ABSTRACT IMPACT: Future exercise interventions for people with mobility disability should be tailored to the level of the individual and responsive to intervention adherence. A promising area of research is the use of adaptive interventions as a mechanism for tailoring and 'titrating’ the intervention based on data obtained during early intervention stages. OBJECTIVES/GOALS: The purpose of the study was to understand adherence to a home-based exercise trial delivered to people with a mobility disability. The objective was to develop a multi-dimensional model for engaging and retaining participants not adhering to an exercise trial by using a grounded theory approach involving both qualitative and quantitative data. METHODS/STUDY POPULATION: An exercise trial utilized telehealth technology to deliver a home-based exercise intervention for adults with a mobility disability. In order to understand factors of adherence to the exercise trial, a mixed methods study design was used involving baseline data and semi-structured interviews. Maximum variation sampling was used to select participants based on level of adherence, gender, race, and functional level. Categorization based on adherence to exercise videos during the first 12 weeks of the intervention included 3 groups: 1) high adherence (≥80% weekly median exercise video minutes viewed), 2) sub-optimal adherence (< 80% but ≥20%), and 3) low adherence (< 20%). Interviews were conducted with 10 participants in each group (n = 30) and data were analyzed using a grounded theory approach. RESULTS/ANTICIPATED RESULTS: A sample of 30 participants from a large pragmatic, home-based exercise trail have completed interviews. All interviews were transcribed and uploaded to NVivo software for coding. Emerging codes include lack of time to exercise, inappropriate exercise intensity, and lack of support for exercise. Using grounded theory approach, results include: 1) identifying risk factors for low adherence to a home-based exercise program delivered to people with mobility disability, 2) discovering themes for not responding to program activities in a home-based exercise program for adults with physical disabilities, and 3) determining the relationships between variables that emerge from thematic and statistical analyses. A model for adherence to home exercises among people with mobility disability will be presented. DISCUSSION/SIGNIFICANCE OF FINDINGS: People with a mobility disability are more susceptible to adopting sedentary lifestyles, which result in poor psychosocial and physical health outcomes. There is a clear and pressing need for designing future home-based exercise interventions with a greater level of customization for participants who have low to non-adherence.

The learning sciences have yielded a wealth of insights about the mechanisms and conditions that promote learning, yet the findings from this body of research often do not make their way into educational practice. This fundamentally translational problem is one we believe that educators from translational fields, with their evidence-based orientation and familiarity with the challenges and importance of translation, are well-positioned to address. Here, we provide a primer on the learning sciences to guide educators in the Clinical and Translational Science Institutes and other organizations that train translational researchers. We (a) describe the unique teaching and learning environment in which this training occurs, and why it necessitates attention to learning research and its appropriate application, (b) explain what the learning sciences are, (c) distill the complex science of learning into core principles, (d) situate recent developments in the field within these principles, and (e) explain, in practical terms, how these principles can inform our teaching.

Underrepresented minorities have higher attrition from the professoriate and have experienced greater negative impacts of the COVID-19 pandemic. The purpose of this study was to compare the impact of COVID-19 on the lives of 196 early-career physician-scientists versus PhD researchers who are underrepresented in biomedical research. Participants in the Building Up study answered questions on the impact of the COVID-19 pandemic on their personal and professional lives, and a mixed-methods approach was used to conduct the analysis. While most participants experienced increases in overall stress (72% of PhD researchers vs 76% of physician-scientists), physician-scientists reported that increased clinical demands, research delays, and the potential to expose family members to SARS-CoV-2 caused psychological distress, specifically. PhD researchers, more than physician-scientists, reported increased productivity (27% vs 9%), schedule flexibilities (49% vs 25%), and more quality time with friends and family (40% vs 24%). Future studies should consider assessing the effectiveness of programs addressing COVID-19-related challenges experienced by PhD researchers and physician-scientists, particularly those from underrepresented backgrounds.

