OBJECTIVES/GOALS: (1) Assess challenges with our current continuous improvement processes via stakeholders. (2) Implement a revised continuous improvement process. (3) Evaluate the revised processes to assess implementation and use for strategic improvement. (4) Implement analysis mechanisms for new process to assess trends across the CTSI. METHODS/STUDY POPULATION: We used a mixed-methods, multi-phased, stakeholder-engaged approach with different processes per objective. Obj. 1: We implemented focus groups, surveys, and listening sessions incorporating two populations: both teams required to participate in reporting process, and CTSI leadership. Obj. 2: We utilized data from Obj. 1 processes to develop a revised continuous improvement process. Obj. 3: We integrated qualitative feedback processes onto the structure of continuous improvement processes, and we implemented a survey to assess use and value for the new process. Obj. 4: We developed a qualitative coding schema to assess key trends across teams and over time. RESULTS/ANTICIPATED RESULTS: Obj. 1: Numerous challenges in metrics format and process, including significant limitations in data use to inform decision-making and appropriately assess impact. Obj. 2: Resultant changes to continuous improvement processes, including a restructured reporting format and use-oriented approach that enhanced organizational integration; changes included added focus on facilitators of success, challenge, and key opportunities to better inform decision-making. Obj. 3: The majority of teams experienced the new quarterly process as a better tool for program monitoring and communicating program needs to leadership, but that fuller integration into vertical communication is needed. Obj. 4: Implementation of new analysis process enabling examination of trends and themes across diverse teams within the CTSI. DISCUSSION/SIGNIFICANCE: This work has particular relevance within ACTS given our focus on a clinical and translational research enterprise, the complexity in evaluating the diverse work of translation research entities, and limitations in a commonly-used metrics-monitoring approach. Our focus on improving translational processes advances translational science.

OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a Rockefeller-led 6-CTSA consortium that aims to collect research participant feedback through new Research Participant Perception Survey (RPPS)/REDCap infrastructure and data aggregation to a national database. Here we describe diverse Use Cases and launch dissemination to other hubs. METHODS/STUDY POPULATION: The EPV team refined the RPPS-S and developed fielding and data standards, a multi-lingual RPPS/REDCap project XML, At-a-Glance Dashboard, EPV Consortium Database, and Use Cases to align with local initiatives and stakeholder input. Sites ran full thread tests of the infrastructure before launch. To demonstrate RPPS/REDCap, 5 sites implemented Use Cases, surveyed diverse populations via email, patient portal or SMS, and analyzed results using the At-a-Glance Dashboard External module (which provides visual analytics and enables filtering by participant/study characteristics). Sites continue to collect, synthesize and respond to actionable data. To disseminate infrastructure, we will invite early adopters to implement the RPPS/REDCap infrastructure locally, joining the EPV learning collective. RESULTS/ANTICIPATED RESULTS: To date, 5 sites surveyed 10,199 research participants, at post-consent or end of study. 2833 (26%) research participants responded, from diverse demographic groups. More than 90% gave the Top Box score response regarding courtesy, respect for cultural background, privacy, and lack of pressure to join a study. Disparities were apparent in the informed consent experience, with a Top Box score range of 38-78% in different demographics. Dissatisfaction with out-of-pocket research costs was a recurring theme. Top Box scores varied for feeling like a valued partner in research (69-93%), would recommend research participation to friends or family (56%-81%), and Overall Experience (64%-90%) questions. Sites identified actionable findings in areas of consent, communication, partnership, and study conduct. DISCUSSION/SIGNIFICANCE: The EPV RPPS/REDCap infrastructure enabled sites to broadly collect participant feedback, identify actionable findings and make inter-institutional comparisons. Collaborators are designing local initiatives to increase response rate and diversity, address disparities in research participation experiences, and discover better practices.

