OBJECTIVES/GOALS: To evaluate the FAITH! (Fostering African-American Improvement in Total Health) App mHealth lifestyle intervention by using post-intervention feedback obtained from participants in our intervention pilot study. METHODS/STUDY POPULATION: We used qualitative methods (focus groups) to elicit post-intervention feedback. Participants who completed the pilot study were recruited to one of two focus groups. Semi-structured focus groups were conducted to explore participants’ views on the app functionality, utility and satisfaction as well as its impact on healthy lifestyle change. Sessions were audio-recorded, transcribed verbatim and qualitative data were analyzed by systematic text condensation thematic analysis. RESULTS/ANTICIPATED RESULTS: Nine individuals participated (N = 4 and N = 5) in each of the two focus groups. Their mean age was 47.9 years (SD 12.1), 67% were women, and all had at least an education level of some college. Six overarching themes emerged from the data: (1) overall impression, (2) content usefulness (3) formatting, (4) implementation, (5) impact and (6) suggestions for improvement. Underpinning the themes was a high level of agreement that the intervention facilitated healthy behavioral change through cultural tailoring, multimedia education modules and social networking. Among the suggestions for improvement were streamlining of app self-monitoring features, personalization based on individual’s cardiovascular risk and attentiveness to nuanced cultural perspectives. DISCUSSION/SIGNIFICANCE OF IMPACT: This formative evaluation found the FAITH! App mHealth lifestyle intervention had high reported satisfaction and impact on the health-promoting behaviors of African-Americans, thereby improving their overall cardiovascular health. The findings provide further support for the acceptability of mHealth interventions among African-Americans. CONFLICT OF INTEREST DESCRIPTION: None.

OBJECTIVES/GOALS:

• To improve and expand health and research literacy throughout Indiana by sharing health-focused resources and research outcomes.

• To encourage and increase health research participation throughout Indiana by promoting health research opportunities, including clinical studies.

METHODS/STUDY POPULATION:

• Discover and understand community concerns and barriers to good health and clinical research participation by providing a platform for individuals and communities to share their voices.

• Educate Indiana residents on the importance of participating in health research.

• Engage with the community to meet them where they are (online) and continue to build relationships throughout the state.

• Promote healthy living for Indiana residents by sharing health education and resources from existing state health organizations and initiatives.

• Develop and maintain the largest statewide database of research volunteers.

RESULTS/ANTICIPATED RESULTS:

• The anticipated results from this program include engagement of all populations and all communities throughout the state in conversation and education around good health and health research, as well as participation in health research across the CTSI’s partner organizations. Large-scale growth is expected in both the online community and consented volunteer registry is expected to include and engage racially and ethnically diverse populations, as well as special health populations, such as representatives of rural communities, aged, rare disease survivors, and transgender individuals.

DISCUSSION/SIGNIFICANCE OF IMPACT:

• Thorough this work, the Indiana CTSI has developed a unique program, educating the public about health research and opportunities to participate, while simultaneously supporting research departments with marketing promotion of their efforts, and a ready statewide volunteer community.

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

OBJECTIVES/GOALS: Aims 1&2: Develop (1) and implement (2) online, guided self-help intervention for ED psychopathology and weight reduction. Aim 3: Follow-up to track remission of ED psychopathology and symptoms and WL maintenance at end of treatment and 6-months. METHODS/STUDY POPULATION: N = 60 college students meeting criteria (clinical/sub-clinical binge-type ED with BMI > 25) will complete a baseline survey and then will be randomized into a condition. Students in the intervention group (n = 30) will be offered 8 weeks of an online, guided self-help intervention for ED and WL. Students in the control group (n = 30) will receive an email message to seek support from Student Health Services. All participants will receive follow-ups 9 weeks and 6 months after baseline. Data analysis will compare Eating Disorder Examination Questionnaire (EDE-Q) scores and WL (change in BMI) at all three time-points. Group comparisons will be assessed via two-way mixed-model ANOVA. RESULTS/ANTICIPATED RESULTS: Recruitment is still ongoing. Data collected by the time of the conference will be presented on the poster. DISCUSSION/SIGNIFICANCE OF IMPACT: Online, guided self-help interventions have been used for WL, as well as for treatment of EDs separately, but no program exists to manage these commonly comorbid conditions concurrently. Thus, this pilot study will examine the effectiveness of combined programs to breach this treatment gap.

