OBJECTIVES/GOALS: To evaluate the association of maternal delivery history with a brachial plexus birth injury (BPBI) risk in subsequent deliveries, and to estimate the effect of subsequent delivery method on BPBI risk. METHODS/STUDY POPULATION: We conducted a retrospective cohort study of all livebirth deliveries occurring in California-licensed hospitals from 1996-2012. The primary outcome was recurrent BPBI in a subsequent pregnancy. The exposure was prior delivery history (parity, shoulder dystocia in a previous delivery, or previously delivering an infant with BPBI). Multiple logistic regression was used to model adjusted associations of prior delivery history with BPBI in a subsequent pregnancy. The adjusted risk (AR) and adjusted risk difference (ARD) for BPBI between vaginal and cesarean delivery in subsequent pregnancies were determined, stratified by prior delivery history, and the number of cesarean deliveries needed to prevent one BPBI was determined. RESULTS/ANTICIPATED RESULTS: Of 6,286,324 infants delivered by 4,104,825 individuals, 7,762 (0.12%) were diagnosed with a BPBI. Higher parity was associated with a 5.7% decrease in BPBI risk with each subsequent delivery (aOR 0.94, 95%CI 0.92, 0.97). Previous shoulder dystocia or BPBI were associated with 5-fold (aOR=5.39, 95%CI 4.10, 7.08) and 17-fold increases (aOR=17.22, 95%CI 13.31, 22.27) in BPBI risk, respectively. Among individuals with a history of delivering an infant with a BPBI , cesarean delivery was associated with a 73.0% decrease in BPBI risk (aOR=0.27, 95%CI 0.13, 0.55), compared with an 87.9% decrease in BPBI risk (aOR=0.12, 95%CI 0.10, 0.15) in individuals without this history. Among individuals with a previous history of BPBI, 48.1 cesarean deliveries are needed to prevent one BPBI. DISCUSSION/SIGNIFICANCE: Parity, previous shoulder dystocia, and previously delivering a BPBI infant are associated with future BPBI risk. These factors are identifiable prenatally and can inform discussions with pregnant individuals regarding BPBI risk and planned mode of delivery.

ABSTRACT IMPACT: Evaluate the impact that the Kidney Allocation System has had on racial and ethnic disparities in pediatric deceased donor kidney transplant recipients. OBJECTIVES/GOALS: Racial and ethnic minority pediatric transplant candidates have known disparities in access to kidney transplantation. The Kidney Allocation System (KAS), implemented in 2014, was designed in part to alleviate some of these disparities thereby making transplant more equitable. We investigated the effect of KAS on reported disparities. METHODS/STUDY POPULATION: We utilized Scientific Registry of Transplant Recipients (SRTR) data to determine differences in new waitlist registrants, deceased donor (DDKT) and living donor kidney transplants (LDKT), HLA mismatch, and allograft survival among pediatric patients of different racial and ethnic backgrounds. RESULTS/ANTICIPATED RESULTS: Black pediatric patients represented 21.3% of new waitlist registrants pre-KAS and 18.9% post-KAS. Waitlist time increased for pediatric patients of all races post-KAS with the highest increase (131 days) in Asian patients (p < 0.01). The racial distribution of DDKT pre- and post-KAS was unchanged (White 38.4% vs 38.3%, Black 24.5% vs 22.5%, Hispanic 30.6% vs 31.1%, Asian 3.7% vs 4.4%, p = 0.12). The 3-yr graft failure rate is disproportionately worse in Black children compared to other races pre- and post-KAS (White 6.8% vs 5.3%, Black 14% vs 8.7%, Hispanic 8% vs 4.5%, Asian 6.6% vs 6.7%, Other 6.5% vs 2.9%) although there is a trend towards better graft survival in the post-KAS era. Graft survival worsened in Asian children in the post-KAS era (HR 2.34,95% CI 1.05 - 5.25, p=0.038). DISCUSSION/SIGNIFICANCE OF FINDINGS: Racial and ethnic disparities in pediatric ESRD patients have not been ameliorated by KAS. Children of color have longer waitlist time and are more likely to have graft failure. Alarmingly, allograft failure rate increased in Asian patients post-KAS, which merits further evaluation.

ABSTRACT IMPACT: Advanced spatial analysis techniques are used to target a community education intervention for Immigrant and African American women to increase breast cancer screening. OBJECTIVES/GOALS: We are addressing breast cancer screening disparities through the development of the COmmuNity kNowlEdge to aCtion Toolkit (CONNECT). CONNECT implements a mixed-methods approach using GIScience, community education, and social media to mitigate the impact of breast cancer screening disparities for Immigrant African and African American women. METHODS/STUDY POPULATION: We used advanced spatial analysis techniques, Spatially Adaptive Filters (SAF) to reveal mammography screening rates below the state level. SAF create screening maps of This new information allows lay health educators to identify and engage their communities in the Breast Cancer Champions program. We transformed and curated existing cancer educational material into culturally relevant educational training for lay health educators. Lay health educators participate in educational trainings and receive stipends for conducting formal and informal breast cancer education and screening events. RESULTS/ANTICIPATED RESULTS: We have identified four principles for designing culturally relevant education materials.

