OBJECTIVES/SPECIFIC AIMS: This study sought to determine the accessibility, utilization, and preference for mobile phone use among a marginalized population of teens enrolled in an adolescent substance abuse treatment program and their parents. Specific study aims were to: (1) characterize mobile phone use, (2) assess the accessibility and reliability of mobile phone usage, (3) determine specific barriers to mobile phone use, and (4) examine parent and teen perceptions of the utility of integrating communication technology in substance use treatment. METHODS/STUDY POPULATION: In total, 103 (78.6% female; 75.7% Hispanic) parents of teens participating in an outpatient substance abuse treatment program with an average age of 42.60 (SD=9.28) participated in our study. Upon enrollment in a substance abuse treatment program between October 2014 and July 2016, parents completed a technology use survey as part of program development and a chart review of clinic outbound calls to parent mobile phones was completed to evaluate reliability of parent mobile phone access throughout treatment. Survey collection among teens is ongoing. Study population information for teens will be presented at the conference. RESULTS/ANTICIPATED RESULTS: The vast majority of parents owned a cell phone and used it as their primary phone (97.1%); 83% of parents owned smart phones in particular, with the majority being Android phones (68.7%). Parents were more likely to have pay-as-you-go (41.4%) and yearly (32.3%) contracts, and only 15% of the sample endorsed changing their phone number more than once in the past year (64%=never; 21%=once). Parents reported using several of the phone features: text (97%), email (76%), pictures (93%), and accessing the internet (92%); 92% reported they did not have a texting limit; and the most popular use of the mobile phone was to send and receive text messages (58.6%), followed by accessing the internet (19.2%). During the course of a 10-week treatment program, the clinic made 2776 confirmation phone calls to parents who completed surveys. Report of accessibility matched the clinic’s ability to reach parents. Of the 2776 calls, 97.2% were made to the original number provided, which was in service. Only 2.7% were determined to be disconnected, with the median number of days for disconnected service being 2 days with no voice and no texting capabilities (range=14) and 2 days with no voice, but with texting capabilities (range=28). In terms of parent perceptions of the utility of integrating communication technology in substance use treatment, 91% of parents reported they would be receptive to receiving text messages with parenting tips as aftercare support. Preferred content areas included: strategies for monitoring teen substance use (56%), strategies for using consequences (62%), suggestions for encouraging positive activities (62%), and ways to improve parent-child communication (63%). Accessibility, utilization, and preference for mobile phone use in a treatment program among teen respondents will be presented at the conference. DISCUSSION/SIGNIFICANCE OF IMPACT: This study characterized both subjective and objective mobile phone accessibility and usability among teens participating in an adolescent substance abuse treatment program and their parents. This study also provides information on teen and parent perceptions of using mobile phones during the aftercare period and ratings of acceptable messages following treatment. This data will help researchers design mobile-based interventions both during and after treatment, which is the future direction of our research group.

OBJECTIVES/SPECIFIC AIMS: Translating conventional and regenerative medicine strategies from the research laboratory into the clinic is a complex process that can delay bringing novel therapies to the patient. Navigating the increasingly complex regulation surrounding cell-based and combination product technologies is a major challenge for the translational biomedical scientist. To this end, Mayo Clinic created a new position, the “Translational Integrator,” as part of the cGMP Biomaterials Facility in the Center for Regenerative Medicine. METHODS/STUDY POPULATION: The Translational Integrator educates investigators about FDA standards and regulatory pathways; determines where the product is on the translational spectrum; works to understand the science behind the product; determines what additional studies may be needed; supports investigators in preparing for FDA communications and submissions; and educates researchers about institutional resources and funding mechanisms needed to move their product into manufacturing and trials. A primary objective is to meet investigators at an early stage in product development to avoid conducting potentially redundant work to meet regulatory requirements. RESULTS/ANTICIPATED RESULTS: Robust training in clinical and translational research methodology enables the integrator to facilitate the collaboration necessary between investigators, clinicians, institutional resources, regulators and funders to move products towards FDA IND/IDE approval and first-in-human trials. It is an iterative process using technology/translational readiness criteria, project management and review by subject matter experts that is highly interactive and customized to each project. Current projects include topics in orthopedic surgery and ENT. In creating and refining this position, several key lessons have been learned. DISCUSSION/SIGNIFICANCE OF IMPACT: First, the Translational Integrator must undergo constant reflection and assessment of investigator needs, which requires flexibility and understanding that their role may change in the context of each product. Second, the support that the Translational Integrator provides can shift the mindset of the investigator from being averse to engaging in the translational process to eager to move their product forward. Finally, for the investigator who does not personally want to move their work into first-in-human trials, establishing connections to intellectual property generation and licensing may support movement of their findings into patients.

