OBJECTIVES/GOALS: Despite calls for the integration of Education for Sustainable Healthcare (ESH) into health professional training programs, most curricula have yet to adapt accordingly. This qualitative study sought to understand faculty perspectives on ESH knowledge, interest, barriers, and facilitators. METHODS/STUDY POPULATION: From 2018 to 2020, 71 health professional education faculty from 6 University of California (UC) campuses participated in ESH integration workshops. Using purposeful sampling based on gender and campus, a subset of workshop faculty participants were selected to participate in individual interviews. Interviews were conducted via Zoom using a structured interview guide, eliciting participants experience integrating ESH, perceived barriers and facilitators, and perspectives on student, faculty, and health science leadership knowledge and interest. Transcripts were double coded with an inductive-deductive approach using Dedoose, reconciled, and analyzed to identify themes. RESULTS/ANTICIPATED RESULTS: Participants included 17 faculty at 6 UC campuses representing diverse health disciplines. Although participants noted high general awareness of and interest in climate change among students and faculty, they observed a lack of specific, health-relevant knowledge, resulting in discomfort communicating with others on climate and health. Perceived barriers to expansion of ESH included limited curricular space, competing topics, and lack of faculty expertise. Participants posited that framing climate change in health terms, establishing learning objectives and protected faculty time, identifying connections to ESH within existing research and curriculum, and obtaining commitments from campus leadership would facilitate successful ESH integration. DISCUSSION/SIGNIFICANCE: Our findings reinforce student and faculty interest in ESH curricular integration and identify important barriers and facilitators, lending context for educators planning ESH infusion. Training of faculty on climate health is urgently needed for ESH integration in health professional education.

ABSTRACT IMPACT: Our results reveal a limited amount of breast cancer survivorship print materials as both understandable and actionable, and indicate a need to supplement material with personalized teaching. OBJECTIVES/GOALS: Using educational print material for young women breast cancer survivors (YBCS) is considered a best practice in patient teaching. Little is known about how well YBCS understand or act upon the material. The purpose of this study was to assess the understandability and actionability of commonly distributed breast cancer survivorship print materials. METHODS/STUDY POPULATION: We used an environmental scan approach to obtain breast cancer survivorship print materials available in eight outpatient oncology clinics and one electronic medical record used in a Midwestern state. Print materials were included if they were freely available to patients, were specific to breast cancer, provided detailed information about survivorship, and were directly given to patients by physicians or nurses. Print materials were excluded if topics were related to treatment, diagnosis, or prevention. All brochures, drug advertisements, and advertisements for support services were excluded. The understandability and actionability analyses of the breast cancer survivorship print materials were analyzed using Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P). RESULTS/ANTICIPATED RESULTS: The environmental scan resulted in 82 individual print materials. After applying the inclusion and exclusion criteria, eight breast cancer survivorship print materials were included in the final sample. The final sample included two books, two patient education handouts from the electronic medical record, two multi-page booklets, and two pamphlets. The overall mean understandability score of the print materials was 68.9% ? 11.3 with a range of 47% to 80%. Five materials scored above the recommended 70% in understandability. The overall mean actionability score of the print materials was much higher at 81.3% ? 21.6 with a range of 67% to 100%. Five materials scored above 70% in actionability. However, only three of the eight materials scored above the recommended 70% in both understandability and actionability. DISCUSSION/SIGNIFICANCE OF FINDINGS: Limited breast cancer survivorship print materials exist as both understandable and actionable. Personalized instruction provided by oncology team members may be indicated to supplement the material. This additional teaching may help ensure survivors comprehend messages and act upon specific tasks as indicated in survivorship print material.

The rate at which the coronavirus disease (COVID-19) spread required a rapid response across many, if not all, industries. Academic medical centers had to rapidly evaluate, prioritize, and coordinate the multiple requests for clinical trial participation. This involved redirecting resources and developing a collaborative system for assessment, decision making, and implementation. Our institution formed a team with diverse representation from multiple stakeholders to review and prioritize all research protocols related to COVID-19. To accomplish this, a prioritization matrix was developed to help determine the order in which the protocols should be placed for consideration by the treating clinician. The purpose of the team was to review the COVID-19 clinical trials in the pipeline, prioritize those trials that best met the needs of our patients, oversee training and resource needs, and lead the formulation of procedures for integration with clinical care. Resources from the Clinical Research Unit were then allocated to support the swift execution of such studies. This manuscript describes that process, the challenges encountered, and the lessons learned on how to make all clinical trials more successful in a complex and dynamic environment.

