OBJECTIVES/GOALS: Mobile health applications are widely used by the public but vary in how they are classified and regulated. This study examines the evidence of the safety and efficacy of mobile medical applications specifically focusing on those that are used to manage diabetes. METHODS/STUDY POPULATION: To understand the current regulatory landscape of mobile health applications (mHealth apps) for diabetes, a literature survey was conducted using the Pubmed database. Top mHealth apps were identified by searching the Apple store website using 10 key terms associated with diabetes management applications. A maximum of ten results, when available for each key term, were studied by exploring the FDA databases to understand how the products were regulated and if any were subject to recalls. These selected mHealth apps were also searched on clinicaltrials.gov to see if there were ongoing or completed clinical trials and if the trials were designed to include efficacy and safety outcome measures. RESULTS/ANTICIPATED RESULTS: Of the 71 mHealth apps for diabetes management that were identified, 16 were regulated. These products spanned a diverse range of functions including device data and decision support systems. Although 11 had clinical trial data demonstrating efficacy, only 4 had data demonstrating both efficacy and safety. Two of the regulated applications were subject to product recalls due to programming errors that resulted in incorrect insulin dose recommendations. These two applications had clinical trials evaluating efficacy but not safety. The companies noted that the incorrect insulin calculation from their respective mHealth app could cause either a low- or high-impact hypoglycemic event. DISCUSSION/SIGNIFICANCE OF IMPACT: With little to no clinical trial data to support their safety and efficacy, mHealth apps in the diabetes marketplace pose risks for patients as evidenced by recent safety-related recalls. The results of this study indicate that these products may need to be more tightly regulated.

OBJECTIVES/GOALS: Securing seed funding and external support can be a daunting process. Institutions are increasingly looks for quantitative assurance of impact and accountability. This study investigates factors predictive of seed funding selection, including pace of submissions as well as external support. METHODS/STUDY POPULATION: Using Generalized Logistic Mixed Models (GLMMs), we model factors found to be predictive of researcher success, and model demographic factors as well, to understand the complex interplay of researcher background, professional networks and preparation, and researcher persistence. The following factors were modeled as potentially predictive of researcher success: faculty rank; co-PI; h-index; rate of application; prior award funding amounts; and research-focused social media posts. RESULTS/ANTICIPATED RESULTS: After effects are finalized, we expect that pace of seed fund applications and the strength co-PIs, as measured by h-indices, to be significant predictors of researcher success for both securing seed funding and external support. DISCUSSION/SIGNIFICANCE: This study identifies features associated with eventual research program success and can be used to support accountability and impact efforts at an institutional level. Research institutes strive to ensure equal access to these opportunities and train applicants to produce improved project proposals. Results from this study inform these efforts.

Accelerating innovation translation is a priority for improving healthcare and health. Although dissemination and implementation (D&I) research has made significant advances over the past decade, it has attended primarily to the implementation of long-standing, well-established practices and policies. We present a conceptual architecture for speeding translation of promising innovations as candidates for iterative testing in practice. Our framework to Design for Accelerated Translation (DART) aims to clarify whether, when, and how to act on evolving evidence to improve healthcare. We view translation of evidence to practice as a dynamic process and argue that much evidence can be acted upon even when uncertainty is moderately high, recognizing that this evidence is evolving and subject to frequent reevaluation. The DART framework proposes that additional factors – demand, risk, and cost, in addition to the evolving evidence base – should influence the pace of translation over time. Attention to these underemphasized factors may lead to more dynamic decision-making about whether or not to adopt an emerging innovation or de-implement a suboptimal intervention. Finally, the DART framework outlines key actions that will speed movement from evidence to practice, including forming meaningful stakeholder partnerships, designing innovations for D&I, and engaging in a learning health system.