OBJECTIVES/SPECIFIC AIMS: To improve the quality of evidence synthesis projects, including systematic reviews and other comparative effectiveness reviews, at the University of Utah. METHODS/STUDY POPULATION: Systematic reviews and other types of evidence syntheses are best when collaborative teams with expertise in multiple disciplines participate, including content experts, librarians and information specialists, systematic review methodologists, and statisticians. The Center for Clinical & Translational Science (CCTS), due to its interdisciplinary nature, connectivity to clinical experts, and existing Cores of methodologists, presented an opportune location for a Systematic Review Core. We designed the Systematic Review Core to focus on 2 primary aspects of evidence synthesis support: overall systematic review methodology guidance and in-depth information retrieval planning and execution. After establishing a conceptual partnership, a new position, Evidence Retrieval and Synthesis Librarian, was created to build capacity within the Core. RESULTS/ANTICIPATED RESULTS: Close connections with the CCTS’s Population Health Research Foundation have led to better interdisciplinary coverage of systematic reviews and other evidence syntheses produced by the University of Utah. We are able to partner with statisticians and clinical experts from formulating the question to completing the final manuscript. Hourly rates charged through a cost recovery model have enabled us to grow our staff able to work on the Core, as well as offset costs for major databases and resources these bibliographic data-heavy research methods require. After 1 year of existence, the Core is already at maximum capacity, with no sign of slowing. Projects have ranged from brief consultations to highly intense interactions for the duration of the research spectrum. We have also been added as key personnel to grants with systematic review components. DISCUSSION/SIGNIFICANCE OF IMPACT: Systematic reviews and other evidence syntheses are a labor-intense, interdisciplinary team effort that fit well within the scope of CTSA’s. They are a key component of the translation of science to practice, and can be used at all stages of the translational science spectrum. Quality of systematic reviews remains poor, particularly surrounding protocol development, sensitive search strategy design and reporting, and overall reporting. Librarians and information specialist involvement has been shown to positively correlate to the search strategy design and reporting aspects of systematic reviews, and librarians and information specialists increasingly act as systematic review methodologists. By including librarians and information specialists as part of the CTSA’s official Core structure, these systematic review methodologists are able to connect with statisticians, other methodologists, and clinical experts in a nexus of interdisciplinarity. At the University of Utah, the visibility and structure provided by the CCTS helps the Systematic Review Core with promotion, creating connections and opportunities for collaboration across the campus. This partnership has already led to increased uptake in services, and over time, we believe it will increase the quality of the science produced. CTSA’s have a natural partner with their health science library colleagues in translational science, as shown by this model.

OBJECTIVES/SPECIFIC AIMS: In this study, we propose to investigate effectiveness of 2 core services provided by the Center for Clinical and Translational Science (CCTS), home for CTSA program in the School of Medicine at the University of Utah. METHODS/STUDY POPULATION: We will apply a longitudinal database of research and tenure track faculty (n>600) in the School of Medicine at the University of Utah from 2006 to 2016 to estimate the effect of initial usage of the biostatistics and clinical services cores of the University of Utah CCTS on the probability of (a) ≥1 peer reviewed publication, (b) external grant funding, and (c) academic promotion within 1, 2, and 3 years after the initial contact. We will apply a “new users” design (Hernan et al., Epidemiology, 2008; 19: 766–779) to compare the outcomes of faculty initiating use of the 2 CCTS cores Versus faculty without prior use of these cores in a series of cohorts defined by the calendar year of initial contract with the 2 cores, with covariate adjustment performed within each cohort to account for measured confounders. Separate outcome models will be specified for each cohort, but the statistical models will be fit to stacked augmented data sets which include the data from each cohort. Using the stacked data set, results will be pooled across each of the cohorts to increase statistical power. Robust sandwich estimates of standard errors will be used to account for the inclusion of multiple assessments for each faculty member. RESULTS/ANTICIPATED RESULTS: Estimates of the effect of initiation of new CTSA usage on academic productivity outcomes will be obtained, and provided in conjunction with sensitivity analyses to address the potential impact of uncontrolled confounding. DISCUSSION/SIGNIFICANCE OF IMPACT: The proposed evaluation strategy should overcome some of the biases inherent in typical metrics for effectiveness of CTSA programs, and will be applied to evaluate success of future initiatives.