OBJECTIVES/SPECIFIC AIMS: MicroRNAs are small, non-coding RNAs that control gene expression by inhibiting protein translation. Preclinical studies in rodent stroke models suggest that changes in microRNA expression contribute to neural repair mechanisms. To our knowledge, no one has previously assessed microRNA changes during the recovery phase of human stroke. Our goal was to determine whether patients with significant upper limb recovery following stroke have alteration of neural repair-related microRNA expression when compared to those with poor recovery. METHODS/STUDY POPULATION: Plasma was collected at 19 days post-stroke from 27 participants with mild-moderate upper extremity impairment enrolled in the Critical Periods After Stroke Study. MicroRNA expression was assessed using TaqMan microRNA assays (Thermo Fisher Scientific). Good recovery was defined as ≥6 point change in the Action Research Arm Test (ARAT) score from baseline to 6 months. Bioinformatics analysis compared the plasma microRNA expression profiles of participants with good Versus poor recovery. Candidate biomarkers were identified after correcting for multiple comparisons using a false discovery rate <0.05. RESULTS/ANTICIPATED RESULTS: Eleven microRNAs had significantly altered expression in the good (n=22) Versus poor (n=5) recovery groups, with 2 showing increased expression—miR-371-3p and miR-520g, and 9 showing decreased expression—miR-449b, miR-519b, miR-581, miR-616, miR-892b, miR-941, miR-1179, miR-1292, and miR1296. Three of these could be implicated in neural repair mechanisms. Elevated miR-371-3p levels increase the likelihood that pluripotent stem cells will differentiate into neural progenitors. MiR-892b decreases levels of amyloid precursor protein, which has been implicated as a regulator of synapse formation. Finally miR-941, the only known human-specific microRNA, downregulates the CSPα protein which is involved in neurotransmitter release. DISCUSSION/SIGNIFICANCE OF IMPACT: This preliminary study suggests that circulating microRNAs in the plasma may help serve as biomarkers of neural repair and aid in understanding human neural repair mechanisms. If validated in larger studies with appropriate controls, these markers could aid in timing rehabilitation therapy or designing recovery-based therapeutics.

OBJECTIVES/GOALS: The purpose of this study is to evaluate average pain scores in patients with Hidradenitis Suppurativa (HS) and determine if racial disparities influence HS-related pain management. METHODS/STUDY POPULATION: We surveyed 3,140 adult patients about demographics, HS, pain levels, medical history, and health-related quality of life. Among respondents (N=162), pain scores (0-10) were grouped as high (8+, N=54) and low (<7, N=108). We used logistic regression to calculate adjusted odds ratios (aOR) and 95% confidence intervals (95% CI). RESULTS/ANTICIPATED RESULTS: Respondents were female (88.9%), Black race (59.4%), with a median age of 36 (IQR 25-42) and a mean pain score of 7 (IQR 5-8). Half (48.2%) of respondents disagreed or strongly disagreed with, “I am satisfied with how my pain related to HS is being managed by my doctors.” Independent risk factors for high pain included Black race (aOR=7.95, 95% CI 3.11-20.26), history of prescribed pain medications (aOR=2.37, 95% CI 1.06-5.30), and former/current tobacco use (aOR=4.12, 95% CI 1.76-9.64). DISCUSSION/SIGNIFICANCE: The preliminary data support the hypothesis that race influences HS-related pain. In addition, less education, a history of prescription pain medication use, and tobacco use are all independent risk factors contributing to higher pain scores in patients with HS. Further analysis will be conducted to evaluate racial influences on pain management.

Implementation of clinically useful research discoveries in the academic environment is challenged by limited funding for early phase proof-of-concept studies and inadequate expertise in product development and commercialization. To address these limitations, the National Institutes of Health (NIH) established the National Centers for Accelerated Innovations (NCAI) program in 2013. Three centers competed successfully for awards through this mechanism. Here, we present the experience of one such center, the Boston Biomedical Innovation Center (B-BIC), and demonstrate its remarkable success at the translation of innovations to clinical application and commercialization, as well as skills development and education.