Interim analyses in clinical trials can take on a multitude of forms. They are often used to guide Data and Safety Monitoring Board (DSMB) recommendations to study teams regarding recruitment targets for large, later-phase clinical trials. As collaborative biostatisticians working and teaching in multiple fields of research and across a broad array of trial phases, we note the large heterogeneity and confusion surrounding interim analyses in clinical trials. Thus, in this paper, we aim to provide a general overview and guidance on interim analyses for a nonstatistical audience. We explain each of the following types of interim analyses: efficacy, futility, safety, and sample size re-estimation, and we provide the reader with reasoning, examples, and implications for each. We emphasize that while the types of interim analyses employed may differ depending on the nature of the study, we would always recommend prespecification of the interim analytic plan to the extent possible with risk mitigation and trial integrity remaining a priority. Finally, we posit that interim analyses should be used as tools to help the DSMB make informed decisions in the context of the overarching study. They should generally not be deemed binding, and they should not be reviewed in isolation.

OBJECTIVES/GOALS: The goals of this study are to 1) adapt a mindfulness-based intervention that supports the development of trust-promoting behaviors of OBGYN providers with patients who identify as Black women based on the input of providers and patients, and 2) assess the feasibility of implementation for OBGYN healthcare providers. METHODS/STUDY POPULATION: Goal 1: Focus groups will be conducted with members of the populations of providers and Black women patients in Alachua County, Florida to identify essential intervention content to complement the central component of mindfulness and spiritually based practices. This complementary content will serve to address the institutional and cultural context of the intervention setting. Goal 2: Providers will be recruited to participate in interviews about their perceptions of intervention feasibility. These aspects include recruitment potential, acceptability of the intervention content and delivery, implementation practicality, identification of appropriate outcomes, and identifying strategies to recruit Black women patients to participate in program evaluation. RESULTS/ANTICIPATED RESULTS: Goal 1: We will elicit the perspectives of providers and Black women patients regarding the respective roles and relationship of mindfulness and spirituality to increase trust-promoting behaviors with patients who are Black women. We also anticipate identifying additional content to complement the core intervention components that participants perceive as necessary to develop the knowledge, skills, and behaviors which convey the trustworthiness of providers to patients. Goal 2: We expect to gain key insights into intervention design, implementation, and evaluation feasibility from the perspective of providers. Interview data will be aggregated and qualitatively analyzed for themes pertaining to feasibility. DISCUSSION/SIGNIFICANCE: An intervention that builds on mindfulness and spiritual practice is an innovative approach to improving interpersonal outcomes in provider-patient relationships. By investigating the feasibility of such an intervention, we will gain insight into how to design and deliver a program to increase the trust-promoting behaviors of OBGYN providers.

Clinical trials are constantly evolving in the context of increasingly complex research questions and potentially limited resources. In this review article, we discuss the emergence of “adaptive” clinical trials that allow for the preplanned modification of an ongoing clinical trial based on the accumulating evidence with application across translational research. These modifications may include terminating a trial before completion due to futility or efficacy, re-estimating the needed sample size to ensure adequate power, enriching the target population enrolled in the study, selecting across multiple treatment arms, revising allocation ratios used for randomization, or selecting the most appropriate endpoint. Emerging topics related to borrowing information from historic or supplemental data sources, sequential multiple assignment randomized trials (SMART), master protocol and seamless designs, and phase I dose-finding studies are also presented. Each design element includes a brief overview with an accompanying case study to illustrate the design method in practice. We close with brief discussions relating to the statistical considerations for these contemporary designs.