1. 1. Visual representation of the community in materials

2. 2. Positive Framing

3. 3. Statistics and graphs should be minimal

4. 4. Appropriate reading level and minimizing jargon

Due to COVID-19, our breast cancer champions are engaging with their community in socially responsible ways (i.e., engaging through social media, developing and placing community education flyers, community radio spots). Our social media campaign, which began in October has already attracted over 1000 followers. DISCUSSION/SIGNIFICANCE OF FINDINGS: Despite the disruption of COVID-19, our project continues reduce breast cancer screening disparities. We have developed and created culturally appropriate materials and are currently training Champions. By incorporating an online presence into our community outreach, we are increasing the ways we connect with our community.

OBJECTIVES/SPECIFIC AIMS: Focus groups are being conducted to describe and identify barriers and/or facilitators to Hispanic males’ health literacy, culture, and language related to cervical cancer prevention practices METHODS/STUDY POPULATION: A purposive convenience sample was recruited to participate in focus group sessions with English or Spanish speaking Hispanic males 21 years of age and older. Groups were segmented by age (21–29, 30–39, 40–49, and 50–65), and language (English or Spanish). Focus group discussions (n=8) were led by a bilingual/bicultural female researcher using a discussion guide that followed Zarcadoolas et al. (2005) health literacy model 6 as related to their partners’ cervical cancer screening and prevention practices. All sessions were audio-recorded and transcribed verbatim. Participants completed standardized questioners regarding demographic data and their health literacy. Qualitative content analysis was used for analyzing focus group interviews. RESULTS/ANTICIPATED RESULTS: Preliminary qualitative analysis shows the struggle Hispanic males’ face accepting cervical cancer screening for their female partners. One participant reported that it was “a clash of cultures.” A “clash of cultures” was described as a constant struggle and acceptance between science, personal knowledge, and Hispanic cultural taboos. DISCUSSION/SIGNIFICANCE OF IMPACT: Hispanic male’s health literacy, communication, language preferences, and cervical cancer risks, will further enhance the knowledge needed to design intervention measures for cancer prevention among Hispanics. Understanding the factors that contribute to the unequal burden of cervical cancer incidence and mortality among Hispanic women in South Texas is critical to prevent cervical cancer among this population.

OBJECTIVES/GOALS: This study aims to assess the outcomes of a new virtual multidisciplinary immune-related toxicity (IR-tox) team implemented at Johns Hopkins Hospital. In particular, to understand if the IR-tox team’s input reduced the number of inpatient hospitalizations for irAEs for referred patients. METHODS/STUDY POPULATION: Since August 2017, nearly 250 patient referrals to the IR-tox team have been created and stored in an electronic database. Through retrospective chart review, hospitalization and irAE management data will be collected for these patients to assess whether rates for suspected irAEs have decreased. These rates will be compared against historical controls. We will assess the features of hospitalized patients, their immunotherapy regimens, and management to identify high-risk groups who may require early intervention. Additionally, we aim to understand what patient features are associated with IR-Tox team referral and subsequent hospitalization. RESULTS/ANTICIPATED RESULTS: The IR-tox team provided a new multidisciplinary channel to help physicians diagnose and manage complex irAEs. The goal of the team was the reduce the number of irAE-related hospitalizations as, historically, 85% of high-grade irAEs have required hospitalization. A clinically meaningful reduction is defined as lowering the hospitalization rate to 75%. Planned analyses includes calculating the hospitalization rate, using descriptive statistics to summarize patient features, multivariate analyses to understand features associated with both IR-Tox team referral and hospitalization, and computing the relative risk reduction to assess the efficacy of subspecialist referral implementation. DISCUSSION/SIGNIFICANCE OF IMPACT: IrAEs are challenging to diagnose and treat. They contribute to a notable proportion of hospitalizations in those treated with immunotherapy. With expanding use of immunotherapy, widespread implementations of IR-Tox teams may help reduce hospitalizations and costs associated with care for irAEs.