Introduction. Family health history (FHx) is an important factor in breast and ovarian cancer risk assessment. As such, multiple risk prediction models rely strongly on FHx data when identifying a patient’s risk. These models were developed using verified information and when translated into a clinical setting assume that a patient’s FHx is accurate and complete. However, FHx information collected in a typical clinical setting is known to be imprecise and it is not well understood how this uncertainty may affect predictions in clinical settings. Methods. Using Monte Carlo simulations and existing measurements of uncertainty of self-reported FHx, we show how uncertainty in FHx information can alter risk classification when used in typical clinical settings. Results. We found that various models ranged from 52% to 64% for correct tier-level classification of pedigrees under a set of contrived uncertain conditions, but that significant misclassification are not negligible. Conclusions. Our work implies that (i) uncertainty quantification needs to be considered when transferring tools from a controlled research environment to a more uncertain environment (i.e, a health clinic) and (ii) better FHx collection methods are needed to reduce uncertainty in breast cancer risk prediction in clinical settings.

Clinicians who are interested in becoming principal investigators struggle to find and complete training that adequately prepares them to conduct safe, well-designed clinical and translational research. Degree programs covering these skills require a significant time investment, while online trainings lack engagement and may not be specific to local research contexts. Staff at Tufts Clinical and Translational Science Institute sought to fill the gap in junior investigator training by designing an eight-module, noncredit certificate program to teach aspiring clinician-investigators about good clinical practice, clinical research processes, and federal and local regulatory requirements. The first iteration of this program was evaluated using pre- and posttest questionnaires and by gathering clinician learner feedback in a focus group. Based on the pre- and posttest questionnaires, learners experienced an increase in self-efficacy and confidence related to clinical research competencies. Feedback from learners also highlighted important program strengths, including an engaging program format, a manageable time commitment, and an emphasis on identifying crucial research resources. This article describes one approach to creating a meaningful and efficient clinical trial training program for clinicians.

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

OBJECTIVES/GOALS: Using the NIH’s expanded definition of underrepresented populations in the biomedical, clinical, behavioral and social science research enterprise, we examined the impediments for conducting translational research experienced by those from underrepresented groups. [https://acts.slayte.com/calls/detail/740a13de-316c-11ee-90f4-0e0ce905385c/draft/389221c1-434e-11ee-90f4-0e0ce905385c#_ftn1] #_ftn1 METHODS/STUDY POPULATION: One hundred and ninety-nine people completed a survey distributed to 750 persons who had interacted with our Center’s service cores as users, awardees, mentors, committee members, seminar attendees, and/or participated Center sponsored programming (response rate = 26.5%). The survey addressed barriers to conducting clinical and translational research at the respondent’s institution, awareness of and interest in using specific Advance RI-CTR services, and satisfaction with their institution’s efforts to support clinical and translational research. RESULTS/ANTICIPATED RESULTS: Women reported access to collaboration across institutions as a barrier to clinical and translational research that existed to a great extent (28%) significantly more than men (10%). More than half (53%) of the other underrepresented researchers surveyed identified insufficient grant administration supportas a barrier that occurs to a great extent, compared with 35% of researchers who were not from an underrepresented group. Other barriers reported more frequently among underrepresented researchers included lack of pilot project funding, inadequate space for conducting research, lower access to collaborators across institutions, and difficulty obtaining advice on regulatory issues and commercial development. DISCUSSION/SIGNIFICANCE: Efforts to address the barriers identified by underrepresented groups will include, but not be limited to, improving collaborations across institutions, support for grant administration, and a discussion of plans for the Center to augment and advocate at the partner institutions on behalf of these underrepresented individuals.

