OBJECTIVES/GOALS: In this study, the ability of a pathologist to detect malignancy on digital pseudo-H&E slides obtained via structured illumination microscopy (SIM) imaging of fresh diagnostic breast biopsies was assessed. The speed of imaging and processing was also assessed for potential clinical implementation. METHODS/STUDY POPULATION: This study was conducted in accordance with an Ochsner Medical Center of New Orleans IRB. 200 patients undergoing either stereotactic or ultrasound-guided diagnostic breast biopsies were consented and an additional core from the suspicious lesion was collected for research use. Research biopsies were transported to the lab and stained with DRAQ5 and Eosin-Y and imaged with SIM before being submitted for histology processing. Imaging and digital processing times were recorded. The resulting SIM images and histology slides were given to a pathologist for blind review to assess accuracy. RESULTS/ANTICIPATED RESULTS: The ex-vivo structured illumination microscopy images and subsequent histology slides from 79 research cores have been assessed to date. Some samples were excluded from the total data set and not included in the final assessment due to technical failures of the imaging protocol. Of the current set, the pathologist has a specificity of 88% and a sensitivity of 65%, as well as an NPV of 88% and a PPV of 65%. Staining time for each biopsy was completed within 3 and a half minutes and imaging at 20x magnification took between 4 and 12 minutes, depending on size and implementation of autofocus to the imaging system. Image processing took approximately 5 minutes per biopsy and is a direct function of biopsy size. DISCUSSION/SIGNIFICANCE: Decreased time between cancer suspicion and treatment will improve the prognosis of breast cancer patients. SIM imaging of fresh breast biopsies could ultimately allow primary and secondary histology to be performed simultaneously and minimize histopathology time, thus allowing clinicians and patients to implement treatment course more quickly.

OBJECTIVES/GOALS: The Community Engagement and Advisory Board (CEAB) has been an active and sustainable source of expert recruitment, retention, and community engagement advice. Our goal is to describe the strategies offered by the CEAB to university researchers and discuss which are most and least likely to be implemented. METHODS/STUDY POPULATION: The University of Illinois at Chicago’s (UIC) Center for Clinical and Translational Science’s (CCTS) CEAB was established in 2009 and is one of the longest-standing boards across the CTSA network. Our CEAB consists of 28 members, each representing a community-based organization or underrepresented community, which has provided 16 consultations since 2021. Our analysis consisted of: 1) reviewing and coding consultation notes (n= 16) to extract common recruitment and retention strategies provided to researchers; 2) reviewing feedback forms (n = 10) completed by the research team to code the strategies most likely to be implemented by researchers; 3) analyzing the codes to identify the strategies least likely to be implemented. RESULTS/ANTICIPATED RESULTS: Our preliminary analysis indicated that the majority of researchers reported they are most likely to implement strategies to reduce burden for research participants (make study participation more convenient, e.g., allowing participant accompaniment, avoiding commuting to study site, providing transportation provide them with resources to their healthcare) and enhance recruitment from trusted community sources (e.g., Aldermen, local agencies, libraries). Researchers are least able to follow recommendations to alter their budget (e.g., increase participant stipends, hire community staff). DISCUSSION/SIGNIFICANCE: In a previous paper focused on this CEAB, Matthews etal. (2018) found researchers indicated that they plan to implement at least one recommended strategy. In this follow-up examination, we describe the recommended strategies to guide CEABs to align recommendations with researcher priorities to best assist with their translational science goal.

ABSTRACT IMPACT: Understanding the women community leaders’ sense of relational and financial empowerment in the social entrepreneurship context will be key to developing a sustainable pathway to scale-up community-based HPV self-sampling programs in low resource settings. OBJECTIVES/GOALS: The Hope Project, a social entrepreneurship (SE) near Lima, Peru, trains women leaders (Hope Ladies) to promote human papillomavirus (HPV) self-sampling in their communities. This study aims to evaluate the Hope Ladies’ own relational/financial empowerment after participating in the program. METHODS/STUDY POPULATION: The Hope Ladies participated in semi-structured in-depth interviews (n= 9) and 8-question 5-point Likert-scale survey (n=16) that evaluated their relational/financial empowerment after participating in the social entrepreneurship. The interview and the survey questions were developed using validated empowerment frameworks, indicators, and theory, respectively: 1) Kabeer’s conceptual framework, 2) International Center for Research on Women (ICRW), and 3) Relational Leadership Theory (RLT). Direct content analysis was used to deductively evaluate the interviews with predetermined codes and categories of empowerment. Descriptive statistics were used to analyze the survey results. RESULTS/ANTICIPATED RESULTS: All reported experiencing empowerment in the SE. Interviews: The codes were mapped onto 3 categories/9 sub-categories: 1) voicing confidence (willingness to challenge social/gender norms); 2) social resources (new skills, knowledge, self-efficacy, access to networks, role models); 3) financial gains (helpful but not the primary motivation to continue as Hope Ladies, and not enough to override traditional household roles/priorities). Survey: 75% indicated an increase in social contacts, confidence in discussing reproductive topics (75%), comfort with medical facilities (44%), ability to help the community (62.5%), and ability to make household purchasing decisions (36%) since joining the program. DISCUSSION/SIGNIFICANCE OF FINDINGS: The Hope Ladies’ experience in this SE demonstrated the complex relationship between various domains of empowerment (e.g., relational/financial). More studies are needed to elucidate the relationship between empowerment and worker retention/performance to inform scale-up of HPV self-sampling SE’s.