OBJECTIVES/GOALS: The objectives of this presentation are to discuss 1) the implementation of Consent to Contact at an Academic Medical Center; 2) the access to lists of potential participants by study teams; and 3) the challenges and adjustments made to the initial conceptualized process. METHODS/STUDY POPULATION: Participant recruitment is critical to the success of all research studies. It is particularly challenging when investigators do not have a patient population from which to recruit. Thus, the University of Miami launched the CTC initiative in 2016 to facilitate study recruitment. Study investigators can request access to a registry of participants who agreed to be contacted and meet the initial study eligibility criteria. A multidisciplinary Operational Committee provides oversight and regulates access to the CTC registry. RESULTS/ANTICIPATED RESULTS: The registry has over 110K patients who have agreed to be contacted for eligible research studies. The demographic distribution of the patients in the registry mirrors the diversity of the UHealth population. As of January 2018, when the registry became available to the research community, 25 study teams from different departments, including the All of Us Research Program, have requested potential participant lists. The process of requesting access to patient lists is adapted to studies’ needs, with particular reference to sensitive populations, such as HIV/AIDS, substance abuse, etc. Results on utilization and satisfaction of the CTC initiative are being collected and will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: The CTC initiative allows UHealth patients to opt-in to the registry for research studies. The Operational Committee continues to monitor the successful consent of patients to participate in individual research studies and improving the request process.

Objectives/Goals: Dissemination and implementation scientists often conflate or confuse pragmatic trials and effectiveness-implementation trial designs. This study evaluates the barriers and facilitators affecting these scientists’ collaborative work to design, plan for, and conduct these different kinds of trials. Methods/Study Population: This is a sequential mixed-methods study. For the quantitative evaluation secondary data collection and surveys of roughly 200 investigators constituting an Implementation Science Network were carried out to identify research needs and impacts associated with the Translational Science Benefits Model. Surveys were prepopulated with respondents’ grant awards and prompts to define the study designs being used. Interviews of respondents are being conducted to identify barriers and challenges they faced in conducting different implementation trials and to develop case studies of their resultant research agendas. A peer-reviewed interview protocol designed for Clinical and Translational Research Institutes to conduct case studies of translational research is being used for this qualitative evaluation. Results/Anticipated Results: The 182 ISN members submitted 1590 research proposals since 2020, 52% of which were funded. ISN members responding to surveys (N = 30) self-identified many of these studies as being Hybrid 3 (29%), Hybrid 1 (17%), or Pragmatic trials (7%), although the largest proportion included studies classified “other” (33%), and some could not be classified (12%). Surveys of ISN members also indicated that many want to conduct pragmatic trials (36%) or hybrid trials (8%) but need more opportunities to collaborate (19%). Twelve (40%) ISN members agreed to be interviewed and another 11 (37%) indicated that they would do so in fall 2024 if available. Initial findings suggest that regular interactions with colleagues helped investigators new to the field understand how varied study designs could advance their implementation science. Discussion/Significance of Impact: These findings will show how U-M implementation scientists collaborate to conduct implementation trials. If the kinds of barriers faced by investigators differs by trial type, research supports and initiatives can be tailored to better support all implementation scientists in the CTSA Consortium.

OBJECTIVES/GOALS: Childhood survivors of ALL are at considerable risk for late effects which are exacerbated by excess weight. The proposed study involves the adaption and evaluation of the first empirically supported intervention for childhood survivors of ALL that is consistent with all national recommendations for the treatment of childhood obesity. METHODS/STUDY POPULATION: The proposed intervention will be adapted from family-based behavioral weight loss treatment (FBT) a multicomponent intervention which targets diet, activity, behavioral skills, parenting, and social facilitation among children and their parents. The Framework for Reporting Adaptations and Modifications-Enhanced structure (FRAME), a dissemination and implementation framework, will guide the adaptation, allowing for the incorporation of feedback previously gathered from key stakeholders. A single-arm, non-randomized trial of the adapted intervention will then be conducted to evaluate its acceptability, feasibility, and preliminary indications of efficacy including measures of relative weight change and associated health-related behaviors among 40 childhood ALL survivors and their families. RESULTS/ANTICIPATED RESULTS: Self-reported feedback from families at the end of treatment (EoT) is anticipated to demonstrate that this intervention will be regarded as both acceptable and feasible. Other measures of feasibility will include attendance and retention rates, which are expected to reflect to those of previous FBT trials (92% and 85%, respectively). Preliminary indications of the efficacy of the adapted intervention will be investigated through the comparison of a series of measurements taken at both baseline and EoT. Changes in relative weight will be assessed and are expected to meet a previously established range of clinically meaningful reduction in child percent overweight of 9 units or more. Improvements in dietary intake, physical activity, and health related quality of life are also anticipated. DISCUSSION/SIGNIFICANCE: Knowledge gained from the implementation of the first evidence-based intervention adapted for childhood survivors of ALL will be critical to the justification of a larger-scale, randomized controlled trial and holds promise to effectively modify the risk for chronic disease among a vulnerable population.

