OBJECTIVES/GOALS: The objective of this project was to recruit racially and ethnically diverse participants with an accelerated timeline into a COVID-19 vaccine trial. METHODS/STUDY POPULATION: Recruitment of diverse populations was a priority. Culturally appropriate strategies were implemented to increase enrollment of African Americans and Hispanics from the DC Metropolitan area. These strategies included the use of the Community Advisory Board for consultation, faith-based community events, town halls, radio advertisements which targeted the African American community, and the NIAID COVID-19 registry. Meaningful patient engagement by the study recruiter/coordinator throughout the study was key to recruitment and retention of participants (i.e. listening attentively, sharing personal experiences with vaccination, providing participants with enough information to make an informed decision). Education on the importance of research and vaccines was a component throughout the process. RESULTS/ANTICIPATED RESULTS: The Howard University site screened 188 participants. Of those, 150 were recruited into the vaccine trial from diverse racial and ethnic backgrounds (30% AA, 21% Hispanic, 5% Asian, 1% mixed race), a total of 57% over seven weeks. Of the 150 participants 64% were male and 36% females. The study involved a 2:1 randomization with vaccine vs. placebo. All of the 150participants received the first and second COVID-19 vaccine/placebo doses administered 21 days apart. DISCUSSION/SIGNIFICANCE: Culturally-relevant recruitment strategies allowed for meaningful community and patient interactions and were important determinants for effectively recruiting a racially and ethnically diverse group of participants within a short amount of time. Strategies employed could be applied effectively in other trials.

OBJECTIVES/GOALS: Test the effects of a community health worker supported model to deliver home-based COVID-19 testing in the Yakima Valley (Washington) and Flathead Reservation (Montana) METHODS/STUDY POPULATION: A pragmatic, randomized controlled clinical trial evaluating the effects of a community health worker supported model to deliver home-based COVID-19 testing in the Yakima Valley (Washington) and Flathead Reservation (Montana) vs. a modified direct-to-consumer. 400 participants will be enrolled, 200 from each community. Outcomes include comparing the number of completed testing kits as well as the number of testing kits with successful (detected vs not-detected) results. RESULTS/ANTICIPATED RESULTS: The poster presents preliminary results from 191 participants, blinded to study assignment. To date, 53% of enrolled participants returned a sample for testing and 39% received a usable (detected or not-detected) result. Our populations experienced a high-rate (16%) of sample errors, required 28 replacement kits and had 20 participants randomized to the control arm receive the intervention to ensure participants received testing during the pandemic. DISCUSSION/SIGNIFICANCE: Home-based testing models are build for those who are proficient in verbal and written English, have high tech. literacy and continuous access to internet. For home-based testing to have similar success rates as white Americans, cultural and demographic differences and disparities will need to be accounted for in development and implementation.

OBJECTIVES/GOALS: Through the Community Mini-Grant program, the University of Kentucky Center for Clinical and Translational Science Community Engagement and Research Core (CERC) provides a unique funding mechanism designed to empower community response by supporting local solutions to complex health issues facing central Appalachian Kentucky communities. METHODS/STUDY POPULATION: Four $2500 grants are awarded annually to Appalachian organizations to implement evidence-based programs responsive to community-identified priority health needs. The CERC also supports program implementation and evaluation by facilitating collaborations between the organizations, community practitioners, and academic researchers. RESULTS/ANTICIPATED RESULTS: Since inception, grants have been awarded to 20 community organizations in 14 Appalachian counties. Health issues addressed have ranged from Alzheimers disease, cancer treatment and prevention, obesity, healthy lifestyle, and chronic disease management and prevention. Evidence-based programs have focused on improving health outcomes among older adults, caregivers, youth, children, women and infants, and families. Program outcomes have included immediate health benefits and long-term benefits resulting from community adoption of and ongoing financial support for programs. As example, results of an evidence-based educational program to improve diabetic foot assessment among clinicians in a large Appalachian healthcare network resulted in establishment of a traveling podiatrist program. DISCUSSION/SIGNIFICANCE: Community mini-grant recipients have successfully implemented projects that address the most significant health disparities in the region. Also of benefit are expanded partnerships that are foundational to the creation of new academic-community collaborations to address the challenging health issues of Appalachian populations in Kentucky.