ABSTRACT IMPACT: This work will contribute to the understanding of challenges and best practices for navigating the research review process for collaborative community-engaged research. OBJECTIVES/GOALS: The aim of this scoping review is to comprehensively identify the challenges that researchers, community partners, and the Institutional Review Board (IRB) face, in order to develop best practices to guide future community-engaged research (CEnR). METHODS/STUDY POPULATION: Community-engaged research (CEnR) encompasses all research practices in which traditional researchers collaborate with community partners to identify health disparities that affect the community. CEnR aims to empower communities and prevent exploitative research practices on vulnerable populations. Though many goals of CEnR align with that of the Institutional Review Board (IRB) to protect human research subjects from unethical harm, researchers and community members conducting CEnR are often met with challenges when getting research approval. The search strategy included all publications pertaining to challenges in IRB approval and process for studies in the spectrum in community-engaged research. Systematic searches in PubMed Central and PsycINFO were conducted. RESULTS/ANTICIPATED RESULTS: The search strategy produced 748 publications from peer-reviewed journals. We included 118 publications that met our initial inclusion/exclusion criteria from the search strategy in our analysis. Preliminary results show that common challenges include lack understanding of the duo role of community members as researchers and participants, informed consent language barriers, and lack of understanding community-based participatory research. Best practices when working with the IRB include fostering an environment for open communication with the IRB early in the research process, understanding timeline constraints from both researcher and community agencies and supporting the role of community members as research staff. DISCUSSION/SIGNIFICANCE OF FINDINGS: Community-engaged research efforts are advantageous in empowering and providing agency for community members to address important health concerns within their communities. To prevent the exploitation of vulnerable and underserved populations, more research should engage in collaborative community-based partnerships.

OBJECTIVES/GOALS: IgA1 nephropathy, which can lead to kidney failure, is caused by complexes formed between aberrant galactose-deficient IgA1 and antibodies directed against it. Our goals are to characterize shifting glycosylation patterns at the level of single IgA1 molecules and to apply this to patient samples for early detection and understanding of the disease. METHODS/STUDY POPULATION: To characterize glycosylation patterns on single IgA1 molecules, labelled IgA1 in low concentration was physisorbed to borosilicate glass in a fluidic cell and labelled Jacalin was flowed in to bind with Glycans on IgA1. The samples were observed with a Nikon TiE epi-fluorescence microscope. FRET images were created by exciting the Jacalin dye with a blue laser and recording the red emission of the IgA1 dye with an EMCCD camera. FRET emission intensities of individual IgA1 molecules over time were analyzed to determine how frequent and how long Jacalin binds to each of them. The rate of binding is roughly inversely proportional to the amount of abnormal glycans on a given IgA1 molecule. After the method is perfected, we intend to compare the glycosylation patterns of healthy and diseased patient samples. RESULTS/ANTICIPATED RESULTS: Addition of the competitive binder Galactose to the solution led to an increase in the off times of Jacalin and IgA1 and a decrease in the on times in a concentration-dependent manner, yielding an increase in the dissociation constant. Dissociation constants of individual molecules within a single experiment vary by 3 orders of magnitude, which cannot be attributed to stochastic fluctuations but rather reflects differences in the adsorption geometry. Nevertheless, the unaffected dissociation constant can be identified. We expect that when this method is applied to samples from healthy and IgA1 Nephropathy patients, specific IgA1 molecules from patients will have higher dissociation constants for Jacalin compared to those from healthy patients. DISCUSSION/SIGNIFICANCE: The binding rates of Jacalin to single IgA1 vary by 3 orders of magnitude. The observed heterogeneity shows the Jacalin probe can differentiate between different IgA1 populations. An understanding of which IgA1 molecules in patient samples are problematic and what their distribution of Glycans is can lead to discovering biomarkers and treatments.

