NIH/NIGMS-funded IDeA-Clinical and Translational Research (CTR) networks seek to expand translational research infrastructure to support research that has at its endpoints measurable clinical, public health, technological, or economic benefits. This retrospective case study followed 14 projects that received Pilot funding from the Great Plains IDeA-CTR (GP IDeA-CTR) at the University of Nebraska Medical Center. It focuses on the impact of pilot funding and GP IDeA-CTR resources on subsequent clinical and translational research. Metrics include extramural awards, lessons learned that relate to clinical and translational research infrastructure, and demonstrated and potential benefits using the Translational Science Benefits Model (TSBM).

Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.

Objectives/Goals: Despite persistent health disparities, rural individuals are underrepresented in clinical trials, due in part to access barriers. We investigated if targeted strategies enhanced recruitment, engagement, and retention of rural adolescents in the TEENS+ randomized clinical trial, a 4-month family-based behavioral weight loss intervention. Methods/Study Population: Adolescents (12–16 y) and parents with obesity were eligible for TEENS+. Treatment converted to virtual in COVID-19, allowing eligibility to expand to more rural areas. We leveraged Informatics, a practice-based research network, and direct marketing to identify potential rural participants. Targeted engagement strategies included: rural physician outreach, physician-endorsed letters, providing tablets and mobile hotspots, reimbursing travel, and offering in-person or remote assessment visits. Chi-square tests evaluated differences in screener completion and enrollment of rural families before (T0) and after (T1) changes were made. Noninferiority tests evaluated rural vs. nonrural retention and engagement (% attendance, % dietary self-monitoring) and engagement based on digital tool receipt. Results/Anticipated Results: N = 211 dyads enrolled (n = 54 in T1: 48% male; 41% Black). Screener completion by rural families significantly increased from T0 (9.8%) to T1 (15.1%; p = .043). Yet, there was no significant change in rural adolescent enrollment (T0 = 10%; T1 = 9%; p = .844). Sixteen adolescents (30%) received study tablets, and none needed mobile hotspots. Mean adolescent attendance was 75%±28% for group and 94%±18% for individual sessions, with no significant differences based on rural status or tablet use. Rural adolescent self-monitoring (via app) was 28%, compared with 50% for non-rural adolescents (p = .074). Retention was 94% at 4m and 89% at 8m for T1 participants, with no differences based on rural status. At the primary endpoint (12 m), retention was significantly higher for rural (100%) vs. non-rural (87%) participants; p = .013. Discussion/Significance of Impact: Rural adolescent screener hits increased yet enrollment was unchanged. However, rural attendance was comparable and retention exceeded, compared to nonrural participants. Strategies to yield equitable representation and engagement in clinical trials are essential for geographic generalizability and to reduce rural health disparities.

ABSTRACT IMPACT: The results from this study will improve needs assessment practices. OBJECTIVES/GOALS: The discovery phase in project development is necessary to better understand the needs and requirements of the intended market. This paper compares the outcomes of two virtual data collection methodologies, NSF I-Corps Customer Discovery interviews and REDCap surveys, for a needs assessment. METHODS/STUDY POPULATION: Clinical and Translational Science Award (CTSA) Directors and Academic Administrators across the Consortium were asked about the types of skills needed to assess clinical research professional competencies and the need for a competency-based self-assessment tool (CBST). Parallel methods were used to extract qualitative and quantitative data. The first approach was to conduct interviews using I-Corps customer discovery guidelines, and data was collected using Innovation Within software. Targeted requests were sent via cold email outreach to 102 individuals within 63 CTSA hubs. The second approach involved the use of the NJ ACTS Training and Education Offering Inventory REDCap Survey which was distributed via LISTSERV to 63 CTSA hubs. Response rates and user insights from each method were compared. RESULTS/ANTICIPATED RESULTS: Twenty-one of 63 CTSA hubs responded to the survey (response rate: 33%) while 18 of 63 hubs participated in an interview (response rate: 28%). Twenty-two individuals out of 102 were interviewed (response rate: 21%). Fifty-nine percent of interviewees and 62% of survey respondents indicated a clear need for a CBST; types of responses varied. Forty user insights were obtained from ten interviews. Two insights were gained in the survey from the eight who were prompted to fill out the free-text response. Both survey participants and interviewees indicated that communication and team science soft skills were the most important competencies. Regarding hard skills, interviewees preferred written skills while survey participants favored ‘scientific design and concept’ skills. DISCUSSION/SIGNIFICANCE OF FINDINGS: Results suggest the use of a survey or an interview for a needs assessment is dependent on several factors: need for insights, burden of time, desire to obtain quantitative vs. qualitative data, and question format. The interview was more effective than the survey in addressing the key question and obtaining insights from the intended market.