OBJECTIVES/GOALS: AA are over-represented on the waitlist for kidney transplant and are often unaware of how waitlist acceptance practices differ across transplant programs and influence access to transplant. We will develop a culturally sensitive transplant program report card to communicate these variations. METHODS/STUDY POPULATION: Scientific Registry of Transplant Recipients (SRTR) data will be used to identity clinical factors strongly associated with AA access to transplant. Interviews and focus groups with AA kidney transplant candidates and their families will collect feedback on the SRTR report card and inform the development of the culturally sensitive report card. Additional focus groups will evaluate its effect on knowledge and medical decision making. We will collaborate with the stakeholders, including AA transplant candidates and their families, transplant programs, SRTR, and providers, to identify strategies to disseminate the report card in the AA community RESULTS/ANTICIPATED RESULTS: To date, no investigation has systematically collected feedback on the SRTR transplant program report card from AA candidates to ensure that the tool is accessible and effective in the AA community. We hypothesize that a culturally sensitive report card will improve AA candidates’ knowledge of program factors that impact access to transplant and enable informed decisions about where they pursue a transplant evaluation. The results of this study have the potential to change how AA patients are counselled while seeking transplantation. DISCUSSION/SIGNIFICANCE OF IMPACT: A culturally sensitive report card can reach more AA patients and enable more informed decision making by providing education about differences in transplant programs that may impact their access to transplant. In the future, we will design a trial to evaluate the prototype.

OBJECTIVES/GOALS: To describe preliminary results of Alzheimer’s and dementia caregivers’ (CGs) mobile app use and intention to adopt mHealth apps for their own chronic condition self-management. To discuss implications for designing and implementing mHealth interventions for CGs. METHODS/STUDY POPULATION: This study aims to recruit 110 racially and ethnically diverse family caregivers (CGs) who have a chronic condition, provide care for persons with Alzheimer’s disease or related dementias, and have access to a mobile device. This is a cross-sectional correlational study collecting data with computer-assisted telephone interviews stored through REDCap. The study survey was created using existing surveys about mobile app use; relevant, well-validated research instruments; and questions from the U.S. Census and other national surveys. CGs are being actively recruited from the Baltimore-Washington metropolitan area using various recruitment strategies that have been effective in prior studies. RESULTS/ANTICIPATED RESULTS: The majority of CGs used websites (86%), mobile devices (68%) or apps (53%) to manage their own health. CGs using health-related apps were tracking their exercise (60%), diet (60%), medical records (50%), and physical health measures (50%). More than 4 out of 5 (82%) predicted they would use mobile apps to self-manage their chronic condition, though only 68% actually planned to use them. 86% of CGs were using mobile apps for non-health related purposes, with the most popular app being weather (90%), followed by social media (74%), music/entertainment (68%), and banking/business apps (63%). CGs used weather and social media apps most often (2 or more times/day) and spent 9 hours/week on apps. DISCUSSION/SIGNIFICANCE OF IMPACT: Websites and mobile apps appear to be feasible modes to deliver health interventions to CGs. Researchers should consider including features of apps most frequently used by CGs, such as the weather, ways to connect with others, and music/entertainment, when delivering mHealth interventions to CGs.