OBJECTIVES/GOALS: Prior work has established subtypes of OSA and linked them to risks of future adverse events but rarely with the longitudinality and richness of data available in the EMR. Our goal is to leverage EMR data identify clinically meaningful sub-phenotypes of OSA and better study how they affect risks of adverse outcomes. METHODS/STUDY POPULATION: Vanderbilt’s EMR database has over 61,000 adult patients with a literature-validated EMR definition of OSA with a median EMR follow-up period of 4 years after OSA diagnosis. Of these patients, 12,516 have fully recorded sleep study data in addition to EMR variables such as age at study and most recent BMI. We applied several clustering methods including to identify natural sub-phenotypes of OSA and assessed cluster quality. We also applied techniques which allow a single patient to belong to multiple clusters in various degrees. After selecting final clusters, we plan to analyze the associations between OSA sub-phenotypes and risks using statistical tools like logistic regression and Cox proportional hazards regression, with and without adjusting for factors such as age, gender, and certain medications. RESULTS/ANTICIPATED RESULTS: Preliminary clustering with primarily sleep study data has shown overlap with literature-described patient clusters, including a severe, high non-REM stage 1 sleep, high BMI cluster and a high nocturnal limb movement cluster. As we incorporate more EMR variables, we will select a final set of OSA sub-types. We anticipate patients in different clusters to have different risks of various adverse OSA-associated outcomes that are tracked in our EMR data. Notable outcomes with sufficient incidence rates (>3%) after OSA diagnosis include essential hypertension (43.4%), hyperlipidemia (28.8%), type 2 diabetes (21.9%), anxiety disorder (19.2%), coronary atherosclerosis (14.9%), cerebrovascular disease (7.7%), and pulmonary heart disease (5.9%). DISCUSSION/SIGNIFICANCE: If our results match anticipations, we will show how EMR data can be used to define OSA sub-phenotypes and predict patient risks of various OSA-associated outcomes. This analysis enables work in personalized risk and treatment predictions for OSA patients. By better understanding these risks, providers can better tailor treatments to patients.

OBJECTIVES/GOALS: Improving physical activity of African American women experiencing disproportionate health risks from sedentarism, educational and socio-environmental barriers. BeFit: Building Empowerment through Fitness is based on “What I Learned At Home” project, run by Women Under Construction Network, for residents of the Birmingham Housing Authority. METHODS/STUDY POPULATION: A qualitative study design to understand unique cultural context and challenges faced by African American women residing in the Birmingham Housing Authority, regarding physical activity engagement, including sedentarism. A needs assessment approach will help determine barriers, support systems, and social networks. Semi-structured, pre, mid, and post program focus groups will identify challenges and opportunities for health, such as diet and exercise, and will be analyzed by hand with a thematic analysis. The project framework uses exercise and home repair tools with a life-building/life repair curriculum to influence health, self-efficacy, and program engagement. The Study enrollment will include 50 women over two cohorts in a 12-week project. RESULTS/ANTICIPATED RESULTS: This research addresses the urgent health needs of African American women in low-income communities. These women face heightened health risks due to sedentary lifestyles, educational gaps, and socio-environmental barriers. This project targets the pronounced prevalence of allostatic burden in this population by applying a culturally sensitive, bottom-up approach. Our goal of incorporating healthy lifestyles to improve health in at-risk women and their families requires multiple projects. This project is a necessary first step in engaging with a community to identify local environmental circumstances and barriers to increasing the relevance of physical activity within the home. These barriers can then be addressed by adapting an exercise promotion program to the needs of this community. DISCUSSION/SIGNIFICANCE: Black women in under-resourced communities are more likely to be sedentary and have poor health. Exercise programs can be a powerful tool to address disparities and help prioritize health. The circumstances of women in public housing in Birmingham, AL, need community partners to adapt exercise engagement programs to meet environmental challenges.

