OBJECTIVES/GOALS: The objective of this study is to assess the feasibility and preliminary impact of a physiotherapy protocol for developing an individualized home-based physical activity program to increase physical activity (PA) levels in sedentary older adults with Type II Diabetes Mellitus (T2DM) living in Puerto Rico (PR). METHODS/STUDY POPULATION: This will be a pilot study with two phases. In phase 1, we will design a novel patient-centered home-based PA program protocol for adults ≥65 years with T2DM based on the Information-Motivation-Behavioral Skills model. Its content validity will be assessed through focus groups with 10 experts and 10 older adults and analyzed using a directed content analysis. Phase 2 we will be program implementation using a one-group, repeated measures design with 12 adults ≥65 years with T2DM. PA levels will be assessed by recording active minutes with a Fitbit. Risk of falls, balance, strength, and physical function will be assessed through standardized tests validated for this population. Statistical analysis will include descriptive statistics, comparisons via chi-square/Fisher’s exact test, and non-parametric tests. RESULTS/ANTICIPATED RESULTS: We expect to recruit a minimum of 12 participants and to administer the program for 12 weeks at a frequency of two visits per week. We anticipate that implementing and supervising the home-based PA protocol will be feasible as determined by recruitment and retention rates, patients’ satisfaction, and compliance with the program. We also expect that this protocol will increase physical activity levels, improve general strength, balance, physical function, and reduce the risk of falls in sedentary older adults with T2DM. DISCUSSION/SIGNIFICANCE: As the third cause of death in PR, T2DM represents a public health challenge. An effective home-based PA program may decrease morbidity and mortality rates in older adults by increasing PA and functional health. This study will provide data for planning a randomized controlled trial to assess its effectiveness in the outcomes of interest.

OBJECTIVES/GOALS: Frontiers CTSI developed applications to ensure its science teams have technological tools to advance their community engagement and trial management. The Trial Finder app is a mobile application that allows users to navigate available trials. The Accrual app will help study teams monitor their recruitment performances in real time. METHODS/STUDY POPULATION: The Data Science team at the University of Kansas Medical Center (KUMC) had previously developed similar applications for The University of Kansas Cancer Center. Both retrieve information from KUMC’s clinical trial management system and ClinicalTrials.gov. This was replicated to include KUMC Pulmonary Critical Care (PCC) and KUMC Neuromuscular (NM) trials. Frontiers CTSI is working with both groups for piloting and feedback. Recruiting and marketing strategies for investigators to add their trials to both apps will be done through existing communication channels and be highlighted on Frontiers trial resource website. Recruiting and marketing strategies of the Frontiers Trial Finder app to the external community will have a focus on, but not limited to, paid social media advertising. RESULTS/ANTICIPATED RESULTS: The Trial Finder app can help providers search for trials their patient may be eligible for during clinic visits and to engage with the community by allowing anyone to download and browse on their Android/iOS device. Built in REDCap forms are used to capture contact information. The Accrual app is a web-based application that helps study teams monitor their recruitment performances in real time and provide an opportunity to adjust strategies. It uses an in-house algorithm to predict if trials will meet timeline goals. This data is conveniently laid out on a single web page so that science teams can overview all their trials’ recruitment performances simultaneously. The next phase of developing these applications is to market their use within Frontiers CTSI and its community catchment area. DISCUSSION/SIGNIFICANCE: Through collaboration, Frontiers CTSI is developing resources to support community engagement and trial management. New innovative applications like these ensure all the main stakeholders involved with clinical trial execution are always engaged and have access to iterative contemporary technologies that support their research.

OBJECTIVES/GOALS: Childhood Sjögren’s disease (cSD) is a rare autoimmune disease. Despite the profound impact on children and their families, pediatric-specific clinical trials to inform therapeutic strategies in cSD are lacking. In 2022 we participated in the Trial Innovation Network (TIN) Design Lab with the purpose of designing a series of N-of-1 trials for cSD. METHODS/STUDY POPULATION: New medications have the potential to be safe/effective treatments for cSD but must be evaluated in randomized trials. To overcome limitations of traditional parallel-group designs given the rarity of cSD, we developed an N-of-1 trial approach. Our proposal was selected by the Tufts TIN Design Lab. The Design Lab multi-stakeholder process involved parents of and patients with cSD, pediatric and adult rheumatologists, and experts in clinical trial design and outcomes. We engaged all stakeholders in protocol development to maximize the impact of the proposed approach on clinical care, ensure a successful recruitment plan, and inform the choice of endpoints as there are no widely accepted cSD outcome measures to determine treatment efficacy. RESULTS/ANTICIPATED RESULTS: Using the Design Lab methodology, we clarified the N-of-1 study goals and engaged in an iterative process to develop a “briefing book” that ensured a sound premise for our study. We reviewed and accumulated published literature to support our focus on mucosal/glandular manifestations, identified potential interventions to be used in the N-of-1 trials, and enumerated possible outcomes, including outcomes important to patient/parents. This work culminated in a full-day Design Lab event that included multiple stakeholders who provided expertise from different perspectives on the full drug development pathway. Study design feedback focused on three specific areas. 1) Inclusion and exclusion criteria; 2) Identification of outcome measures; 3) Treatment and washout periods. DISCUSSION/SIGNIFICANCE: To address the critical need and move treatment of cSD forward, we are designing a prototype N-of-1 trial in children with rheumatic disease. We will continue to engage stakeholders by using a series of Delphi surveys and an in-person meeting to create composite outcome measures to test cSD therapies in personalized trials.