OBJECTIVES/GOALS: To describe a study to develop, test, and collect implementation data on a youth-led hypertension (HTN) education digital intervention that acts as an electronic tool to guide youth through learning and then teaching adults on how to achieve better HTN control. Adults with uncontrolled HTN are recruited from a New Jersey emergency department (ED). METHODS/STUDY POPULATION: Adults with HTN and youth (15-18 years) participate in a remote user-centered design session focus group to provide input in the development of the youth-led HTN education digital intervention. 100 adult ED patients with uncontrolled HTN (blood pressure (BP) ≥130/80 mm Hg) who live with a youth (15-18 years) and the youth themselves are recruited for a randomized control trial (RCT). The adult-youth dyad is randomized to one of two arms, each a 6-week program with youth earning a digital badge: 1) intervention- youth-led HTN education with the adult, or 2) control- youth learn life skills (such as job readiness/resume building). Implementation metrics are collected through a post-intervention survey and qualitative interviews on the digital badge intervention including acceptability, feasibility, and fidelity. RESULTS/ANTICIPATED RESULTS: We completed two youth focus groups (total of 8 participants) and data collection is ongoing. Youth have shown great interest in the intervention prototype and thought their peers would find it acceptable. They suggested additions to nutrition education activities, such as adding a sodium tracker and examples of high sodium foods. For the RCT, the primary study outcome is adult BP change (from baseline to 1 week and 2-months post-intervention), with secondary outcomes of HTN knowledge and youth self-efficacy. We anticipate that intervention arm adults will have a more significant decrease in BP than control arm adults. We also expect that HTN knowledge and youth self-efficacy will be higher for the intervention arm. Implementation data collected will allow for improvements to future renditions of the intervention. DISCUSSION/SIGNIFICANCE: Bringing health education home while simultaneously empowering youth is an innovative technology-driven model for improving BP for patients with uncontrolled HTN who may lack access to care. Outcomes of this project will result in a scalable and easily adoptable model to reach an otherwise difficult to reach adult population.

OBJECTIVES/GOALS: Despite a disproportionate impact of COVID-19 on minority and under-resourced communities, nearly all COVID-19 resources have only been online in English. A statewide coalition of community and academic partners used community-engaged strategies to provide tailored outreach to diverse populations. METHODS/STUDY POPULATION: The STOP COVID-19 CA statewide team had a workgroup focused on communications. Members of this group represented different sectors, racial/ethnic groups, disciplines, and regions across the state. They had regular meetings to discuss and strategize how to overcome the impact of historic and structural racism on access to COVID-19 resources, including testing, vaccines, and protective equipment. The team also shared regular updates about changes in community concerns and needs as well as new, tailored resources. RESULTS/ANTICIPATED RESULTS: Together, the team has been able to reach diverse populations across the state, including providing information about COVID-19 in multiple languages and formats, from radio to virtual town halls to local health fairs. The multiple sites also increased access to vaccines and testing through trusted community leaders and locations, including church-based locations to bringing vaccines and testing directly to workplaces. These community pop-up vaccination sites have helped to vaccinate large numbers of diverse populations, some of whom were initially unsure about getting the vaccine, which has helped to reduce the gaps in community vaccination rates by race/ethnicity. DISCUSSION/SIGNIFICANCE: This network of community-engaged strategies utilized for rapid COVID-19 response could also be used to for responses to future public health emergencies, addressing chronic diseases (e.g., diabetes, hypertension), or even other complex issues that affect society and health (e.g., climate change).

OBJECTIVES/GOALS: Children with medical complexity (CMC) experience frequent transitions of care (e.g., hospital to home) and are at increased risk for medication-related harm. This study aimed to identify transition-related medication safety barriers experienced by family caregivers, as they shoulder most of the caregiving responsibility following discharge. METHODS/STUDY POPULATION: We conducted semi-structured qualitative research interviews of 6 family caregivers and 10 healthcare professionals with roles assisting families during hospital discharge. Interviews focused on identifying key stages of the hospital-to-home transition period as well as medication-related tasks, decisions, and contexts. Transcribed audio interviews and research meeting notes were content analyzed to develop journey maps visually depicting key phases of the families experiences managing medication at home and their decision points and unmet needs. RESULTS/ANTICIPATED RESULTS: Journey mapping identified key decision points, medication management needs, and way points navigated by family caregivers during the hospital-to-home transition. Findings were salient for each phase of the family journey: 1) initial admission/intra-unit transfer; 2) in-patient care; 3) peri-discharge planning; 4) discharge; 5) immediate post discharge period (we termed post-discharge configuration); and 6) period of ongoing tasks and needs. Illustrative examples will be presented and discussed. DISCUSSION/SIGNIFICANCE: Family caregivers of CMC have needs that evolve throughout the medication use journey, suggesting a need for interventions that account for the time variant nature of this work. Findings lay a foundation for the next step of our study which aims to develop a prototype medication safety intervention that will be evaluated with family caregivers.