OBJECTIVES/GOALS: 1) In this literature review we want to explore the literature on DMHI (Interventions delivered via digital technologies, such as smartphones, websites, or text messaging), specifically designed to treat Posttraumatic Stress Disorder (PTSD), and/or to promote positive change & resilience after trauma. 2) We also want to evaluate the literature in terms of the theoretical model used in each DMHI, engagement, effectiveness, & potential harms/challenges. METHODS/STUDY POPULATION: We will review the literature that describes DMHI for PTSD, resilience, & positive change in persons exposed to psychological trauma (Exposure to actual or threatened death, serious injury, or sexual violence, as defined by the fifth edition of the Diagnostic & Statistical Manual of Mental Disorders). We will review the following databases: PsychINFO, EBSCOhost, PubMed, & PsychiatryOnline. The following inclusion criteria will be used: 1) Interventions delivered by computer, smartphones, or online, 2) studies published between 1999-2019. Exclusion criteria will include reviews, opinion, or discussion articles, & unpublished works. RESULTS/ANTICIPATED RESULTS: We expect to find that the most popular therapeutic model for DMHI is cognitive behavioral therapy. We also expect to find a higher number of web-based interventions, as opposed to phone-based interventions, or other types of DMHI. We also expect to find variable drop-out rates, low engagement, & small to moderate effect sizes. DISCUSSION/SIGNIFICANCE OF IMPACT: We expect our contribution to center on evaluating available DMHI for psychological trauma. This systematic literature review is expected to provide scientific justification for the development (or validation), & implementation of a DMHI that takes into account the results of previous studies. This contribution is expected to be significant because it will help in choosing, or developing an effective future intervention with DMHI. CONFLICT OF INTEREST DESCRIPTION: There is no conflict of interest in this study.

OBJECTIVES/GOALS: Geographic and linguistic isolation is associated with negative mental health outcomes, including increased risk for suicide, among ethnic/racial minorities. This study explores the feasibility of using smartphone technology with active and passive sensing to assess mental health symptoms and social behavior among at risk Spanish-speakers. METHODS/STUDY POPULATION: Participants were 13 Spanish-speaking adult outpatients who reported hopelessness/suicide ideation in the last month. Participants completed a baseline interview, 2-weeks of remote ecological momentary assessments (EMA; 4xday) using a smartphone with optional passive sensing (GPS, ambient sound recording), and a final interview. All participants identified as Hispanic (84.6% female, M age = 42.24 years). 53.8% identified as White, with 46.2% reporting race as Other (e.g., Indio, Trigueña). On average, participants had lived in the USA for 6.56 years (SD = 12.63 years). A majority (69.2%) met for Major Depressive Episode Current. At baseline, 53.8% reported passive and 23.1% reported active suicide ideation in the last month. 46.2% of participants reported a previous suicide attempt. RESULTS/ANTICIPATED RESULTS: A majority (84.6%) of participants consented to all passive data collection (GPS tracking and ambient sound recording). One participant dropped out after baseline and did not complete the EMA study portion. Participants completed on average 76.93% EMA survey instances (SD = 18.01%). Baseline depression/anxiety severity were significantly positively associated with symptom severity at 2-week follow-up (p < .01); however, baseline suicide ideation was not associated with ideation at follow-up. Participants did not report significant changes in mood or ideation from baseline to 2-week follow-up. Symptom severity at baseline was not associated with EMA instances completed. Percent of EMA instances completed were also not associated with symptom severity at follow-up, controlling for baseline severity. DISCUSSION/SIGNIFICANCE OF IMPACT: Results support the feasibility of smartphones to assess mental health symptoms and behaviors in real time, real world settings with Spanish-speakers. A majority of patients consented to active and passive remote assessments. Adherence to remote EMA was good and study attrition was minimal. Implications and future directions will be discussed.

OBJECTIVES/GOALS: To demonstrate how brief online audiovisual presentations, “learning shots”, informed by evaluation, can be used to quickly and effectively provide essential just-in-time research-related education in the complex and evolving world of clinical and translational science. METHODS/STUDY POPULATION: “Learning shots” are an educational tool, originally developed by the University of Virginia IRB for Health Sciences Research, that cover a broad spectrum of methodological, regulatory, and ethical topics in research. They are designed to be responsive to adult learners, a rapidly changing research environment, and the need for flexible offerings. Learning shots target different groups involved in research including clinical research coordinators, investigators, and trainees. A survey was used to assess the role of learning shots in meeting learning needs. Moving forward, continuous evaluation will occur through the addition of tracking and a short evaluation survey to each learning shot. RESULTS/ANTICIPATED RESULTS: The University of Virginia has an online library of over 30 learning shots. Learning shots are used to cover foundational topics (e.g. GCP) as well as more specialized topics (e.g. comparative effectiveness research). They can also be used to quickly respond to breaking issues (e.g. single IRB review). In an initial survey targeting University of Virginia clinical research coordinators, 54 (68%) of 79 respondents reported having viewed a learning shot. Among those who had, 41 (84%) of 49 respondents reported that learning shots were helpful to their learning needs. Continuous evaluation is expected to further inform how learning shots meet clinical and translational science education needs. DISCUSSION/SIGNIFICANCE OF IMPACT: Learning shots are an innovative and versatile educational tool for clinical and translational science that can be used to quickly and effectively convey important research information in response to an increasingly complex research environment and diverse learner needs.