OBJECTIVES/GOALS: African-Americans are at increased risk for nutrition disparities; home cooking is a strategy to optimize dietary quality. to develop a cooking intervention, a mixed-methods community-based participatory, acceptability study was conducted to understand cooking behaviors, options for intervention content, and implementation factors. METHODS/STUDY POPULATION: Self-identified African-American adults were recruited from a larger community-based study within Washington, D.C. Five moderated virtual focus groups with four participants in each group were conducted in March and April of 2021. A semi-structured moderator’s guide focused on cooking, meal habits, food choices, and the proposed cooking intervention was utilized. Qualitative data collected were verbatim transcriptions and notes from research team members. Thematic analysis was conducted using an iterative process among research team members. Participant validation interviews were conducted following the research team analysis. Electronic self-administered surveys were used to measure demographic, food environment, cooking behavior, health behavior, and psychosocial variables. RESULTS/ANTICIPATED RESULTS: Study participants (n=20 females, mean age 60.1 years) lived in low-food resource neighborhoods but reported high food security (n=14). Barriers to the intervention included traveling distances to other neighborhoods for produce, poor quality of vegetables and fruit within neighborhood stores, lack of trustworthiness from neighborhood store experiences, perception of decreased cooking skills, and competing priorities related to time and weekday schedules. Motivators included health promotion for self, family, community, and enjoyment from cooking. Virtual or in-person sessions were suggested. Intervention options included costs of recipe ingredients, using recipes with ingredient flexibility, nutrition information, and provisioning of or compensation for ingredients used in virtual classes. DISCUSSION/SIGNIFICANCE: Use of virtual focus groups for a participant-based design of a cooking intervention among African American adults living in low-food access neighborhoods provided acceptability results that were food and home environments contextual and provided barriers and motivators to participation and implementation of behavior from the intervention.

OBJECTIVES/GOALS: The present work aims to use baseline data to identify demographic, clinical, and psychosocial factors associated with patients who receive analgesic benefit from temporary neurostimulation. METHODS/STUDY POPULATION: This study presents baseline data from our descriptive, prospective, longitudinal study. Consecutive patients who present to the University of Arkansas for Medical Sciences Interventional Pain Management Clinic for implantation of a neurostimulation device, have met clinical criteria for implantation of a neuromodulation device, and are able to speak and understand English are invited to participate. Prior to the placement of the temporary stimulator, each patient completes demographic and symptom-related questionnaires. Clinical characteristics are obtained through medical record review. RESULTS/ANTICIPATED RESULTS: We anticipate enrolling 50 participants in order to have 30 patients that report analgesic benefit from temporary neurostimulation. Variability in demographics, clinical characteristics, and psychosocial factors will be reported between patients who receive and those who do not receive analgesia following temporary neurostimulation. Gender differences will also be reported. DISCUSSION/SIGNIFICANCE: Despite the use of varying outcome measures, studies to date have not incorporated validated patient reported outcomes or controlled for key demographic and clinical characteristics. Our analysis evaluates clinical and psychosocial variables associated with successful temporary neurostimulation.

OBJECTIVES/SPECIFIC AIMS: To explore associations among bio-psychosocial factors predictive of overall physical and mental health status as assessed using the SF-12 Health Survey. METHODS/STUDY POPULATION: Community-dwelling, male and female elders with peripheral arterial disease (PAD) were administered an assessment battery to identify factors associated with self-assessed physical and mental health status using the SF-12 Health Survey. The battery included an assessment of pain, depressive symptoms, perceived social support, perceived psychological stress, physical function, as well as selected demographic variables. RESULTS/ANTICIPATED RESULTS: Preliminary linear regression analyses have identified several factors predictive of physical and mental health status including depressive symptoms, pain, perceived stress, and physical function. A more in-depth examination using path analysis is anticipated to reveal important mediational associations, wherein physical function is a strong mediator between bio-psychosocial factors and overall physical and mental health status. DISCUSSION/SIGNIFICANCE OF IMPACT: Aging is often associated with a reduction in physical and mental well-being, frequently exacerbated by the development and progression of chronic disease. PAD is a common chronic condition that places significant burden on the older patient and their family. Identifying and developing a more in-depth understanding of the factors that impact health status in PAD is an important and timely objective. We anticipate that our findings will inform development of more targeted and effective intervention strategies we can employ to improve the quality of life among elders struggling to manage PAD.