OBJECTIVES/GOALS: This theory analysis aims to evaluate a middle-range framework, the HSDF1, in the context of sexual assault stigma incorporating the myriad levels within within culture and society through which stigma can occur and be reinforced. METHODS/STUDY POPULATION: Databases: PubMed, CINAHL, EMBASE, Google Scholar, Organization websites, Citation searchesn = 32Mark Risjord’s “Middle-Range Theories as Models: New Criterion for Analysis and Evaluation” (2019) RESULTS/ANTICIPATED RESULTS: The innovative approach of the HSDF guides understanding of sexual assault stigma in a holistic way, incorporating individual and institutional stratum of the phenomenon. Understanding through integration of this theoretical framework alongside current knowledge may more succinctly inform trauma-informed care for survivors, policy, and cultural awareness for nurses, healthcare providers, police, social workers, and myriad others with whom survivors interact. DISCUSSION/SIGNIFICANCE: Applying the HSDF framework to sexual assault stigma could help break down barriers and raise survivors out of stigmatization, affecting population health through reduced negative health sequelae experienced by survivors.

OBJECTIVES/GOALS: To describe an Honest Broker (HB) tool and workflow integrated with the Institutional Review Board (IRB) to automate requests, approvals and delivery of both de-identified and identified data extractions from a clinical research data warehouse (CRDW). METHODS/STUDY POPULATION: The HB tool has predefined domain tables and is closely integrated IRB for quick and easy review and approval. Investigators can access patient data using query tools, barcodes from biospecimens or build a query in TriNetX and provide the patient list as an input for the HB tool. For de-identified data extraction, the required data domain tables and date ranges can be selected and submitted in the HB tool. For identified data extractions, investigators with an approved IRB protocol can enter the protocol number and the approved date range in the HB tool. This request is automatically forwarded to the IRB for review. RESULTS/ANTICIPATED RESULTS: For de-identified data extraction, an email alert is automatically sent to the investigator once the data extract is completed. For identified data extraction, if IRB approves the request, an HB is immediately notified to release the data. Data release triggers two emails to the investigator: (1) a link to an encrypted zipped file with the requested data, and (2) a password to unlock the encrypted file. If the request is denied, the IRB sends an email to the investigator with the reason for denial and options for remediation. The entire HB workflow is accomplished in a secure environment with an audit trail from the initial data request to data download by the investigator. Since the launch of the HB tool, the time from data request to delivery is approximately an hour for deidentified data and 24 hrs for identified data. DISCUSSION/SIGNIFICANCE: The HB tool has increased successful data delivery in support of publications, grant submissions, and clinical trial recruitment. Optimization of data extraction from the CRDW through automation and integration with the IRB can minimize interaction with data analysts and IRB staff, thus accelerating the conduct of clinical research.

A decline in routine vaccinations, attributed to vaccine hesitancy, undermines preventative healthcare, impacting health and exacerbating vaccine disparities. University-public health partnerships can improve vaccination services. This study describes and evaluates a university-public health use case employing social determinants of health (SDoH)-based strategies to address vaccination disparities. Guided by the Translational Science Benefits Logic Model, the partnership offered no-cost preventative vaccines at community-based organization (CBO) sites, collected CBO clientele’s vaccination interest, hesitancy, and demographic data, and conducted descriptive analyses. One hundred seven vaccination events were held, administering 3,021 vaccines. This partnership enhanced health outcomes by addressing disparities through co-located vaccination and SDoH services.

