Basic/Translational Science/Team Science
2015 Behavioral clinical trials: Considerations for design and conduct using the new NIH study protocol template
- Susan L. Murphy, Nancy Yovetich, Melissa Riddle
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- 21 November 2018, p. 52
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OBJECTIVES/SPECIFIC AIMS: (1) To discuss key differences of behavioral clinical trials from trials involving drugs, devices, and biologics and (2) to discuss NIH efforts to provide a study protocol template for use by investigators conducting behavioral clinical trials. METHODS/STUDY POPULATION: A working group was convened by NIH to refine the commonly used protocol template required for investigators conducting Phase 2 or 3 NIH-funded clinical trials. The committee met by phone regularly for 4 months to review, discuss, and refine each section of the template as needed to include aspects relevant to behavioral trials. RESULTS/ANTICIPATED RESULTS: The behavioral trial protocol template draft has been created and is being further modified by feedback from the research community. DISCUSSION/SIGNIFICANCE OF IMPACT: Use of the NIH behavioral trial protocol template is expected to enhance the quality of any behavioral study, because the template and supporting materials were developed with the unique aspects of behavioral research in mind.
2174 Building the next generation of translational researchers in health disparities
- Carlamarie Noboa, Zulmarie de Pedro-Serbía, Lourdes E. Soto de Laurido, Aracelis H. Chardon
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- 21 November 2018, p. 52
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OBJECTIVES/SPECIFIC AIMS: Translational research involves researchers’ teams working together to address health issues. However, successful translational researchers in health disparities require a set of competencies and skills. In order to increase the number of new minority investigators in translational research focused on health disparities, the Hispanics-in-Research Capability: SoHP & SoM Partnership and the Puerto Rico Clinical and Translational Research Consortium designed and implemented a webinar series “Fostering the Next Generation of Researchers in Health Disparities.” METHODS/STUDY POPULATION: From March 31 to July 14, 2017, this webinar series offered the theoretical perspectives of health disparities, research methodology specific to its study, and intervention strategies to address health disparities in communities through minority investigators. National and local interdisciplinary experts were the presenters. Participants’ experience and impact were assessed through a self-administrated questionnaire. RESULTS/ANTICIPATED RESULTS: A total of 78 minority investigators participated in this webinar. Overall, participants indicated that the webinar improved their knowledge and skills about health disparities research. DISCUSSION/SIGNIFICANCE OF IMPACT: Results guide the programs actions plans to enhance and support the translational researchers’ capacity. Diverse capacity building initiatives including peer-to-peer education, online course, tailored coaching, and other interventions have been designed to address researchers’ needs. This webinar was a pathway to build the next generation of translational researchers in health disparities.
2140 Clinical and translational research (CTR) platform for undergraduate health sciences programs (UHSP) at University of Puerto Rico-Medical Sciences Campus (UPR-MSC) and Universidad Central del Caribe (UCC): Pipeline for students and faculty
- Rubén G. García, Margarita Irizarry-Ramírez, Efraín F. Rivera, Carlamarie Noboa, José Moscoso-Álvarez, María E. González-Méndez, Mildred I. R. Vázquez
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- 21 November 2018, p. 52
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OBJECTIVES/SPECIFIC AIMS: The University of Puerto Rico-Medical Sciences Campus and Universidad Central del Caribe, through the Title V Cooperative Project, devised a clinical and translational research (CTR) platform to pipeline students/faculty of undergraduate health sciences programs into CTR. Educational interventions in CTR—introductory intervention (II) and Annual Symposium (AS)—were designed to promote awareness, stimulate interest of students and faculty in CTR. METHODS/STUDY POPULATION: In the II the participants (n=159) were surveyed before and after a presentation and panel discussion about CTR. In addition, after the sessions—plenary, panel, and workshop—about CTR, the participants of AS (n=42) were surveyed for satisfaction and learning experience in CTR. RESULTS/ANTICIPATED RESULTS: Most participants of the II, 134 (84.3%) were students. In total, 58 (58, 36.5%) completed the post II survey. Of these, 53.4% satisfactorily defined the CTR concept Versus only 31.0% that could define CTR in the pre survey, 47 (81.7%) were unable to identify a CTR researcher and 45 (78.3 %) expressed interest in learning about CTR. In total, 28 (28, 66.7%) participants of the AS completed the satisfaction survey, out of which 17 (60.6%) were students. One hundred percent (100%) agreed that the AS served as a vehicle to increase their knowledge in CTR. DISCUSSION/SIGNIFICANCE OF IMPACT: The educational interventions demonstrated to be an effective strategy to promote awareness and stimulate interest of students and faculty in CTR. In addition, the results obtained, provided valuable baseline information for the planning—development of training cycles in CTR.
2199 Critical and creative thinking course: Fundamental for a junior researcher
- Lourdes E. Soto de Laurido, Marie K. Norman, Doris Rubio
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- 21 November 2018, p. 52
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OBJECTIVES/SPECIFIC AIMS: Explain the difference between creative and critical thinking. Practice and enhance the critical thinking skills. Display innovative thinking through creative solutions and insights. Critically evaluate evidence in research. Think imaginatively, actively seeking out new points of view. METHODS/STUDY POPULATION: Offer an online course in Critical and Creative Thinking to junior researchers to improve their capacity to think and transforms their ideas in research questions and aims that bring new option to the field of clinical and translational research. Evaluate their improvement through evaluation forms and exercises that show their process to think imaginatively. RESULTS/ANTICIPATED RESULTS: The Scholars will understood the importance of critical and creative thinking in their careers, believed they could apply the insights and knowledge from the course in their grant and paper writing, recognized that they don’t always consider if they are being critical or creative in their thinking and actions. DISCUSSION/SIGNIFICANCE OF IMPACT: The course helped the participants to improve their capacity to think and saw a need to develop a more systematic thought processes in their life and work. The junior research will understand the difference between opinion, reasoned, judgment and fact and they will be able to judge the credibility of an information source using criteria such as authorship, currency and potential bias that can improve their grant submission and scientific writing skills.