OBJECTIVES/SPECIFIC AIMS: Skillful research staff members are critical to productive translational research teams and yet their ongoing professional development is rarely formally addressed. Through the Strategic Teamwork for Effective Practice-Mentor Development Program (STEP-MDP), we aimed to both create a community of practice (COP) for research staff and build the skills needed to enhance research team performance. METHODS/STUDY POPULATION: We selected 16 participants of 32 staff-level applicants from among the NYU Schools of Medicine, Social Work and Nursing for the first STEP-MDP cohort. Participants included research assistants, coordinators, managers, and directors. We delivered 3, two-hour workshops, scheduled 3 weeks apart, focused on team communication, identifying team areas for improvement, and mentorship/coaching skills. Peer-Coaching Teams (PCTs) were created by pairing participants at the same position level, and PCTs worked together at each session to explore and practice learned skills. Sessions featured brief didactics, group-based learning and exercises based on participants’ real issues. A variety of active learning techniques such as brainstorming, role-playing, problem solving, and peer coaching were used. Practical core readings, worksheets, and summary cards were provided. PCTs met between sessions to practice coaching skills, and troubleshoot problems. RESULTS/ANTICIPATED RESULTS: Participants (n=16) completed a 37-item retrospective pre/post self-assessment of team behaviors and skills, and a STEP-MDP evaluation survey at the end. We saw pre-post improvements in each of 5 self-assessment domains: Communication (4 items, pre-mean 2.66, post mean 3.36, p≤0.001), Leadership (8 items, pre-mean 2.76, post mean 3.55, p≤0.001), Empowerment and Motivation (12 items, pre-mean 2.86, post mean 3.51, p≤0.001), Coaching (6 items, pre-mean 2.40, post mean 3.58, p≤0.001), and Community (3 items, pre-mean 2.33, post mean 3.76, p≤0.001). On average, PCTs met twice (range 2–4 times) between workshop sessions. Learners valued the PCTs, and 1 commented on the value of working with peers in PCTs, having no one in a similar position within his immediate work environment. Participants’ written comments strongly endorsed the value of the workshops for their work, with the coaching skills session seen as the most valuable. Some participants worry that skills will decrease over time without continued reinforcement. All but 1 participant reported that they planned to continue with the PCT. DISCUSSION/SIGNIFICANCE OF IMPACT: The number of applicants to our program suggests a need and motivation for staff to participate in the STEP-MDP. Participants’ reported improved skills and sense of community. To maintain the COP and address worry about degradation of skills we are planning to remind PCTs to meet once a month and will follow-up with them 3 and 6 months post intervention to evaluate their continued development. This spring a second cohort will receive the training. We believe developing these core teamwork skills will lead to more collaborative, efficient, and innovative research. We have implemented a successful program targeting critical members of research teams with potential to facilitate expansion of institutional capacity for translational research. It will be important to understand the long-term impact of the program on individuals, on team science, on research, and ultimately on the health of the public.

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

OBJECTIVES/SPECIFIC AIMS: This report describes the evolution of scientific culture since the NIH/translational science (TS) mandate. The transition of the conduct of science to an increasingly translational model involves 2 dimensions of change. The first dimension consists of change in the structure and process of scientific work, in terms of factors such as funding, administration, application of new knowledge, and so forth. The second dimension consists of change in culture of scientific work. The culture of science is the set of values, assumptions, meanings, and traditions that inform the conduct of science. As part of the comprehensive evaluation of TS at the University of Texas Medical Branch-Galveston, we have monitored the status of the culture of science there through a sociological framework. We focused on the ways the changing culture of science facilitates and/or inhibits creative and effective medical research. We argue that the long-term success of TS is dependent upon the evolution of assumptions, everyday practices, and taken-for-granted ways of conducting research. Culture also provides meanings for who its people are and helps us define who we are to ourselves (ie, self-concept). In terms of the scientific enterprise, self-identity provides the motivation to participate in group activities or to be content with being a “lone ranger” researcher; the orientation to be either a leader or a follower; the security to take creative chances with one’s work or to simply conduct “normal science”; and the sense of esteem for being the best or simply doing one’s job. TS requires a constant “reengineering” of its total enterprise. Consequently, we raised the following research questions: (1) What is the traditional culture of science at UTMB? (2) How has the culture of science at UTMB changed since the introduction of the Clinical and Translational Science Award project? (3) What has been the relationship between the culture of science and the conduct of science at UTMB since CTSA? (4) How have cultural influences on self-concept changed? METHODS/STUDY POPULATION: Data have been collected by means of ongoing 1-on-1 interviews with CTSA participants at all levels; observations of lab and classroom interaction; participation in organizational and planning committees; and other everyday organizational activities. RESULTS/ANTICIPATED RESULTS: Following the grounded theory method of qualitative analysis and discovery, we found 3 stages of cultural change. Stage 1 is Cultural Invasion of the existing culture at UTMB by the implementation of the CTSA project. Stage 2 is Cultural Accommodation by which internal responses to change follow the normal scientific paradigm. Stage 3 is Cultural Expansion by which the organizational and cultural platform for conducting science has expanded regionally, nationally and cross-disciplinarily. DISCUSSION/SIGNIFICANCE OF IMPACT: Whether a distinct fourth stage emerges depends on such factors as funding and programmatic directives from NIH; the tension between research and clinical demands for resources; and the emergence of junior investigators schooled on the principles of TS.