OBJECTIVES/GOALS: We conducted a review of CTSA websites to understand the current landscape for CRP institutional professional development and training revealed in the CTSA hub websites. METHODS/STUDY POPULATION: We accessed and reviewed 59 currently funded CTSA hub websites for evidence of CRP training opportunities. Parameters reviewed included: 1) opportunities were specified for CRPs versus K and T trainees; 2) mandated training; 3) leveling; 4) delivery methods/resources; 5) public accessibility; 6) unique features. The website reviews informed a REDCap survey sent to the CTSA Administrators (n = 149) and the Coordinator Taskforce (n = 105) listservs to gain additional knowledge of CRP training available at the institution. A subsequent repeat review of the CTSA hub websites will be conducted to determine evolving trends. RESULTS/ANTICIPATED RESULTS: A total of 40 responded to the survey from 59 CTSA hubs. Survey results are being analyzed. Website review data are being tabulated and the subsequent review of websites will be collected in February. Those findings are pending and will include a comparison of prior findings. 42% of CRP hubs list CRP training within the CTSA hub website. Required onboarding training (beyond CITI certificates) is revealed for some hubs (15%). DISCUSSION/SIGNIFICANCE OF IMPACT: On our initial website review less than half of the CTSA hub websites list specific CRP training on their website. Many were hidden behind firewalls and could not be reviewed for content. The REDCap Survey will provide more granular descriptions of programs. Data from a second website review will be collected for comparison. Based on a preliminary re-review of sites, there is a suggestion of increasing CRP workforce development information. CTSAs are well-positioned to be a central hub for promoting educational excellence of the institutional workforce, for medical centers and in other venues where clinical research is performed.

OBJECTIVES/GOALS: Project Extension for Community Health Outcomes (ECHO), a telehealth model, was launched at Penn State University in 2018 to connect specialists with community providers to provide education on best clinical practices. We aim to describe clinical topics covered and relevant provider level outcomes. METHODS/STUDY POPULATION: The heart of the ECHO model is a hub-and-spoke knowledge-sharing system. The ECHO model has four core principles: 1) use technology to leverage scarce resources; 2) share best practices to reduce disparities; 3) employ case-based learning to master complexity; 4) monitor outcomes to ensure benefit. Unlike telemedicine, where outside specialists assume the care of the patient, Project ECHO is a guided learning community aimed at practice improvement: providers receive mentoring and feedback on de-identified patient cases, strengthen their skillset, and retain responsibility for their patients. RESULTS/ANTICIPATED RESULTS: Clinical topics launched include Medication Assisted Treatment for Opioid Use Disorder, Ehlers Danlos Syndrome, Polyneuropathy, and Dementia. In addition, we launched a nutrition-focused ECHO with Boy Scout summer camp leaders in 26 states, reaching 107,347 scouts. Over the past year we have reached 118 clinicians in 62 clinics within 19 counties in Pennsylvania, providing a total of 268 CME hours. These providers have treated 2,294 patients and reported increased knowledge (94%), decreased sense of professional isolation (86%), and improvement in ability to provide patient care (92%) following completion of an ECHO series. DISCUSSION/SIGNIFICANCE OF IMPACT: Project ECHO is a powerful telehealth model providing mentorship and education to clinicians, encouraging them to treat more complex cases in their primary care clinics. As a result, patients receive higher quality care when they need it, and close to home, particularly important in rural areas.

