. Interviews and surveys with 36 caregivers are ongoing to evaluate program satisfaction. Discussion/Significance of Impact: The data suggest that this innovative healthcare delivery model is feasible. District-level enrollment demonstrates a demand for the program. Results from the interviews and surveys will further characterize the program’s acceptability among caregivers and lay the groundwork for future efficacy testing.

Objectives/Goals: Translational researchers spend significant amounts of time finding available datasets and other research data resources for their purposes. Objectives of this program are develop and evaluate a multipronged approach to supporting researchers with existing data resources. Methods/Study Population: We established a dedicated service with expertise in data resources to increase awareness, understanding, and utilization of existing data resources. This program assists investigators and trainees discover appropriate data resources, formulate scientific problems in computable formats, advise on state-of-the-art data analytics, data management, build collaborations, mentor data users, and develop a service pipeline for streamlined data resource project management. This is accomplished through these essential functions: (1) Discover, catalog, document, and manage metadata resources, (2) train and present data resources to the research community, (3) provide individual consultations, and (4) explore and assess novel data resources. Results/Anticipated Results: In a phased approach, the data navigation program is performing outreach to the research community and integrating with existing data efforts on campus, presenting and demonstrating existing data resources, established a consultation service, and building core competencies into long-term usage and navigation of resources across campus. Evaluating the program monthly has shown an increase in various metrics for evaluating commitment and engagement including number of requests for access to data resource, consultations, publications and presentations, co-authorship, and proposals. Unawareness and inappropriate use of data resources leads to delays in performing research and potentially unnecessary duplications of efforts. Discussion/Significance of Impact: Our data navigation program has increased use of data resources in research. Next steps are to continue evaluation and further streamline informatics approaches to data discovery, abstraction, formulation, and analysis. Harmonized data resource programs are important translational science approach to foster the next generation of research.

Objectives/Goals: The overarching goal of the GRAMM study is to address racial health disparities by increasing access to genetic counseling and testing among the Black community. Specific objectives are to determine patient acceptability of risk assessment at time of mammography and to evaluate subsequent access to and uptake of genetic counseling and testing. Methods/Study Population: All women presenting for screening mammography at the Ypsilanti Health Center under the University of Michigan were invited to enroll. After providing written informed consent, study participants entered family cancer and personal health information in the InheRET software tool which links to the National Comprehensive Cancer Network genetic testing guidelines. Upon completion, each participant was informed immediately if they did or did not meet the criteria to meet with a genetic counselor. For those who met the criteria, referral to genetic counseling was provided. All enrollees were invited to complete a post-assessment survey on acceptability of the service and genetics knowledge. Patients will be followed over time for completion of genetic counseling and testing. The study was approved by the Umich IRB. Results/Anticipated Results: As of 10/18/24, a total of 53 were enrolled, with 52 eligible for the study and were between the ages of 30–75 years. 51 identified as women and 1 identified as nonbinary. 21 (40.4%) identified as Black, 30 (57.7%) identified as White, 2 (3.8%) identified as Hispanic, and 1 (1.9%) identified as mixed race. Of the total enrolled, 25 (48.1%) met criteria to meet with a genetic counselor. Twelve (23.1%) have been scheduled to with meet with a genetic counselor and 2 (3.8%) of this group completed their appointment, but did not pursue genetic testing. 28 (53.8%) completed the survey and reported that they were satisfied with the service. Of the 16 people who screened positive and completed the survey, all 16 (100%) stated that they intended on proceeding with testing. Our study is still ongoing. Discussion/Significance of Impact: While this model has demonstrated acceptability so far, there are still possible barriers to genetic counseling and testing after the referral has been provided that need to be explored. However, this approach could provide a novel framework for combining risk assessment with screening mammography for all women nationwide.

