ABSTRACT IMPACT: Measuring and analyzing qualitative and quantitative traits using phenomics approaches will yield previously unrecognized heart failure subphenotypes and has the potential to improve our knowledge of heart failure pathophysiology, identify novel biomarkers of disease, and guide the development of targeted therapeutics for heart failure. OBJECTIVES/GOALS: Current classification schemes fail to capture the broader pathophysiologic heterogeneity in heart failure. Phenomics offers a newer unbiased approach to identify subtypes of complex disease syndromes, like heart failure. The goal of this research is to use data-driven associations to redefine the classification of the heart failure syndrome. METHODS/STUDY POPULATION: We will identify < 10 subphenotypes of patients with heart failure using unsupervised machine learning approaches for dense multidimensional quantitative (i.e. demographics, comorbid conditions, physiologic measurements, clinical laboratory, imaging, and medication variables; disease diagnosis, procedure, and billing codes) and qualitative data extracted from an integrated health system electronic health record. The heart failure subphenotypes we identify from the integrated health system electronic health record will be replicated in other heart failure population datasets using unsupervised learning approaches. We will explore the potential to establish associations between identified subphenotypes and clinical outcomes (e.g. all-cause mortality, cardiovascular mortality). RESULTS/ANTICIPATED RESULTS: We expect to identify < 10 mutually exclusive phenogroups of patients with heart failure that have differential risk profiles and clinical trajectories. DISCUSSION/SIGNIFICANCE OF FINDINGS: We will attempt to derive and validate a data-driven unbiased approach to the categorization of novel phenogroups in heart failure. This has the potential to improve our knowledge of heart failure pathophysiology, identify novel biomarkers of disease, and guide the development of targeted therapeutics for heart failure.

OBJECTIVES/SPECIFIC AIMS: This work develops an algorithm that identifies patients in a Sequential Multiple Assignment Randomized Trial (SMART) who should switch treatments prior to the end of a stage because clinical effectiveness via their current intervention is unlikely. This algorithm uses as inputs patient baseline and interim measurements to assign a probability that a patient should switch or stay on their current intervention. First, the algorithm will be derived assuming both a linear and non-linear patient trajectory. Second, the performance of the algorithm will be assessed using trial data from the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care† (EMBARC) study. The primary objective of the algorithm is to switch treatment in patients who will not reach clinical effectiveness by the end of the stage, and the secondary objective is to avoid accidentally switching treatment in patients who will reach clinical effectiveness by the end of the stage. †Trivedi et al. Journal of Psychiatric Research 78 (2016) 11-23 METHODS/STUDY POPULATION: First, the algorithm was derived assuming a linear or non-linear trajectory. Next, performance of the algorithm was assessed using data from the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care† (EMBARC) study. This two-stage SMART design measured the effectiveness of sertraline in 242 patients with nonpsychotic Major Depressive Disorder (MDD). The algorithm was applied to baseline and interim measurements from the EMBARC study to predict end-stage Hamilton Depression (HAMD17) scores, the primary outcome of the study. True positive rate (TPR) and false positive rate (FPR) were used to measure respectively the primary study objective (switching treatment in patients who will not reach clinical effectiveness by the end of the stage), and the secondary study objective (avoiding accidentally switching treatment in patients who will reach clinical effectiveness by the end of the stage). TPR and FPR were calculated for the following prediction scenarios: (1) three separate two-point predictions: Baseline and Week 2, Baseline and Week 4, Baseline and Week 6, and (2) a single three-point prediction: Baseline and Weeks 2 and 6. †Trivedi et al. Journal of Psychiatric Research 78 (2016) 11-23 RESULTS/ANTICIPATED RESULTS: When using two-point prediction, we found TPR to increase and FPR to decrease as the interim measurements approached closer to the end of the stage. We also found TPR to increase when using a three-point prediction, but at the expense of FPR also increasing. Across these scenarios, TPR ranged between 70 and 90%, and FPR ranged between approximately 20 and 50%. DISCUSSION/SIGNIFICANCE OF IMPACT: Although SMART designs ultimately assign patients to more effective treatments, this process can take time and leave a patient (currently on an ineffective treatment) waiting until the end of a stage to try a potentially superior treatment. This disadvantage of the SMART design is currently addressed by this algorithm. By introducing a regression and likelihood approach to predict whether a patient should switch or stay on their current treatment, we move closer to the goal of designing rigorous, patient-centered studies. This work has the potential to improve individual clinical outcomes for patients enrolled in pragmatic clinical trials.