OBJECTIVES/GOALS: Research on the safety of perinatal kratom use - an herb that acts on opioid receptors - is scarce. Our transdisciplinary clinical and translational science (CTS) team is conducting parallel qualitative analyses of subreddit posts related to kratom use during (1) pregnancy and (2) breastfeeding. METHODS/STUDY POPULATION: Pregnancy- and breastfeeding-related keywords are being used to extract posts and selected metadata from the following subreddit communities: r/kratom, r/quittingkratom, r/pregnant, and/or r/breastfeeding. After the removal of duplicate posts, posts written in a non-English language and those that state in the post text and/or title that they were published by minors ( RESULTS/ANTICIPATED RESULTS: Among the eligible posts, the number of unique usernames of the sources publishing the posts; the range of publication dates; and the mean, median, & range of the number of comments per post will be presented. Inter-rater concordance in thematic coding will be computed. A word cloud will be created with the most used nouns from the eligible posts. Verbatim quotes will be shown to illustrate themes depicted in the sample. The quantitative and qualitative analyses will be conducted separately for the posts related to kratom use during pregnancy and breastfeeding. DISCUSSION/SIGNIFICANCE: These findings could assist clinicians in identifying questions that obstetric patients may have regarding the perinatal use of this emerging substance of concern. Further research is needed to validate these findings using other social media data, such as Twitter.

OBJECTIVES/SPECIFIC AIMS: Our study aims to create a novel state level HIV-ESRD dataset and compare patient-level characteristics on rates of transplant referral, evaluation, waitlisting, and transplantation for HIV-positive versus HIV-negative patients. Our main hypothesis is that HIV-positive patients in Georgia are less likely to be referred to kidney transplant compared with HIV-negative patients. METHODS/STUDY POPULATION: Three datasets will be merged in order to create the HIV-ESRD dataset. The datasets are United States Renal Data System (USRDS), a southeast Transplant Referral Dataset and patient-level Georgia Department of Public Health HIV Incidence Database. The resulting study population will include patients that are older than 18, but less than 70, are HIV-positive and are on dialysis in Georgia. This dataset will also identify those patients who have been referred to transplantation, have been waitlisted, and have received kidney transplants between January 2012 and December 2017. If within a 1-year period, the prevalence of HIV-positive patients referred to transplant was lower than the 1-year period prevalence of HIV-negative patients for 3 consecutive years, the dialysis facility will be classified as having a within-facility disparity. We will then characterize patient level and dialysis facility-level factors that may contribute to observed findings. Patient characteristics will include demographic, clinical data, proxies of socioeconomic status, and geospatial relationships to transplant centers and rural vs urban neighborhoods. Facility-level characteristics includes profit status (profit vs. nonprofit), total number of staff (including full-time and part-time employees), aggregate demographic and clinical facility characteristics, and total number of treated patients. RESULTS/ANTICIPATED RESULTS:. We anticipate the successful creation of the proposed dataset that will allow for accurate identification of HIV-positive patients on dialysis in Georgia.. This dataset will provide the ability to determine referral, waitlisting, and transplantation rates.. We predict the overall rate of referral, waitlisting, and kidney transplantation in HIV patients will be relatively low, and that dialysis facilities with a higher proportion of HIV-positive will have lower referral rates compared to dialysis facilities treating a higher proportion of HIV-negative patients. It is foreseen that among patient-level characteristics, the strongest predictor for decreased referral rates will be HIV serostatus and among dialysis facility factors, profit status will be associated with decreased referral rates. DISCUSSION/SIGNIFICANCE OF IMPACT: This pilot study offers the creation of the first regional dataset of HIV-ESRD patients that will include patient-level characteristic of HIV-positive patients and provide a model for other states to adopt. We will contribute improved state-level description of incidence data of HIV-positive patients on dialysis, current rates of transplant referral, waitlisting, and transplantation, and offer potential associated factors that influence these processes. This knowledge will be used to determine the next steps in improving access to care; conducting qualitative research to understand dialysis facility views on transplant in HIV patients, understanding HIV patient’s position on transplantation, providing education on the value of kidney transplant referral, and expanding the approach of combining patient level HIV data to the southeast.