ABSTRACT IMPACT: This formative evaluation can inform selection and development of implementation strategies for implementing this and other similar interventions in future implementation studies or practice. OBJECTIVES/GOALS: Al-Anon mutual-help groups help concerned others (COs; e.g., families, friends) of persons with an alcohol use disorder better cope with their own problems. Despite widespread availability of Al-Anon meetings, participation is limited. We developed and evaluated an intervention to facilitate CO engagement in Al-Anon. METHODS/STUDY POPULATION: Al-Anon Intensive Referral (AIR) was developed to facilitate COs’ engagement in Al-Anon through four coaching sessions and is being tested in a NIAAA-funded randomized controlled trial (RCT). Consistent with a hybrid type 1 effectiveness-implementation design, we also conducted a formative evaluation to learn about facilitators, barriers and recommendations for AIR implementation in substance use disorder (SUD) treatment programs. We interviewed key informants (director and two staff) at eight sites in the AIR RCT and two ‘naive’ sites unfamiliar with AIR. Sites included community and Veterans Administration (VA) treatment programs in Arkansas, California, and Nebraska. Semi-structured interviews were based on the Consolidated Framework for Implementation Research, and were thematically analyzed. RESULTS/ANTICIPATED RESULTS: Facilitators included AIR’s face validity, adaptability, and alignment with staff values and skills, requiring only minimal training. Several community sites thought AIR would fit with their current practices (e.g. family groups), and some sites reported having sufficient staff available for delivering AIR. Barriers included limited staff time (some sites), and VA sites having limited resources for providing services to COs. Furthermore, many clients have no COs, or COs who are unwilling or unable to engage. Recommendations included fitting AIR within existing workflows and focusing on COs with highest readiness. Participants also thought AIR could be adapted as an online or smartphone app, which may expand its reach to younger and more tech-savvy populations while decreasing staff burden. DISCUSSION/SIGNIFICANCE OF FINDINGS: AIR has strong potential for implementation, but sites vary on implementation capacity and readiness. Most sites could implement it partially (e.g., case-by-case basis), and sites with sufficient capacity (e.g., family groups, staff time) could implement it more fully. An app-based AIR could help mitigate some barriers.

OBJECTIVES/SPECIFIC AIMS: To describe how Michigan Institute for Clinical & Health Research (MICHR) has engaged communities in its leadership and governance structure. This presentation will describe these practices, how they are being evaluated, and future plans for institute-wide engagement of communities in translational research. METHODS/STUDY POPULATION: Engaged partners from various communities across Michigan in various ways within MICHR’s Community Engagement Program. RESULTS/ANTICIPATED RESULTS: MICHR has utilized participatory practices in the development of the CAB to strengthen existing relationships and build new ones with potential partners. DISCUSSION/SIGNIFICANCE OF IMPACT: MICHR-wide Community Advisory Board (CAB) will ensure community voices are heard and utilized in leadership and strategic decisions for CTSA activities.

Objectives/Goals: To assess the attitudes toward social justice of residents and faculty following the didactic series and evaluate the impact of the longitudinal curriculum on resident engagement in social justice activities through community engagements. Methods/Study Population: Data were gathered through questionnaires collected from participating residents and faculty. The session topics were chosen based on “Precepting Toward Social Justice” curriculum from the University of Minnesota Department of Family Medicine and Community Health, including sessions on advocacy, diversity, and implicit bias, among others. The self-assessment questionnaires were specific to the topics of the lecture, assessing knowledge, skills, and attitudes before and after the education sessions. Participants were asked to rate these aptitudes of each topic from “none” to “expert.” Results/Anticipated Results: Out of 22 total participants, 16 returned surveys. Overall, there was a substantial improvement in aptitudes after the lecture. There was an increase in reported above average knowledge of topics: Agency (12.5% to 56.25%), Humility (18.75% to 62.5%), Dignity (12.5% to 62.5%), Partner (18.75% to 50%), Awaken (37.5% to 75%), Place (12.5% to 43.75%), Asset (0% to 37.5%), Sanctuary (6.25% to 50%), Belonging (0% to 37.5%), Whole (0% to 43.75%), Liberation (12.5% to 68.75%), and Heal (37.5% to 75%). 31% reported that the lectures alone had an above average influence on pursuing more social justice activities through community engagement. 44% reported that the lectures had an above average impact on their subsequent patient encounters. 69% stated that this series helped develop their overall social justice skills. Discussion/Significance of Impact: All patients deserve equitable care. Family physicians have a unique role in addressing social justice concerns to eliminate inequalities and drive for better health outcomes. By enforcing social justice in education and implementing it into practice, satisfaction, trust, and well-being of patient and provider will be improved.