OBJECTIVES/GOALS: Young women (18 – 45 years of age) with breast cancer have complex medical and psychosocial needs. Educational materials are often used as tools in patient-centered communication. However, these materials disseminate complex health information in print-heavy formats and can be difficult to understand for women with varying health literacy levels. METHODS/STUDY POPULATION: In the first phase of this study, the principal investigator (PI) will recruit 40 diverse women to participate in four focus groups (FG) to explore the perceived usefulness of the most frequently used cancer educational materials. The PI will also obtain demographics and heath literacy levels of the FG participants using the Newest Vital Sign. In the second phase, the PI will assess the literacy demands of the ten most frequently used cancer educational print materials and five most frequently used websites described by the FG participants. The perceptions of the usefulness of materials and the literacy demands will then be used to appraise the effectiveness of materials within patient-centered cancer communication. RESULTS/ANTICIPATED RESULTS: Results from this study will provide a patient-centered blueprint that will be used to design more effective educational materials that treatment centers can incorporate into their patient-centered cancer communication process. The next step of this research will be to determine providers’ perceptions of cancer education materials used to exchange information within the patient-centered communication process. This will complement the patient findings and inform the development of the provider aspect of a communication intervention centered on designing educational materials for women with various health literacy levels within the patient-centered cancer communication process. DISCUSSION/SIGNIFICANCE OF IMPACT: Detecting the usefulness of cancer educational materials, as perceived by young women with breast cancer, is foundational to developing communication interventions that improve cancer outcomes. This study will identify how materials can be improved in the critical informational-exchange component of the patient-communication process.

OBJECTIVES/GOALS: The University of Rochester CTSI Research Education Hub is designed to: 1) connect the local research community with essential internal and external educational resources; 2) create a community of inquiry and collaboration across the translational science workforce pipeline within the university. METHODS/STUDY POPULATION: The Research Education Hub (RE-Hub) utilizes the university’s widely used Learning Management System (LMS), Blackboard, and accessible to anyone at the university with a BlackBoard account. The RE-Hub greets users with an overview, an introduction of key local faculty experts in relevant research methodologies, and links to institutional research programs and helpdesks. Users are provided with curated educational resources organized by topic areas including, but not limited to, research methodology, statistical analysis, and grantsmanship. Discussion boards were created for users to ask general research questions and to connect with others in the translational research community. RESULTS/ANTICIPATED RESULTS: The RE-Hub was designed in Fall 2019 with the purpose of increasing utilization of university resources, including workshops, seminars, methods forums and consultation resources to improve translational science at the university. The RE-Hub was designed to be flexible and responsive to the changing needs of the local research community. User feedback will be used to identify improvements in the organization and content of the RE-Hub. Future improvements will include additional topic areas that span translational competencies, additional materials added to existing topic areas, and facilitation of better collaboration and integration of career development programs and grantsmanship resources. DISCUSSION/SIGNIFICANCE OF IMPACT: The Research Education Hub provides the University of Rochester translational science research community with a space to explore educational resources, to interact with colleagues and ask research related questions, and to help develop and/or improve other educational programs at the university.

OBJECTIVES/GOALS: (1) Determine nurse (age, education level, years of experience, ID education/training, contact with people with ID, communication apprehension, beliefs about patient quality of life), and nursing unit (teamwork, staffing and resources, person-centered care) characteristics that are associated with and predictive of nurses’ attitudes, positive emotions, and negative emotions toward caring for adults with ID. (2) Explore nurses’ perspectives of perceived barriers and facilitators to providing nursing care to hospitalized persons with ID and medical comorbidity, and how nursing care differs when caring for a person with ID. METHODS/STUDY POPULATION: This mixed methods nested analysis will employ an internet survey of medical-surgical registered nurses to collect nurses’ attitudes and emotions toward caring for hospitalized persons with ID and medical comorbidity, nurse characteristics, and nursing unit characteristics. We intend to recruit 150 medical surgical nurses currently practicing in the United States via email invitation to the membership of the Academy of Medical Surgical Nurses. Purposeful maximum variation sampling will be used to invite a subset of respondents for qualitative, semi-structured telephone interviews to elicit barriers and facilitators to nursing care of persons with ID and how nursing care differs when caring for persons with ID. RESULTS/ANTICIPATED RESULTS: We hypothesize that lower nurse education level, fewer years of experience, less ID education/training, lower amount of contact with people with ID, increased communication apprehension, and lower beliefs about the quality of life of persons with ID will be associated with negative nurse attitudes and emotions toward caring for people with ID. Further, we hypothesize that lower levels of nursing unit teamwork, staffing and resources, and person-centered care practices will be associated with negative nurse attitudes and emotions toward caring for people with ID. DISCUSSION/SIGNIFICANCE OF IMPACT: The proposed research is an important first step in determining potential nurse and nursing unit factors influencing nurses’ attitudes toward caring for people with ID. It will lead to targeted interventions to enhance nursing care quality and reduce hospital-associated healthcare disparities among people hospitalized with intellectual disabilities and medical comorbidities.