OBJECTIVES/SPECIFIC AIMS: Biostatistics and Epidemiology courses within clinical research or public health training programs are typically developed and taught separately. As a result, students may have trouble in their research outside the classroom, where biostatistical and epidemiological concepts must be well integrated. Case method teaching is a participant- and discussion-centered pedagogical approach that has been used in business and law schools for more than 50 years to improve student learning, yet has taken longer to be adopted in health professional schools. The case method is distinguished by presenting learners with a real-world problem without a single unique solution. Designed to mimic the constraints and incomplete information found in real life, it is an ideal approach for integrating multiple related disciplines. A team of Clinical and Translational Science (CTS) faculty from the Tufts CTSI collaborated to develop a new course that integrates epidemiology and biostatistics disciplines using the case method. METHODS/STUDY POPULATION: We developed an intermediate-level, case-based course integrating epidemiology and biostatistics topics using modern, real-world clinical examples. Recognizing the importance of technical skill building, this intermediate-level Tufts CTS course adopted a hybrid approach, incorporating lecture and in-class laboratory exercises, alongside cases. We surveyed CTS faculty to identify a set of core methodological competencies. These included randomized trials, case-control and cohort studies, confounding, effect modification, propensity scores, linear and logistic regression, and survival analysis. Faculty provided us with clinical questions and deidentified data sets corresponding to these competencies; we also reviewed publicly available data sets. RESULTS/ANTICIPATED RESULTS: CTS faculty collaborated to develop 10 cases (with accompanying data sets) from modern clinical research examples that illustrate the connections between epidemiology and biostatistical concepts. Each case contains a background section, a statement of the core problem, a data set with data dictionary, articles from the primary literature (often the publication of the data set) with discussion questions and in-class lab exercises (R programming). One case presents students with the challenge of whether acupuncture may be an effective therapy for pain associated with chronic headache. Through case activities, students gain experience weighing observational Versus experimental evidence, apply directed acyclic graph theory, and analyze clinical trial data. Qualitative evaluations in 2015 (pilot year) and 2016 indicate students preferred the integrated approach to separate courses, and found the integration facilitated application of methods to their independent research projects. Significant rewards for faculty include cross-disciplinary collaboration, sharpened teaching skills, and engaging with learners in a dynamic classroom environment. DISCUSSION/SIGNIFICANCE OF IMPACT: Despite administrative and pedagogical challenges, a case-based, integrated curriculum offers rewards for faculty and students. The case method may be a useful pedagogical strategy to integrate other closely related topics or courses in translational science to better prepare scholars for the challenges of independent research.

OBJECTIVES/SPECIFIC AIMS: Describe the process used to develop job descriptions and how this translates into consistent hiring practices. Describe how competencies are used to provide transparency into professional development opportunities. Discuss planned incorporation of competencies into efforts to train the clinical research workforce. METHODS/STUDY POPULATION: These processes were developed at Duke, an academic medical center with over 2000 active clinical research protocols and 300 new clinical trials per year. Over 1000 employees were evaluated for mapping into clinical research positions, with 685 mapping into new research positions (makeup of workforce to be depicted). RESULTS/ANTICIPATED RESULTS: Prior to this initiative, the clinical research workforce was not well-defined. Through the mapping process, employees were mapped from over 80 different positions into 10 (figure), resulting in a workforce that allows for visible career ladders and greater opportunity for development. As the initiative evolves and grows to include competency-driven performance evaluations, training modules, and assessments, we anticipate the ability to see the relationship between the competencies and high-quality clinical research support. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of competencies in the context of workforce development is not new, yet in clinical research, they provide a much-needed framework for an ever-evolving profession. This comprehensive use of competencies throughout a workforce development initiative is key to ensuring strong support of high-quality clinical research.

OBJECTIVES/SPECIFIC AIMS: We aim to leverage our analysis of the scientific collaboration network at a research university to design an innovative pilot program and foster scientific productivity. We test the impact of creating a new collaboration in a research community, which decreases the average network distance and accelerates the diffusion of information and expertise among the community’s investigators. METHODS/STUDY POPULATION: We mapped the whole network of co-authorship on publications and co-participation on extramurally awarded grants at the University of Florida (UF) between 2013 and 2015. We used network science methods to identify research communities of investigators who have consistently worked together and/or have other collaborators in common with at least one researcher based in the UF Health Science Center. We selected pairs of communities with (i) similar productivity levels, research interests, and network structures and (ii) no research projects in common. Communities in each pair were randomly assigned to a treatment or control group. In each treatment community, we selected 1 pair of investigators who had not collaborated in the past 3 years and whose connection would maximally reduce average network distance in the community. The pair was provided with an economic incentive to collaborate for the submission of a CTSA pilot proposal. RESULTS/ANTICIPATED RESULTS: We successfully identified 15 pairs of treatment/control communities. In each of 8 treatment communities, a pair of potential collaborators agreed to participate in the intervention. DISCUSSION/SIGNIFICANCE OF IMPACT: Network-informed Clinical Translational Science Awards (CTSA) pilot programs can identify research communities and create innovative collaborations. Statistical experiments can establish the programs’ causal effects on scientific productivity.