OBJECTIVES/SPECIFIC AIMS: (1) Evaluate the relative incremental cost-effectiveness [cost per quality-adjusted life year (QALY) gained] of antibiotics, laparotomy, and laparascopy for the initial treatment of uncomplicated appendicitis. (2) Detect if the relative incremental cost-effectiveness of each treatment differs by age, namely in pediatric patients, adult patients, and geriatric patients. (3) Use deterministic and probabilistic sensitivity analyses to assess the robustness of our findings when varying multiple model parameters. METHODS/STUDY POPULATION: Study Population and Analytic Approach: The population under analysis is a simulated population of those aged 1–90 diagnosed with uncomplicated appendicitis with computed tomography (CT) in the emergency department. Pregnant women and those younger than 1 year old were excluded from our analysis. We simulated our population through a Markov state-transition simulation model. Using this model, we estimated the lifelong costs and effects on QALYs from the use of antibiotics, laparoscopy, and laparotomy for a given hypothetical individual with uncomplicated appendicitis. This model allowed for the incorporation of both the short-term and long-term effects of each respective treatment option. The primary outcome of the model was the cost per additional QALY gained. The analysis was conducted using a healthcare perspective. A 100 age-year time horizon was used. A 3% discount rate was applied to both the costs and effects in the model. Transition states are depicted. Surgical state rates were derived from HCUP. Treatment failure of antibiotics was defined as recurrent appendicitis within one year of antibiotic treatment. This was determined using results from prior RCTs and a Cochrane review of antibiotic management for uncomplicated appendicitis. Recurrent appendicitis was defined as recurrent appendicitis after 1 year of antibiotic treatment, using rates of appendicitis applied to the general population by age group. National age-adjusted mortality rates were applied to account for death due to causes unrelated to appendicitis. To assess differential results by age, different acute and long-term outcome, cost, and state transition rates were applied to 3 age groups: a pediatric group (1–17 years old), an adult group (18–64 years old), and a geriatric group (65+ years old). As an individual progressed through the model until age 100, the respective parameters would change to adjust for the transitions between the 3 life stages. Outcomes After Appendicitis: Lifetime QALYs were incorporated throughout the study for short-term and long-term health states. There is limited availability of QALY data in the literature pertaining to the health states specific to appendicitis. Due to this limitation, however, calculated quality of life (QoL) indices for 2015 created by Wu et al. were utilized for this study. QALYs were subsequently derived by multiplying QoL by the appropriate duration of time spent in a respective health status. Transition rates between health states were abstracted from the existing literature. Costs: Direct medical costs were obtained from HCUP statistics from the 2014 fiscal year for all age groups in the nationwide network. This database contains all costs of care related to surgical appendicitis intervention, however it lacks costs associated with antibiotic-only management. To account for these costs, data was extracted from current available literature, and the resulting average was applied to our model. Sensitivity Analysis: One-way analyses by cost of procedure and effectiveness of antibiotic protocol were undertaken to account for regional variation in costs and improvements in antibiotic therapy, respectively. For cost of procedure sensitivity analysis, costs were varied by 1 standard deviation below and above the mean cost per treatment group per age. These costs were then compared to a designated reference group. Antibiotic sensitivity analysis was conducted by reducing the effectiveness of antibiotics from the maximum reported effectiveness down to 0, with the goal of obtaining a level of effectiveness at which antibiotics were no longer cost-effective. A probabilistic Monte-Carlo sensitivity analysis was then employed to determine the percent likelihood of each treatment arm being cost-effective at a level of $100,000 per additional QALY. The probabilistic sensitivity analysis was then repeated to determine the percent likelihood of each treatment arm being the dominant option, in that it lowers costs and adds QALYs. RESULTS/ANTICIPATED RESULTS: Our model examined the cost-effectiveness of 3 different treatment options for patients with acute uncomplicated appendicitis: laparoscopic appendectomy, laparotomy appendectomy, and an antibiotic regimen. We first examined the cost-effectiveness of each of these strategies in comparison to laparotomy. Laparoscopic appendectomy was shown to be superior to laparotomy in regards to costs and QALYs for patients ages 18 to 65+, while there was very little difference for patients ages 1–17. For those aged 1–17, laparoscopy had an additional cost of $90.00 with an associated gain of 0.1 QALYs compared with laparotomy. For those aged 18–64, laparoscopy had a net cost-savings of $3437.03 with an associated gain of 0.13 QALYs compared with laparotomy. For those aged 65+, laparoscopy had a net cost-savings of $5713.55 with an associated gain of 0.13 QALYs compared to laparotomy. Antibiotic management was superior to laparotomy as it relates to both costs and QALYs for all 3 age cohorts. For those aged 1–17, antibiotic management had a net cost-savings of $5972.55, with an associated gain of 0.6 QALYs compared with laparotomy. For those aged 18–64, antibiotic management had a net cost-savings of $6621.00 with an associated gain of 0.5 QALYs compared with laparotomy. For those aged 65+, antibiotic management had a net cost-savings of $11,953.00 with an associated gain of 0.21 QALYs compared with laparotomy. We then assessed the cost-effectiveness of antibiotics relative to laparoscopy. In all 3 age groups, antibiotics added QALYs and were cost-saving. For those aged 1–17, antibiotic management had a net cost-savings of $6062.55, with an associated gain of 0.6 QALYs compared with laparotomy. For those aged 18–64, antibiotic management had a net cost-savings of $3183.97 with an associated gain of 0.5 QALYs compared with laparotomy. For those aged 65+, antibiotic management had a net cost-savings of $6239.45 with an associated gain of 0.21 QALYs compared with laparotomy. Sensitivity Analysis: We first examined the effect of varying costs on our results. Costs for all interventions were varied by 1 standard deviation above and below the average costs used in our original model, yielding 3 cost estimate levels: high cost (1 standard deviation above), middle cost (average cost reported in model), low cost (1 standard deviation below). For all 3 cost estimate levels of antibiotics, antibiotics persistently dominated laparotomy for all 3 age groups. Laparoscopy dominated at all cost levels in age groups 18–64 and 65+ but had a positive ICER for both high and medium cost levels in the 1–17 age group. We then varied effectiveness (one minus the failure rate) of antibiotic treatment in each age group to assess at what level of effectiveness to antibiotics become dominant relative to laparotomy. In ages 1–17, antibiotic treatment became dominant at 43.8%; in ages 18–64, antibiotic treatment became dominant at 33%; and in ages 65+, there was no level of antibiotic effectiveness that did not result in this therapy being dominant over laparotomy. Probabilistic Monte-Carlo sensitivity analysis is pending, but we anticipate antibiotics having a high likelihood of being both cost-effective and dominant relative to the other 2 treatment options. DISCUSSION/SIGNIFICANCE OF IMPACT: We performed a cost-effective analysis comparing surgery versus antibiotic management for uncomplicated appendicitis. Our study found that antibiotic therapy was the dominant strategy in all age groups as it yielded lower costs and additional QALYs gained compared with laparotomy and laparoscopy. Appendicitis is the most common surgical emergencies worldwide, with a lifetime risk of 6.9% in females and 8.6% in males (Körner 1997). For over 100 years, open appendectomy had been the established treatment for appendicitis, but current management has evolved with the advent of laparoscopy and now growing use of antibiotics for treatment of appendicitis. There is growing interest in nonoperative management of uncomplicated appendicitis, given both an aging population that is increasingly frail and vulnerable to surgical complications and concerns over skyrocketing medical costs. Our model showed that antibiotic-only management was cost-effective in all age groups. This has important implications for management of appendicitis, where current management is to offer antibiotic-only management only in the “rare cases” where the patient is unfit for surgery or refuses surgery. Our data show that medical management of appendicitis not only is cheaper, but also provides more QALYs in all age groups. Our study has several limitations. First, we conducted our analysis under the assumption that all patients will be cured of appendicitis following surgical intervention. Some patients following appendectomy will develop symptoms of appendicitis and be diagnosed with “stump appendicitis,” which can occur in stumps as short as 0.5cm and can present as late as 50 years following initial surgery (Kanona, 2012). Additionally, any intraperitoneal surgery can lead to late complications such as small bowel obstruction from adhesions following surgery. Thus, our assumption that patients following appendectomy will return to the general population’s QALYs and mortality rate is not necessarily an accurate reflection of all clinical courses. However, the overwhelming majority of appendectomy patients recover fully post-surgery and we do not believe the above complications would significantly change our analysis. We also assumed that all patients with recurrent appendicitis following medical management would undergo surgery. However, patients who underwent nonoperative management at initial appendicitis may be more likely to be ineligible for surgery or refuse surgery during this second case of appendicitis. In addition, data were sparse for QALYs for the complications of open and laparoscopic surgery. We estimated these numbers from the EQ-5D, which while perhaps not accurate, we believe to be the best approximation given the available data. The next steps in evaluating the use of nonoperative management in uncomplicated appendicitis would be to validate the use of nonoperative management in elderly populations and to develop more accurate diagnostic criteria for uncomplicated Versus complicated appendicitis. Additionally, with increasing attention on antibiotic-resistant micro-organisms, policy decisions on the use of nonoperative management must also consider antibiotic stewardship. While one dose of perioperative antibiotics is indicated for appendectomy, treatment strategies from trial protocols for antibiotic-only management require significantly more antibiotics—some protocols require 1–3 days of IV antibiotics followed by up to 10 days of oral antibiotics. This study provides a cost-effectiveness analysis of treatment options for acute uncomplicated appendicitis among varying age groups. Our analysis demonstrates the benefit of antibiotics for initial therapy in the management of acute uncomplicated appendicitis. While the historic gold standard of laparotomy still is present as the first line treatment option in many physicians’ minds, new evidence indicates that the advancement of other methods, whether surgical via laparoscopic removal of the appendix or medical via improved antibiotic regimens, suggests better alternatives exist. Our study builds upon a growing body of literature supporting initial treatment of acute uncomplicated appendicitis with antibiotics, before surgical intervention.