OBJECTIVES/GOALS: Clinical and Translational Science Award (CTSA) hubs are launching D&I Science cores to provide resources and services to promote the translation of clinical evidence into practice. We developed a D&I Science Core strategic plan reflecting our research community’s needs by assessing Implementation Science (IS) competencies. METHODS/STUDY POPULATION: The Tufts CTSI D&I Science Core was launched in early 2023. To design services that meet research community needs, we conducted a survey and key informant interviews based on Padek etal.’s list of Implementation Science (IS) competencies. The competencies are organized into four domains (Definition, Background, and Rationale; Theory and Approaches; Design & Analysis; and Practice-Based Considerations) and categorized by expertise level (beginner, intermediate, advanced). Participants who had attended or expressed interest in a D&I interest group were asked via an email survey to rate their level of confidence in completing selected IS-related research activities, about their experience with IS research or practice, and the types of resources, services and training they desired. RESULTS/ANTICIPATED RESULTS: Twenty researchers (20/65, 31%) submitted survey responses and six researchers participated in in-depth interviews. Survey respondents felt most confident in engaging stakeholders in IS research and least confident selecting a model or framework for a study. Results suggest that researcher capacity building is needed to: • Understand IS models and frameworks and their approaches, strengths, and limitations • Select and use models and frameworks in studies • Assemble IS teams and prepare grant proposals Suggestions for resources, services, and training, include: • Customized education to address diverse needs, knowledge levels, and learning styles • Promotion of D&I Core consultations and grant support services • Sharing of successful proposals to help researchers learn how to apply IS methods DISCUSSION/SIGNIFICANCE: A strategic workplan for the D&I Science Core was developed and implemented to address the findings. Initial emphasis is on developing easily accessible resources and timely consultations for investigators new to IS needing to apply these methods in current grant proposals, while also providing training resources for deeper skill building.

OBJECTIVES/GOALS: Utilizing clinical electronic health record (eHR) data pulled en masse from data warehouses provides unique challenges when applying it to retrospective studies. Use of this data in conjunction with metabolomic and genomic results to predict response to lisinopril or ondansetron has been completed. METHODS/STUDY POPULATION: Study population consists of >2000 subjects recruited from the Emergency Medicine Specimen Bank at University of Colorado Denver (UCD). All patients presenting to the emergency department are approached to participate which significantly increases demographic diversity of our study populations. Clinical data is pulled from Health Data Compass (data warehouse at UCD that collects all electronic health record (EHR) data to be able to deliver de-identified). Effectiveness of lisinopril and ondansetron were investigated using metabolomic data collected via ultra-high performance liquid chromatography mass spectrometry and genomic data from Illumina chip technology to find relevant correlations. RESULTS/ANTICIPATED RESULTS: Obtaining retrospective clinical data from data warehouses comes with significant challenges to be addressed. Verifying all clinical variables from patient EHRs is a crucial step that requires extensive quality control steps. As well, ensuring data validity, appropriateness of data points pulled as relate to the study criteria and identifying alternate EHR data points is needed. Chart review is a critical step necessary to surmount these challenges. Additionally, use of retrospective EHR data often necessitates the development of novel definitions of clinical effectiveness that can be abstracted from the EHR– such as how to determine decrease in nausea without a visual analogue scale. DISCUSSION/SIGNIFICANCE OF IMPACT: Utilizing data warehouses to deliver EHR data provides a valuable tool for completing retrospective precision medicine projects. The validation of definitions for clinical outcomes identifiable retrospectively are necessary and provide novel guidance for future studies.

