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OBJECTIVES/GOALS: In line with NCATS funding requirements, the Michigan Institute for Clinical and Health Research (MICHR) established a continuous quality improvement (CQI) process and used the process to guide the implementation of a benchmarking project to evaluate and set goals for MICHR’s production of Clinical and Translational Science manuscripts. METHODS/STUDY POPULATION: We aimed to increase the number of Clinical and Translational Science papers MICHR produces and to set a reasonable goal for improvement. Benchmarking was used to obtain a baseline and inform the identification of a reasonable goal for improvement. 11 Peer institutions were identified with similar funding levels. 1,225 Publications from 2022 for all 12 CTSAs were obtained from NIH Reporter. All publications were reviewed by title to identify probable CTS content. Two staff reviewers confirmed a total of 108 CTS publications across all CTSAs, and coded each paper to characterize the theoretical approach, method (quantitative and/or qualitative), analytic method and topic. All publications that were selected for benchmarking were also tracked and compared using Altmetrics for Institutions and Overton platforms. RESULTS/ANTICIPATED RESULTS: A total of 108 CTS publications were produced by 12 benchmarked CTSAs in 2022; of those, 70% (77) regarded research infrastructure, 37% (41) regarded research methods, and 15% (16) regarded clinical care. Over half, 53% (58), of the benchmarked papers are empirical research papers; of those, 67% (39) used quantitative methods, 28% (16) used qualitative methods, and 5% (3) used mixed methods. A clear majority of the benchmarked papers, 70% (76), provided only descriptive analyses, 18% (19) provided inferential analyses, and 12% (13) provided predictive analyses. We identified an opportunity to produce more manuscripts with descriptive analyses of research infrastructure. In the long-term, we saw an opportunity to produce predictive analyses of translational initiatives designed to impact clinical care. DISCUSSION/SIGNIFICANCE: The benchmarking results helped MICHR identify goals for its production of Clinical and Translational Science to fill gaps in the field. Expanding the scope of this benchmarking project might achieve greater interrater reliability using larger representative sets of publications drawn from institutions across the CTSA Consortium.

Objectives/Goals: The goal of this project was to, first, identify potential improvements to administrators’ processes surrounding the maintenance and export of a digital research platform using human-centered design and, second, explore whether this approach could be integrated into a system evaluation of implementation and impact of the platform. Methods/Study Population: In alignment with the A3 template for quality improvement, MICHR staff prepared to conduct a systems evaluation of MICHR’s support and dissemination of Your Health Research (YHR), a digital platform for study participant recruitment by (1) identifying the background of programmatic and scientific opportunities being addressed, (2) assessing the current state of MICHR’s management of YHR, and (3) identifying S.M.A.R.T. goals for improvement, as well (4) the drivers of improvement. The iterative nature of the work that was undertaken aligns with the intent of A3 framework which presents these 4 steps as an iterative process. These iterative efforts included a tabletop exercise, a blueprinting workshop, and a survey of MICHR program staff about potential improvements. Results/Anticipated Results: YHR is designed to facilitate recruitment into clinical and translational research studies; the findings presented here show that it is feasible to evaluate the way MICHR deploys this tool for increasing effect. The use of Systems Evaluation Theory was not only appropriate (Renger, et al, 2025), this work shows how human-centered design approaches can be integrated into systems evaluations to facilitate the identification and continuous improvements to those systems (Melles, et al., 2021; Holman, et al, 2019; Meyer, et al, 2022). This work shows how clinical and translational science organizations like MICHR can contribute to the emergence of learning health systems by evaluating the infrastructure of academic medical centers designed to facilitate participant recruitment into research (Lopez et al., 2025). Discussion/Significance of Impact: This study responds to an enduring need for more research into the ways research institutions like MICHR can increasingly provide investigators with better infrastructure and tools, such as access to population-based data for real-time adjustments to their clinical and translational research studies.