2468 CTSI 500 Stars Initiative (CTSI of SE-Wisconsin)
- Doriel D. Ward, Orsolya Garrison, Chamia Gary, Memory Bacon, Tim Sobotka
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- 21 November 2018, p. 53
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OBJECTIVES/SPECIFIC AIMS: Our Goal is to enroll 500 students over 10 years into the CTSI 500 Stars Initiative. Student family members and community members are essential to career achievement and success; as such, the program also engages student families, along with key community members, as part of an Advisory Group, throughout the entire student experience. Besides programmatic and planning activities, students, family, and community members participate in our CTSI Community Engagement Science Café monthly series, where students may also present on a number of research and health-related topics of interest. The Advisory Group meets every 3–4 months in ensuring continuous engagement and overall program success. METHODS/STUDY POPULATION: Our Initiative takes both direct and supportive roles in offering 2 educational and training pathways; namely, our Summer Internship Program (6–8 wk duration) and our Students Modeling a Research Topic (SMART) Year-round Education Program (usually offered in Fall and Spring academic semesters) for high school students only. In the SMART Teams program, we work with regional public and private school districts to train science teachers, and assist them in developing and/or enhancing their science curriculum, thus creating pathways towards careers in translational science settings. Our aim is that students who participate in the year-round program (along with additional students) subsequently participate in our summer program. Therefore, overall program engagement is continuous throughout the year. In Summer, 2017 we engaged with well-established regional partners and collaborators (CTSI affiliated numerous public school districts, and community-based organizations) to move the translational workforce along existing regional diversity education and training pipelines. A Kick-off event was held on June 15, 2107 and attended by students and family members. We offered 6–8 weeks of hands-on experiences working with faculty researcher mentors and their research teams conducting real-life studies, in addition to professional experiences in research “support” settings, as well as in the community. We also developed established a “Summer” SMART (Students Modeling a Research Topic) Teams Program and a Summer “Advanced” SMART Teams Program, where a number of students were placed at 2 CTSI partner and collaborator institutions. The primary goal of the SMART Teams experience is to introduce students to translational science by building upon laboratory research to better understand clinical and community impact of disease within a patient population. Overall, internship sites included research labs, protein modeling labs, numerous research support settings, clinical care settings, and community sites for those students who were interested in population health sciences. In addition, students were offered career enrichment and professional development lunch and learn sessions, career panel sessions presented by long term, expert professionals in various fields translational science, and confidence building and networking sessions. Students also participated in a community volunteer day activity, a trip to the Chicago Science Museum, and numerous CTSI engagement activities (Science Cafés, simulation lab tours, etc.). RESULTS/ANTICIPATED RESULTS: The 2018 year-round program will initiate in the Fall. Our 2017 Summer Internship Program received 192 students/trainees applications of whom 133 were underrepresented minorities (URMs). We enrolled 109 participants, including 83 URMs (84 high school students and 25 college students). A total of 53 Wisconsin high schools and 19 colleges and universities (local and out of state) participated. Students engaged in all activities as outlined in the Methods section. At the end of the summer program, students created and presented posters as part of the closing ceremony. Certificates of completion were given to the students by program leadership and the Al Hurvis/ADAMM leadership (program funding agency). Students wore white lab coats to create an atmosphere of cohesion and accomplishment. Parents and other family members attended the closing ceremony, demonstrating strong support for students and the program. Our anticipated results for CTSI 500 Stars Initiative is to increase diversity in the Translational Science Workforce via education and training of 500 high school and college students over 10 years. We will also remain engaged and track student’s various venues for at least 10 years to determine the outcome of their experiences towards careers in Translational Science settings. We will continue to engage community members and community-based organizations as collaborators and advisors to participate in every stage of our activities. Moreover, we plan to broaden our reach by establishing additional relationships with additional high schools and middle schools to further enhance the 500 Stars Initiative. In addition, we will develop metrics by which to measure the validity and success of our program. DISCUSSION/SIGNIFICANCE OF IMPACT: The aim of the CTSI 500 Stars Initiative is to provide real-life, practical experiences in translational science settings as a part of our efforts to train and cultivate the translational science workforce, while also engaging patients, families and community members in every phase of the translational process. Targeting under-represented minority students contributes towards increasing diversity in the workforce. It is also our hope that by increasing URMs in the workforce, there will be positive impact on communities of color, with respect to increasing participation in their health care decision making and in clinical/translational research; thus, ultimately leading to better health outcomes in the communities we live and serve. Our overall framework is to engage, educate, enrich, empower, elevate, enable students towards careers in clinical and translational settings.
2515 Cure Quest: Teaching the complexities of drug discovery and development through an adventure game
- Benjamin Chang, Shawn Lawson, Kathleen Ruiz, Mei Si, Jeremy Stewart, Emilia Bagiella, Janice L. Gabrilove, Emma K. Benn
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- 21 November 2018, p. 53
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OBJECTIVES/SPECIFIC AIMS: “Cure Quest” is an adventure quest game for mobile tablets that aims to teach the player about the complexities of discovery and development of new medicines. The game instills a sense of wonderment into the learning process, taking the player to a world of magic where a mysterious condition has affected the land and they must follow the steps of the discovery and development process to find a treatment. METHODS/STUDY POPULATION: The game is being developed through a collaboration between faculty and students at ISMMS and the Games and Simulation Arts and Science Program at Rensselaer Polytechnic Institute. The first target audience is 2nd–3rd year medical students, with the future goal of adapting the game to a broader population. RESULTS/ANTICIPATED RESULTS: The game is currently in development, but the project has yielded insight into the design process for serious games in medicine. We found that for a game of this type it is essential not just to have both designers and subject matter experts, but to enable cross-pollination of modes of thinking. Through multiple design iterations and focus groups, we found that a game design approach rooted in narrative and allegorical abstraction would have a better ability to engage the target audience than one focused only on realistic simulation. When complete, we anticipate that the game will improve understanding of the core concepts in drug discovery. DISCUSSION/SIGNIFICANCE OF IMPACT: If successful, the game-based learning approach can help fill key gaps in current formal medical and scientific training, as well as gaps in understanding among the general public. The design process serves as an informative model of evolving collaborative team science.