OBJECTIVES/SPECIFIC AIMS: HIV is a chronic disease that affects the immune system. HIV+ people live more thanks to effective antiretroviral treatments. The scientific data demonstrate that HIV+ is associated to the cognitive impairment presented in the 50% of the patient. The objective of this study is to determine the correlation between emotional dysfunction and perceived stigma in HIV+ women and its effects HIV-associated neurocognitive disorders (HAND). METHODS/STUDY POPULATION: HIV+ women will be recruited form the Hispanic Longitudinal Cohort and evaluated questionnaires for emotional dysfunction and stigma, neuropsychological tests, and MRI. RESULTS/ANTICIPATED RESULTS: We anticipated that women with HIV+ will experience higher levels of emotional dysfunction (ie, fear) and perceived stigma when compared with the control group. Women with HIV infection will present an association between emotional dysfunction most like fear and perceived stigma when compared with the control group. This correlation will be associated with HAND. The women with HIV infection will present circuit integrity dysfunction associated with emotional dysfunction and perceived stigma as determined by DTI and connectivity (MRI). DISCUSSION/SIGNIFICANCE OF IMPACT: HIV stigma and emotional dysfunction have a negative impact in quality of life (QOL). This effect can be improved with several treatment interventions with eventual improvement in adherence, emotional control, and QOL.

OBJECTIVES/SPECIFIC AIMS: Knowing how to deliver culturally responsive care is of increasing importance as the nation’s patient population diversifies. However, unless cultural competence is taught with an emphasis on self-awareness (Wear, 2007) and critical consciousness (Kumagai and Lypson, 2009) learners find this education ineffective (Beagan, 2003). This study examines how physicians perceive their own social identities (eg, race, socio-economic status, gender, sexual orientation, religion, years of experience) and how these self-perceptions influence physician’s understandings of how to practice culturally responsive care. METHODS/STUDY POPULATION: This exploratory study took place at a university in the Intermountain West. We employed a qualitative case study method to investigate how academic physicians think about their identities and approaches to clinical care and research through interviews and observations. In total, 25 participants were enrolled in our study, with efforts to recruit a diverse sample with respect to gender and race as well as years of experience and specialty. Transcriptions of interviews and observations were coded using grounded theory. One major code that emerged was defining experiences: instances where physicians reflected on both personal and professional life encounters that have influenced how they think about themselves, how they understand an aspect of their identity, or why this identity matters. RESULTS/ANTICIPATED RESULTS: Two main themes emerged from an analysis of the codes that show how physicians think about their identities and their approaches to practice. (1) Physicians with nondominant identities (women, non-White) could more easily explain what these identities mean to them than those with dominant identities (men, White). For example, women in medicine had much to say about being a woman in medicine, but men had barely anything to say about being a man in medicine. (2) There was a positive trend between the number of defining experiences a physician encountered in life and the number of connections they made between their identities and the manner in which they practiced, both clinically and academically. It appeared that physicians who have few defining experiences made few connections between identity and practice, those with a moderate number of experiences made a moderate number of connections, and those with many experiences made many connections. Physicians who mentioned having many defining experiences were more likely to be able to articulate how those experiences were incorporated into their approaches to patient care. DISCUSSION/SIGNIFICANCE OF IMPACT: (1) According to literature in multicultural education, those with dominant identities do not think about their identities because they do not have to (Johnson, 2001). One privilege of being part of the majority is not having to think about life from a minority perspective. This helps to explain why women and non-White physicians in this study had more anecdotes to share about these identities—because they have had defining experiences that prompt reflection on these identities. (2) We propose that struggles and conflict are what compel physicians to reflect on their practice (Eva et al., 2012). Our findings suggest that physicians are more prepared to apply what they have learned from their own identity struggles in delivering culturally responsive care when they have had more opportunities to reflect on these identities and situations. Findings from this study have implications for transforming approaches to medical education. We suggest that medical education should provide learners with the opportunity to reflect on their life experience, and that providers may need explicit instruction on how to make connections between their experiences and their practice.

OBJECTIVES/SPECIFIC AIMS: To conduct a preliminary evaluation of the Social and Behavioral Research Best Practices Course. METHODS/STUDY POPULATION: Learners are sampled from 5 institutions: University of Michigan, University of Rochester, University of Florida, Boston University, and University of Buffalo. Learners who take the course and consent to be in the study receive a web link to a survey immediately after course completion and at 2–3 months follow up. In addition to demographic information, learners will report their perceptions of usefulness and relevance of the course to their job, their satisfaction with the course and associated job aids, and at follow-up, if and how the course impacted their work. Additional information will be collected from the learning management systems which host the course at each institution. The data collected will include the number of participants who take the course, the number who complete, how many times the course was attempted, and pass rates. RESULTS/ANTICIPATED RESULTS: We anticipate that several hundred learners will take the course by the end of our project. Of learners who agree to participate in the survey, we anticipate that they will find the course useful and relevant to social and behavioral clinical trials and will be satisfied with the course. Information including suggestions about missing content, items or content that were not extremely clear, or any other comments will be collected to iterate and expand the course. DISCUSSION/SIGNIFICANCE OF IMPACT: This course was developed to fill a gap in training in good clinical practice for social and behavioral research. An evaluation of how the training provided in the course impacts the jobs of learners is needed both to ensure that the most relevant information is included in the course as well as to identify ways that the training may contribute to the quality and safety of social and behavioral clinical trials.