Objectives/Goals: Undergraduate Medical Education (UME) may apply Just-in-Time training (JITT) to provide medical students with learning experiences closely aligned with real-time clinical needs. The purpose of this scoping review is to offer an overview of the implementation of JITT training in UME. Methods/Study Population: Following the five-stage framework by Arksey and O’Malley to methodically collect and analyze studies on JITT in UME, five electronic databases were searched, and a supplemental search for grey literature was conducted. Studies exploring the integration of JITT principles into UME clinical training and their time to follow-up after training were included. Bloom’s Taxonomy was used to assess educational goals of JITT interventions. Results/Anticipated Results: The review yielded 21 studies across 4 countries. The majority were cohort studies (13) and randomized control trials (5). Assessment definitions and use of JITT varied widely. Most studies focused on short-term outcomes, defined by being measured immediately after JITT session (15) or at the end of JITT-based rotation or clerkship (3). Three studies evaluated outcomes at a period longer than 2 weeks after completion of session or clerkship. Attitudes (9), followed by skills (8) were the most common educational goals of intervention. The efficacy and utility of JITT in improving educational goal acquisition was demonstrated in 90% (17/19) of the studies with reported outcomes. Discussion/Significance of Impact: The introduction of JITT in UME has been shown to meet the immediate needs of healthcare environments; however, evidence is limited in the evaluation of longer-term outcomes. Further research to determine the impact of JITT on long-term learning retention and education goal acquisition in UME is merited.

OBJECTIVES/SPECIFIC AIMS: The specific objective of this proposal is to identify and validate targetable tumor-associated antigens (TAAs) in ovarian and pancreatic cancer. It is our central hypothesis that the accurate identification and selection of appropriate TAAs will provide a foundation on which to develop of novel and effective cancer immunotherapies. We have formulated this hypothesis on the basis of preliminary results in which we have used high-throughput tandem mass spectrometry (MS) to successfully identify TAAs from melanoma patient tumors. We have subsequently generated TAA-specific T-cells that showed specific recognition and killing of tumor cells, and will form the basis of an upcoming clinical trial for our melanoma patients. We now have extended this antigen identification pipeline into ovarian cancer to accomplish our objective of developing effective T-cell-based immunotherapies for ovarian cancer and pancreatic patients. METHODS/STUDY POPULATION: We have collected patient tumor specimens, and we performed HLA immunoprecipitation, peptide elution, and completed high-throughput tandem MS on these eluted samples to identify TAAs. In addition, we have validated the safety of potential targets through the use of the publicly available RNA sequence data sources GTEX and TCGA. RESULTS/ANTICIPATED RESULTS: To date, we have successfully completed over 60 peptide elutions from ovarian and pancreatic patients samples. In total, we have found several potential novel tumor-associated targets. VGLL1, is one of these identified antigens, and in conjunction with our collaborators, we have successfully generated T-cells against it. Additionally, we have found that VGLL1 is a potential novel TAA for 3 other cancer types, including bladder, gastric, and triple negative breast cancers. We are now focusing our efforts on testing these T-cells against additional ovarian cancer cell lines and these cancer types to determine their specificity. We plan to continue the generation and testing other identified potential TAAs as well. We plan to use these T-cells directly in clinical trials in the future. DISCUSSION/SIGNIFICANCE OF IMPACT: The rationale for this proposal is that through the identification and validation of TAAs, we can open the door to a new world of therapies that can potentially increase the survival rate in a disease with a historically grim prognosis.