2234 Developing the future translational science workforce at the University of Iowa
- James Torner, Beth R. Knudson, Kimberly Dukes
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- 21 November 2018, pp. 53-54
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OBJECTIVES/SPECIFIC AIMS: To evaluate the extent to which the curriculum delivered via an innovative program, the Early Scholars Certificate in Clinical and Translational Science (CCTS) at the University of Iowa (UI), develops a translational science workforce pipeline by increasing awareness of and interest in translational science as a career goal for highly prepared undergraduates. METHODS/STUDY POPULATION: The CCTS’s objective is to increase the awareness of the philosophy and tools of translational science and to incorporate critical evaluation and self-appraisal of the translational aspects of a scholar’s own research. CCTS is a 16-semester-hour (sh) academic certificate program introducing translational science concepts and careers to undergraduate students. The CCTS is a selective program with requirements including a minimum GPA, minimum sh completed, completion of course prerequisites, and already engaged and supported by mentored research. The curriculum includes electives in the area of their research interests (6 sh); graduate level Epidemiology (3 sh); Biostatistics (3 sh); and 2 core Translational Research courses (4 sh total). The first core course, an Introduction to Translational Research, is a survey course providing students the opportunity to learn how translational research is conceived and developed. It is designed to instruct the student how to interpret their research in a translational T1 to T4 paradigm. The program’s capstone course, Practicum in Translational Research, provides undergraduate students the opportunity to address how their research experience translates into clinical practice. Student’s spend the majority of this course’s contact hours in a shadowing experience with a clinician in the area of their research. Students reflect on this shadowing experience and its relevance to their academic and professional goals. The students also spend time developing skills in peer review—not only learning to provide constructive feedback to other research professionals, but also how to receive and integrate the feedback. The course includes a mock research fair where both UI faculty and classmates provide feedback that is later integrated into their capstone projects—a poster presentation at the UI Carver College of Medicine Research Fair as well as a final translational paper. As part of the ongoing evaluation of the program and graduates, we examined the participant data, the course satisfaction with content, the change in understanding of translational science, and the intention to incorporate translational science into research and career goals. We also conducted course evaluation surveys and qualitative analysis of a focus group and interviews. RESULTS/ANTICIPATED RESULTS: Since 2015, the CCTS program has introduced translational science curriculum to 20 undergraduate participants (men/woman 40%/60%; 5% Hispanic or Latino; 15% Center for Diversity and Enrichment Eligible). Areas of academic interest include: biology, genetics, engineering, bioinformatics, biochemistry, neuroscience, psychology, and microbiology. Graduates of the Certificate and degree program to date (n=8) have gone onto: Fullbright awards (1), medical school/Masters in public health (1), combined MD/PhD programs (2), biomedical PhD program (1), or currently work in translational science positions in industry (2). In questionnaire and focus group results, we found that in general, students reported increased understanding of the translational spectrum and felt the certificate program helped them clarify their educational or career goals. Data from both the focus group and the questionnaire demonstrate that students are strongly positive about the program in general, including its quality, faculty and guest speakers, structure, goals, opportunities, personality, and personnel. All students highly valued many elements of the program and each course, and particularly the opportunity for clinical shadowing. Among the questionnaire findings for 2016–17, all students (100%) rated program quality “excellent,” and 7 of 8 (87.5%) “strongly agreed” that they better understood translational science, that they saw themselves continuing in translational science research after graduation, and they were better able to communicate how their lab research fits within the translational spectrum. In each case 1 of 8 “agreed.” Participants also generally felt that their career goals had been affirmed or realigned, and that they were better able to communicate the meaning of translational science to multiple audiences. Responses on changes to career aspirations and plans were mixed, and are ambiguous. Questionnaire Item 4, “My UI curricular and/or co-curricular plans changed as a result of the CCTS program,” which had mixed responses, asked specifically about the CCTS program as a reason for change, but it is not clear if, whether, or how the program specifically wants to change curricular plans. In the focus group, students reported using their individual shadowing and lab experience in determining preferences and intentions about future career choices (e.g., whether or not to apply to medical school and/or pursue basic science research). Participants perceived the shadowing experience, complementing or contrasting their lab research, as particularly relevant in deciding about their future careers. Other themes that emerged from the focus group and/or open section of the questionnaire demonstrate the impact of various course elements on participants’ understanding of translational science and potential careers, including: quality of instruction, program and course content (including guest speakers, the shadowing experience, and the poster development process); the exposure to a range of possibilities along the translational spectrum and the expansion of ideas about what research could look like; the value of connections (to faculty, researchers and clinicians, and other CCTS students and alumni); the attributes of the cohort; and the “personality” of the program and personnel. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a pipeline for translational science workforce development has been problematic because a lack of the understanding of the need of translational research and a structuring a time efficient program for early career clinical and basic scholars. Undergraduates making critical decisions about educational paths and career goals and plans may not be aware of opportunities in translational science or the type of choices they need to make to prepare for such opportunities. Our data demonstrates that CCTS was an effective way of introducing translational science concepts and career paths to undergraduate students and potentially a powerful way to encourage them to consider these career paths. Participants in our program improved their knowledge of the field and expressed interest and intention to incorporate translational science training into their career plans. However, improvements can be made in the CCTS program. Additionally, CTSAs should consider ways to incorporate findings like these into a wider sphere of training to help develop and strengthen a translational science workforce for the future. The exposure to a variety of translational science career possibilities and specialties was important to students. Based on both focus group discussion and questionnaire data, a few students did expand slightly their sense of career possibilities, but the larger benefit may be their concrete experiences that validate or solidify their interests, making them more skilled at talking about and supporting their career goals on applications and in interviews. Shadowing did not always encourage students to go into clinical medicine, but often solidified interests or leanings students already had, giving them a more grounded basis for refining their decisions. For some students, shadowing a clinician confirmed ideas of being a physician; for others, it steered them away from it. Some now found ethical challenges, bureaucracy, or emotional challenges daunting or newly necessary to consider before focusing on clinical careers. This may be just what students need at this point, and emphasizes for them the relation between different kinds of research and application within translational science. Our evaluation suggests that CCTS contributes to academic choices for career development and additionally can help attract highly skilled students into TS research, including students of color. Future work to evaluate CCTS impact on graduates’ career outcomes will inform the translational research direction and content. In terms of program design, it could be useful to build in multiple opportunities for students to understand the diversity of translational science careers and provide students more exposure to different possibilities in clinical and translational work.