OBJECTIVES/SPECIFIC AIMS: Compare effectiveness of a patient case-based, interactive teaching approach that included optional student genotyping with traditional didactic teaching strategies for increasing students’ knowledge and ability to effectively use pharmacogenomic data in clinical decision making. METHODS/STUDY POPULATION: The UF College of Pharmacy offers a required Personalized Medicine (PM) course for pharmacy students as well as an elective course, Clinical Applications of Personalized Medicine (CAPM). Students dual enrolled in the PM and elective CAPM courses comprised the intervention (INT) group, with interactive patient case-based teaching and the option to undergo personal genotyping, whereas students enrolled in PM alone comprised the control (CTR) group, which primarily used a traditional didactic teaching format and did not include personal genotyping. Both groups completed a pre- and post-course patient case-based test (15 questions/1 point each) to evaluate their knowledge and abilities to apply genotype and other patient-specific data to drug therapy recommendations. Pre- and post-course test scores for knowledge were compared between the INT and CTR groups using the Student t-test. RESULTS/ANTICIPATED RESULTS: In total, 52 students completed surveys (INT group, n=21; CTR group, n=31). Race was similar between groups, but there were fewer females in the INT compared with CTR group (8 vs. 22, p=0.02). Pre-course knowledge scores did not differ between INT and CTR groups (6.8±2.2 vs. 6.3±1.6 respectively, p=0.34), however, post-course scores were significantly higher in the INT Versus CTR group (10.0±2.3 vs. 7.5±1.7, p<0.0001). DISCUSSION/SIGNIFICANCE OF IMPACT: There have been significant advancements in the clinical applications of pharmacogenomic and genomic data, however, barriers to routine clinical adoption of genomic medicine persist. Developing education and training methods that equip practitioners to effectively translate genomic data into evidence-based clinical recommendations has been identified as a key strategy to overcome such barriers. Our data suggest that a personalized medicine course that employs patient-centered, case-based teaching strategies and includes optional personal genotyping for students compared with traditional didactic instruction improves students’ knowledge and abilities to apply pharmacogenomic data in practice-based scenarios. These results can inform future strategies for educating healthcare professionals on the clinical use of pharmacogenomic and genomic data.

OBJECTIVES/SPECIFIC AIMS: The first goal of this project is to test the reliability and validity of an objective structured clinical exam (OSCE) that was designed to assess competency in clinical and translational research. The second goal is to evaluate the impact of MICHR’s Summer Research Program on the participating trainee’s competency development. METHODS/STUDY POPULATION: The methodology used for this study was reviewed and exempted from oversight by the U-M Institutional Review Board (HUM00113293). The participants in the study include 17 pre-doctoral students in health professions programs at U-M who participated MICHR’s Summer Research Program. The Research OSCE was administered using a pretest, post-test design. The pretest was administered once during the 1st week of program in the Summer of 2016 and the post-test during the 10th week of the program. The Research OSCE was proctored and rated by trained staff members. We will assess the reliability of the Research OSCE using Generalizability Theory (Webb et al., 2006). And the construct validity of the Research OSCE will be tested using factor analysis and other statistical analyses. Growth in the competence of the trainees participating in the Summer Research program will be evaluated by testing for significant differences between their pretest and post-test scores. RESULTS/ANTICIPATED RESULTS: We anticipate that this study will show that the Research OSCE is a reliable competency assessment with proven construct validity. We also anticipate that the use of the Research OSCE will show the trainees participating in the Summer Research program experienced a gain in competence during the course of the 10-week program. DISCUSSION/SIGNIFICANCE OF IMPACT: This project uses a common and standardized testing approach. The primary goal of this project is to evaluate the reliability and validity of an OSCE to assess competency in clinical and translational research. It represents a new application for a well-studied testing method used extensively in the health professions to assess the clinical competency of health practitioners. This project will lead to a better understanding of (a) the reliability and validity of the Research OSCE designed to test research competency and (b) the effectiveness of the Summer Research Program curriculum in better preparing participants to conduct clinical and translational research. Showing how a specific competency assessment can be used for this purpose will provide the administrators, evaluators, and other stakeholders of clinical and translational research training programs with information that can be used to design more rigorous and relevant evaluations of their research training programs.

