Objectives/Goals: Lack of comparative data limits research operations quality improvement (QI). The Northwest Participant and Clinical Interactions (NW PCI) Network, a group of 17 unaffiliated university and health system-based research centers, built an operations dashboard to track efficiency and enable multisite QI projects. Methods/Study Population: A Data Governance Working Group was assembled to establish shared data governance, draft nondisclosure (NDA), and data transfer and use agreements (DTUA) suitable across organizations and standardize research operations metric definitions. Sites in the NW PCI Network were recruited to participate in a pilot program to assess data sharing and governance infrastructure, data collection, upload procedures, and data visualization tools. The NW PCI Coordinating Center developed an analytical data dashboard of research operations metrics and conducted semi-structured interviews with participating sites to understand barriers and facilitators of program success. Results/Anticipated Results: Four sites (2 health systems, 2 universities) were recruited for the pilot and reviewed and executed NDAs and DTUAs. Three of the sites have submitted data for a total of 1,405 studies. Of the 24 requested data operations metrics (e.g., study startup, recruitment, implementation, and basic study information), 71% of the metrics were submitted by all three sites (n = 17), 25% were submitted by at least one site (n = 6), and 4% were not submitted by any site (n = 1). Interviews with sites after data submission found areas for improvements (clarification of data definitions, efficiency of data upload process) and positive effects for sites (e.g., process improved insight into own data operations). Discussion/Significance of Impact: Unaffiliated research centers created data governance procedures to enable sharing of operations data. Pilot sites successfully loaded most but not all operations data to the dashboard. Interviews identified process limitations and opportunities for improvement to inform expansion to all NW PCI sites.

OBJECTIVES/GOALS: An environmental scansoughtto understand research processes, areas for improvement, and opportunities for collaborative quality improvement (QI)across the Northwest Participant and Clinical Interactions Network (NW PCI). METHODS/STUDY POPULATION: NW PCI site champions were invited for semi-structured single and group Zoom-based interviews. Interviewers asked participants about local research processes, strengths and weaknesses, existing infrastructure to support QI, and interest in collaborative QI across the Network. Audio transcripts were coded using Dedoose and analyzed with deductive and inductive coding. RESULTS/ANTICIPATED RESULTS: Between February and April 2023, 10 interviews collected data from 7 research decision makers and 7 staff members across 7 sites. Most participants (n=13, 92%) agreed the diagram shown during the interview was representative of the local process. Organizations consistently identified strengths and weaknesses within the domains of study start-up, recruitment, budgets, and compliance. QI infrastructure was inconsistent (n=5, 36%) and all (n=14, 100%) saw potential for success in multisite QI initiatives to enhance efficiency. DISCUSSION/SIGNIFICANCE: NW PCI sites use similar processes, share common strengths and weaknesses, and universally reported interest in collaborating on QI. Study startup was reported as both a strength and weakness within the same organization, requiring unpacking of key elements before pursuing QI initiatives.

OBJECTIVES/GOALS: To test the effect of a trusted Community Health Worker (CHW) support model to increase accessibility, feasibility and completion of COVID-19 home-testing in Native American and Latino communities. METHODS/STUDY POPULATION: We conducted a multi-site pragmatic randomized controlled trial among adult Native Americans and Latinos from the Flathead reservation in Montana and Yakima Valley in Washington. Participants were block randomized by site location and age to either an active or passive study arm. Participants in the active arm received assistance with online COVID-19 test kit registration and virtual swabbing support from CHWs, while the passive study arm received the standard-of-care support from the COVID-19 home testing kit vendor. Simple and multivariate logistic regression modeled the association between home-testing distribution mechanism and test completion. Multivariate models included community and sex as covariates. Descriptive feedback was collected in a post-test survey. RESULTS/ANTICIPATED RESULTS: Overall, 63% of the 268 enrolled participants completed COVID-19 tests, and 50% completed tests yielding a valid result. Active arm participants had significantly higher odds of test completion (OR 1.66, 95% CI: [1.01, 2.75], p-value=0.04). Differences were most pronounced among adults ≥60 years, with 84% completing testing kits in the active arm, compared to 58% in the passive arm (p=0.07). Ease of use and not having to leave home were top positive aspects of the home-based test while transporting and mailing samples to lab and long/overwhelming instructions were cited as negative aspects. Most test completers (93%) were satisfied with their experience and 95% found CHW assistance useful. Sample expiration and insufficient identifiers were top causes of non-valid test results. DISCUSSION/SIGNIFICANCE: While test completion rates were low in both study arms, the CHW support led to a higher COVID-19 test completion rate, particularly among older adults. Still, CHW support alone does not fully eliminate testing barriers. Socio-economic differences must be accounted for in future product development for home-based testing to improve health equity.

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.

A collaborative research model was developed and tested to enable regional healthcare systems to join multisite clinical trials emanating from the Clinical and Translational Science Award (CTSA) Trial Innovation Network (TIN) by the Institute of Translational Health Sciences at the University of Washington and the Northwest Participant and Clinical Interactions (NW PCI) Network. The NW PCI is a collaborative group of regional research programs located at medical centers, healthcare systems, and universities across Washington, Wyoming, Alaska, Montana, and Idaho. This article describes the purpose, development, barriers, and initial experience with feasibility assessment for TIN-supported studies in the NW PCI. The tools and processes of the NW PCI Network were adapted to enable network sites to assess studies for clinical relevance and feasibility. Seven of seventeen TIN-supported studies were reviewed for consideration; three of which resulted in successful completion of study documentation for site selection by NW PCI sites. The NW PCI/TIN model can be adapted by other CTSAs to increase involvement of regional research programs in national multisite clinical research studies. Barriers to expanding TIN-supported trials to regional networks include short timelines for study document submissions, insufficient site reimbursement rates, and non-feasible study designs.