Objectives/Goals: The Michigan Institute for Clinical & Health Research (MICHR) created an eight-phase adaptive Translational Science Framework to guide us in selecting and solving translational science problems. We operationalized the initial problem selection phases and assessed utility of various methods in shaping complex problems for solution design. Methods/Study Population: We identified three high-priority strategic domains where there was potential to improve the efficiency and effectiveness of research and related processes. Starting with broad problem statements, we engaged a wide array of stakeholders and end-users in a sequence of methods to reduce ambiguity, uncover root causes, and clarify actionable challenges. The methods we selected align with the four problem selection/problem analysis phases of our Translational Science Framework: contextualize, frame, map, and craft. Methods used included landscape and workforce assessments; purpose and scoping sessions; design research strategies; systems mapping; quantitative needs assessments; and translational science proposal pitches. Results/Anticipated Results: Across the three strategic domains, we successfully reframed and scaled ill-defined problem statements into translational science questions that are actionable, meaningful, feasible, and relevant. The outputs of each problem selection/problem analysis phase served as critical inputs for subsequent phases; for example, synthesis of landscape and workforce assessments in the contextualize phase provided critical substrate for structuring the design research and broad scale needs assessments in the frame phase. This funneling approach brought continuous focus and clarity to the problem statements. A variety of metrics embedded within the phases informed performance, progress, and decision-making, which enabled rapid adjustments in the face of evolving contexts and unforeseen challenges. Discussion/Significance of Impact: In the absence of translational science problem analysis, we risk not addressing actual needs, duplicating effort, and/or creating unwanted solutions. The methods and metrics within the analysis phases of our Translational Science Framework promote iterative refinement of intractable problems, with the goal of yielding impactful solutions.

Objectives/Goals: The demands on MICHR’s Evaluation team are profuse and varied. Quarterly team meetings were used to keep track projects, identify new projects, and relay important new initiatives from MICHR leadership. The MICHR Translational Innovation team took on the task of assessing the Evaluation team’s processes to design better workflow and effectiveness. Methods/Study Population: The process included 5 stages, Empathize, Define, Ideate, Prototype and Test. Sixteen interviews were conducted with MICHR faculty and staff. Interviews were coded and summarized. Seventeen themes were mapped and distilled into 5 key insights. From the key insights, design principles were identified to guide a design session with Translational Innovation staff and Evaluation staff. New work processes were proposed, designed, and tested by both teams. The Evaluation team “test-drove” the prototype and iterative design sessions were conducted to determine which new elements were successful. The Evaluation team was positioned to begin utilizing the newly designed process at the beginning of MICHR’s new grant year. Results/Anticipated Results: The MICHR Evaluation team is instrumental to the development, conduct, and dissemination of Clinical & Translational Science (CTS), a primary objective of MICHR’s work. Three types of evaluation projects were identified through the design process: required reporting, CQI/program improvement, and CTS/impact evaluation. The service design process enabled the Evaluation team, and MICHR program leads to better identify and prioritize collaborations between the Evaluation and program teams that improved the quantity and quality of MICHR CTS outputs. Discussion/Significance of Impact: Generating CTS is critical to the missions of NCATS and MICHR. Thoughtfully designing processes that facilitate and increase CTS output that can be shared and duplicated across the consortium is invaluable.