2346 Development of toolkits to support for researchers integrating dissemination and implementation science into their translational research
- Rachel Tabak, Enola Proctor, Ana A. Baumann, Alexandra Morshed, McKay V, B. Prusaczyk, D. Gerke, A. Ramsey, E. Lewis, S. Small, E. Kryzer
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- 21 November 2018, p. 54
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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.
2145 Drug formulation strategies: A vital but nearly invisible component in translational education
- Robert B. MacArthur, Roger Vaughan, Barry S. Coller
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- 21 November 2018, p. 54
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OBJECTIVES/SPECIFIC AIMS: To develop a KL2 curriculum on the science and art of drug formulation. METHODS/STUDY POPULATION: Develop training materials for KL2 scholars that outline the art of formulation development. Materials will include syllabi, reading materials, and course work. RESULTS/ANTICIPATED RESULTS: This will enhance the training of KL2 scholars by incorporating formulation development concepts into their human health enhancing research projects. DISCUSSION/SIGNIFICANCE OF IMPACT: For new chemical entities, formulation goals must be realistic and move along in a step-wise manner from the laboratory bench, through toxicology studies, and on to Phase 1 studies. By training scholars in phase-specific formulation goals, their interactions with funding agencies, formulation scientists, and regulators will be more efficient, productive, and successful. For those scholars who are working to improve existing treatments, introducing the concept of formulation improvements that can create new indications, or improve efficacy, safety and patient compliance will open up more possibilities for creative product development.
2526 E-learning for best practices in social and behavioral research: A multisite pilot evaluation
- Susan L. Murphy, Elias M. Samuels, Christine Byks-Jazayeri, Ellen Champagne, Jordan Hahn, Brenda Eakin, Robert Kolb, Linda S. Behar-Horenstein, Susan Gardner, Fanny Ennever, Mary-Tara Roth, Margarita L. Dubocovich
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- 21 November 2018, p. 55
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OBJECTIVES/SPECIFIC AIMS: To evaluate the NIH-sponsored Best Practices for Social and Behavioral Research e-learning course. METHODS/STUDY POPULATION: Four universities partnered in a pilot study to evaluate this new course. Outcomes from 294 participants completing the course included efficient progress through the training, perceived relevance of the course to current work, level of engagement with the course material, intent to work differently as a result of the course, and downloading digital resources. RESULTS/ANTICIPATED RESULTS: Participants rated the course as relevant and engaging (6.4 and 5.8 on a 7-point Likert scale) and 96% of respondents said they would recommend the course to colleagues. Qualitative analysis of participant testimonials suggested that most respondents had a readiness to change in the way they worked as a result of the course. Overall, results suggest participants completed the course efficiently, perceived outcomes positively and worked differently after the training. DISCUSSION/SIGNIFICANCE OF IMPACT: These results will inform new guidelines for future participants (e.g., average time to complete, expectations for knowledge checks in the training). Future studies should include larger samples and closer coordination and communication between study sites.
2292 Evaluating the impact of a K-award on clinical and translational research
- Elias M. Samuels, Thomas E. Perorazio, Ellen Champagne, Brenda Eakin
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- 21 November 2018, p. 55
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OBJECTIVES/SPECIFIC AIMS: Identify the impact of the provision of clinical and translational research training awards on investigators’ pursuit of clinical and translational research careers. METHODS/STUDY POPULATION: Propensity score matching and qualitative analysis/investigators receiving MICHR’s KL2 research training awards. RESULTS/ANTICIPATED RESULTS: While the evaluations of the impact of this service have shown participants find them to be valuable it is expected that participation in the workshop may be more beneficial to investigators with certain types of prior research experiences and who utilize more CTSA research support. DISCUSSION/SIGNIFICANCE OF IMPACT: Because this evaluation of a research service incorporate data representing investigator’s receipt of different CTSA resources, the findings can be used to inform the ongoing coordination of these services in ways that optimize their impact on the production of clinical and translational research. There is an enduring need for evaluations of CTSA programs to account for investigators’ use of different constellations of research services in order to identify what combinations of services over time are most effective at fostering successful clinical and translational research careers.
2242 Evaluation of a clinical investigation curriculum: Post-graduate outcomes
- Julie H. Shakib, Carol Sweeney, Jodi Cullum, Ruben Rocha, Anthea Letsou
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- 21 November 2018, p. 55
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OBJECTIVES/SPECIFIC AIMS: Many CTSA programs have implemented curricula leading to clinical investigation master’s degrees. Evaluation of long-term outcomes for graduates can support curriculum improvement. METHODS/STUDY POPULATION: We evaluated graduates 1–3 years post completion of an MS in Clinical Investigation at the University of Utah. We administered the 12-item Clinical Research Appraisal Inventory (CRAI-12) describing confidence in ability to perform research tasks; we derived 6 CRAI sub-scales. Additional questionnaire items assessed current engagement in research, including percent of effort devoted to research and level of involvement in research projects using specific research methods. RESULTS/ANTICIPATED RESULTS: Graduates reported high confidence for the CRAI domain of reporting, interpreting, and presenting (on a scale of 0–20, mean 17.9±SD 1.9) and the domain of conceptualizing and collaborating (16.5±2.2) on research projects; confidence was somewhat lower in the domains of planning (14.6±3.3) and funding (14.9±2.8) projects. Graduates’ estimated current professional effort devoted to research had a median of 32%, interquartile range (IQR) 20%–70%; among graduates with clinical responsibilities, median effort devoted to research was 23%, IQR 15%–45%. In total, 74% of graduates reported moderate or high involvement in research using existing large databases, 46% reported moderate or high involvement in comparative effectiveness research, and 54% reported moderate or high involvement in quality improvement. DISCUSSION/SIGNIFICANCE OF IMPACT: A majority of clinical investigation graduates remain engaged in research but most are able to devote less than one-third of professional effort to research. Evaluation of clinical investigation graduates who have moved into their research careers can inform program directors about domains of research expertise and methodological areas that may merit additional emphasis in the curriculum.