OBJECTIVES/GOALS: Improving physical activity of African American women experiencing disproportionate health risks from sedentarism, educational and socio-environmental barriers. BeFit: Building Empowerment through Fitness is based on “What I Learned At Home” project, run by Women Under Construction Network, for residents of the Birmingham Housing Authority. METHODS/STUDY POPULATION: A qualitative study design to understand unique cultural context and challenges faced by African American women residing in the Birmingham Housing Authority, regarding physical activity engagement, including sedentarism. A needs assessment approach will help determine barriers, support systems, and social networks. Semi-structured, pre, mid, and post program focus groups will identify challenges and opportunities for health, such as diet and exercise, and will be analyzed by hand with a thematic analysis. The project framework uses exercise and home repair tools with a life-building/life repair curriculum to influence health, self-efficacy, and program engagement. The Study enrollment will include 50 women over two cohorts in a 12-week project. RESULTS/ANTICIPATED RESULTS: This research addresses the urgent health needs of African American women in low-income communities. These women face heightened health risks due to sedentary lifestyles, educational gaps, and socio-environmental barriers. This project targets the pronounced prevalence of allostatic burden in this population by applying a culturally sensitive, bottom-up approach. Our goal of incorporating healthy lifestyles to improve health in at-risk women and their families requires multiple projects. This project is a necessary first step in engaging with a community to identify local environmental circumstances and barriers to increasing the relevance of physical activity within the home. These barriers can then be addressed by adapting an exercise promotion program to the needs of this community. DISCUSSION/SIGNIFICANCE: Black women in under-resourced communities are more likely to be sedentary and have poor health. Exercise programs can be a powerful tool to address disparities and help prioritize health. The circumstances of women in public housing in Birmingham, AL, need community partners to adapt exercise engagement programs to meet environmental challenges.

OBJECTIVES/GOALS: The goal of this study was to perform a comparative, multi-reader, retrospective clinical evaluation of prostate multiparametric MRI (mpMRI) at 3 Tesla (3T) vs. 7 Tesla (7T) primarily in terms of prostate cancer localization. Subjective measures of image quality and artifacts were also evaluated. METHODS/STUDY POPULATION: Nineteen subjects were imaged at 3T and 7T between March 2016 and October 2018 under IRB-approved protocols. Four radiologists retrospectively and independently reviewed the data, and completed a two-part assessment for each dataset. First, readers assessed likelihood of cancer using Prostate Imaging Reporting & Data System (PI-RADS) guidelines. Accuracy of cancer detection was compared to findings from prostate biopsy. The numbers of correctly or incorrectly classified sextants were summed across all four readers, then used to summarize detection performance. Second, readers assigned a score on a five-point Likert scale to multiple image quality characteristics for the 3T and 7T datasets. RESULTS/ANTICIPATED RESULTS: Sensitivity and specificity of 3T and 7T datasets for sextant-wise cancer detection were compared by paired two-tailed t-tests. Readers identified more sextants harboring cancer with the 3T datasets while false-positive rates were similar, resulting in significantly higher sensitivity at 3T with no significant differences in specificity. Likert scores for image quality characteristics for 3T and 7T datasets were compared by applying paired two-tailed t-tests to mean scores of the four radiologists for each dataset. Readers generally preferred the 3T datasets, in particular for staging and assessment of extraprostatic extension as well as overall quality of the contrast-enhanced data. DISCUSSION/SIGNIFICANCE OF IMPACT: Readers agreed 7T prostate mpMRI produced images with more anatomic detail, though with equivocal clinical relevance and more pronounced artifacts. Reader unfamiliarity with 7T images is a major extenuating factor. Forthcoming technological developments are anticipated to improve upon the results.

Translation of research discoveries into health impact can take many years, creating delays in improving clinical outcomes. One approach to promoting timely translation is to examine successful cases in order to understand facilitators and strategies for overcoming barriers. We examined the development of evidence-based management for neonatal abstinence syndrome (NAS) at one academic medical center, with a primary focus on pharmacologic treatment. Despite a substantial increase in NAS case incidence starting in the early 2000s, significant sociocultural, policy, and regulatory barriers limited collaborative NAS research. Facilitators for translation encompassed: 1) pursuing research of societal interest, 2) building an effective interdisciplinary team, 3) intentionally linking clinical, research, and advocacy efforts, 4) broad stakeholder engagement across clinical, policy, and research arenas, and 5) leveraging local resources. Challenges included lack of commercially available U.S. Food and Drug Administration approved neonatal drug formulations, legal and regulatory barriers related to off-label and illicit use of opioids, recruitment for a treatment associated with drug withdrawal syndromes, misalignment of research design needs with real-world scenarios, and episodic funding. Benefits of successful translation included improvements in clinical care, reduced healthcare costs related to NAS, and enhanced legislative, policy, and research strategies to support broader neonatal investigations.