OBJECTIVES/GOALS: The goal of this project is to understand vaccine hesitancy and barriers to COVID-19 vaccine uptake among underserved communities in South Florida, to promote vaccine awareness, and to tailor education and communication based on the findings, in partnership with local community-based organizations. METHODS/STUDY POPULATION: By partnering with local community organizations, leaders, faith groups, and other trusted sources, the FL-CEAL teams will conduct a nationally developed CEAL survey in minority communities in South Florida to understand vaccine hesitancy and barriers, conduct outreach activities such as webinars and virtual townhalls to address hesitancy and promote vaccine uptake, and develop and disseminate educational materials and social media communications based on findings. The communities in South Florida include the Latinx farm working community, Latinx sexual/gender minorities, and Haitian and Black populations in South Florida. RESULTS/ANTICIPATED RESULTS: Early findings have indicated that hesitancy drivers vary among specific communities, while lack of trust is an overall barrier. Over 100 outreach activities have been conducted, including events with subject matter experts and community partners addressing vaccines. A credit-earning Community Health Worker (CHW) curriculum on COVID vaccine hesitancy was created in partnership with the Miami CTSI and the Florida CHW Coalition and has been delivered to over 200 Florida CHWs. The training focuses on evidence-informed best practices for CHWs to increase vaccine acceptance. At least 350 surveys will be conducted to understand beliefs and concerns around COVID-19 vaccines, and tailor education materials and communication strategies. DISCUSSION/SIGNIFICANCE: The FL-CEAL Alliance has successfully leveraged their ongoing state-wide effort at addressing COVID-19 disparities to focus on COVID vaccine hesitancy in minority communities and leveraged data and findings to inform community-specific approaches in addressing some of those barriers.

Well-designed, accessible short-term research training programs are needed to recruit and retain underrepresented persons into clinical and translational research training programs and diversify the workforce. The Michigan Institute for Clinical and Health Research developed a summer research program, training over 270 students in 15 years. In response to the 2020 COVID-19 pandemic, we pivoted swiftly from an in-person format to a fully remote format. We describe this process, focusing on factors of diversity, equity, and inclusion including enabling student participation in remote research activities. We collected data about students’ learning experiences since the program’s inception; therefore, we could evaluate the impact of remote vs. in-person formats. We examined data from five cohorts: three in-person (2017–2019; n = 57) and two remote (2020–2021; n = 45). While there was some concern about the value of participating in a remote format, overall students in both formats viewed the program favorably, with students in the remote cohorts rating some aspects of the program significantly more favorably. In addition, more students who identified as Black or African American participated in the remote format than in the in-person format. We describe lessons learned from this unprecedented challenge and future program directions.

OBJECTIVES/GOALS: The Colorado Community Engagement Alliance Against COVID-19 Disparities (CO-CEAL) Team has worked with 5 racial/ethnic communities in Colorado to understand COVID-19 vaccine hesitancy and develop messages, materials and dissemination strategies to impact vaccine hesitancy. Relationships have been key facilitators of this work. METHODS/STUDY POPULATION: CO-CEAL was funded for one year as a part of the national CEAL Teams effort. CO-CEAL engaged urban Hispanic/LatinX, rural Hispanic/LatinX, urban African/American, rural African Immigrant and urban American Indian/Alaska Native communities through Community Connectors in each community. Our Community Connectors led recruitment of community members for our community survey data collection (goal of 200 surveys from each community) and participation in our 5 Community (Boot Camp) Translations. Where possible we worked with Community Connectors and leveraged community relationships with whom we had worked over multiple years and projects. In two communities we worked to quickly build and establish new relationships with Community Connectors and their communities. RESULTS/ANTICIPATED RESULTS: The rapid nature of the CO-CEAL project, its timeline and the unusual nature of the funding mechanism required adaptations to usual ways of working on both the academic and community side.In our CO-CEAL partner communities where there was a history of working together, concerns, possible barriers and other issues tended to be rapidly addressed. The prior existing, long-standing relationships fostered trust that enabled open airing of concerns and an ability to address issues as they arose. In CO-CEAL partner communities where new relationships were being forged, trust needed to be build from the ground up. This made adaptations more challenging and the ability to address concerns and issues as they arose more problematic. Although the work has moved forward in all communities, extra care has been required in some. DISCUSSION/SIGNIFICANCE: When crises necessitate rapid action in communities, the depth of prior investments in building and maintaining relationships makes a difference in how rapidly and successfully partners can work together to address a crisis like the COVID-19 pandemic. Funders and Academic researchers should invest broadly in communities to enable rapid responses.