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/SPECIFIC AIMS: The Rockefeller University Center for Clinical and Translational Science (RU-CCTS), Clinical Directors Network (CDN), and Carter Burden Network (CBN), a multi-site senior services organization serving East Harlem, NY, formed a community-academic research partnership to characterize the health of the CBN seniors (many who are racial/ethnic minorities, low-income, and suffering from multiple chronic conditions) and to explore the use and associations of a measure of overall health status and frailty in this population. A simple validated measure of health status could standardize and streamline community-based translational research to study the impact of CBN’s services on health outcomes. The CCTS-funded Pilot Project aims to: 1) Engage CBN seniors and stakeholders in priority-setting, joint protocol development, research conduct, analysis and dissemination; 2) Characterize the health status of the CBN seniors using validated measures; 3) Establish an electronic database infrastructure for current and future research; 4) Understand how health and senior activities information can be used to implement programs to improve senior health and well-being. METHODS/STUDY POPULATION: 1) We used Community Engaged Research Navigation (CEnR-Nav) methods to facilitate partnership development, and to engage CBN seniors and stakeholders in each step of the research; 2) Research staff conducted recruitment, informed consent, and physical assessments (e.g., pulse, blood pressure, BMI); and administered validated surveys to collect health status information. 3) Data were captured on a REDCap-based platform. The primary outcome, frailty, was measured by the validated Short Physical Performance Battery (SPPB). 4) Secondary outcomes include the association of use of services/activities with the primary outcome. Research participants consented to sharing of their health, demographic and services utilization data compiled by CBN staff and the NYC Department for the Aging (DFTA). DFTA provided comparison datasets of de-identified health and demographic data for clients attending other NYC DFTA-funded senior centers. RESULTS/ANTICIPATED RESULTS: 1) 43 residents and stakeholders engaged in partnership-building, study design and implementation. 2) 218 participants from two senior centers were enrolled. Mean age, 68 ± 11 years; 58% Hispanic; 33% African American, 23% White, 1% Asian, 18% Unknown, 17% Other; 69% reported <$20000 annual income; 40% had not completed high school; 30% scored as moderately or severely frail; 83% were overweight or obese; and 33% reported a history of diabetes. 84% had uncontrolled high blood pressure; many participants were previously aware of their hypertension diagnosis. 3) A REDcap database was developed to store historical and prospective data. 4) Across frailty categories, there was a significant difference in utilization of non-meal (p = 0.0237) and meal services (p = 0.0127) and there was an inverse proportional relationship between the number of meal and non-meal visits, and frailty. Additional associations among health status measures (e.g., SPPB, demographics, biological measures: pulse, blood pressure, BMI; psychosocial and nutritional scales) and CBN service utilization (i.e., meals vs. non-meals activities) will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: We developed a community-academic research partnership, infrastructure and capacity, built through our Community-Engaged (CEnR-Nav) model, to conduct a pilot study characterizing the health status and services utilization of low-income minority seniors. Our pilot study identified an urgent health priority, uncontrolled hypertension in 84% of CBN’s seniors. We then leveraged the team’s expertise and CBN’s meal services program to develop a research proposal for external funding to conduct a community-based multi-component intervention study. Replacement of a typical Western diet with the Dietary Approaches to Stop Hypertension (DASH) diet has been proven to reduce blood pressure in hypertensive and normotensive individuals in as little as 14 days, yet effective implementation has been lacking, and it is relatively untested in community-living seniors who receive their meals in settings such as CBN. We are also exploring mechanistic questions that relate to blood pressure control, such as the impact of the DASH diet on inflammation, which may lead to a better understanding of the underlying mechanism of action of the DASH diet. Our community partner, CBN, was awarded the DHHS-ACL nutrition innovation grant to conduct this 2-year study with CDN and RU-CCTS. The resulting study developed out of the community engaged pilot study represents a unique combination of community-centered care, within an implementation science framework (with embedded mechanistic measures under development). This is an example of the novel, full-spectrum approach to translational research that the RU-CCTS/CDN Community Engaged Research Core has been developing over the last decade. The research to characterize CBN clients’ health status is now being extended to address cardiovascular health by way of intervening on diet quality and food insecurity, a key component of the social determinants of health, in partnership with agencies outside of the healthcare delivery system. The outcomes of the DASH Diet implementation study will also serve to inform the broader aging service provider network and the healthcare community about the impact of senior center congregate meal composition and services on health outcomes.