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.

We conducted a survey study of clinical research coordinators (CRCs) at the member institutions of the Pediatric Emergency Care Applied Research Network, to determine the demographic and linguistic characteristics of CRCs around the network, and any perceived impact of those characteristics on their duties. A total of 53/74 CRCs completed the survey. Most respondents identified as “female,” “white,” and “not Hispanic/Latino.” Most respondents felt that their race/ethnicity and their ability to speak a language other than English would positively impact recruitment. Four female respondents felt that their gender hindered their recruitment efforts and their sense of belonging within the research team.

OBJECTIVES/GOALS: To adapt and evaluate motivational interviewing (MI) as a tool for better understanding the beliefs that underlie vaccine hesitancy and effectively respond to these beliefs with emphasis on reaching underserved communities disproportionately impacted by COVID-19. METHODS/STUDY POPULATION: Our group reviewed the principals for motivational interviewing, rationale for vaccination, and likely beliefs underlying hesitancy and developed a guide for MI to address vaccine hesitancy. We recruited lay members of Black and Hispanic communities in Washington, DC and Baltimore, MD. 90-minute zoom facilitator training sessions included didactic material, questions and discussion, and role playing. We were not successful recruiting unvaccinated individuals to provide written consent to be followed re vaccination status. Facilitators indicated incorporating MI in their job-related and informal interactions. Surveys were developed to obtain feedback regarding beliefs underlying hesitancy, perceptions of MI effectiveness, and more recently (Oct 2022), evolving concerns regarding the pandemic. RESULTS/ANTICIPATED RESULTS: 67% of facilitators were Black, their average age was 39 years, and 67% had at least a high school education. All had received a COVID-19 vaccination. 82% endorsed utilizing MI in discussions receiving the COVID-19 vaccine. 46% of the facilitators endorsed that MI was moderately effective (46%) in clarifying objections and very effective (50%) in persuading friends, family, and co-workers to consider getting vaccinated. The most common elicited objections to the vaccine were side-effects (21%) and beliefs in government conspiracies (21%). In the second survey respondents indicated receiving another booster followed by getting their children vaccinated as the most common identified concerns. DISCUSSION/SIGNIFICANCE: MI can be adapted to address vaccine hesitancy in underserved minority groups and appears promising for identifying beliefs underlying hesitancy and possibly for increasing vaccination rates among these communities.

OBJECTIVES/GOALS: Histopathological descriptions of kidney tissue provide more information about kidney disease severity and prognosis than serum measures, yet most patients with chronic kidney disease do not undergo kidney biopsy. We aim to develop a method to determine the degree of renal injury in patients with diabetes and hypertension without the need for biopsy. METHODS/STUDY POPULATION: Clinical data and renal tissue samples were collected from 864 patients undergoing tumor-associated nephrectomy in seven medical centers in the United States. Exclusion criteria included age < 18, presence of pyelonephritis or non-diabetic or hypertensive renal disease or incomplete clinical or histopathologic data. 19 histologic parameters were scored in a blinded manner by one renal pathologist. We examined the relationship between and functional variables (such as estimated glomerular filtration rate (eGFR)). Polynomial regression analysis was performed to model histopathologic variables and important clinical parameters such as eGFR RESULTS/ANTICIPATED RESULTS: 607 samples met inclusion criteria and were stratified as: control (no history of diabetes or hypertension, n = 160), hypertension alone (n = 224) and both diabetes and hypertension (n = 223). Interstitial fibrosis (IF) and glomerulosclerosis (GS) had the strongest correlations with eGFR. Regression analysis was used to model histopathologic score for a given eGFR. We found that diabetes and hypertension modified the relationship between tubulointerstitial fibrosis and eGFR. For example, while hypertensive patients without diabetes had 33% IF at an eGFR of 30 ml/min/1.73m2 (r2 = 0.64, p<0.01), hypertensive patients with diabetes had 32% IF at an eGFR of 30 ml/min/1.73m2 (r2 = .43, p<0.01) and control patients had approximately 23% IF at an eGFR of 30 ml/min/1.73m2 (r2 = 0.22, p<0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: Here, we describe the relationship between renal structural changes and renal function and show that hypertension significantly modifies the relationship at a given eGFR. These data can be used to reasonably predict renal structural changes given clinical information without the need for renal biopsy and may provide prognostic value.