OBJECTIVES/SPECIFIC AIMS: INTRODUCTION: Many of the innovative therapies used in regenerative medicine, such as additive manufacturing and stem cell engineering, rely on novel technologies and techniques for which standards for safety, efficacy, and quality have not been fully explored and established. As these therapies and technologies develop at a rapid pace, there is a need for the development of scientifically-based metrics to assess whether new treatments are effective and safe for clinical translation. Research and development of such standards is known as “regulatory science,” and is needed by the United States Food and Drug Administration (FDA) to support the creation of the evidence-based guidances and regulations that are used in review of product submissions. As outlined by the FDA’s description of their Centers for Excellence in Regulatory Science and Innovation (CERSIs) and the Association for Clinical and Translational Science’s (ACTS) Regulatory Science Working Group, here is a need to train investigators and clinicians to conduct regulatory science research to support successful clinical translation of regenerative treatments. OBJECTIVE: To develop a course to expose scholars to regulatory science concepts, to empower them to apply these concepts to their personal areas of research, and to challenge them to engage in the dialogue surrounding regulatory science on a national level. METHODS/STUDY POPULATION: METHODS: The “Introduction to Regulatory Science” course was developed jointly by the Yale-Mayo CERSI and the Mayo Clinic Center for Clinical and Translational Science (CCaTS) in 2017 as a didactic in-person survey course. The course objectives included exposing scholars to the ideas of regulatory science and affairs; reviewing the FDA’s Priority Areas for Advancing Regulatory Science; and determining what safety, quality, and efficacy concerns may need to be addressed when using new technologies, such as those used in regenerative medicine research. To meet these intended learning objectives, the course addressed one FDA Priority area each week, with a team of experts providing one-hour of lecture and discussion each class session. Regenerative medicine-related topics included a bioethics of stem cell therapy development, evaluation of additive manufacturing as an emerging technology, and the application of cGMPs to the manufacture of new therapies. Assignments and assessments included a quiz each week, which served as a knowledge check of that week’s lecture content, and a final paper analyzing regulatory concerns associated with a technology or product of the scholar’s choosing. RESULTS/ANTICIPATED RESULTS: RESULTS: The course was first delivered as an elective in 2017, with an enrollment of 8 scholars and 3 auditors. Scholars enrolled included 7 trainees and established investigators from Mayo Clinic Rochester and one from Arizona. Of the 8 scholars enrolled, 7 completed the post-course survey. Scholars strongly agreed that the “course objectives were met” (7/7) and that the “course was well worth the effort I put into it” (7/7). Five scholars stated that they learned “a lot” during the course; two said they learned “an incredible amount.” Scholars unanimously gave the course a grade of “A.” Qualitative feedback was positive, indicating that the team-taught and in-person course design choices were highlights for trainees. The course is currently in its second delivery (2018), with an enrollment of 16 scholars across Mayo Clinic Rochester, Arizona, and Florida. DISCUSSION/SIGNIFICANCE OF IMPACT: CONCLUSIONS: The developed course was successfully piloted and well-received. Scholars reported that they agreed that the course aims were achieved, and indicated that they would like to see additional coursework to continue to learn how to engage in regulatory science. Next steps include utilizing course feedback to iterate on the current course, expanding course delivery to include scholars at the Yale site of the Yale-Mayo CERSI, and the creation of a second course.

OBJECTIVES/GOALS: Patients on chronic opioids face gaps in transitions of care in the time following surgery, increasing the risk for adverse events, specifically high-risk opioid prescribing. The objective of this study is to determine how rates of high-risk prescribing differ between patients with public and private insurance. METHODS/STUDY POPULATION: A retrospective cohort study of 1,435 adult patients with preoperative chronic opioid use on Medicaid or commercial insurance who underwent surgery between November 2017 and February 2021. Patients were identified using the Michigan Surgical Quality Collaborative (MSQC) database, a collection of perioperative data from 70 hospitals across the state of Michigan. Data from the MSQC were merged with Michigan’s prescription drug monitoring program to provide additional information on pre- and postoperative opioid prescribing. Multivariable logistic regression was used to assess high-risk prescribing by the presence of a preoperative usual prescriber and insurance type. RESULTS/ANTICIPATED RESULTS: Overall, 22.7% of patients on private insurance and 23.6% of patients on Medicaid fulfilled criteria for new, postoperative high-risk prescribing. Among criteria for high-risk prescribing, multiple prescribers was the most significant contributor (private insurance: 17.4%, Medicaid: 18.9%). Patients on Medicaid insurance did not have increased odds of new postoperative high-risk prescribing (OR = 1.067, 95% CI: 0.813-1.402). While fewer patients on Medicaid had a preoperative usual prescriber (86.9% and 90.9% respectively, p = 0.015), there was no significant difference between the two insurance types in baseline rates of high-risk prescribing prior to surgery (private insurance: 43.4%, Medicaid: 46.0%, p = 0.352). DISCUSSION/SIGNIFICANCE: While we do not observe disparities in high-risk prescribing between insurance types, rates of high-risk prescribing postoperatively are high across payer types. Further studies to determine the factors driving rates of high-risk opioid prescribing among patients with chronic opioid use are needed to identify areas for future intervention.