OBJECTIVES/GOALS: The MEF2 family of transcription factors regulate gene expression controlling cell differentiation and synapse development. Mutations or deletions in the MEF2C gene cause a neurodevelopmental disorder that includes symptoms of autism spectrum disorder. In this study, we aim to study the role of MEF2C in GABAergic populations using an animal model. METHODS/STUDY POPULATION: MEF2C Haploinsufficiency Syndrome (MCHS) occurs when there is one functional allele and one disrupted allele of MEF2C. To study the role of MEF2C in GABAergic populations during mouse development, we bred Vgat (vesicular GABA transporter)-Cre mice, which express cre recombinase broadly in early developing GABAergic neurons, with a floxed Mef2c loss-of-function mouse to create offspring that are GABAergic cell-specific Mef2c heterozygous mutants (Mef2c cHetVgat-cre). We then subjected these mutants and littermate controls to a battery of tests measuring MCHS-relevant phenotypes, including spatial working memory, anxiety-like behavior, social preference, sensory sensitivity, and Pavlovian learning and memory. RESULTS/ANTICIPATED RESULTS: Mef2c cHetVgat-cre mice showed significant deficits in spatial working memory, social preference, and contextual fear memory, all of which are prefrontal cortex (PFC)-dependent behaviors. Interestingly, we noted that conditional Mef2c knockout mice (Mef2c cKOVgat-cre) showed embryonic and early postnatal lethality, probable seizures, and severe motor coordination problems, highlighting the importance of MEF2C function in GABAergic populations. DISCUSSION/SIGNIFICANCE: We hypothesize that MEF2C plays a cell-autonomous role in GABAergic cells to control the balance of excitatory and inhibitory synaptic transmission in the developing and mature brain, which in the Mef2c cHet mice might be critical for PFC-dependent learning and memory and sociability.