OBJECTIVES/GOALS: This project aims to improve the design of medical technology for global health by addressing gaps in engineering education. Our primary goal is to develop open educational resource’curriculum boosters’ that can be added to existing BME curricula to build skills in transdisciplinary collaboration, practical ethics, and failure resilience. METHODS/STUDY POPULATION: A phasic mixed-method research strategy has been employed. The Needs Analysis includes a systematic review and meta-analysis of existing knowledge regarding the three conceptual pillars of Transdisciplinary Collaboration, Practical Ethics, and Integrated Resilience. The Behavioral Study includes surveys, interviews, observations, and biometric data collection from working engineers, engineering students, global health stakeholders, and clinicians. The Validation Study will be conducted via small group workshops, a semester-long engineering design course, and a summer study-abroad course. Data collected will be analyzed and used to refine the proposed educational strategies. RESULTS/ANTICIPATED RESULTS: The final educational strategies will be structured into 'curriculum boosters' and published as open educational resource materials. The boosters and their supporting data will be made available to other engineering education programs with the goal of promoting widespread adoption and integration of these methods. DISCUSSION/SIGNIFICANCE: The long-term outcome of this ongoing work is to train a new generation of engineers prepared to participate adeptly in the co-design of technological solutions for complex global healthcare challenges by working ‘with, not for,’ clinicians, communities, and other stakeholders in peripheral healthcare settings.

OBJECTIVES/GOALS: To develop the Adherence to Medications In Latinx adults with Depression and Anxiety (AMILDA) intervention using community engaged research principles, AMILDA will integrate culturally tailored messaging to improve depression and anxiety symptoms and adherence to antidepressant medications. METHODS/STUDY POPULATION: Bilingual steering committee members representing primary care and behavioral health professionals from 2 primary care clinics, and 1 lay community member met monthly for 1 year to develop the intervention. One clinic is an academic health center and the other is a federally qualified health center. Members identified, developed, and voted on the interventions components, therapeutic goals, and the mechanisms underlying its effectiveness that needed to be studied. To evaluate AMILDAs components, we conducted an observational study of health care providers (N=13) and Latinx adults with depression and/or anxiety (patients; N=26) from both clinics, and community pharmacists (N=9) from surrounding pharmacies to gather feedback. Based on their input, we revised the intervention. RESULTS/ANTICIPATED RESULTS: AMILDA consists of culturally tailored collaborative drug therapy management with a collaborative practice agreement between the physician and pharmacist. Patients recently started on an antidepressant receive language and culturally concordant motivational interviewing, teach back, and infographics; AMILDA is designed to improve symptoms, adherence, and health determinants. Most provider, pharmacist, and patient participants reported that AMILDA could be beneficial. Several participants indicated a lack of understanding about a US pharmacists scope of practice. Recommendations included ensuing language concordance, incorporating more statistics and scientific data, using images that are relatable, avoiding idioms and stereotypes, taking the time to build rapport, and being friendly. DISCUSSION/SIGNIFICANCE: AMILDA will be tested in a pilot effectiveness randomized controlled study to determine if it improves depression and anxiety symptoms and adherence to antidepressants among Latinx adults compared with enhanced usual care. The mechanisms to be assessed include self-efficacy, antidepressant knowledge, and personal health literacy.