Clinicians who are interested in becoming principal investigators struggle to find and complete training that adequately prepares them to conduct safe, well-designed clinical and translational research. Degree programs covering these skills require a significant time investment, while online trainings lack engagement and may not be specific to local research contexts. Staff at Tufts Clinical and Translational Science Institute sought to fill the gap in junior investigator training by designing an eight-module, noncredit certificate program to teach aspiring clinician-investigators about good clinical practice, clinical research processes, and federal and local regulatory requirements. The first iteration of this program was evaluated using pre- and posttest questionnaires and by gathering clinician learner feedback in a focus group. Based on the pre- and posttest questionnaires, learners experienced an increase in self-efficacy and confidence related to clinical research competencies. Feedback from learners also highlighted important program strengths, including an engaging program format, a manageable time commitment, and an emphasis on identifying crucial research resources. This article describes one approach to creating a meaningful and efficient clinical trial training program for clinicians.

OBJECTIVES/SPECIFIC AIMS: Because clinical trial results are instrumental in the approval of a new drug or changes to the practice of medicine, ensuring the accuracy and validity of collected data is critical in the clinical trial process. This function, routinely carried out by clinical trial monitors in industry-sponsored trials, is often lacking in investigator-initiated trials (IITs) conducted in academia. To address this challenge, we have developed a self-study module that can be used to cross-train academic researchers in essential concepts and practical approaches to monitoring. Furthermore, we are applying a framework drawn from implementation science in the development and launch of this initiative. This framework, as used in other educational programs, is employed here to close the gap between initiative and practice, thereby effectively disseminating this training would improve the quality of clinical trials in academia. METHODS/STUDY POPULATION: This research project applied exploration, installation and implementation stages of the implementation science process by 1) exploring the need for a new initiative, 2) disseminating results, 3) engaging stakeholders, 4) creating standard operating procedures (SOPs) for installation and implementation, 5) studying user satisfaction and effectiveness, 6) addressing feedback and 7) conducting implementation. RESULTS/ANTICIPATED RESULTS: From literature review and internet searches we determined that although numerous GCP training resources exist, most are too broad and lack the practical approaches to meet the complex requirements of monitoring. Moreover, most of the offerings identified are costly or inaccessible. With only about 65% of IITs reported as being monitored (Figures 1 and 2), it appears that there is a clear need for training tools that are easily available to a broader audience. And because monitoring skills are substantially different from those associated with research coordination, it is not surprising that research professionals believed that they would need additional training to become proficient. To address this need, we began developing a monitoring module. We engaged key stakeholders from academia and industry to gain insights into their needs. The results indicated that although our training module was effective, supplementary information on the fundamentals of clinical trials should be included for those new to the field. After incorporating suggested changes and completing the module, we conducted user testing to determine if our module is ready to be broadly disseminated (Figures 3 and 4). Following positive feedback from the group, we are currently in the process of disseminating our module and studying its impact. DISCUSSION/SIGNIFICANCE OF IMPACT: IITs are instrumental in translating academic research into product development. Deficiencies in the quality control of these trials can lead to inadequacies in data accuracy and validity that could lead to significant delays in bringing innovative therapies to patients. Recent NIH policies require data and safety monitoring for all of the trials it supports. The latest addendum to ICH GCP, E6(R2), discusses a need for quality management across the clinical trial lifecycle. As we continue to disseminate and share information during the development of our self-study monitoring module, we are engaging key stakeholders from academia, government, and private institutions to understand and address quality challenges in conducting clinical trials. Finally, this research informs dissemination and implementation research, specifically for creating training for academic research professionals.

Advancing the new field of translational science and developing innovative solutions to overcome translational roadblocks are key priorities of the Clinical and Translational Science Awards (CTSA) Program of the National Center for Advancing Translational Science (NCATS). However, interpreting this emerging concept of “translational science” (TS) as a field of inquiry distinct from “translational research” (TR) and developing real-world investigations in TS can be challenging. The goal of this paper is to share the obstacles the Einstein-Montefiore CTSA hub has faced in generating institutional interest and research in TS and to present potential strategies for addressing them. The aim is to stimulate dialog within the wider CTSA community and beyond about the need to systematically examine how TS should be efficiently and effectively pursued, that is, the science of translational science. The collective sharing of experiences and innovative approaches to overcoming TS challenges that arise at CTSA hubs is critical if the field is to grow and gain wider recognition and acceptance by the scientific and broader communities.