OBJECTIVES/GOALS: CTSIs around the country rely on Community Engagement Advisory Boards (CEABs) to bridge research and communities. The history of this 22-year-old board offers insight on 1) how it was created and has been sustained over time 2) its evolution, and 3) members’views of their contributions to translational research at UIC. METHODS/STUDY POPULATION: As founding members began to step down from this long-standing board, we started to document its history and members’ narratives and perspectives of the work conducted at UIC since its inception. Using an Oral History methodology, we conducted three virtual focus groups with 13 short and long-term members (n=6, n=4, n=3) to learn about changes within CEAB and in members’ roles, and individual semi-structured interviews with three long-standing members to expand on the origin and evolution of CEAB. Focus group data was coded and analyzed. We also extracted data on key events from archived files including grant proposals and CEAB meeting notes. A steering committee of three CEAB members helped guide this process. RESULTS/ANTICIPATED RESULTS: The CEAB was founded at the UIC College of Nursing in 2001 under the Center for Research on Cardiovascular Respiratory Health, with a grant from the National Institutes of Nursing Research (NINR). It was established as college-wide advisory board of community experts to help engage underserved communities and to contribute to research beyond recruitment and retention. In 2009, upon receipt of a Clinical Translational Science award that established the Center for Clinical Translational Science (CCTS), the CEAB became a campus-wide board. Over 30 community organizations and many non-affiliated community members have contributed to translational research at UIC throughout the board’s history. DISCUSSION/SIGNIFICANCE: Over twenty years later, the CEAB continues to help bridge researchers and communities, and to raise awareness about community needs, the importance of cultural relevance, and the inclusion of underserved communities in research. Long-term members have played a key role in providing continuity over the years.

OBJECTIVES/GOALS: The goal of this study is to explore the effectiveness of a digital health education curriculum aimed at increasing syphilis beliefs and screening behavior among young African American females residing in Jefferson County, AL. METHODS/STUDY POPULATION: Study Population: African American, cis-gender women, aged 18-29, who reside in Jefferson County, AL Sample Size: N = 50 Measurements: 1) Champion Health Belief Model scale adapted for measuring syphilis perceptions and syphilis screening behavior Analysis Plan: IBM SPSS Statistics 29 will be used to analyze intervention data. Pre-and post-intervention data will be analyzed to calculate a screening request rate for each period. We will use Cohen’s D effect sizes to measure screening requests rate differences post intervention completion. The small sample size and exploratory nature of this project make the descriptive statistics valuable. RESULTS/ANTICIPATED RESULTS: We anticipate that the digital syphilis prevention intervention will positively influence participants’ beliefs regarding syphilis and their syphilis screening behaviors. DISCUSSION/SIGNIFICANCE: Innovative preventive approaches to reducing syphilis disease spread is a national priority as rates have risen annually throughout the last decade. African American women experience the greatest disease burdens associated with syphilis. This study leverages tailored strategies to effectively address this ailment in the target population.

Quality clinical research is essential for health care progress and is the mission of academic health centers. Yet ensuring quality depends on an institution’s ability to measure, control, and respond to metrics of trial performance. Uninformed clinical research provides little benefit to health care, drains institutional resources, and may waste participants' time and commitment. Opportunities for ensuring high-quality research are multifactorial, including training, evaluation, and retention of research workforces; operational efficiencies; and standardizing policies and procedures. Duke University School of Medicine has committed to improving the quality and informativeness of our clinical research enterprise through investments in infrastructure with significant focus on optimizing research management system integration as a foundational element for quality management. To address prior technology limitations, Duke has optimized Advarra’s OnCore for this purpose by seamlessly integrating with the IRB system, electronic health record, and general ledger. Our goal was to create a standardized clinical research experience to manage research from inception to closeout. Key drivers of implementation include transparency of research process data and generating metrics aligned with institutional goals. Since implementation, Duke has leveraged OnCore data to measure, track, and report metrics resulting in improvements in clinical research conduct and quality.