OBJECTIVES/GOALS: Currently physicians are able to order CT Chest/Abd/Pelvis images as STAT or Routine. STAT images denote an emergency and are done immediately. We aim to determine the percentage of CT images that are inappropriately ordered as STAT, determine physician image ordering habits, and develop targeted interventions to encourage appropriate STAT image ordering. METHODS/STUDY POPULATION: A fishbone diagram helped reveal possible causes of inappropriate STAT image ordering. Based on the fishbone diagram, a survey was created to assess CT image ordering habits amongst radiology and internal medicine residents and attending physicians. All CT Chest/Abd/Pelvis images ordered over a 3 month period of time (July-Oct 2017) was obtained. The dataset included whether the image was ordered Stat vs Routine, time of image order, physician name and location, and reason for the imaging study.The STAT images were evaluated based on the explanation provided in the CT image order. Currently 2 radiology residents, 2 internal medicine residents, and 2 internal medicine hospitalists are evaluating all STAT CT images to determine appropriateness and how long they are willing to wait for the image to result in a read. RESULTS/ANTICIPATED RESULTS: Analysis of all CT Chest/Abd/Pelvis imaging orders revealed that 51% (1710/3345) of them were ordered as STAT. The preliminary analysis of 227 STAT images showed that 6% were inappropriate. We anticipate results of our survey to show differences in how long a STAT vs Routine image orders should take amongst Radiology and Internal Medicine clinicians. We also anticipate our survey to show differences in factors that warrant STAT imaging amongst the different medical fields. We anticipate that the clinician manual evaluation of all STAT CT image will reveal a large percentage of imaging orders to be inappropriate. All STAT imaging that were flagged as inappropriate will be characterized by the department who ordered the image and the reason provided for the imaging to assess for common themes. DISCUSSION/SIGNIFICANCE OF IMPACT: STAT images are the new routine with more images ordered STAT than Routine. Inappropriate STAT imaging results in truly urgent patients not getting the medical care they need. Many images ordered stat could potentially be switched to routine. By evaluating why clinicians are ordering STAT CT image inappropriately, we will be able to develop targeted interventions to decrease inappropriate STAT CT imaging.

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/GOALS: Scientists are increasingly confronted with 'science critical' #_msocom_1 belief systems. The politicization of science fuels hesitancy towards evidence-based therapies. To overcome these barriers, we aim to devise strategies to communicate clinical translational science (CTS) through art. METHODS/STUDY POPULATION: A two-year pilot artist-in-residency (AIR) program embedded in the Translational Research Immersion Program (TRIP). Since 2009, TRIP contributes to CTS Workforce Development (WD) through a 10-week mentored, curriculum-rich summer undergraduate research experience. Students are recruited from 5 regional institutions, 6 HBCUs, and the University of Puerto Rico. AIR is composed of 3 phases: the “Immersive Phase” where the artist gains intensive exposure to the scientific process through the lived experience of TRIP students, the “Productive Phase” where the artist conceptualizes the process of CTS into works of art, and the “Engagement Phase” where the CTS workforce, artists, and community members coalesce around science-to-art materializations. RESULTS/ANTICIPATED RESULTS: In 2022 & 2023 the AIR participated in ~35hrs of CTS research seminars, panel discussions, and professional skills workshops. Additional TRIP student-AIR interaction occurred in focus groups including visits to mentor’s labs. An AIR-led workshop culminated in an Empowering CTS Communication event where TRIP students engaged with community members through elevator pitches of their CTS summer project on a speed-rotating basis. A month-long art-CTS exhibition planned for 3/2024 will feature contributions from AIR, TRIP students, and ITMAT community members. Qualitative insights were that TRIP is an effective art-science incubator, students strengthened their CTS communication skills, art functions as an icebreaker between science and communities with an ocean of opportunities for science education. DISCUSSION/SIGNIFICANCE: AIR embedded into existing CTS WD programs is proposed as creative approach to strengthen the reputation of science in the public. CTS-informed art functions as connective tissue between public and CTS workforce. The hands-on experience to adopt art as a science communication tool is a powerful soft skill for the next generation of CTS investigators.