2513 Evaluation of the current status of urologic training programs in the delivery of transgender care
- Daniel Schoenfeld, Beth Drzewiecki
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- 21 November 2018, p. 55
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OBJECTIVES/SPECIFIC AIMS: Transgender individuals remain an underserved population with a unique set of healthcare needs. Given the recent increase in demand for gender affirmation surgery, there is a need to train urologists in the various aspects of surgical management of transgender patients. It is unclear how many urologic residency programs are participating in transgender care. In this study, we sought to determine the current status of urologic training programs in the delivery of transgender care and the sentiments regarding the current and future need to train urologists. METHODS/STUDY POPULATION: Between June and August 2017, a 22 item cross-sectional survey was emailed to all 138 program directors (PDs) as listed by the ACGME. Participation was voluntary and responses were anonymous. Statistical analysis was performed using SAS version 9.4. RESULTS/ANTICIPATED RESULTS: In total, 48 PDs completed the survey (36% of US PDs) and 1 declined to participate. All AUA regions had at least 25% representation, except the Western region (13%). In total, 42% of urology programs that responded participate in institutional transgender health programs; 76% of PDs believe there is a current or future need to train urology residents in the surgical care of transgender patients. PDs were significantly more likely to endorse a need for transgender training if their institution has a transgender health program (95% vs. 58%, p<0.005). Similarly, expressed interest in transgender care by trainees was associated with increased belief among PDs in the need for transgender training (95% vs. 58%, p<0.005). There was also an association between the presence of a transgender health program and trainee interest in transgender care (64% vs. 33%, p=0.04). Need for resident training in the following procedures was cited most often by PDs: complicated catheter placement (91%), orchiectomy (89%), urethral fistula repair (82%), penile/testicle prosthesis insertion (77%), phalloplasty (69%), vaginoplasty (66%), and metoidioplasty/urethral lengthening (54%). Despite the overall consensus that residents should be trained in transgender care, 83% of PDs responded that urologic transgender surgery should be trained in fellowship rather. DISCUSSION/SIGNIFICANCE OF IMPACT: There is an increased demand for surgeons competent in providing gender affirmation surgery. The majority of urology residency PDs believe in the need to train residents in the surgical care of transgender patients. A formalized curriculum for the urologic management of transgender patients should be instituted across residency programs to ensure adequate exposure and competency.
2358 Expanding our educational reach: Development of a massive open online course (MOOC)
- Nicole L. O’Dell, Eric Fredericksen, Sarah Peyre
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- 21 November 2018, pp. 55-56
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OBJECTIVES/SPECIFIC AIMS: Translational Science 101 aims to: (1) Orient the public to the field of clinical and translational science; (2) Provide a brief overview of each phase of translation (T0-T4); (3) Provide real-world examples of clinical and translational researchers and research projects that have directly impacted patients; (4) Provide learners with information on how they can become involved in clinical and translational science through many different avenues (study volunteer, student, faculty member, or study coordinator). METHODS/STUDY POPULATION: The primary audience for Translational Science 101 is the general public and media outlets who are interested in learning more about clinical and translational science and how this research is improving population health. The University of Rochester Clinical and Translational Science Institute created the course in order inform the public about the field of clinical and translational science, orient the public to the types of research that fall under the translational science umbrella, and demonstrate how translational research impacts populations. The Coursera Massive Open Online Course (MOOC) platform was selected to host the course in order promote the greatest level of exposure and also to expand the educational reach of the UR-CTSI to new external audiences. The course was constructed from scratch utilizing the Community of Inquiry (CoI) framework, an approach that is often utilized to guide the design and construction of asynchronous online coursework. CoI highlights the elements of social presence, cognitive presence and teaching presence as key factors impacting the educational experience learners have when enrolled in an online course. Discussion boards, embedded quizzes, and end of module quizzes were integrated in to the course design to promote learner engagement, collaborative learning, and interactions among learners. The “storytelling” instructional strategy is the backbone of the Introduction to Clinical Science modules, with various researchers from the University of Rochester Medical Center explaining their lines of research and how the research impacts patients and communities. Educational research has shown that there are many benefits to including storytelling in instruction (Green, 2004; Geanellos, 1996), including: (1) Stories create interest: The narrative structure increases learner interest and engagement as they are drawn in to a good story. (2) Stories create a more personal link between the learner and the content: Storytelling allows exploration of shared lived experiences without the demands of practice and allows students to make connections between the shared experiences and their own previous experiences and knowledge. (3) Stories provide a structure for remembering course materials: The inclusion of stories facilitates remembering because it is easier to remember a story rather than a list of disparate facts, and stories evoke vivid mental images which are an excellent cue for recall. (4) Stories are a familiar and accessible form of sharing information: Storytelling aids in overall learner understanding as it is a nonthreatening way of sharing information. Storytelling can also enhance course discussions as students feel more at ease discussing a story than discussing abstract or new concepts that they are still in the process of mastering. RESULTS/ANTICIPATED RESULTS: Introduction to Translational Science was launched on October 16, 2017, and is automatically scheduled to begin a new session every 3 weeks. To date the course has reported the following analytics: (1) 2308 learners have visited the course page, (a)476 learners have enrolled in the course; (b) 244 learners are currently active in the course; (c) 11 learners have completed all of the requirements of the course. (2)Learners by Continent, (a) North America 31%; (b) Asia 30%; (c) Europe 23%; (d) Africa 