OBJECTIVES/GOALS: The primarygoal is to understand the challenges and barriers associated with the procurement of innovative technologies.Specifically, our research will answer the following question: what are the minimal requirements for a startup’s solution to beprocuredby anOntariohealthcare institution? METHODS/STUDY POPULATION: Participants will include procurement professionals at startups, healthcare institutions, and procurement facilitating agencies. Semi-structured interviews will be conducted in order to understand different procurement pathways and the possible procurement related gaps or barriers that startups face. Through qualitative ethnographic methods, participant interviews will characterize existing relationships and examine the rationale behind startup procurement decision-making. Data collection will include recordings, verbatim transcripts, and researcher field notes. Through inductive qualitative analysis, the data will be examined to build an intervention to assist in startup procurement. RESULTS/ANTICIPATED RESULTS: Our investigation will yield insight into expectations between hospital procurement requirements and startup procurement. The qualitative analysis will identify targets for engagement, and appropriate actors that can bridge gaps. Our results will identify pathways for procurement and the minimal procurement requirements to aid startup procurement planning. Our research will support innovators by delivering an intervention that will enable easier implementation of market ready solutions in a Canadian context. In line with principles from the National Center for Advancing Translational Sciences, this research can be used towards enhancing efficiency, speed of translation, and innovation. DISCUSSION/SIGNIFICANCE: We will contextualize the needs of start-ups and empower them to understand their procurement ecosystem. Facilitating better navigation of the procurement space allows for innovators to present solutions that healthcare organizations can adopt, resulting in improved clinical and patient outcomes.

The prioritization of English language in clinical research is a barrier to translational science. We explored promising practices to advance the inclusion of people who speak languages other than English in research conducted within and supported by NIH Clinical Translational Science Award (CTSA) hubs. Key informant interviews were conducted with representatives (n = 24) from CTSA hubs (n = 17). Purposive sampling was used to identify CTSA hubs focused on language inclusion. Hubs electing to participate were interviewed via Zoom. Thematic analysis was performed to analyze interview transcripts. We report on strategies employed by hubs to advance linguistic inclusion and influence institutional change that were identified. Strategies ranged from translations, development of culturally relevant materials and consultations to policies and procedural changes and workforce initiatives. An existing framework was adapted to conceptualize hub strategies. Language justice is paramount to bringing more effective treatments to all people more quickly. Inclusion will require institutional transformation and CTSA hubs are well positioned to catalyze change.

OBJECTIVES/GOALS: Incorporating health equity, diversity, and inclusion (HEDI) development during community advisory board meetings is essential for ensuring that perspectives of all community members are considered, that health research is centered on the experiences of historically marginalized groups, and organizational strategies align with the community. METHODS/STUDY POPULATION: All IN for Health is a public engagement program that promotes health and research literacy, seeking to increase the public’s understanding of the role and value of research in improving health. It is guided by an active CAB providing advice on strategic directions, feedback to all efforts, contributing ideas, priorities, and most importantly, accountability. In 2023, ALL IN for Health started to incorporate HEDI professional development during staff team meetings and most recently, into our quarterly CAB meetings. Initially, the CAB was asked to provide feedback about talks and potential presentations related to health-research, sponsored, and shared by All IN for Health. During this exercise, board members were asked to provide HEDI topics of interest. Their responses informed a plan for team and board members. RESULTS/ANTICIPATED RESULTS: Some of the topics suggested by board members include: understanding health equity in relation to research studies and protocols, and topics specific to health research such as: health care access for rural areas and vulnerable populations, culture-based attitudes and beliefs and how they impact decisions related to health care, being aware of limitations certain communities have and what they may not have access to. The initiative was positively received and unanimously adopted. We hope to introduce the HEDI integration model for CABs at this conference. (Conceptual Model attached). DISCUSSION/SIGNIFICANCE: It is important to learn and grow alongside our community members. Such practice is bound to sustain partnerships that promote health equity, and exemplify meaningful community engagement, bidirectional learning, and a shared leadership model. By consistently incorporating and prioritizing HEDI, HAB can contribute to more equitable initiatives.