OBJECTIVES/GOALS: Heart failure (HF) is a clinical condition that notably affects the lives of patients in rural areas. The partnering of a rural satellite hospital with an urban academic medical center may provide geographically underrepresented populations with HF an opportunity to access controlled clinical trials (CCTs). METHODS/STUDY POPULATION: We report our experience in screening, consenting and enrolling subjects at the VCU Health Community Memorial Hospital (VCU-CMH) in rural South Hill, Virginia, that is part of the larger VCU Health network, with the lead institution being VCU Health Medical College of Virginia Hospitals (VCU-MCV), Richmond, VA. Subjects were enrolled in a clinical trial sponsored by the National Institutes of Health (ClinicalTrials.gov: NCT03797001) and assigned to treatment with an anti-inflammatory drug for HF or placebo. We used the electronic health record and remote guidance and oversight from the VCU-MCV resources using a closed-loop communication network to work with local resources at the facility to perform screening, consenting and enrollment. RESULTS/ANTICIPATED RESULTS: One hundred subjects with recently decompensated HF were screened between January 2019 and August 2021, of these 61 are enrolled to date: 52 (85 %) at VCU-MCV and 9 (15%) at VCU-CMH. Of the subjects enrolled at VCU-CMH, 33% were female, 77% Black, with a mean age of 5210 years. DISCUSSION/SIGNIFICANCE: The use of a combination of virtual/remote monitoring and guidance of local resources in this trial provides an opportunity for decentralization and access of CCTs for potential novel treatment of HF to underrepresented individuals from rural areas.

OBJECTIVES/SPECIFIC AIMS: We hypothesized that increasing percent calories from MUFA (%MUFA) would be associated an increased FFM/FM index. METHODS/STUDY POPULATION: Nine consecutive HFpEF patients with obesity participated in a 12-week pilot feasibility trial of UFA supplementation (NCT03310099). Subjects were educated at baseline by a dietitian on UFA rich foods including high MUFA choices such as extra-virgin olive oil, canola oil and avocados. Participants were given a list of items, corresponding serving sizes and asked to eat at least one serving of these UFA rich foods per day for 12 weeks. Adherence was encouraged through weekly phone calls by the dietitian. Standardized 5-pass 24-hour dietary recall was performed by a dietitian at baseline and 12 weeks. The recalls were analyzed to establish intake of MUFA in percent calories (%kcals) with Nutrition Data Systems for Research software (NDSR). Body composition including FM%, fat free mass percent of body weight (FFM%) and ratio of FFM to FM (FFM/FM Index) was measured with bioelectrical impedance analysis (RJL systems) at baseline and 12 weeks. Statistical analysis was performed with SPSS (24.0). Spearman rank test was used for correlations. Values are expressed as numbers and percentages or as median and interquartile range (IQR). RESULTS/ANTICIPATED RESULTS: Subjects were mostly female (56%) with a median age 56 (IQR 50-59). Baseline median body mass index (kg/m2) was 36.7 (36.2-48.0), median FM% was 44.5 (IQR 32.5-53.4), median FFM% was 55.5 (IQR 46.7-67.5) and median FFM/FM Index was 1.25 (IQR 0.88-2.1).The only significant change was an increase in %MUFA from baseline 12.4% (IQR 6.9-14.3) to 12 weeks 21.8% (17.6-36.9) (p = 0.008). Increased %MUFA was highly associated with increased FFM% (r = 0.783, p = 0.013) (Figure 1A), decreased FM%(r = −0.783, p = 0.013)(Figure 1B) and increased FFM/FM index (r = 0.800, p = 0.010) (Figure 1C). All correlations remained statistically significant after adjustment for changes in energy intake. DISCUSSION/SIGNIFICANCE OF IMPACT: Increasing dietary %MUFA is protective against negative changes in body composition in patients with obesity and HFpEF, independent of changes in caloric intake. Future work should focus on whether the correlation found in this pilot study translate in improved body composition and finally, exercise tolerance and clinical outcomes.