ABSTRACT IMPACT: Interventions designed to improve access to healthy food are needed as a mechanism to improve diet quality and ultimately prevent diet-related chronic diseases. OBJECTIVES/GOALS: For people living in food deserts, access to grocery stores is an important consideration toward improving diet quality. The Grocery Access Program (GAP) provided discounted Lyft rides to grocery stores for residents in Baltimore, MD. This study will assess how the GAP impacted access to different food retail stores and healthy food purchases. METHODS/STUDY POPULATION: A mixed methods sequential explanatory design will be used. We collected survey data at baseline and mid-pilot on primary grocery shopping store, frequency of purchasing fruits and vegetables, and frequency of using the discounted Lyft rides for 90 program enrollees. The Healthy Food Availability Index (HFAI), a validated, observation-based instrument, will be used to measure healthy food availability at participants’ primary grocery shopping stores; HFAI scores range from 0-27. We will also compare frequency of self-reported fruit and vegetable purchases before and after GAP participation. Quantitative data analysis using paired sample t-tests and chi square tests will be followed by in-depth interviews with GAP participants; thematic analysis will be used to analyze qualitative data. RESULTS/ANTICIPATED RESULTS: This research is in progress; survey data collection is complete and store-level HFAI data collection will begin soon. We hypothesize that GAP participants will have shopped at stores with higher HFAI scores than non-participants, and that participants will have purchased healthy foods more frequently than they did prior to GAP participation. If these hypotheses are not supported, our qualitative findings will elucidate potential reasons and mechanisms for improving the program. If our hypotheses are supported, it will provide evidence for the GAP as a convenient, low-cost intervention to improve healthy food access for people in low-income communities. DISCUSSION/SIGNIFICANCE OF FINDINGS: Access to healthy foods is an important social determinant of health, and innovative strategies that can facilitate better dietary habits are needed in the area of food access research. Findings from this study could be used to scale up efforts that will foster better food access, healthier diets, and ultimately better health outcomes.

Objectives/Goals: As translational science (TS) emerges as a field, there is a need for research organizations to understand how to develop capacity for and support the advancement of TS. To support such institutional and infrastructural change, this poster outlines a Translational Science Promotion and Research Capacity (T-SPARC) framework. Methods/Study Population: The T-SPARC framework was developed by members of the Duke University Clinical and Translational Science Institute (CTSI) primarily from CTSI Pilots, Team Science, Evaluation, and Administration, all of whom had identified the need for building institutional capacity for TS at our institution. The group reviewed literature on TS to ensure grounding in current knowledge, drafted an initial TS logic model, and then determined the value of developing a framework addressing building TS institutional capacity. The group then identified other frameworks/models related to behavioral, organizational, and system change; examined scholarship addressing the building of research capacity in colleges and universities; and iterated on a TS-focused framework in multiple working sessions. Results/Anticipated Results: The resultant T-SPARC framework provides a foundation to 1) inform the development of interventions and programs advancing TS and 2) evaluate their effectiveness. It outlines: organizational levels for TS capacity building (large-scale systems, research institutions, teams, and individuals); intervention activities (policies and processes, funding, collaboration and partnership, and training); proximal outcomes (knowledge/attitudes, behaviors, resources/infrastructure, and connections); next-stage outcomes (e.g., interdisciplinary team processes, and research infrastructure); and ultimate goals (fewer translational impediments, improved public health, and health equity). It ingrates TS principles as foundational to, and outcomes of, capacity-building efforts. Discussion/Significance of Impact: T-SPARC, as a framework for building capacity in TS, provides added foundation for advancing the conceptualization and practice of TS. Ultimately, T-SPARC seeks to advance broader goals of reducing longstanding challenges in the translational research process and improving health outcomes.