OBJECTIVES/GOALS: Heart failure and depression are important public health problems. Depression has been identified as an independent risk factor for increased cardiovascular morbidities. It is estimated that 1 out of every 5 patients living with heart failure suffer from depression. (Kop, W. J.) Studies have found that Hispanic patients have a higher rate of heart failure than non-Hispanic whites. Current guidelines recommend that proper screening tools must be used to identify and manage major depression disorder in HF patients, however many of these patients go unrecognized in the medical setting. The prevalence, management, and outcomes of depression among PuertoRican Hispanics living with heart failure is unknown. Objective: The purpose of this study is to evaluate the relationship between heart failure and depression in Hispanics with heart failure METHODS/STUDY POPULATION: To this end, we will perform a secondary analysis of data from the PR CardiovascularSurveillance Study (PRCSS). We will extract personal data from 4,461 medical records of patients admitted with heart failure (ICD-9 Codes 428) at 21 hospitals in Puerto Rico, during the years 2007, 2009 and 2011. For statistical methods, we will implement chi-square and t-tests at a significance level of 0.05 RESULTS/ANTICIPATED RESULTS: We expect to see older aged women with higher NYHA and pro-BNP levels to be associatedwith diagnosis of major depression disorder and worse in-hospital outcomes DISCUSSION/SIGNIFICANCE OF IMPACT: With this study, we would like to raise awareness about depression in patients with heart failure, and its role in improving patient outcomes. Moreover, we would like to determine if there are gender-specific health disparities among Puerto Rican Hispanics with heart failure

Successful completion of industry-sponsored clinical trials requires effective collaboration between sponsors and clinical research sites recruiting patients. As pharmaceutical companies specialize in more therapy areas, complexity and volume of clinical trials increases, with study sites facing growing operational and logistical challenges. These may be administrative, financial, technological, or workforce-related and can prevent sites from meeting trial obligations, inhibiting long-term site sustainability. Here we outline a suggested framework (with metrics) designed to address three key pillars: site infrastructure, workforce, and the establishment of a ‘trial funnel’ to maintain sufficient trial volume. We review key site-level challenges and barriers to success in clinical trial conduct and argue that issues could be mitigated by sponsors investing programmatically in their site partnerships, including investing in research-naïve sites. Long-term programmatic planning and investment has the potential to deliver greater efficiency and sustainability in trial delivery; site investment upfront would increase working capital for the site, maximizing commitment and security on both sides. This, however, requires safeguarding through the implementation of targets and metrics of success. Many of the challenges faced in modern clinical research can be mitigated by new and longer-term thinking, concerning the working relationship and methods adopted between sponsors and research sites.