OBJECTIVES/GOALS:

• Develop strong network of science teachers interested in promoting scientific research to their students.

• Place students in an immersive summer research internship that, when possible, matches their career interests.

• Expose students to the numerous career paths within the STEM field.

METHODS/STUDY POPULATION:

• The program recruits socio-economically disadvantaged students and provides them a stipend, and also accepts students who can participate unpaid.

• Local school teachers are engaged in a summer fellowship to learn biotechnologies and research. In Spring these teachers help recruit students and during the subsequent Fall help students with college and scholarship applications.

• Students are placed in a variety of laboratories within the Schools of Medicine, Science, Dentistry, Public Health, Informatics, Health and Human Sciences, Engineering and Technology, especially in biomedical engineering. Students are also placed in industry laboratories such as Eli Lilly and the Indiana Bioscience Research Institute.

• Long-term program follow-up is done through post-internship surveys to assess impact on graduate and professional school admission.

RESULTS/ANTICIPATED RESULTS:

• Since the Indiana CTSI was established in 2008, 872 students have participated in the summer internship.

• 71% of past interns are underrepresented minorities in science or classified as disadvantaged by NIH criteria.

• 17% of students interned during grade 10, 72% during grade 11, and 11% during grade 12.

• 21% of students engage in the program for more than one year.

• 100% of past interns are currently enrolled in or have graduated college.

• Over 60% of those with a bachelors degree proceed to graduate and professional schools and over 80% stay in STEM related fields. These rates are equal for interns from underrepresented minorities or those classified as disadvantaged by NIH criteria.

DISCUSSION/SIGNIFICANCE OF IMPACT:

• Students engaged in the Indiana CTSI STEM program are progressing through the translational science pipeline based on their graduating from college and remaining in the STEM field.

OBJECTIVES/GOALS: Coordinating research studies is multifaceted and requires a foundational level of research knowledge, skills and abilities in order to contribute to high-quality, ethical research projects that adhere to local and federal regulations as well as Good Clinical Practice. Oftentimes, coordinators who are new to research or new to an institution have trouble navigating the research landscape. Departments within the University of Minnesota have limited resources to devote to developing robust training programs above and beyond protocol or department-specific training. Therefore, UMN’s CTSI created a comprehensive training and support program for research professionals at the University of Minnesota. METHODS/STUDY POPULATION: CTSI employs several strategies to provide a comprehensive training program for the University of Minnesota Research Workforce. The offerings are based on the The Joint Task Force for Clinical Trial Competency (JTF). In addition to training programs, valuable resources, materials, and connections are provided to trainees.

• An Onboarding process for new coordinators that includes a welcome email upon hire that provides resources as well an opportunity to meet face-to-face to get their questions answered about where to start with research training.

• Foundations for Research professionals, two week (20 hour) training program, provides a foundational level of knowledge to new coordinators via in-person and online training modules.

• Informed Consent 1 & 2 provides in-person training on the informed consent including the process, documentation, and ethical issues around consenting vulnerable populations.

• Over 40 on-line research training modules that coordinators can take at anytime.

• An active list serv that connects >600 research professionals with training updates and opportunities.

• Bi-weekly seminar series that provides a forum to share current regulations, best practices, resources, and guidelines pertaining to clinical research at the University.

• An online training “Roadmap” tool that customizes individual research training plans, and includes an inventory of training available.