OBJECTIVES/GOALS: To evaluate the incidence of brachial plexus birth injury (BPBI) and its associations with maternal demographic factors. Additionally, we sought to determine whether longitudinal changes in BPBI incidence differed by maternal demographics. METHODS/STUDY POPULATION: We conducted a retrospective cohort study of over 8 million maternal-infant pairs using California’s Office of Statewide Health Planning and Development Linked Birth Files from 1991-2012. Descriptive statistics were used to determine BPBI incidence and the prevalence of maternal demographic factors (race, ethnicity, age). Multivariable logistic regression was used to determine associations of year, maternal race, ethnicity, and age with BPBI. Excess population level risk associated with these characteristics was determined by calculating population attributable fractions. RESULTS/ANTICIPATED RESULTS: The incidence of BPBI between 1991-2012 was 1.28 per 1000 live births, with peak incidence of 1.84 per 1000 in 1998 and low of 0.9 per 1000 in 2008. Incidence varied by demographic group, with infants of Black (1.78 per 1000) and Hispanic (1.34 per 1000) mothers having the highest incidences. Controlling for relevant covariates, infants of Black (AOR=1.88, 95% CI 1.70, 2.08), Hispanic (AOR=1.25, 95% CI 1.18, 1.32) and advanced-age mothers (AOR=1.16, 95% CI 1.09, 1.25) were at increased risk. Disparities in risk experienced by Black, Hispanic, and advanced-age mothers contributed to a 5%, 10%, and 2% excess risk at the population level, respectively. Longitudinal trends in incidence did not vary among demographic groups. Population-level changes in maternal demographics did not explain changes in incidence over time. DISCUSSION/SIGNIFICANCE: Although BPBI incidence has decreased in California, demographic disparities exist. Infants of Black, Hispanic, and advanced-age mothers are at increased BPBI risk compared to White, Non-Hispanic, and younger mothers.

OBJECTIVES/GOALS: This project focuses on investigating the potential of Simalikalactone D (SKD) as an anticancer agent, exploring the mechanisms underlying SKD’s induction of cell death, and assessing the impact of SKD on diverse breast cancer cell lines. Also, it Investigates the compound’s mechanisms of action beyond caspase 3-dependent pathways. METHODS/STUDY POPULATION: Three breast cancer cell lines were used: SKBR3, MDA-MB-231, and MDA-MB-468. Two triple-negative breast cancer cell lines are included to address cancer disparities across diverse ethnic backgrounds. Viability assays were conducted to determine half-maximal inhibitory concentrations (IC50). Caspase 3 activity assay was performed to evaluate apoptosis as a possible cell death pathway. Wound healing and colony formation assays are used to assess cell migration and clonogenic capacity. Proteomic analysis and phosphoarray analysis are planned for a deeper understanding of SKD’s anticancer properties, as well as testing for caspase 3 independent pathways. RESULTS/ANTICIPATED RESULTS: SKD demonstrated substantial cytotoxicity against all three breast cancer cell lines. IC50 values for SKBR3, MDA-MB-231, and MDA-MB-468 were 60.0 nM, 65.0 nM, and 116 nM, respectively. SKD induces cell death via caspase 3-independent pathways. Further experiments are needed to confirm and elucidate the molecular pathways being impacted. SKD inhibited cancer cell migration and clonogenic potential, suggesting it can reduce tumor growth and metastatic tendencies. DISCUSSION/SIGNIFICANCE: The study highlights SKD’s cytotoxicity across diverse breast cancer cell lines. It underscores the mechanism of action, a caspase 3 independent pathway. These findings hold promise for the development of innovative anticancer treatments and emphasize the importance of exploring varied cellular responses to mitigate global cancer disparities.

OBJECTIVES/GOALS: To truly improve health equity and accessibility, we must develop a diverse and inclusive workforce. The BUILD EXITO program developed as a collaboration between a network of undergraduate programs and a CTSA hub and now has become a sustainable resource that will outlive NIH funding. We will disseminate our successful model. METHODS/STUDY POPULATION: The BUILD EXITO program has completed 10 years of NIH funding, a partnership between OCTRI and Portland State University (PSU), to create a new model of research training for underrepresented and disadvantaged students. This model provides an opportunity to learn about clinical and translational research academic careers; participate in a research enhancement and professional development curriculum;have a long-term authentic research experience; and receive enhanced mentorship. BUILD EXITO includes PSU, and local and 3 US Pacific territory 2-year colleges. We have developed a sustainable plan that includes these core elements after NIH support for the program ends. We have tracked long-term student outcomes for entry into graduate programs and the research workforce. RESULTS/ANTICIPATED RESULTS: We will describe the experimental model and the network of university and community colleges in BUILD EXITO, including PSU, U of Alaska, and colleges in US territories of Guam, Northern Mariana Islands, and American Samoa. All these universities and colleges have high proportions of underrepresented and disadvantaged students. We will present data on characteristics of the >600 students who have participated in BUILD EXITO to demonstrate the diversity of the cohort. We will also describe 4-year degree completion, engagement in the research workforce, and entry into graduate or professional programs. We will show how this has positively affected faculty inclusion of students in research, institutional policies at the 2-year and 4-year programs, and how this model has become sustainable. DISCUSSION/SIGNIFICANCE: The BUILD EXITO program developed as a collaboration of the CTSA hub at OHSU and a highly diverse undergraduate programs. We have developed a successful model for training a diverse research workforce and will disseminate this sustainable model.