ABSTRACT IMPACT: This work highlighs the significant burden of Trauma in Nigeria and will help inform policy decisions on improving Nigeri’s current Trauma care system OBJECTIVES/GOALS: To evaluate trauma care delivery at the pre-hospital, hospital and health systems level in Nigeria in order to identify the burden of trauma, gaps in the delivery of trauma care, and interventions, implemented or recommended, to improve upon the limitations to trauma care delivery. METHODS/STUDY POPULATION: A two-concept search - one being trauma and the other being Nigeria - of the Pubmed (Medline) and Embase databases, in addition to Global Index Medicus and grey literature was performed between September 2018 and September 2019. The search yielded 3,970 articles that underwent title screening and 331 articles that underwent abstract screening. 101 articles were identified for full text screening and the majority were extracted for inclusion into the review. The extracted literature was grouped into 4 categories - articles outlining the burden of trauma in Nigeria, and articles outlining the delivery of trauma care at the pre-hospital, hospital and health systems level. RESULTS/ANTICIPATED RESULTS: Results were classified as an identified challenge or an intervention, recommended or implemented, to address Nigeria’s trauma care system. There was a highlighted need for pre-hospital infrastructure, training of frontline providers, continued competency assessments of frontline providers, in-hospital diagnostic resources, and trauma care surveillance systems to guide health policy. DISCUSSION/SIGNIFICANCE OF FINDINGS: There is a significant burden of trauma in Nigeria. Coordinated interventions and policies at the pre-hospital level, the hospital level, as well as the health systems level are needed in order to address the gaps in Nigeria’s current trauma care system.

ABSTRACT IMPACT: This work will help assess the effectiveness of the mentored career development programs. OBJECTIVES/GOALS: There is increased attention on assessing the impact of the CTSA in building a research workforce through mentored career development programs. We propose using data visualization to assess and communicate the impact of the programs on the scholars career development. METHODS/STUDY POPULATION: Evaluators from two CTSAs collaborated to visualize the KL2 data such as demographics, scholarly productivity (publications, grants, intellectual property), and time to promotion that is already tracked through REDCap at their institutions. Excel, Tableau, and Microsoft PowerBi were then used to generate trends in scholarly productivity over time. The goal was to compare how different tools can be used to visualize bibliometric data, based on what is available at the respective institutions. RESULTS/ANTICIPATED RESULTS: Longitudinal visual summary reports were produced for the entire program as well individual scholar progress. These reports can be used to identify trends such as how long after program completion do participants achieve their next milestone, what type of milestones are achieved, when in their career is their scholarly productivity the highest, etc. Answers to these questions could tell a story of the effectiveness of a mentored development program in the participants’ career. It can also highlight gaps and areas of opportunities that the program must address, either by adapting their curriculum or clarifying their intended outcomes. DISCUSSION/SIGNIFICANCE OF FINDINGS: Data visualization provides better understanding of the impact of the training programs on the scholars career development. Such insights are otherwise missing when evaluations are only focused on the percentage of scholars who were still engaged in research after completion of the program.

ABSTRACT IMPACT: Practical evaluation approaches using case studies and success stories present a chain of evidence to demonstrate to stakeholders that resources are being used as required and producing desired results and effectively document the impact of clinical and translational research. OBJECTIVES/GOALS: This project describes the overall evaluation plan of the Miami CTSI by combining the Translational Sciences Benefits Model (TSBM) and the Kirkpatrick Model to evaluate scientific outcomes and impact of CTSI-supported research, and education and training programs developed by the CTSI. METHODS/STUDY POPULATION: Using case studies, the TSBM framework will be applied to CTSI-supported projects to evaluate scientific outcomes and impact on domains that include: clinical and medical; community and public health; economic; legislative and policy. We will apply the framework to projects that have received funding through CTSI’s Pilot and Translational Studies and Mentored Translational Scholars KL2 Programs, and that have at least one publication. Application of the Kirkpatrick model will be demonstrated by using the four levels of evaluation - reaction, learning, behavior, and results - to assess training outcomes and impact of the KL2 and the I-Corps Programs. RESULTS/ANTICIPATED RESULTS: About 20 pilot projects and 8 KL2 research projects will be assessed using the TSBM framework. We anticipate that all projects will show potential or demonstrated benefits in at least two of the four domains of the model. KL2 Program evaluation was conducted by collecting data on all the four levels of the Kirkpatrick model. Reaction and learning were assessed through feedback from KL2 scholars. Behavior was assessed using semi-annual updates on research and training progress of the scholars and the program. Results were measured using indicators such as program graduates that continue to engage in clinical and translational research and their transition to research independence. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our evaluation approach using the two models is well aligned with overall CTSI aims and its three focus areas - infrastructure, education and culturalization/community engagement and will allow us to conduct a comprehensive yet practical evaluation of Miami CTSI programs.