OBJECTIVES/SPECIFIC AIMS: More partial nephrectomies are performed every year as a surgical treatment for kidney cancer. However, this procedure remains technically challenging. Surgeons require a substantial number of cases before their performance plateaus. No established practice mode exists; thus, there is a need for training models to simulate real tumor excisions and kidney suturing. In this study, we seek to validate these silicone models using multiple simulations with urologists of different training levels. METHODS/STUDY POPULATION: We created silicone renal tumor models using 3D printed molds of a patient’s kidney with a mass. Medical students, urology residents, fellows, and attending surgeons are recruited to perform simulated partial nephrectomies on these models. Four trials are performed with a da Vinci surgical robot on 2 different days. We are evaluating surgeon performance and improvement using validated measures as well as operation-specific metrics. Operation-specific metrics include renal artery clamp time and surgical margins. Validated measures of self-assessed operative demand (NASA TLX) and reviewer-assessed surgical performance (GEARS) are also recorded across trials. RESULTS/ANTICIPATED RESULTS: The preliminary results of 2 medical students, 10 urology residents, 3 endourology fellows, and 2 attending urologists are reported here. Model face validity was evaluated on a 0–100 sliding scale anchored at unrealistic and realistic. Mean results thus far are 77.7 for overall feel, 82.7 for needle driving, 75.6 for cutting, and 73.2 for visual representation. Between trials 1 and 4 there was a mean reduction of 3.26 minutes in renal artery clamp time, and a 75% reduction in positive margins. There was a reduced incidence of positive surgical margins with advanced training stage. Fellows, residents, and medical students had positive tumor margins in 25%, 50%, and 75% of their trials, respectively. We expect to recruit 15 additional subjects for this study. Upon completion of data acquisition, more robust statistical comparisons and measures will be reported. DISCUSSION/SIGNIFICANCE OF IMPACT: Face validity measures indicate the model adequately represents reality. Preliminary data suggest improved surgical performance over the course of the training and better performance in urologists of higher training levels. This model may have potential for broader application and integration into minimally invasive surgery training programs.

OBJECTIVES/SPECIFIC AIMS: Stakeholder and community engagement (SCE) is a national priority for the National Center for Advancing Translational Science (NCATS). An established framework for stakeholder engagement exists for the latter stages (T2-T4) of translational, but no such framework currently exists for early stages of translational science (T1). Four Clinical and Translational Science Award (CTSA) hubs launched a collaboration to develop a new framework for engaging communities and stakeholders in T1 research. METHODS/STUDY POPULATION: We led structured individual and group discussions with T1 investigators to learn about: (1) the health decisions they seek to inform with research evidence, (2) the actors who make those decisions, and (3) the individuals and organizations that are affected by those decisions. In total, 18 individuals connected to 4 CTSA hubs participated in the discussions. Participants came from the fields ranging from basic chemistry and drug development to infectious disease and pediatrics and represented both methodological and topical experts. Focus groups lasted, on average, 1 hour, were audio recorded. Interviews lasted ~30 minutes. Audio recordings were transcribed and deidentified, and transcripts were coded using Dedoose™. We used a deductive-inductive procedure to develop the framework for stakeholder engagement in T1 research. A deductive codebook was development from the focus group and interview guides; emergent themes were added and the codebook was revised after preliminary inductive analysis. Two coders analyzed all transcripts using a constant comparison approach. We used an inductive process to identify themes and form them into a framework that could be used by T1 researchers in their work. The framework was developed through sequential reviews with coauthors and research participants. RESULTS/ANTICIPATED RESULTS: Preliminary findings suggest that stakeholders in early stage translational research (T1) do not fit into the same framework as those further down the translational spectrum (T2-T4). Basic scientists can identify stakeholders, however, and would like more guidance on who, how, and when to engage them in their research. DISCUSSION/SIGNIFICANCE OF IMPACT: By showing T1 researchers how to identify and involve their stakeholders in (1) defining research questions, (2) carrying out research activities, and (3) disseminating research evidence, this work has the potential to improve the use of basic science evidence in latter stages of translation from bench to bedside.

OBJECTIVES/SPECIFIC AIMS: Provide an innovative, integrative, and interdisciplinary training program which will leverage a unique and internationally recognized strength of BU and establish an environment that facilitates translational team science interactions with MD scientists and clinicians, thereby synergistically bridging research strengths with interdisciplinary approaches. METHODS/STUDY POPULATION: This overall mission of the RMTP is pursued through 2 independent aims. Aim 1: Provide an innovative, integrative, and interdisciplinary training program which will leverage a unique and internationally recognized strength of BU. Aim 2: Establish an environment that facilitates translational team science interactions with MD scientists and clinicians, thereby synergistically bridging research strengths with interdisciplinary approaches. To achieve these aims, we have developed a specialized didactic curriculum that is fully integrated in graduate school training and can be shared for the benefit of others outside of the BU community. We are also developing online iPSC practicum workshops for more efficient distribution of didactic content. Interdisciplinary team science approaches to stem cell research related to cures for human diseases are fostered across investigators across diverse hubs at BU, BU Medical Center, the Charles River Campus and the Framingham Heart Study. All methodology, data and materials are provided in a transparent and open-source manner to benefit the greater scientific community and ensure rigorous reproducibility. RESULTS/ANTICIPATED RESULTS: As a nascent TL1 training program, we are just arriving at the end of our second year. At this point, 5 out of a total of 11 appointed trainees have concluded RMTP support, all of whom have transitioned into biomedical science-related pursuits; 2 predoctoral trainees were awarded F31 fellowships, 2 postdoctoral trainees were awarded career transition grants (K99/R00 and LERN fellowship), and 1 postdoctoral trainee became a Senior Scientist at a Biopharmaceutical company. Given the quality of our trainees and their RMTP mentors, we anticipate that close to 100% of those supported by this mechanism will continue their career development in the biomedical sciences. DISCUSSION/SIGNIFICANCE OF IMPACT: Implementation of the RMTP TL1 would not only serve to increase the capacity of trainees within the CReM, but would also extend the scope of regenerative medicine research to other CTSI-participating hubs and more broadly to other scientific disciplines.