OBJECTIVES/GOALS: The objective of this initiative was to promote MICHR staff’s production of Clinical and Translational Science publications. MICHR leadership approved this initiative, including an evaluation plan with measurable outcomes goals, and contracted with an experienced scientific writing coach with over 20 years of experience working with CTSAs. METHODS/STUDY POPULATION: A sequential mixed methods program evaluation designs was used. Pre- and post-surveys were used to measure participating staff’s gain in skill, understanding & satisfaction. An interview with the instructor was then conducted to characterize staff performance, and identify possible areas of programmatic improvement. This initial phase of the program evaluation was conducted in the Summer of 2023. The results were used to inform an expansion of the program to include more staff in the the Fall of 2023. Pre- and post-program surveys of the participants were conducted and interviews with each program participant were conducted. Finally, interviews with non-participating staff were conducted to assess their need for writing support and the challenges and facilitators of their scientific writing. RESULTS/ANTICIPATED RESULTS: Preliminary evaluation results obtained in the summer of 2023 were positive. All participants completed the course, and spent an average of 3.3 hours working between sessions. Six manuscripts were developed, five of which are being readied for submission and one submitted as of August 2023. Analysis of the pre-and post-program surveys indicated that all participants gained writing skill and authorship knowledge. Specifically, they gained confidence in 7 writing skills and 6 first-author roles evaluated during the course. All participants were satisfied with their experience and recommended the course to their colleagues, and the course instructor was also satisfied with the course. However, the participants noted that competing work demands and variable preparation hindered their work in the course. DISCUSSION/SIGNIFICANCE: With the increasing focus on Clinical and Translational Science taking place across the CTSA Consortium it is important to involve research staff in paper writing teams, including in first-author roles. Professional development in scientific writing can support Clinical and Translational Research staff contributing to this emerging science.

Mentorship is a vital part of the training provided in the K and T programs funded by the Clinical and Translational Science Awards (CTSA). However, the inputs, indicators, and outcomes associated with a successful mentoring relationship remain poorly understood. In this review, we critically examine the current body of literature on mentorship in a CTSA context. We conducted a comprehensive search of the literature for relevant research articles. We included articles that were contextualized within a CTSA hub, examined a mentorship program, and conducted evaluation research. Through an initial search of online databases and by reviewing reference sections of relevant articles, we identified 141 potentially relevant articles. Twenty-five of these articles met our inclusion criteria. We identified three categories of research: nationwide institutional surveys of CTSA mentorship programs, mentored research training programs, and mentor training programs. While the findings highlighted the effectiveness of mentor training and mentored training programs, there is a notable lack of assessment of mentoring inputs and indicators. Based on our review, we propose a model for the evaluation of CTSA mentorship that includes measurable inputs, indicators, and outcomes. This model provides a holistic framework for evaluators and CTSA program directors to better understand their mentorship programs.

Objectives/Goals: The CTSA at the University of Michigan, MICHR, has conducted a sequential mixed-methods needs assessment of a network of over 250 dissemination and implementation scientists working at the university. The purpose of this evaluation is to identify the research training needs of this network and to inform efforts to improve the networks’ productivity. Methods/Study Population: An IRB-approved sequential mixed-methods needs assessment of a network of over 250 dissemination and implementation scientists was conducted. First, surveys were sent to all members of the network using Qualtrics. This survey was designed to measure the challenges and facilitators encountered by members of this network, using response categories aligned with the Translational Science Benefits Model (Luke et al., 2018) to facilitate the identification of programmatic improvement goals. The survey also asked questions regarding network members’ training preferences, and their current plans to design specific types of implementation science clinical trials (Fortney et al., 2024). Survey respondents also indicated their availability for subsequent interviews to explore their career and training paths. Results/Anticipated Results: Surveys were sent out to over 250 individual members of the Implementation Science Network supported by MICHR. This network includes 249 U-M employees representing 44 departments or units, 7 individuals from Veterans Affairs and 16 from other Institutions, and of these 32 individuals (11%). Despite this low response rate, the results clearly indicated that accessing D&I training/educational resources, or learning about relevant measures, metrics and testable strategies was a major barrier to 71% of network members, with 61% particularly interested in training on developing and testing strategies. Most respondents (54%) reported that having more financial resources was a facilitator of their work and 62% volunteered to be interviewed about their careers. Interviews are being conducted and analyzed. Discussion/Significance of Impact: The results of this evaluation suggest dissemination and implementation scientists need more formal training programs, specifically ones focused on the selection of implementation strategies for testing in pragmatic and hybrid clinical trials. This work provides a rigorous and reproduceable methods for CTSAs to conduct needs assessments.