OBJECTIVES/GOALS: As hospitals across the nation respond to the need to address community violence, there is a dearth of Hospital-based Violence Intervention Programs (HVIPs) in the South despite having disproportionate rates. This research aims to identify key factors and strategies for implementation of an HVIP among rural patient populations in a southern state. METHODS/STUDY POPULATION: Semi-structured interviews will be conducted with medical providers, social service organizations, and patients transferred from four high-risk rural areas in Arkansas. Data will be analyzed using Framework Analysis, a rapid analysis approach involving framework development, code application, impactful statement identification, and content analysis. Evidence- Based Quality Improvement (EBQI), a group consensus making process, will be conducted to identify key implementation strategies and factors to adapt based interview findings. Priority areas for adaptation will be identified via systematic rating. The EBQI team, including researchers and key rural stakeholders will engage in a series of discussion, vote on final strategies, and develop a guide for future HVIP implementation and pilot testing. RESULTS/ANTICIPATED RESULTS: Findings from this study will result in a prioritized list of barriers and facilitators across sample groups. Factors will be rated by level of importance. Cluster maps will display the relationships among factors. Go and no-go zones will be identified based on importance and feasibility. Implementation strategies will be mapped to barriers and facilitators. DISCUSSION/SIGNIFICANCE: The findings will result in a culturally and geographically relevant HVIP model and package of implementation strategies to test in future hybrid trials (feasibility pilot & multi-site RCT); and shape the future of violence prevention efforts in healthcare settings across the rural South.

OBJECTIVES/GOALS: Febrile infants are a model population for exploring communication, implicit bias, and health disparities in the pediatric emergency department. Using mixed methods, we performed an in-depth analysis of disparities and physician-parent communication, a potentially modifiable driver of inequities. METHODS/STUDY POPULATION: We performed a multicenter cross-sectional study of febrile infants with low-risk for invasive bacterial infection evaluated between 2018-19 across 32 institutions. We performed logistic regression to assess the association between 1) race and ethnicity (Non-Hispanic White [NHW], Non-Hispanic Black [NHB], Hispanic [H], Other Race and/or Ethnicity [O]) and 2) limited English proficiency (LEP) with the standard of care, discharge without lumbar puncture and without antibiotics. We concurrently performed in-depth semi-structured interviews with physicians to explore physician–parent communication and implicit bias in the management decisions for febrile infants. RESULTS/ANTICIPATED RESULTS: Of 3629 low-risk febrile infants, 74.2% received standard of care. NHB, compared to NHW, infants were more likely to receive standard of care (aOR 1.3 [95% CI 1.0-1.7]; aOR H: 1.1 [95% CI 0.9-1.4]; aOR O: 1.0 [95%CI 0.8-1.4]). There was no association between LEP and standard of care (aOR 0.8 [0.61–1.1]). When accounting for documented use of professional interpretation, families with LEP without documented professional interpretation were less likely than families without LEP to receive standard of care (aOR 0.6 [95% CI 0.4–0.9]). Thematic analysis of 13 physician interviews is expected to elucidate aspects of the physician-parent interaction that influence management decisions. DISCUSSION/SIGNIFICANCE: Infant race, ethnicity, and use of professional interpretation, are associated with the management of low-risk febrile infants. Physician behaviors that are influenced by the physician-parent interaction may represent modifiable targets for future interventions to promote health equity.

Contactless photoplethysmography (cPPG) is a method of physiological monitoring. It differs from conventional monitoring methods (e.g., saturation probe) by ensuring no contact with the subject by use of a camera. The majority of research on cPPG is conducted in a laboratory setting or in healthy populations. This review aims to evaluate the current literature on monitoring using cPPG in adults within a clinical setting. Adhering to the Preferred Items for Systematic Reviews and Meta-analysis (PRISMA, 2020) guidelines, OVID, Webofscience, Cochrane library, and clinicaltrials.org were systematically searched by two researchers. Research articles using cPPG for monitoring purposes in adults within a clinical setting were selected. Twelve studies with a total of 654 individuals were included. Heart rate (HR) was the most investigated vital sign (n = 8) followed by respiratory rate ((n = 2), Sp02 (n = 2), and HR variability (n = 2). Four studies were included in a meta-analysis of HR compared to ECG data which demonstrated a mean bias of –0.13 (95% CI, –1.22–0.96). This study demonstrates cPPG can be a useful tool in the remote monitoring of patients and has demonstrated accuracy for HR. However, further research is needed into the clinical applications of this method.