The NIH Center for Accelerated Innovations at Cleveland Clinic (NCAI-CC) was funded by the National Heart Lung and Blood Institute (NHLBI) to support academic investigators in technology development and commercialization. NCAI-CC was one of three multi-institutional Centers established in the fall of 2013. The goal of each Center was to catalyze the growth of an ecosystem of commercialization within their affiliated institutions and regions by managing a program of funding and guiding translational project development and by delivering commercialization education programs to participating investigators. NCAI-CC created and managed such a funding program, ultimately supporting 75 different projects across seven separate academic institutions and developed tailored educational content following the National Science Foundation I-Corps™ curriculum and delivered the program to 79 teams from 12 institutions. We determined early on that in establishment and implementation of projects, it is important to support the teams and principal investigators throughout the program. The support includes a change in principal investigator mindset from specific aims orientation to goals and deliverables on projects. Our skills development efforts emphasized commercialization and a deep understanding of customer needs for new technology adoption. Here, we review our experiences, outcomes, and insights, including the challenges identified in program implementation.

ABSTRACT IMPACT: Recommendations for increasing trainee productivity will be highlighted. OBJECTIVES/GOALS: Using a combination of qualitative (interview) and quantitative (publications tracking) data, we undertook to describe the hurdles and concerns impeding academic accomplishments among T and K awardees at one CTSA hub and to examine whether hurdles at 6 months would predict academic output within one year following completion of the training program. METHODS/STUDY POPULATION: Semi-structured interviews were conducted with 29 trainees (28 TL1 and 8 KL2) 6 months into their training. Interview transcripts were analyzed using Atlas.ti to identify hurdles (factors that had already impeded research progress) and concerns (future challenges anticipated by the trainee). PubMed searches yielded the number of publications within one year of exiting the training program. Frequencies of hurdles and concerns were examined to characterize the factors most likely to impact trainee progress during the first 6 months of their training program. Among 18 trainees who had completed their training, the mean number of publications within one year of exiting the program (identified via verified PubMed searches) was compared across the total number of hurdles reported at 6 months (range = 0 to 3). RESULTS/ANTICIPATED RESULTS: The thematic analysis yielded 19 categories of hurdles and 14 categories of concerns. The top three hurdles were technological challenges (e.g., issues with equipment or data reduction; reported by 63% of trainees), professional competing responsibilities (40%), and navigating collaborations (30%). The top three concerns were future funding (33%), potential as an independent researcher (27%), and institutional context (e.g., departmental structure; 23%). The number of hurdles reported at 6 months significantly predicted number of publications one year post-exit (F (3,14) = 3.14, p < .05). Trainees reporting zero hurdles generated a mean of 8.67 publications; those with 3 hurdles generated a mean of 2.4 publications. DISCUSSION/SIGNIFICANCE OF FINDINGS: Future concerns were completely different from past hurdles, suggesting that the issues impeding research progress are not anticipated. Results suggest trainees would benefit from training related to how to balance competing professional responsibilities and navigate collaborations and that early attention to hurdles may enhance productivity.

Rapid whole genome sequencing (rapid WGS) is a powerful diagnostic tool that is becoming increasingly practical for widespread clinical use. However, protocols for its use are challenging to implement. A significant obstacle to clinical adoption is that laboratory certification requires an initial research development phase, which is constrained by regulations from returning results. Regulations preventing return of results have ethical implications in cases which might impact patient outcomes. Here, we describe our experience with the development of a rapid WGS research protocol, that balanced the requirements for laboratory-validated test development with the ethical needs of clinically relevant return of results.