Objectives/Goals: The informed consent (IC) process is similar between clinical trials and expanded access (EA), which allows clinical use of investigational products outside studies. Physicians face unique barriers to IC in clinical environments. This project assesses IC documentation, identifies potential barriers, and evaluates efforts to improve compliance. Methods/Study Population: This is a continuous quality improvement project. To assess the compliance of IC processes for EA patients, informed consent documents signed by EA patients in 2023 were collected and reviewed against institutional standards. Five components of each form were evaluated, and the number and type of noncompliant documentation were tracked. Five physicians who provided EA treatments in 2023 were interviewed and the transcripts were analyzed to identify barriers to physician’s and teams’ IC processes. Efforts made to address these barriers and improve the compliance of informed consent documentation are being tracked and trends in compliance are being evaluated. Results/Anticipated Results: Sixty seven (67) signed informed consent documents for EA treatments were systematically reviewed and 34% were found to be compliant in all key aspects assessed. Analyses of interview notes, transcripts, and memos identified barriers to informed consent processes for expanded access treatments, including the infrequent or irregular occurrence of EA treatments making it difficult for care teams to develop and maintain their understanding of IC process and resources. Efforts made to improve compliance by pre-populating available information into informed consent documentation and removing unnecessary boxes in these forms may have driven improvement in compliance with further efforts underway. Discussion/Significance of Impact: This project evaluated the compliance of IC documentation for EA treatments and identified drivers affecting physicians’ IC processes for these patients. Different strategies to improve the compliance of IC documentation were evaluated and potential best practices for EA support were identified.

In 2009, the University of Michigan’s Michigan Institute for Clinical and Health Research developed a three-session K Writing workshop. Beginning in 2016, we implemented a non-attendance fee to encourage attendance across the three sessions. We examined whether this fee improved attendance, increased submission of an NIH K or R grant proposal, and improved success rates. Between 2012 and 2021, 373 participants attended the workshop. After the non-attendance fee was implemented, significantly more participants attended all three sessions of the workshop, and there was a statistical trend suggesting an increase in the success rate, while submission rates remained constant.

Objectives/Goals: This evaluation seeks to demonstrate the feasibility and impact of a new funding program for clinical and translational research launched by U-M Michigan Medicine. ’Research Scouts’ with established research agendas at U-M were identified and trained to invite and fund research proposals from U-M colleagues they had not collaborated with. Methods/Study Population: In 2023, Research Scouts identified and orientated to the program and goals. Each Scouts was given a year to invest $150,000 in innovative research projects. A web-based submission portal was used to anonymize the proposals to remove the potential for bias. All projects were granted a two-year funding period. The sequential mixed methods used for this evaluation includes surveys of ’Research Scouts’ and awardees, followed by the collection on administrative data regarding the awardees scientific production, including both research publications and grants. The survey results and administrative data were analyzed and informed the iterative refinement of an interview protocol designed to investigate the impact of the funding on awardees’ development of novel and collaborative research agendas. Results/Anticipated Results: Surveys of the 2023 Scouts (N=24) and Awardees (N=51) had a 59% response rate. Awardees agreed they were able to pursue new lines of investigation (Mean 4.62, on a 5-point Likert scale); test a new idea that otherwise would go unexplored (Mean 4.62); had more latitude for intellectual creativity and exploration than traditional funding mechanisms permit (Mean 4.46); had new scientific conversations and new connections (Mean 4.54). The results also indicate that Research Scouts agreed with these benefits. Analysis of Awardee’s administrative data yielded evidence that they were actively producing new research; for example, of 146 papers, at least 30 were relevant to their award. Ongoing interviews will yield evidence indicating how the award accelerated their clinical and translational research agendas. Discussion/Significance of Impact: Given the long gestation time for new research ideas to yield new publications or extramural funding, the full impact of the program won’t be known for years. However, preliminary evidence indicates that the Research Scouts program successfully provides a mechanism for pursuing novel ideas with minimal administrative costs and burden.