OBJECTIVES/GOALS: CEnR plays a crucial role in rapidly translating science to improve health by bridging gaps between research and practice although skills development is critical to enable successful community/academic partnerships. We have developed a curriculum mapped to CEnR domains and competencies that meets the needs of community partners and investigators. METHODS/STUDY POPULATION: We located three comprehensive efforts to identify CEnR domains and competencies that we aligned to develop our curriculum, which we then mapped to these competencies. The first was undertaken by a NCATS Joint Workgroup which identified curricula, resources, tools, strategies, and models for innovative training programs. Using Competency Mapping, they developed a framework for curriculum mapping that included eight domains, each with two to five competencies of knowledge, attitudes, and skills. The second aligned CEnR competencies with online training resources across the CTSA consortium, while the third focused on Dissemination and Implementation training. Informed by a conceptual model to advance health equity, we adapted and integrated these frameworks into a set of six educational modules. RESULTS/ANTICIPATED RESULTS: Although many CEnR training programs have been developed, few curricula are mapped to identified domains and competencies, and fewer still address institutional and community barriers to effective CEnR training. However, many outstanding curricula effectively address these competencies, and our curriculum draws from and builds upon these programs of excellence, including those from our sister CTSA hubs. Our modules serve our local community by educating and empowering faculty, students, and community partners. To date, no CEnR curriculum has been implemented at our institution that meets the needs of all parties who play a significant role in community-engaged research (e.g., IRB members, investigators, and community-based partners). This curriculum thus fills an important gap in our workforce training. DISCUSSION/SIGNIFICANCE: This educational program is designed to educate and empower investigators, trainees, students, and community partners to engage in effective CEnR that promotes community projects and fosters relationships and trust. Following evaluation, we will offer the curriculum for use by others interested in using or adapting it for their own programming.

ABSTRACT IMPACT: This is the first study to use QUINT analyses to examine heterogeneity of treatment effect for group medical visits among individuals with type 2 diabetes. QUINT is a data driven method that assumes no a priori assumptions regarding effect moderators - an important step in the path towards personalized medicine. OBJECTIVES/GOALS: To examine heterogeneity of treatment effect (HTE) in Jump Start, a trial that compared the effectiveness of group medical visits (GMVs) focused on medication management only versus the addition of intensive weight management (WM) on glycemic control for patients with type 2 diabetes and body mass index >=27kg/m^2. METHODS/STUDY POPULATION: Jump Start patients (n=263) were randomized to a GMV-based medication management plus low carbohydrate diet-focused WM program (WM/GMV; n = 127) or GMV-based medication management only (GMV; n = 136) for diabetes control. We used QUalitative INteraction Trees (QUINT), a tree-based clustering method, to determine if there were subgroups of patients who derived greater benefit from either WM/GMV or GMV. Subgroup predictors included 32 baseline demographic, clinical, and psychosocial factors. Outcome was hemoglobin A1c (HbA1c). We conducted internal validation via bootstrap resampling to estimate bias in the range of mean outcome differences among arms. RESULTS/ANTICIPATED RESULTS: QUINT analyses indicated that for patients who had not previously attempted weight loss, WM/GMV resulted in better glycemic control than GMV alone (mean difference in HbA1c improvement = 1.48%). For patients who had previously attempted weight loss and had lower cholesterol and blood urea nitrogen levels, GMV alone was better than WM/GMV (mean difference in HbA1c improvement = 1.51%). Internal validation resulted in moderate corrections in the mean HbA1c differences between arms; however, differences remained in the clinically significant range. DISCUSSION/SIGNIFICANCE OF FINDINGS: Among patients with diabetes and BMI>=27kg/m^2, a low-carbohydrate, weight loss focus may better improve HbA1c in those who have never attempted weight loss. A medication management focus may be better in those who have attempted weight loss and have lower cholesterol and blood urea nitrogen.