9%;(e) South America 5%; (f) Oceania 2%. (2) Learners by Country: Learners have come from 84 different countries from around the world. The 15 highest enrollment numbers are: (a) USA 25%, (b) India 11%, (c) Egypt 3.7%, (d) United Kingdom 3.4%, (e) Mexico 3.2%, (f) Brazil 2.8%, (g) China 2.8%, (h) Saudi Arabia 2.2%, (i) Spain 2.2%, (j) Germany 1.7%, (k) Russian Federation 1.7%, (l) Malaysia 1.5%, (m) Turkey 1.5%, (n) Italy 1.5%, and (o) Canada 1.5%. (3) Gender: 48% women and 50% men. (4) Age: (a) 13–17: 0.72%, (b) 18–24: 19.6%, (c) 25–34: 44%, (d) 35–44: 14.4%, (e) 45–54: 8.6%, (f) 55–64: 7.2%, (g) 65+: 3.6%. (5)Highest Education Level o Doctorate Degree: 17%; (a) Professional School Degree: 14%; (b) Master’s Degree: 31%; (c) Bachelor’s Degree: 27%; (d) Associate’s Degree: 2.3%; (e) Some College But No Degree: 4.5%; (f) High School Diploma: 3.8%; (g) Some High School: 0.75%. DISCUSSION/SIGNIFICANCE OF IMPACT: The Massive Open Online Course (MOOC) platform offers new, exciting opportunities for CTSA institutions to create courses and trainings that are accessible by learners all over the world. This greatly expands the educational reach that the CTSA education programs can have, moving beyond hub-focused or consortium-focused education to a much broader audience. The expansion of educational reach can promote increased visibility of the CTSA program, encourage collaborations amongst researchers at different institutions, and also inform the public about clinical and translational science, potentially fostering advancement opportunities.
2503 First year medical student characteristics associated with readiness to talk about race
- Brooke Cunningham, Rachel Hardeman, Samantha Carlson
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- 21 November 2018, p. 56
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OBJECTIVES/SPECIFIC AIMS: Calls to break the silence around the effects of racism on health are growing. Few researchers have examined the relationship between medical student characteristics and students’ comfort, motivation, and skill to discuss racism. This paper examines medical student characteristics associated with readiness to talk about racism among first-year medical students at the University of Minnesota. METHODS/STUDY POPULATION: In February 2017 prior to a lecture on racism and health, we invited first year medical students to participate in a web-based survey about their experiences and comfort discussing racism. We calculated descriptive statistics and measured differences by student race (White vs. Asian vs. Black/multiracial/other) and undergraduate major type (STEM vs. non-STEM) using χ2 tests for variables with categorical responses and generalized linear regression models with pairwise comparisons (i.e., 2-sample t-tests) for variables with continuous responses. RESULTS/ANTICIPATED RESULTS: (n=107/163). The majority of students were male (53%); White (75%); and majored in STEM majors in college (85%). College major was not associated with race. Students’ responses to multiple items suggest that the vast majority perceived racial inequality as a major problem in the United States. Race was significantly associated with only 1 of these items. Specifically, 100% (16/16) of Black/multiracial/other students [under-represented minority (URM) students] reported “too little attention” is paid to race and racial issues, while only 53% of White students (42/79) and 55% of Asian students (6/11) chose this response. Students with non-STEM majors and students who identified as URM students reported talking about racism with friends more often than STEM majors and white students, respectively. In conversations about race at school, two-thirds of students were concerned that they might unintentionally offend others or be misunderstood. However, non-STEM majors and URM students were significantly less worried that they would unintentionally offend others in conversations about race at school than STEM majors and white students. Larger percentages of URM students (50%) than White students (25%) were afraid that others would not respect their views because of their race. White students were more afraid that they might that they would be called racist than URM students. DISCUSSION/SIGNIFICANCE OF IMPACT: Many students find it challenging to discuss race and racism in medical education settings. URM students and non-STEM majors reported greater frequency talking about racism with friends and appear to be less anxious in conversations about racism than White students and STEM majors respectively. Given non-STEM majors' greater psychological safety discussing racism, future research should explore whether non-STEM majors are better prepared and more motivated to address racial disparities in health and health care than STEM majors. Such research could have important implications for medical school admissions.
2426 Fostering cross-disciplinary research: Lessons learned from STTEP-UP
- Hannibal Person, Adjoa R. Smalls-Mantey, Oluwasheyi Ayeni, Dagmar Hernandez-Saurez, Emma K. T. Benn, Emilia Bagiella, Janice L. Gabrilove
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- 21 November 2018, p. 56
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OBJECTIVES/SPECIFIC AIMS: N/A. METHODS/STUDY POPULATION: N/A. RESULTS/ANTICIPATED RESULTS: N/A. DISCUSSION/SIGNIFICANCE OF IMPACT: There is an increasing need to foster cross-disciplinary research to address complex problems within healthcare. The Sinai Team-based Translational Education Program: the URM Propeller (STTEP-UP) is a NCATS funded program through the Icahn School of Medicine at Mount Sinai. Its goal is to facilitate URM post-doctoral trainees becoming innovative leaders in clinical and translational research. The program includes a team-based research component, where fellows collaborate on a project. This year, disciplines represented by the four fellows include Cardiology, Psychiatry, Neurology, and Pediatrics. Identifying a clinical question and designing an investigation was facilitated by group brainstorming meetings with program mentors. Fellows designed a project to identify medical testing and prescribing that were not clinically indicated throughout the healthcare system, with the goal of exploring whether an intervention, including provider education, could reduce ordering practices. In addition to regular in-person meetings, a licensed virtual learning environment and free web-based sharing platform were used to foster collaboration. Challenges faced throughout this process, included fellows struggling to find protected time, difficulties accessing broad sets of data across the healthcare system, and overcoming administrative barriers between departments. Strengths of this approach, included fellows learning new research strategies and feeling a deeper sense of commonality with their peers. Overall, this experience supports the idea that cross-disciplinary research improves the collaboration and education of emerging researchers. However, addressing logistical and systems-based barriers may better facilitate this education and research.