Clinical research coordinators are increasingly tasked with a multitude of complex study activities critical to scientific rigor and participant safety, though more than half report not receiving appropriate training. To determine the reproducibility of an established clinical research workforce orientation program, collaborative partners across Clinical and Translational Science Award institutions seeded core principles and structure from Mayo Clinic’s Clinical Research Orientation program within Penn State University and the University of Mississippi Medical Center from 2019 to 2021. Training concepts were established and tied to those domains deemed critical by the Joint Task Force for Clinical Trial Competency for the conduct of clinical research at the highest levels of safety and quality possible. Significant knowledge and confidence gains and high overall program satisfaction were reported across participants and partner sites, despite programs being required to pivot from traditional, in-person formats to entirely virtual platforms as a result of the COVID-19 pandemic. The successful standardization and translation of foundational clinical research training has important efficiency and efficacy implications for research enterprises across the USA.

ABSTRACT IMPACT: This effort will ultimately improve both human and community health and translational science by showing the impact of CTR services on different types of projects that meet overall CTR missions and aims. OBJECTIVES/GOALS: CTRs seek to advance translational research to generate clinical, healthcare delivery, policy and community benefits. We conducted retrospective case studies for selected funded Pilot Projects for the Great Plains IDeA-CTR, focusing on facilitators and barriers to research translation and contrasting community-engaged and other proposals. METHODS/STUDY POPULATION: We analyzed 8 CTR-funded projects (4 community-engaged (CE) projects and 4 other pilot awards) focusing on outcome domains of the Translational Science Benefits Model (TSBM): Clinical, Economic, Policy and Community Benefits as endpoints of successful research translation. We adapted an existing TSBM case study template for use with data required by NIH/NGIMS to map progress toward one or more TSBM outcomes. Using email, we posed three brief open-ended questions to investigators: 1) challenges/ barriers for the project; 2) how the CTR helped move research along and (how it could have moved it further); and 3) how research is progressing and how it could progress further. RESULTS/ANTICIPATED RESULTS: All investigators reported the CTR advanced their project. Non-CE projects appeared to have a more straightforward trajectory, with 2 investigators reporting no challenges and 2 reporting solely institution-internal ones. In contrast, the 4 CE projects reported both benefit from the engagement of the CTR (most prominently the efforts of the community advisory board (CAB) and community liaisons). Yet, they also reported some challenges beyond the CTR’s ability to address, including delays in securing community buy-in and community buy-in of the investigator’s research approach. Some barriers appeared beyond the CTR’s current immediate ability to provide support to advance the project. DISCUSSION/SIGNIFICANCE OF FINDINGS: Findings contribute to efficient approaches for retrospective case studies and emerging information on challenges and opportunities for CE projects. The study will help identify: 1) intermediate milestones and timelines for different projects; 2) advance data for TBSM endpoints; and 3) CTR activities that leverage the translational process.

Little is known about the number of minors enrolled in clinical research today. IRB administrators at leading pediatric medical centers were surveyed regarding studies with minors. Analyses were descriptive in nature with adaptive Bayesian bootstrap imputation used with missing data. Officials from 17/41 (41.5%) pediatric research centers responded: 74,204 active studies were estimated, 29,078 (39%) included minors, and 6574 (23%) were “more than minimal risk.” Minors accounted for 0.7–2.87M research subjects. Pediatric medicine desperately needs a more accurate and reliable reporting system for tracking the recruitment, retention, and involvement of minors in clinical research.