OBJECTIVES/SPECIFIC AIMS: To improve translational research, we have developed a program called Duke Multidisciplinary Education and Research in Translational Sciences (Duke MERITS). Duke MERITS will facilitate cross-disciplinary collaboration among faculty involved in foundational, clinical and/or health care research and in turn also prepare them to train the next generation of translational researchers. METHODS/STUDY POPULATION: The program aims are (1) to define metrics and outcomes measures so faculty can track their progress and identify impact of their collaborative research in translational sciences; (2) to offer a multi-modal faculty development series to promote team science, improve didactic teaching, and incorporate innovative resources to promote interdisciplinary approach to translational research; (3) to provide module-based hands-on-training sessions in bench to bedside research and training in translational grant writing to facilitate the development of multidisciplinary research collaborations. The present study describes results from Aim 1 and includes (a) development of baseline outcome assessment tools necessary to gauge the impact of our programs on both the participating faculty and the research culture within Duke University, (b) impact of a specific course offering in Translational Medicine. In order to achieve this, we conducted multiple focus group sessions with faculty self-identified as junior-, mid-, or advanced-career, a mixed group at any career level and included a group of graduate students and postdoctoral trainees to study the impact of a graduate level course in Translational Aspects of Pathobiology. The activities during these translational science focus groups were designed to define what successful translational science is, to determine what resources support translational Science at Duke, and to decide what resources we need in order to enhance Duke’s position as a leader in research and scientific education. RESULTS/ANTICIPATED RESULTS: We identified that translational science is changing standards while incorporating leadership, teamwork, collaborations, and movement primarily focusing on the overall goal of improving all aspects of health. Participants categorized their field of study and the fields of their coparticipants most frequently as basic discovery and a combination of intervention and health services. The most frequently identified pros/benefits of performing translational science at Duke include industry connections, collaborations with other departments resulting in disciplines being bridged, improving patient care, and access to resources as well as money. The most frequently identified cons/barriers of performing translational science includes the expensiveness, silos, and lack of resources willing to absorb risks. DISCUSSION/SIGNIFICANCE OF IMPACT: The identification of these defined factors from the focus groups has allowed us to issue a comprehensive, sliding Likert scale-based anonymous survey from the secure RedCap system and is being rolled out throughout Duke University, including schools of medicine, nursing, Trinity, biomedical engineering. We envision that Duke MERITS education program will facilitate interprofessional efforts, which we define as a team science approach to identify the clinical “roadblock” and then seek an innovative approach or technology to help overcome this “roadblock”? It can facilitate institutional and departmental recognition in faculty career development. The common goal is to gain fundamental new insights that will result in significant improvement of the existing “standard of care” and meet the challenges of dwindling extramural support.

OBJECTIVES/SPECIFIC AIMS: Addressing Disparities in Asian Populations through Translation research (ADAPT) is a community-research partnership funded by the Tufts Clinical Translational Sciences Institute (CTSI). Founded in 2011, this collaborative brings together 7 Chinatown-serving community-based organizations and academic researchers with the goal of improving health for the local Chinatown community and beyond. The goal of this research project was to document the best practices, lessons learned, and process through which ADAPT has developed and grown. The aim of this project is to disseminate the model to other CTSAs who are currently engaged in METHODS/STUDY POPULATION: We used a combination of qualitative interviews and content analysis to gather data on the evolution of ADAPT over the last 5 years. Current members from both community organizations and the university/medical center were interviewed about their experiences participating in ADAPT. When possible, interviews were recorded and transcribed verbatim. Deidentified transcripts and administrative documents including meeting minutes, conference summaries, bylaws, and mission statements were coded using Dedoose analytic software. RESULTS/ANTICIPATED RESULTS: Established community-based participatory research (CBPR) principles, including mutual respect, transparency, and commitment, are viewed as necessary, but not sufficient. Patience—both with other members and with the group as a work in progress—is highlighted as being a necessary characteristic of participants. Time and funding are 2 of the most important resources, and the majority of members agree that there is no substitute for “skin in the game.” Attempts at last minute, opportunistic engagement were provided as examples of what had not worked. One ongoing tension is the balance between process and product. Individual members are beholden to organizations to different degrees, and the need to produce something in the form of publications or grant money can limit the amount of time members can commit to the collaborative. At the same time, these products are unlikely to materialize if members are not invested in the process of growing and sustaining the collective. DISCUSSION/SIGNIFICANCE OF IMPACT: Out of the 7 community organizations who currently participate in ADAPT, only 1 is explicitly focused on health in the traditional sense. The others are primary service organizations, but because they understand the impact of the social determinants of health on the local community—including housing, employment, education, nutrition, among other factors—the research collaborative is able to leverage the knowledge and expertise of the academic researchers and the community partners to focus on health topics most salient to the local Chinatown community.