2136 Frequently overlooked challenges of pragmatic trials
- Rodger S. Kessler
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- 21 November 2018, pp. 56-57
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OBJECTIVES/SPECIFIC AIMS: To review the multiple differences between traditional research design and on the ground pragmatic trials. To review two pragmatic projects, identify core assumptions and to contrast assumptions with the reality of conducting T3 and T4 research. METHODS/STUDY POPULATION: Observational mixed methods multi trial review of large multi site implementations. RESULTS/ANTICIPATED RESULTS: The complexities of implementation on the ground were consistently greater than anticipated and required changing assumptions and research design elements. DISCUSSION/SIGNIFICANCE OF IMPACT: Research findings are tremendously influenced by design and design implementation decisions. Anticipating the scope and breadth of the challenges will assist potential of successful implementation.
2237 From bedside to benchmarks: A physician-scientist workforce dashboard for biomedical research institutions
- Adrienne Zell, Lindsey Smith, David Yanez, Jeanne-Marie Guise, David Ellison
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- 21 November 2018, p. 57
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OBJECTIVES/SPECIFIC AIMS: A growing concern about the declining physician-scientist workforce prompted the 2014 National Institutes of Health (NIH) Physician Scientist Workforce to recommended that “tools for assessing the strength of the biomedical workforce” be developed. To aid strategic planning, the Oregon Clinical and Translational Research Institute convened key stakeholders at its home university, Oregon Health and Science University (OHSU), to survey the local landscape of physician scientists. Surprisingly, few consensus methods were available to measure and benchmark OHSU with respect to national comparators. To address this deficit, we sought to develop clear and objective metrics describing physician-scientist success at our institution. By focusing on local funding, we were able to generate more complete and robust data than others have reported. These data also permit us to compare ourselves to the national workforce, using well-curated and accessible national databases. The goal of the analyses is to contribute to strategic decision-making by portraying the local physician-scientist workforce, comparing it to the national landscape, and making recommendations about mechanisms to address potential opportunities. This has led us to develop a simple quantitative dashboard, which now permits OHSU to craft strategic targets and address successes and opportunities. These approaches are likely to be valuable elsewhere. METHODS/STUDY POPULATION: OHSU is a medium-sized academic health center in Portland, Oregon with over 1200 principal investigators and over $230M in NIH funding. The primary focus of our investigation was physician-scientists who receive extramural funding. To align with other analyses, we distinguish physician-scientists with an M.D. only, or with an M.D. and a master’s degree, from physician-scientists who hold an M.D./Ph.D. For this distinction, we use the indicator “M.D.-only” to indicate the former. The study design consisted of (a) selection of available and relevant national level data on the physician-scientist workforce, (b) curating of local level data to align it with the national indicators, (c) comparing the 2 sets of data to look for differences in trends over time, and (d) supplementing the analyses with additional local data not available at the national level. Key comparisons were tested for statistical significance and plotted on a dashboard, which was then reviewed by an OHSU internal working group focused on physician-scientists. Data elements included degrees, age, gender, and grants awarded. National data come directly from the NIH Data Book, updated for fiscal year 2016. The NIH makes all funded project data available in the publicly downloadable ExPORTER Data Catalog. These project data were used to supplement the summarized data available from the NIH Data Book, allowing us to extract OHSU investigators and to complete the K to R comparative analysis. For analyses of OHSU investigators holding funding other than RPGs, we relied on institutional data from the OHSU grants and contracts office. Demographic data on OHSU investigators were obtained from departmental and human resource records. The time period for these analyses was 1998–2016. RESULTS/ANTICIPATED RESULTS: At OHSU, as nationally, there has been an increase in RPG-holding Ph.D.s but not in RPG-holding physician-scientists. At OHSU, nearly three-fourth of physician-scientist RPGs hold an M.D.-only degree, compared with nationally, where nearly half of physician-scientists are M.D./Ph.D.s. The percent of younger, early-career, RPG-holding physician-scientists has declined precipitously at OHSU and nationally. At OHSU, the percentage of RPGs held by women physician-scientists is below the national figure. Funding sources for physician-scientists at OHSU were more diverse than for Ph.D. scientists, and physician-scientists comprise the majority of Principal Investigators on clinical trials. These non-RPG sources of funding remain a critical source of support, although local analyses of time spent on research indicate that physician-scientists with NIH funding spend a greater percentage of their time on research than those without. OHSU PI’s have had success in transitioning from K08 and K23 grants to R-level grants, with similar percentages receiving RPGs within 5 years. A dashboard comparing these trends was developed. DISCUSSION/SIGNIFICANCE OF IMPACT: There were 3 key impacts from our analyses. First, we developed and disseminated a dashboard with both local data and national comparators. Second, in consultation with institutional leadership, we selected target values to define success for each metric. Third, we recommended actions that will help OHSU meet the selected targets. A major accomplishment of this structured approach has been the identification of opportunities for change that were not recognized previously. For example, leadership was not aware of the substantial and growing deficit in female physician-scientists at OHSU, compared with the impressive increases nationally. Thus, to reduce gender disparity at OHSU, we have recommended purposeful recruitment; one approach is to target female graduates of Medical Scientist Training Programs for faculty positions, as this group has better success at achieving R-level funding than do M.D.-only applicants. Another outcome is to help set ambitious but reasonable targets for improving the local landscape. Thus, we aim to reduce the average age of RGP-holding physician-scientists at OHSU by one year during the next 5 years. Although reversing current trends will not be easy, our analyses suggest that the average age of RPG level physician-scientists at OHSU would decrease were OHSU were to match the national-level proportions of women and M.D./Ph.D. physician-scientists. In addition to targeting gender disparities, we have recently implemented a program that supplements funding for recruiting young physician scientists, and then supporting their pursuit of RPG funding. Locally, a bright spot is the K to RPG transition rate for K23 awardees, which compare favorably with national data, an outcome that we plan to maintain. In analyzing this area of success, one reason is our strong mentorship program, called OCTRI Scholars, which is provided through our CTSA-sponsored institute. This has fostered an atmosphere of success among young physician-scientists and is one of the reasons that we endorse recommendation #9 from the PSWR, suggesting that Clinical and Translational Science Award (CTSA) Institutes play pivotal roles in monitoring and enhancing the success of the physician-scientist workforce. Thus, several perceived deficiencies might be addressed with adjustment of 1 or 2 specific institutional policies. While the specific opportunities and strengths may be different at other institutions, our proposed dashboard, which couples publicly curated, freely accessible databases, with readily available institutional resources, should help institutions to set and achieve their own goals.