RESULTS/ANTICIPATED RESULTS:

• 218 research professionals participated in our Foundations blended training program with 191 completing (88% completion rate) the entire training. A comprehensive assessment based on national competencies is completed by all participants at Baseline and Post training. Baseline scores average at 75% and Post scores average at 82% (7% increase). Satisfaction is measured and participants are overall satisfied with the training, 4 out of 5 on a Likert Scale.

• 353 research professionals have participated in our Informed Consent Session 1 & 2 in-person training. Satisfaction is measured and participants are overall satisfied with the training, 4.5 out of 5 on a Likert Scale.

• Over 190 research professionals have utilized our research on-line training modules.

• Training participants have been from 27 different departments across the University.

• The Clinical Research Professional Development Seminar Series has offered over 87 seminars with 4907 total attendees. These seminars are offered in-person and live stream.

DISCUSSION/SIGNIFICANCE OF IMPACT: Establishing a comprehensive training program at the University has streamlined the training that research professionals receive across departments. It also ensures that all coordinators have access to research training, a network of other research professionals, resources, and continuing education opportunities.

OBJECTIVES/GOALS: “Cure Quest” is an adventure quest game about the process of new drug discovery and development. The player explores a magical island in search of a cure for a mysterious illness, traveling through different lands based on the stages of the drug discovery pipeline. Along the way, they must solve puzzles, decipher clues, and enlist the help of a ‘team science’ group of collaborators. The game uses a fantastical setting and engaging story to communicate the topic through metaphorical representations, instilling a sense of wonderment in the learning process. Real-world science is embedded into fictionalized lands such as the Labyrinth of Target Identification, the Forest of Small Molecule Discovery, the Tree of Biostatistics, the Mountains of FDA Approval and the Desert of Funding. The project represents a novel application of game-based learning to a complex topic not typically addressed through games. The process of designing and developing the game itself uncovers strong parallels between the interdisciplinary game design process and the interdisciplinary team science process. The objective of the game is to communicate high-level concepts of the drug discovery and development process, starting with the principles of ethical research and the motivations behind medical discovery, through the development of a new drug and finally to FDA approval. The goal is to improve understanding of clinical translational science among the different disciplines involved, and to raise overall awareness of the drug discovery process. 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. The game design is informed by specific learning outcomes, input from players in the target population and an ongoing iterative design process. The game is designed for mobile devices (iOS and Android), with an emphasis on narrative, exploration, and puzzle solving. Future evaluation will be performed through a quasi-experimental design comparing standard lectures with the game on a drug discovery. 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. CureQuest is designed as an episodic game, following the sequence of stages in the drug discovery and development process. In this version of the game, we demonstrate five of the initial episodes: The City of Discovery of Unmet Medical Need; The Labyrinth of Target Identification; the Aquarium of Transgenic Phenotype Expression; the Rival Researcher Gang Quiz Battle; and the Desert of Funding. 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.

OBJECTIVES/GOALS:

• 1. Assess the institutional and individual training needs and gaps in the conduct of human research for PIs at the University of Minnesota.

• 2. Define the training program’s learning objectives.

• 3. Develop and implement an in-person training session that addresses the gaps.

METHODS/STUDY POPULATION:

• Establish a planning committee

• Identify required and optional training that is already available for PIs, then determine gaps

• Understand research training needs based on conversations with departmental and human research protection program leaders.

• Develop learning objectives and curriculum based on Federal and Local regulations, guidelines, and policies.

• Establish a feedback loop regarding research compliance with the HRPP, to assess trends and ensure continuous improvement.

• Evaluate the training program’s participants using confidence and satisfaction measures.

RESULTS/ANTICIPATED RESULTS: Developed and piloted a 90-minute in-person training program entitled “PI Primer” with the goals of:

• Increasing awareness and knowledge of the role and responsibilities of the Principal Investigator (PIs) according to the International Harmonization for Good Clinical Practice (ICH-GCP), Federal Regulations (FDA, DHHS, ect.), and University of Minnesota Policies.

• Identifying root causes for receiving an FDA 483 (inspection findings).

• Addressing and preventing common inspection findings (CAPA).

• Describe individual and institutional conflict of interest (COI), and identify the key steps necessary to manage COIs.