OBJECTIVES/GOALS: Limited specialty care within safety net health systems reduces availability of follow-up appointments for chronic conditions. We evaluated patient acceptability of a 6 month series of telemedicine group medical visits for chronic migraine at a county hospital-based clinic as a potential method to improve access to specialty care in this setting. METHODS/STUDY POPULATION: We developed and implemented a pilot program of monthly physician-led telemedicine group visits to provide routine follow-up care for adults with chronic migraine. Visits were conducted through the neurology clinic at LAC+USC medical center, a safety net hospital in Los Angeles and included an educational component, peer support, and the opportunity to address individual needs or refill medications. We assessed headache severity (HIT-6) and mood (PHQ-9) through telephone surveys before and 6 months after patients’ first telemedicine group visit and compared timepoints using paired t-tests. Patient acceptability of the group visits was elicited through focus groups and key themes identified using grounded field theory. RESULTS/ANTICIPATED RESULTS: Baseline data was available for 18/20 pilot participants. Patients were predominantly female (89%) with mean age of 46 (SD 8.6). Mean HIT-6 was 65/78 reflecting a very severe impact on daily life, and mean PHQ-9 was 8.7 reflecting mild depressive symptoms. There was no statistically significant change in either HIT-6 (mean difference 2.36, p=0.34) or PHQ-9 (mean difference 2.09, p=0.12) after group participation. Key themes from the focus groups included lack of prior exposure to other people with similar headache burden and logistical barriers to care, such as difficulty contacting a provider or extended clinic wait times. Primary patient-reported benefits included more frequent access to a provider and peer support. DISCUSSION/SIGNIFICANCE: Telemedicine group visits for chronic migraine are feasible in a safety net context and were well-received by patients. However, this pilot study did not show a benefit of telemedicine group visits for headache control or mood symptoms.

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: Older adults are affected by insufficient access to digital technology including digital healthcare. The aim of this program is to improve digital literacy in elders who were not using digital devices due to age and socioeconomic inequities. We provided technology and education on topics relevant but not limited to navigating health care. METHODS/STUDY POPULATION: Through partnerships with a non-profit organization helping elders to age well and independently (cohort 1 ongoing n=9) and an urban place of worship (cohort 2 starting), we reached out to elders residing in urban Buffalo, NY’s poorest zip codes. Participants received free tablets and Wi-fi hotspots. Participants received weekly interactive sessions over 6 months at their apartments or a place they felt comfortable with. A curriculum was developed but the sessions were not limited to digital health care, rather were also tailored to other individual needs like shopping on line, communication with loved ones, etc. A baseline, mid and post survey were administered to assess needs before the program and measure the impact of the program. An effort was also deployed in identifying a source of connectivity post program. RESULTS/ANTICIPATED RESULTS: The participants were elders who did not have computer/digital knowledge and/or access to the digital world. Mid-intervention data show that 9/9 used the tablets, learned basic skills and felt more comfortable/confident using a digital device. 5/9 participants used their hotspots and the remaining learned to use Wi-Fi provided by the facility they live in. While at baseline only 1/9 participants had attempted to use patient portals, mid-intervention data showed that 8/9 accessed portals. Importantly, the participants are also using other digital functions essential to their well-being including streaming, shopping, bill paying, and communicating with loved ones. Preliminary post-surveys suggest that all participants now rate their internet literacy and web searching skills at an acceptable/good level. DISCUSSION/SIGNIFICANCE: Tailored support and access to technology led to uptake of digital technology among elders, enabling them to access health-related resources and other web activities which improved their quality of life and led to digital equity. This project can be leveraged to obtain funding to train trusted members of the community as digital literacy ambassadors.

One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.