2518 InCHOIR learning lab: A TL1 and workforce development initiative at Mount Sinai
- Emma K. T. Benn, Janice L. Gabrilove, Layla Fattah, Emilia Bagiella
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- 21 November 2018, p. 57
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OBJECTIVES/SPECIFIC AIMS: Science and clinical practice are widely regarded as being complementary and synergistic. In an effort to enhance the team science, translational research capacity of the TL1 scholars at Icahn School of Medicine at Mount Sinai (ISMMS), the InCHOIR learning lab aims to provide an accessible, workforce-wide lecture series on the fundamental methods and concepts of randomized clinical trials. METHODS/STUDY POPULATION: The InCHOIR learning lab is a monthly 1 hour lecture series delivered by a range of expert clinical and translational researchers, followed by a 1 hour “Meet the Expert” session. The InCHOIR lecture series has covered a wide range of topics including, but not limited to: Decision Models; Race and Causal Inference; Innovative Strategies for Assessing Environmental Health across the Life Course; Statistics for Geneticists and Genetics for Statisticians; and From the Lab to Translation to Policy—The Neuroscience of Addiction. The “Meet the Expert” session offers TL1 predoctoral and postdoctoral scholars and KL2 scholars the opportunity to have intimate, informal discussions with experts about their career trajectories. RESULTS/ANTICIPATED RESULTS: Feedback from participants has been overwhelmingly positive. Participants have gained important insights into key topics relevant to early stage researchers. The “Meet the Expert” sessions have yielded honest and important conversations about crucial topics ranging from finding effective mentors to essential strategies for establishing a work-life balance, to overcoming adversity as underrepresented minorities and women in translational research. DISCUSSION/SIGNIFICANCE OF IMPACT: Attendance at the InCHOIR learning lab is increasing month on month, indicating the perceived need for this learning not just from early stage researchers, but also from students, senior faculty, and research staff more generally. The InChoir series provides added value through the creation of a video library, fostering new collaborations and contributing to the Icahn School of Medicine at Mount Sinai and Graduate Medical Education landscape. Priorities for the program are to increase internal visibility, in order to continue to grow attendance by MSHS students, research staff, nurses, postdoctoral fellows and residents. The program is also exploring how to engage external participation from regional CTSAs and from community advocates actively involved in community-academic research partnerships.
2517 Learning to LEAD: Leadership emerging in academic departments
- Janice L. Gabrilove, Cara D. Ventura, Layla Fattah, Elizabeth Howell, Michele Fredericks, Lisa Bloom, Byron Cryer, Helen Yin
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- 21 November 2018, p. 58
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OBJECTIVES/SPECIFIC AIMS: Leadership is an essential and recognized team science competency. Modeled after the successful LEAD (Leadership in Emerging Academic Departments) program at University of Texas Southwestern (UTSW), ConduITS LEAD Program is designed to: (1) provide personal and professional development opportunities for participants; (2) promote organizational change through applied leadership skills; (3) provide a platform for integrating multiple disciplines and fostering interprofessional relationships among investigators and clinicians. METHODS/STUDY POPULATION: The 1-year structured LEAD program curriculum includes monthly interactive seminars covering: personal and situational leadership; unconscious bias; communication and influence; navigating personal conflict; negotiation and networking; selecting and managing the right team; teamwork; financing the academic mission, budgets and business plan development; strategic planning and vision; presentation skills. To foster the development of leadership skills participants engage in Hogan Assessments, individual and peer mentoring from an executive coach and self-directed learning activities and assignments. Completion of an individual Capstone leadership project empowers learners to enact practice change through the implementation of leadership concepts in practice. RESULTS/ANTICIPATED RESULTS: In collaboration with the Office of Academic Enrichment & Development (OADE), the first competitive RFA was issued in November of 2016. In total, 63 applications were received including: gender: 29 M: 34 F; URM: 10; Degrees: M.D. (40); Ph.D. (11); M.D./Ph.D. (6); M.D./M.P.H. (3); M.D./M.S.C.R. (2); PharmD (1); Departments: 19; Institutes/Centers: 12; MSHS: 3 sites. Through a competitive and rigorous application process, 24 junior faculty with evidence of leadership potential and trajectory were chosen to participate. The current cohort of LEAD participants joined in February 2017, and will complete the program in January 2018. Using qualitative and quantitative survey methodology, participants will be evaluated for self-reported change to attitudes, belief, skills and development of new relationships and collaborations. Submitted Capstone projects were mainly focused on implementing situational and personal leadership concepts to practice, with one additionally focused on the use of behavioral interviewing techniques to optimize team building and teamwork. At the time of abstract submission 30% of the cohort has implemented their Capstone project in practice. Participants will be followed-up in 6 months’ time to evaluate the impact of the LEAD program on their practice. Following a second RFA, 24/52 candidates have been selected as our next cohort, and will start in February 2018. DISCUSSION/SIGNIFICANCE OF IMPACT: Leadership is known to be a core component of team science, and the ability to implement leadership into practice may advance personal and professional change. This program addresses the need to empower Junior Faculty to engage in leadership in practice. In addition, this program is able to provide added value to extend the reach of the OADE, promote new individual collaborations and facilitate additional leadership training efforts at our Institution. Future collaborative studies will focus on common outcomes as well as institutional differences between these 2 CTSA institutions.