DISCUSSION/SIGNIFICANCE OF IMPACT: OHRP’s guidance on the “Responsibilities of Investigators” states that it is the Institution’s responsibility to provide human research training on a wide variety of topics to ensure the ethical conduct of research and protection of participants. PI Primer provides an in-person forum for investigators to build upon required responsible conduct of research and good clinical practice training to be able to apply the role and responsibilities of a PI to their own research. PI Primer also establishes a network of PIs in order to enhance connectivity and shared learning.

OBJECTIVES/GOALS: The Stanford CTSA Program has started to create Clinical Research Units (CRUs) with the goal to establish CRUs in all clinical departments by the end of 2020. CRUs will be responsible for managing the portfolio of projects proposed and conducted by faculty within departments. CRUs will be responsible for reviewing all clinical research studies. METHODS/STUDY POPULATION: CRUs will be an integral part of the Stanford’s research infrastructure, tasked with 5 key functions to ensure clinical research conducted by Stanford investigators: scientific merit, feasibility, funding, compliance, progress. Each CRU will review all clinical research projects proposed by investigators within the department prior to moving forward with IRB review. Studies will be evaluated annually to ensure compliance with the protocol, applicable laws and regulations, and recruitment goals. The Stanford CTSA will provide guidelines, SOPs and personnel to assist CRUs. In fall 2019, a landscape analysis of SoM clinical departments was conducted to identify:

1. 1) similar existing CRU-like systems,

2. 2) unique needs of departments/divisions for developing CRUs and

3. 3) barriers to implementation.

RESULTS/ANTICIPATED RESULTS: Challenges the pilot CRU has faced include communication and concerns regarding additional obstacles to conducting research. However, as study teams moved through the initial CRU formation, the feedback was overwhelmingly positive. Study teams were appreciative of the constructive feedback and the support for setting up studies. Results from the landscape analysis identified CRU-like systems in 5 departments and highlighted concerns regarding resources needed to implement CRUs. Based on feedback from the landscape analysis, a faculty and operational lead was identified in each clinical department to oversee CRU implementation. Facilitated by CTSA personnel, CRU leads have met quarterly since April 2019. Meetings consist of discussing expectations, sharing ideas and identifying potential roadblocks. DISCUSSION/SIGNIFICANCE OF IMPACT: CRUs will constitute a new organizational structure that consists of teams of investigators and staff to promote high quality, efficient clinical research and enhance collaborative opportunities. The CRU leadership will champion new initiatives in CTR and create pathways for investigators to access research infrastructure and resources. CONFLICT OF INTEREST DESCRIPTION: NA.

OBJECTIVES/GOALS: The goal of this project was to develop and evaluate a pilot mentor training program for clinical research professionals. This project presents an evidence- and theory-based mentoring program that has been developed, implemented, and evaluated for this group of translational research professions. METHODS/STUDY POPULATION: The curriculum for the program was designed for aspiring mentors and aligned with the topics of existing Entering Mentoring curriculum for translational workforce (Pfund, Branchaw & Handelsman, 2015). Eleven experienced CRPs participated in the pilot training program. The training was delivered in two-hour meetings over eight weeks. Qualitative e-mail interviews and a validated mentoring competency assessment (Fleming et al., 2013) and mentor role assessment (Dilmore, 2010) tool were used for process and outcome evaluation. Cases studies specific to the CRPs work environment were developed and used to facilitate discussions throughout the training. RESULTS/ANTICIPATED RESULTS: Pre- and post-training scores for mentoring competency assessment were compared across six sub-indexes. Paired t-tests showed a significant difference for the maintaining effective communication competency, p = 0.0202. Comparisons of individual items also showed positive changes in the promoting professional development competency, p = 0.0161). Qualitative assessment revealed that most mentor trainees recognized a distinction between a mentor and a supervisor or on-the-job-trainer. Furthermore, most have been informal mentors without a formal role assignment, the need for ongoing mentoring, and potential of mentoring networks. DISCUSSION/SIGNIFICANCE OF IMPACT: CRPs is a diverse group of research support professionals who may hold the roles of research study coordinators, research nurses, regulatory and compliance specialists. Tailored mentoring can provide essential infrastructure for ongoing professional development and support talent retention.