OBJECTIVES/SPECIFIC AIMS: (1) To assess the prevalence of mental health symptomatology (depressive symptoms, anxiety symptoms, PTSD symptoms, and problematic alcohol use) and psychosocial risk factors for mental health disorders (low social support, immigration stress, acculturation, and marital/partner discord), and their association with immigration status, health care access and contextual risk factors in Spanish-speaking parents of young children (ages 0–5) who attended a well-child visit. (2) To explore acceptability of screening for and discussing parental distress in the pediatric primary care setting, and parental acceptability of a group well-visit format to address both psychosocial risk factors and mental health symptoms in this population. METHODS/STUDY POPULATION: Latino immigrant parents (n=100) of children ages 0–5 attending well-child visits at Johns Hopkins Bayview Children’s Medical Practice were surveyed between October 2015 and February 2016. The verbally administered survey included the Woman Abuse Screening Tool (WAST), AUDIT-C, Primary Care Post-Traumatic Stress Disorder (PC-PTSD) Screener, California Health Interview Survey (CHIS), National Latino and Asian American Study (NLAAS), Appraisal Support Subscale from Interpersonal Support Evaluation List (ISEL), Personal Health Questionnaire Depression Scale (PHQ-8), and Generalized Anxiety Disorder Scale (GAD-2). These questionnaires have been used in large regional or national surveys and most have been validated with US Latino populations. Positive screens were defined as PHQ-8>5 (mild depression or greater), GAD-2>3, AUDIT-C>3 for women and >4 for men, and PC-PTSD>3. Descriptive information and comparisons were obtained by χ2 and Student t-test. Study protocol will allow review of childrens’ pediatric records (n=100). From this sample, parents were separately recruited to participate in in-depth interviews (n=11 of 20 planned have been completed) further exploring both sources of parental distress, acceptability of screening for parental mental health symptoms in the primary care pediatric setting, and acceptability of a potential group-based well-visit model in the pediatric setting. RESULTS/ANTICIPATED RESULTS: Survey participants were 93.0% women, and predominantly<35 years of age. The vast majority (94.0%) were undocumented, recently arrived (<15 years ago) and reported poor or very poor English proficiency (75.0%). Most (84.7%) reported living with a partner or spouse (84.7%), and 58% reported partner relationship strain. In all, 71% reported poor social support. The prevalence of “screen positive” mental health symptoms was highest for depression (55%) and PTSD (35%), followed by anxiety (29%) and alcohol risk use (25%). Having depression was significantly higher (68.4%) (p<0.02) in participants with less education (<6 grade). Partner relationship strain was associated with a higher prevalence of depressive symptoms (59.3%) (p<0.03). Immigration stress (feeling guilty for leaving family and friends) was also significantly associated with depressive symptoms (58.1%) and PTSD (43.5%) (p<0.03). More than half of the participants (60.0%) with depression were not covered by any health insurance and 56.3% of those with depression reported not having been seen by a health care provider in the past 12 months. A high prevalence of symptoms was found in those with poor appraised social support: alcohol risk use (76.0%), depression (69.1%), anxiety (69.0%), and PTSD (68.6%). Among participants, those aged<30 years old and those with more children reported poorer appraised social support. Data from child medical records (including BMI, presence of feeding problems, referrals for social work, or mental health services) has been extracted but not yet linked to parent survey or interview results. Preliminary review of In Depth Interviews suggests that the most common reported source of stress among participants was related to finances, followed by documentation/legal status difficulties, access to childcare, and limited English proficiency. Some mothers also mentioned interpersonal violence and lack of access to healthcare as stressors. All mothers expressed an interest in a pediatric primary care based parent focused the majority of which indicated that a group based intervention would be acceptable, some mothers indicated they preferred a one-to-one intervention if mental health were to be discussed. Mothers seem preferential to social worker-led interventions compared with pediatrician-led, but most mothers were indifferent. Finally, mothers expressed low support from the Latino community in Baltimore. DISCUSSION/SIGNIFICANCE OF IMPACT: Results from this study suggest that this population of parents is experiencing a relatively high rate of mental health symptoms, low perceived social support, and limited access to their own source of care. This suggests that an intervention delivered within a primary care pediatric setting would have the potential to reach parents who might not otherwise interact with their own providers, and that there are an array of problems that could be targeted. Intervening with parents of young children has the potential to affect multiple child outcomes. A group intervention may target poor social support, though this format is not universally preferred. Next steps for this project include assessing the acceptability of and preference for various content components (ie, depression, parenting stress, legal issues) and linking parent data with child data (including developmental screening results, weight, feeding problems, and behavior problems).

OBJECTIVES/GOALS: Innovations with positive health impact are a high priority for NCATS and CTSAs. Program design that uses the Causal Pathway approach incorporates performance indicators that assess impact. We applied Causal Pathway thinking to an ongoing national program to enhance the evaluation of program impact. We report Lessons Learned. METHODS/STUDY POPULATION: We conducted a day-long onsite workshop to introduce the model to the project team, build capacity, and map the existing program elements to Logic Models representing program Specific Aims. A local Causal Pathway (CP) champion was identified. Alignment of the Logic Models with the CP approach (input→activities→ outputs→effects/impact) developed iteratively through biweekly, then monthly conferral among stakeholders. Key tasks included distinguishing among activities, outputs, and effects (impacts), and identification of performance indicators for each stage of the Causal Pathway. Visualization tools and an additional late stage half-day workshop were used to foster consensus. Implementation of the CP model tested the feasibility of collecting specific indicators and prompted model revisions. RESULTS/ANTICIPATED RESULTS: Program leadership and team members (n = 30) participated in the kick-off workshop. Four Specific Aims were mapped to Logic Models. Multiple Causal Pathway (CP) diagrams, one for each project in the program, were developed and mapped to Aims. Alignment of CP threads to Aims and identification of performance indicators required iteration. CP threads converged onto common final Impacts, sometimes crossing to another Aim. Performance indicators for operations were readily accessible to team members, and less so for impacts. Assumptions about program effects were subjected to specific indicators. Over time, Leadership noticed more expression of CP thinking in daily activities. New projects developed during this period incorporated the CP approach. Teams were able to streamline and simplify Logic/CP models. DISCUSSION/SIGNIFICANCE OF IMPACT: Through capacity-building and mentored exercises, an innovation team was able to infuse CP thinking into the evaluation of their ongoing program. The CP approach to design and evaluation maps progress and indicators across the life of a program from initial activities to its ultimate impact.