Objectives/Goals: Both diabetes and obesity are major health issues in the USA. Though much focus is given on the impact of lifestyle modifications to control diabetes and obesity, more information needs to be established about the association of social determinants of health and them. This study explores these associations, focusing on the DMV area. Methods/Study Population: The data for this study were collected for 158 counties which cover two states Maryland and Virginia, and Washington DC from PolicyMap. PolicyMap is a geography information system (GIS) that aggregates different types of data from different sources for research purposes. County-level data on public health related to different SDoH like median age, and percentages proportions of different ethnicity (Hispanic or Latino), percentages of different race, and nativity (foreign born), gender (ratio of male to female), access to primary healthcare, social vulnerability index (SVI), and median household income was used in this study. Statistical methods like multiple regression, one way ANOVA, and Pearson’s correlation coefficients were used to determine which factors are associated with these two conditions. Results/Anticipated Results: For both diabetes prevalence and obesity, multiple linear regression model with backward elimination was used to select variables which associated with them. The backward elimination process selected the set of factors for which the adjusted R square was the highest. In both cases, median household income, median age of population, social vulnerability level, percentage of white population, and percentage of foreign-born population were found to be significant at 5% level of significant. Pearson’s correlation coefficients showed significant positive relationship between factors like obesity and diabetes, median age and access to health care, and negative relationship between obesity and foreign born. Income, healthcare access, and white population were found to be significantly different SVIs from ANOVA. Discussion/Significance of Impact: This research study found that some SDoH affect diabetes and obesity in the same direction. The association is positive for median age and negative for income, SVI, percentage of white population, and foreign born. The associations were found between actionable and non-actionable factors like percentage of white population with access to health care.

Objectives/Goals: The goal of the Accelerated Staff Assist Program (ASAP) is to help fill staffing gaps in clinical and translational research. The program offers centralized staff to fill short-term needs including project startup prior to hiring, project implementation, parental leave, and Spanish-language research support. Methods/Study Population: Promotion of ASAP in the first year was targeted to Penn State College of Medicine faculty to determine demand. Current outreach includes promotion to all Penn State campuses through PSCTSI’s newsletter, seminars, and presentations. Consultation intake data includes a project summary, staffing needs, and funding information. A project agreement, charter, and budget are drafted and agreed to by the principal investigator before work begins. Assessments occur at 6 and 12 months to assess satisfaction of the consultation process and quality of staff support, Net Promoter Score, and qualitative feedback about the program. Results/Anticipated Results: In its first year, ASAP conducted 26 consultations and supported 10 projects. Approximately 75% of staff effort has been recovered through agreements during the most recent 6 months. In anticipation of project delays, we found that booking FTE up to 115% results in a consistent recovery of 75% FTE. Consultee needs include short-term, partial effort support (76% of requests), project start-up (12%), staff leave (4%), and other (8%). ASAP staff tasks include participant recruitment and retention, data collection and analysis in English and Spanish, and community engagement for recruitment. Program assessments with research teams are ongoing; preliminary qualitative and quantitative data are unanimously positive. Discussion/Significance of Impact: The ASAP program has demonstrated fiscal success and sustainability in its first year. Hiring of a well-qualified, bilingual staff person allowed for quick onboarding and project support within one month of hire. ASAP enables CTSI to fulfill our mission by providing critical support for research teams to meet objectives and achieve equity goals.

Objectives/Goals: Patients with multiple chronic conditions (MCCs) face care coordination challenges and poorer health outcomes. Outpatient telehealth may be an effective way to enhance MCC patient care given the need for multiple visits and specialists. This study seeks to describe telehealth utilization between 2013 and 2023 in Arkansas. Methods/Study Population: We utilized the Arkansas All-Payer Claims Database (APCD) to identify patients diagnosed with high-prevalence MCCs comprising diabetes with comorbid hypertension, hyperlipidemia, or asthma. We then measured telehealth utilization defined as any claim associated with a telehealth modifier code, a place of service code defining the service as occurring in the patient’s home, or remote patient monitoring. Finally, we created payer-specific (e.g., commercial or Medicaid) yearly measures of the number of any telehealth claims among MCC patients divided by the number of MCC patients for that year. Linear regression was used to measure the difference in utilization during the COVID-19 pandemic (i.e., 2020–2023) versus prior to the pandemic (i.e., 2013–2019). Results/Anticipated Results: Overall, the COVID-19 pandemic era was associated with an increase of telehealth utilization among commercial patients by 1.01 telehealth claims per MCC patient (95% CI: 0.39 to 1.62, p Discussion/Significance of Impact: Variations in telehealth uptake among MCC patients suggest heterogeneity in its suitability and necessity. We will later evaluate whether telehealth use is associated with different levels of inpatient and emergency department utilization. We expect the findings to provide clarity on the suitability of telehealth use by MCC disease status.