For decades, the research community called for streamlined Institutional Review Board (IRB) review processes for multisite studies. Department of Health and Human Services and National Institutes of Health (NIH) recognized this need and implemented single IRB (sIRB) of record mandates. However, announcing mandates without sufficient operational guidance and tools is insufficient to foster the desired change. Nearly 4 years into implementation of the NIH’s sIRB mandate, operational challenges remain. Fortunately, NIH supports a web-based sIRB platform, the IRB Reliance Exchange (IREx), to facilitate sIRB communication and documentation. IREx has received continuous NIH funding supporting its evolution since 2011 and is now used by over 5,000 Human Research Protection Program and research personnel, 35 sIRBs, and 415 participating sites to operationalize sIRB review and approval on over 400 studies. IREx supports over 2300 reliance relationships with an average of 7 sites per study. The platform is continually used by sIRBs and relying sites, providing a valuable centralized portal for promoting a harmonized sIRB review process. IREx can promote transparency, standardize practice, minimize workflow variation, and mitigate the need for sIRBs to implement significant technical changes to their local electronic systems. IREx has proven to be nimble and adaptable with practice and policy changes over the past decade, as evidenced by continually increasing platform utilization.

OBJECTIVES/GOALS: At least 15 stroke thrombectomies per proceduralist per year are required for Thrombectomy-Capable and Comprehensive Stroke Centers. We sought to estimate the potential impact of these minimum volume thresholds on geographic access to stroke thrombectomy (ST). METHODS/STUDY POPULATION: Using the Florida State Inpatient Database, we will identify patients discharged with acute ischemic stroke from 2015-2019 and all non-federal facilities that performed ≥1 ST procedure per year. We will then calculate the proportion of stroke patients who live within 20, 65, 115, 165 and 200 miles (correlating with estimated ground transport times of 1, 2, 3, 4 and 5 hours, respectively) of centers that perform ST using ArcGIS software and evaluate the impact of varying the threshold ST volume required by each facility on this proportion. We will then perform multiple two proportion z-tests to compare proportions of patients within driving distance over time. RESULTS/ANTICIPATED RESULTS: We hypothesize that over time, and particularly after the pivotal trials of ST were published in 2015, that the number of facilities that perform ST have increased over time, which would increase the geographic access to ST. We also hypothesize that since the Joint Commission set the minimum procedural volume for proceduralists at Thrombectomy-Capable and Comprehensive Stroke Center to 15 per year, this would work to increase regionalization and could work to decrease geographic access to ST. However, we hope to elucidate the net impact of the interplay between these two opposing factors on regionalization of care over time which is currently unclear. DISCUSSION/SIGNIFICANCE: Current ST volume thresholds have focused on technical proficiency but may impact regionalization of care and geographic access to ST. Since access to ST is time-sensitive, a data-driven approach and better coordination on a regional level may be necessary to ensure timely access to ST.

OBJECTIVES/GOALS: Caregivers of patients with ventricular assist devices (VAD) are invaluable contributors to patient health, but they may experience psychological symptoms or worsening quality of life related to caregiving. We aimed to explore VAD caregiving burden and resilience comparing high and low burden patient-caregiver dyads. METHODS/STUDY POPULATION: Using a convergent mixed-methods design, we conducted semi-structured interviews and collected self-reported surveys from patient-caregiver dyads. Patients (n=10, mean age 55.8 years) were mostly white males implanted as destination therapy. Caregivers (n=10, mean age 52.6) were mostly white females. Most dyads were spousal (n=6). Caregiver burden was measured with the Zarit Burden Interview Scale, using the median score to categorize lower and higher burden dyads (median = 12, IQR = 8). Data were analyzed using deductive and inductive coding for thematic analysis. RESULTS/ANTICIPATED RESULTS: Lower and higher burden dyads described the shared burden experience of 1) hyper-vigilance and uncertainty immediately post-implant and 2) changing relationship roles. Lower burden dyads were more likely to able to take on responsibilities outside of caregiving. Contextual differences among higher burden dyads included higher financial strain, less social support, worse quality of life (both patients and caregivers) and worse heart failure severity compared to lower burden dyads. All dyads were resilient, using coping strategies like cognitive reframing, positivity, and adaptation to new roles. Higher burden dyads were more vulnerable to coping fatigue and were more likely to express that the VAD had irreversibly changed their life. DISCUSSION/SIGNIFICANCE: VAD caregiver-patient dyads differ in their levels of caregiver burden. Burden experiences and resilience mechanisms may inform future interventions to reduce caregiver burden in diverse VAD dyads. Knowledge of the caregiver experience and factors contributing to burden can inform the healthcare team in providing essential caregiver support.