OBJECTIVES/GOALS: With the knowledge that population health will not improve without including community voices in research, analysis of the UCI Institute for Clinical and Translational Science (ICTS) Community-Campus Research Incubator (CCRI) grants awarded since 2010 provides the foundation for understanding research partnerships impact on community health. METHODS/STUDY POPULATION: Over the past 13 years, the UCI ICTS CCRI program has funded 63 partnered research pilot or capacity-building projects, providing up to $30K annually to academic-community partnerships. Each year since 2010, between 3 and 7 projects were funded up to $5,000 annually for capacity-building activities and up to $10,000 annually for pilot research activities. Additionally, during the COVID-19 pandemic, a collaboration between the UCI ICTS and the local Healthcare Agency provided up to $20,000 to research partnership teams to study impact and interventions related to the pandemic, where 10 CCRI awards were given out. Evaluations of these research teams was completed at the end of the project, and at years 2 and 3 after the project ended. Analysis of the projects and partnerships aim to reveal the impact of these projects. RESULTS/ANTICIPATED RESULTS: In 2023, we compiled all evaluation data collected from 2010 – 2023 from the CCRI partnership grants, including traditional metrics of publications, subsequent grant applications submitted & awarded, presentations given, and return on investment for ICTS granted funds. Less traditional metrics include number of students trained, new tools or databases created, knowledge disseminated, and advances in clinical care. Since 2020, Translational Science Benefit Model metrics have been collected on community, policy, economic, and clinical domains. Since 2015, data on each CCRI partnership has been collected at the start and end of each project, with questions about attributes of each partner, trust, community engagement principles, and anticipated/actual impact of each project. DISCUSSION/SIGNIFICANCE: Organizing outcomes from the data collected will provide deep understanding of important components, functioning, and types and reach of partnered health research. This understanding will inform future action of the CCRI program in terms of what can be accomplished with a given amount of funding, and the constitution of successful partnerships.

OBJECTIVES/SPECIFIC AIMS: New Beginnings is a 12-week community-based behavioral intervention for improving health, strength, and wellness through a holistic approach to coaching that supports lifestyle change. The program serves predominantly low-income, minority women. Given the substantial focus on exercise, including resistance training, we aimed to test whether pain at baseline is associated with program completion in a prospective cohort. METHODS/STUDY POPULATION: At the entry of the New Beginnings program, women completed a survey that included a body map of sites at which they experienced pain for most days in the prior week. Using logistic regression, we independently tested the association between presence of pain, the total number of pain sites, and grouped location of pain with program completion, assessing the following a priori candidate confounders: age, race/ethnicity, body mass index, and income. We also tested for interaction of pain and age in influencing completion. RESULTS/ANTICIPATED RESULTS: Seventy-five percent of participants, 185 of 247, completed the program. They had an average age of 44.2±11.7 years, weight of 244.5±115.4 pounds, and BMI of 41.3±18.2. Fifty-seven percent were African American and 3% were Hispanic. The majority reported preexisting pain (83%), with an average of 3.4±2.7 pain sites. Completers and non-completers did not differ by the total number of pain sites (p=0.2). Having preexisting pain compared to no pain [odds ratio (OR)=1.3; 95% confidence interval (CI): 0.5–3.4] and to the number of pain sites (OR=1.0; 95% CI: 0.9–1.1) did not influence program completion after adjusting for the sole confounder, which was age. Likewise, we observed no association between limb/joint pain (OR=1.1; 95% CI: 0.6–2.1) or back pain (OR=0.9; 95% CI: 0.5–1.6) with program completion. The association of pain with completion was not modified by age. DISCUSSION/SIGNIFICANCE OF IMPACT: While pain is believed to be a barrier to improving fitness, preexisting pain may not be a strong predictor of completing a holistic lifestyle intervention with a substantial exercise component. Rather, women’s commitment to making a healthy lifestyle change may result in program completion irrespective of preexisting pain. Addressing and accommodating pain-related modifications to exercise interventions promise to be more effective than excluding those with pain from participation.