This article presents a landscape assessment of the findings from the 2021 Clinical and Translational Science Award (CTSA) Evaluators Survey. This survey was the most recent iteration of a well established, national, peer-led systematic snapshot of the CTSA evaluators, their skillsets, listed evaluation resources, preferred methods, and identified best practices. Three questions guided our study: who are the CTSA evaluators, what competencies do they share and how is their work used within hubs. We describe our survey process (logistics of development, deployment, and differences in historical context with prior instruments); and present its main findings. We provide specific recommendations for evaluation practice in two main categories (National vs Group-level) including, among others, the need for a national, strategic plan for evaluation as well as enhanced mentoring and training of the next generation of evaluators. Although based on the challenges and opportunities currently within the CTSA Consortium, takeaways from this study constitute important lessons with potential for application in other large evaluation consortia. To our knowledge, this is the first time 2021 survey findings are disseminated widely, to increase transparency of the CTSA evaluators' work and to motivate conversations within hub and beyond, as to how best to leverage existent evaluative capacity.

The success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the “translational valleys of death” requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Translational Sciences Institute developed a program targeted at increasing that success rate through comprehensive training, education, and resourcing. The Medical Technology Advance Program (MTAP) provides technical, educational, and consultative assistance to investigators that leverages partnerships with experts in the health products industry to speed progress toward clinical implementation. The training, resourcing, and guidance are integrated through the entire journey of medical technology translation. Investigators are supported through a set of courses that cover bioethics, ethical engineering, preclinical and clinical study design, regulatory submissions, entrepreneurship, and commercialization. In addition to the integrated technical and educational resources, program experts provide direct consultation for planning each phase along the life cycle of translation. Since 2008, nearly 200 investigators have gained assistance from MTAP resulting in over 100 publications and patents. This support via medicine–engineering–industry partnership provides a unique and novel opportunity to expedite new medical technologies into clinical and product implementation.

Community engagement is important for reaching populations at risk for health inequities in the coronavirus disease 2019 (COVID-19) pandemic. A community-engaged risk communication intervention implemented by a community-engaged research partnership in Southeast Minnesota to address COVID-19 prevention, testing, and socioeconomic impacts has demonstrated high acceptability, feasibility, perceived efficacy, and sustainability. In this study, we describe the adaptation of the intervention by a community-academic partnership with rural African American populations in three Mississippi counties with high COVID-19 disparities. Intervention reach was assessed by the number of messages delivered by Communication Leaders to members of their social networks. Perceived scalability of the intervention was assessed by the Intervention Scalability Assessment Tool. Bidirectional communication between Communication Leaders and community members within their social networks was used by the partnership to refine messages, meet resource needs, and advise statewide decision-makers. In the first 3 months, more than 8482 individuals were reached in the three counties. The intervention was deemed to be highly scalable by partnership members. Adaptation of a community-engaged pandemic CERC intervention is feasible and scalable, and it has the potential to reduce COVID-19 inequities across heterogeneous populations. This approach may be incorporated into current and future pandemic preparedness policies for community engagement.

ABSTRACT IMPACT: Congregations’ support for social, emotional, mental and spiritual wellness is foundational to human health and their community knowledge and presence can improve resilience and health in socially vulnerable neighborhoods. OBJECTIVES/GOALS: The Indiana CTSI Monon Collaborative is listening and understanding the most pressing health issues in the community and are working together to design and deliver community health solutions. We worked with our community ambassador to launch a health and wellness learning community for ten congregations seeking to build a health-connector network. METHODS/STUDY POPULATION: Study team used qualitative (interviews, focus groups, listening sessions, learning management system, participatory-design research) and quantitative (surveys) data collection methods in the development and ongoing implementation of the learning community. Study Population: Based on initial assessment of health and social vulnerability data within the Marion County neighborhoods in Indianapolis, community ambassador engaged congregations in more vulnerable neighborhoods to seek participation in learning community. Ten congregations signed a covenant of participation; learning community includes 10 clergy and 8 health advocates. RESULTS/ANTICIPATED RESULTS: Since the inception of the Learning Community in May 2020, we have developed a better understanding of the assets and barriers of LC participants around health and well-being. Through ongoing virtual gatherings (facilitated by community ambassador Good to the Soul), sharing of resources through our online modules on Canvas (LMS), and synthesis of data captured throughout our time together, LC participants have developed SMART goals which will inform priority setting for congregations to assist them in identifying the resources and connections necessary to drive forward solutions together as they seek out funding opportunities to support health improvement. DISCUSSION/SIGNIFICANCE OF FINDINGS: The learning community has provided a space and structure for congregations to align around a shared goal focused on health and wellness. Through regular gatherings we were able to connect people, organizations, and systems who were all eager to learn and work across boundaries leading to greater resilience in vulnerable communities.