OBJECTIVES/SPECIFIC AIMS: The Institute for Transnational Sciences (ITS) has developed novel methods to ethically engage stakeholders across the transnational research spectrum, up to and including public health practice and policy. METHODS/STUDY POPULATION: In 2014, the ITS co-founded The Research, Education, And Community Health (REACH), the mission of which was to facilitate communication, collaborative research, and service activities between faculty and scientists and area community leaders. The intent was to identify and meet the needs of our communities without gaps and/or redundancies, thus better leveraging time, funding, and efforts. RESULTS/ANTICIPATED RESULTS: REACH now boasts 23 Centers, Departments, and Institutes, as well as 39 community organizations, including public and mental health agencies, clinicians, policy makers, family service centers, cultural and faith-based organizations, business, and local schools/colleges. We offer 3 methods for consideration as best practices: (1) a comprehensive community health needs assessment, (2) an “Offer and Ask” community/campus partnership mechanism, and (3) Community Science Workshops, based on the European Union’s Science Shops. DISCUSSION/SIGNIFICANCE OF IMPACT: Results of REACH’s work have been used to provide guidance for enhanced, data-driven programs and allocation of resources for local and statewide initiatives. The organization has evolved into an independent coalition seeking 501(c)3 status and is planning to expand its scope to 5 counties. REACH thus serves as model for successful replication across applicable CTSA hubs.

OBJECTIVES/SPECIFIC AIMS: To use a systematic and iterative process to develop and refine toolkits to support dissemination and implementation (D&I) research. METHODS/STUDY POPULATION: Participants included research staff from the Dissemination and Implementation Research Core (DIRC), a research methods core from the Institute of Clinical and Translational Science at Washington University in St. Louis, other D&I experts from the University, and national experts from the D&I field. This project used education design research methodology and a systematic and iterative process involving several phases. The first phase (preliminary research and initial development) consisted of analysis of the educational problem and its context, and led to the development of toolkit prototypes and plans for their implementation. In the second phase (development and formative evaluation), toolkits were iteratively evaluated with emphasis on content validity and consistency and effectiveness as perceived by the users. Finally, in the summative evaluation, the toolkits were evaluated based on their use as intended. RESULTS/ANTICIPATED RESULTS: Our team identified the target audience as DIRC customers and investigators from disciplines across the University, and found that resources for beginners to D&I were lacking. The team developed 8 toolkits: (1) Introduction to D&I; (2) How to develop D&I Aims; (3) D&I Designs; (4) Implementation Outcomes; (5) Implementation Organizational Measures; (6) Assessing Barriers and Facilitators; (7) D&I Designs; and (8) Guideline research. These prototypes were iteratively revised for content validity and consistency. Finally, each toolkit was evaluated by two national experts in D&I science, and further refined. DISCUSSION/SIGNIFICANCE OF IMPACT: This systematic and cyclical process led to the development of 8 toolkits to support researchers in D&I science, which are now available on the DIRC Web site. This set the stage for development of new toolkits as additional needs are identified.

OBJECTIVES/GOALS: Over 50 million people in the U.S. have an eating disorder (EDs), and body dissatisfaction is a key precursor to EDs. The current study seeks to culturally adapt an evidence-based positive body image program administered through a mobile-phone application for use with Latinx women. METHODS/STUDY POPULATION: The positive body image program centers around body functionality, which in contrast to appearance-based body image, emphasizes the body’s capabilities, including physical capacities, health and internal processes, senses, creative endeavors, self-care, and communication with others. Latinx women aged 18-25 years-old (n =15) will be recruited to participate in focus groups and individual qualitative interviews. Interviews will examine how Latinx women relate to the concepts of positive body image and body functionality. Participants will also provide feedback on the application design and program content. RESULTS/ANTICIPATED RESULTS: Results will elucidate how Latinx women relate to their body and can be used to inform our understanding of Latinx women’s positive body image. Results will also inform what components of the intervention need to be tailored to be more relevant for use in this population. Information from the interviews will be used to explore adaptations to create a more acceptable and effective intervention prior to testing the efficacy of the program. DISCUSSION/SIGNIFICANCE: Most evidence-based body image programs are not developed with culturally sensitive programming in mind. Thus, culturally adapting an evidence-based positive body image program that could be widely disseminated through a mobile-application could address body image concerns in Latinx women.