ABSTRACT IMPACT: This work has begun to provide the foundation for better ensuring that translational research funded and supported by our IDeA-CTR grant is more directly addressing community- and stakeholder-authored health priorities. OBJECTIVES/GOALS: In order to effectively engage diverse, societal perspectives, we aimed to determine the relevance and feasibility of purposefully aligning translational research with health priorities adopted by the RI Department of Health, health-focused organizations, and community leaders. METHODS/STUDY POPULATION: Individuals from 27 community organizations in RI were asked, ‘What are your health related goals for your community’ and submitted responses online for 2 weeks. Participants generated 71 goals which they sorted into meaningful clusters and rated for importance and feasibility. Clusters were contrasted with RI health priorities to gauge alignment and saturation. In the next phase of this project, researchers and service users funded by Advance-CTR will be asked in routinely administered surveys how their current work may align with RI health goals and whether their future work can feasibly be connected to those priorities. RESULTS/ANTICIPATED RESULTS: Using Group Concept Mapping software, the 71 health goals identified by community organization representatives were fit into an 8-cluster model. Results suggested highest importance placed on Accessible & Healthy Housing (M=4.12, SD=0.29), Community (M=4.08, SD=0.28), Youth (M=4.04, SD=0.49) and Mental Health (M=4.03, SD=0.46). State agency priorities were found to overlap substantially with clusters defined by community leaders. We expect researchers will rate clusters differently, and find some community-endorsed health goals more relevant to their work than others. Perceived feasibility of tailoring future research to state health goals is expected to vary widely by item and researcher. DISCUSSION/SIGNIFICANCE OF FINDINGS: We intend to: 1) facilitate discussions about successes and challenges of translating community-authored priorities into research, and 2) foster better understanding between researchers and the communities they aim to serve on the role of CTR for addressing health challenges in the state.

ABSTRACT IMPACT: The goal of this evaluation study is to enhance the ability of the External Review Board to advise the CTSA at UTMB how to improve translational science activities. OBJECTIVES/GOALS: The purpose of this study is to evaluate the work of the External Review Board (EAB) for the Institute for Translational Sciences/CTSA at the University of Texas Medical Branch-Galveston. This evaluation is conducted through the perceptions of professional and community board members. The outcome consists of an inventory of best practices. METHODS/STUDY POPULATION: We collected data by means of semi-structured interviews with all eight member of the EAB. The interviews were conducted via telephone, lasted approximately 30 minutes each, and were audio-recorded with respondents’ permission. Respondents’ identities were held in confidence. The IRB at UTMB reviewed our study. The interviews were transcribed. The data were analyzed by means of an inductively-oriented, grounded theory approach (Charmaz, 2006). Emergent themes led to the formation of a series of best practices. RESULTS/ANTICIPATED RESULTS: Common concerns included the need for more extensive training for new members; circulation of the agenda before the meeting; and the value of more structured main leadership. The members generally agreed that the breakout groups were valuable because they encouraged them to engage in hands-on responses to practical problems. One of the key epistemological findings was the consensus view that the evaluation of the EAB should be an ongoing project, as opposed to a yearly task. This serious approach to evaluation would be conducive to a process analysis of the EAB, since medical, social, economic, and cultural conditions surrounding and influencing translational science are generally in flux (e.g., the COVID-19 pandemic and the various stages in the CTSA grant). Overall, the EAB experience was quite positive for them. DISCUSSION/SIGNIFICANCE OF FINDINGS: The strongest sentiment expressed in the interviews was that the CTSA at UTMB should focus and build on its strength--the science of team science--as opposed to any concerted search for weaknesses that the term “evaluation” occasionally implies.

Stakeholder engagement is increasingly expected by funders and valued by researchers in clinical and translational science, yet many researchers lack access to expert consultation or training in selecting appropriate stakeholder engagement methods. We describe the development of a novel Stakeholder Engagement Navigator webtool. We conducted an environmental scan and literature review, along with investigator interviews, surveys, and engagement expert facilitated group discussion. We formally reviewed and cataloged 29 distinct engagement methods. To develop the webtool, we used an iterative design process that followed Design Thinking phases: empathize, define, ideate, prototype, and test. As prioritized during user testing, the Stakeholder Engagement Navigator webtool both educates and guides investigators in selecting an engagement method based on key criteria. The V1.0 Navigator webtool filters methods first by purpose of engagement (noted by 62% of users as the highest priority criteria), then by budget, time per stakeholder interaction, and total interactions. The tool is available at DICEMethods.org. The Stakeholder Engagement Navigator webtool is a user-centered, interactive webtool suitable for use by researchers seeking guidance on appropriate stakeholder engagement methods for clinical and translational research projects.

Leveraging elements of game design and theories of human motivation, gamification provides a variety of techniques to engage learners in novel ways. Our Clinical and Translational Science Award created the software platform (Kaizen-Education©) to deliver gamified educational content in 2012. Here, we explore two novel use cases of this platform to provide practical insights for leveraging these methods in educational settings: (1) national training in rigor, reproducibility, and transparency and (2) attainment of learner competency (n = 7) as a gauge of curricular effectiveness across Master of Public Health degree tracks (n = 5). Data were captured in real time during player interaction with Kaizen-Education© to provide descriptive analyses of player engagement in both implementation examples. We then assessed item analysis to assess knowledge gain and competency attainment. We have just begun to leverage the potential for gamification to engage learners, enhance knowledge acquisition, and document completion of training, across various learning environments. We encourage a systematic approach to gamification applying insights from self-determination theory to learners and learning environments, a methodical approach to game design and rigorous analysis after implementation to generate evidence-based insights to maximize educational return for time invested.

ABSTRACT IMPACT: This paper reveals the myriad techniques that CTSA hubs use to support, promote and expand team science including many ways to involve the community, students, scholars and other multidisciplinary scientists. OBJECTIVES/GOALS: The Great CTSA Team Science Contest (GTSC) was developed in the NCATS Workgroup on Institutional Readiness for Team Science to collect stories describing the many ways hubs were promoting and supporting team science across the CTSA consortium. METHODS/STUDY POPULATION: Our qualitative data analysis examined the different designs from a high level - namely we categorized how many of the stories were competitions for pilot funding, training programs on team science competencies, communication skills training, workshops for educating community collaborators about research and/or training investigators about community-based research, advancing promotion and tenure for team science, etc. We discuss specific examples of different designs and who they were intended to benefit. RESULTS/ANTICIPATED RESULTS: Launched in July 2018, the contest received 170 submissions from 45 unique CTSA hubs. Qualitative analysis addressed the following questions about team science: 1) Who or what group championed it? 2) Who benefitted or who were the intended recipients? 3) What was the desired outcome? (e.g. team science skills, communication skills, getting the community involved, fostering new collaborations, expanding capacity for team science, etc.) 4) What method(s) did they use? 5) What translational science stage was addressed? DISCUSSION/SIGNIFICANCE OF FINDINGS: This analysis includes examples of team science research, resources or interventions including successful team dynamics and knowledge integration. This paper reveals the myriad techniques that CTSA hubs use to support, promote and expand team science including involving the community, students, scholars and other multidisciplinary scientists.

ABSTRACT IMPACT: This research is intended to provide researchers and clinicians information on factors that impact psychiatric health outcomes in a specialty perinatal mood disorders clinic. OBJECTIVES/GOALS: The present study seeks to examine factors that impact psychiatric outcomes at the University of Florida Department of Obstetrics and Gynecology Perinatal Mood Disorders Clinic (PMDC). METHODS/STUDY POPULATION: A hierarchical multinomial logistic regression will be conducted to evaluate predictors that may influence patients receiving a referral to specialty care, a return to primary care or being lost to follow up. Included predictors are changes in insurance status, baseline depression scores, and baseline obsessive-compulsive symptoms (OCS). A multinomial logistic regression will be conducted to determine if OCS and depressive symptoms predict referral to/establishment of psychotherapeutic care. A secondary binary logistic regression will be conducted to evaluate predictors that may predict reduction in depressive symptoms among women seen for more than one session. Included predictors of outcome include time (weeks in psychiatric treatment), OCS at baseline, and referral to psychological therapy. RESULTS/ANTICIPATED RESULTS: Data collection is multiphasic and ongoing via a retrospective chart review of patients seen in the PMDC. Hypotheses include that experiencing a change in insurance will significantly increase the risk of being lost to follow up, as compared to referral to specialty clinic or returning to primary care. It is also predicted that individuals with higher depressive symptoms or OCS will be more likely likely to be assigned to specialty care than to be lost to follow up or primary care. It is believed that greater time in psychiatric care, and lower OCS will increase the likelihood of reductions in depressive symptoms. DISCUSSION/SIGNIFICANCE OF FINDINGS: This study seeks to provide information on predictors that influence outcome this specialty clinic, while extending the limited literature that has examined the influence of OCS on depressive symptoms. It is the hope of the authors to provide information on intervenable factors that influence psychiatric outcomes in a perinatal specialty clinic.