OBJECTIVES/GOALS: Evaluation of the contributions of the CTSI core services to the science of translational science requires focused protocols that are rigorous developed and piloted. The goal of this presentation is to report on the process of protocol development and present the results of protocol pilot implementation. METHODS/STUDY POPULATION: Translational science’ (TS) is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process (Austin, Clin Trans Sci. 2021; 14:1629-1647). A key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects (e.g., incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability, ineffective clinical trial recruitment). The navigation steps and mapping to resources for translational researchers provides an opportunity to develop effective navigation tools and study the barriers to effective translation. RESULTS/ANTICIPATED RESULTS: The UF-FSU Evaluation Committee has developed and piloted an evaluation protocol that aims to assess the role of CTSI service centers in addressing specific TS barriers. The protocol is informed by interviews with CTSI service users, and is grounded in the Donabedian Framework of Quality Assessment and Lean principles. The pilot implementation of the protocol showed its relevance and applicability across multiple UF-FSU core service centers. DISCUSSION/SIGNIFICANCE: The barriers to translational science are not unique but addressing them is rarely within the scope of individual translational research projects. Conversely, service centers within the CTSA institutions are uniquely positioned to address TS barriers thus enhancing to the operational efficiency of the CTS enterprise and promoting the science of TS.

OBJECTIVES/SPECIFIC AIMS: The goal of the eResearch platform is to make consenting for clinical trials more convenient, accessible, and faster while retaining an ethical and informed consenting process. eResearch e-consent also allows for enhanced standardization and efficiency for research collaborations across academic research institutions, which, ultimately, helps drive discovery of better health care for our patients and communities. METHODS/STUDY POPULATION: The UMN’s CTSI and AHC Information Systems developed software, called eResearch Suite, for electronic consenting. The eResearch Suite includes viewing a consent, a “Check Your Understanding” quiz to assess comprehension of critical study details, and a signature block that captures the participant signature electronically and with an automatic date and time stamp. The eResearch Suite also has the capability to randomize participants, track participants via a master list, collect participant data, collect internal study data, and generate emails to participants. The eResearch Suite platform is written in Ruby on Rails. RESULTS/ANTICIPATED RESULTS: We have pilot tested the eResearch platform with one study thus far. Preliminary results of the study show that all participants consented via eResearch, with 64% of participants consenting remotely via eResearch before their first study visit. Participants e-consented using various devices including desktop computers, tablets, and smart phones. Participants also filled out surveys and questionnaires before their study visits, which saved the study team time and money. DISCUSSION/SIGNIFICANCE OF IMPACT: eResearch electronic consenting (e-consenting) changes the way potential participants consent for studies. e-Consenting is important because it allows individuals, or their Legally Authorized Representatives, to consent remotely. This may be faster, more convenient for people, reduce coercion, increase comprehension, and allow for consenting information or process to be shared with an individual’s family/friends. In acute and emergent settings we anticipate eResearch e-consenting will result in significant reduction of consent time by replacing faxed and paper consent with e-consent available via email and mobile devices. This allows legally authorized representatives to sign consent remotely, reduces the time physicians spend faxing consents, and allow them to avert more focus back on their patients. Time savings, whether for consent or study visits, may also result in a cost savings for studies.

OBJECTIVES/GOALS: The goal of Miami CTSI’s Mentored Translational Research Scholars (KL2) Program is to identify outstanding early-stage investigators and prepare them to become the next generation of highly skilled independent researchers who translate fundamental knowledge and new technologies from the laboratory to the clinic and to the community. METHODS/STUDY POPULATION: Evaluation of the KL2 program focused on assessing progress in the following areas: 1) scholar productivity during and after graduating from the program; 2) continued engagement of KL2 program graduates in clinical and translational research; scholar productivity during and after graduating from the program; 3) outcomes such as establishing independent research careers, obtaining research funding, and establishing collaborations; and 4) research impact. We used a developmental evaluation approach and benefits-framework model to conduct program evaluation, incorporating both in a program-specific logic model. Bi-annual surveys were used to measure scholar feedback and progress, and utilization of CTSI services. RESULTS/ANTICIPATED RESULTS: Since 2013, the KL2 program has trained 21 scholars,17 of whom have completed training, and four are still in the program. Of the 21 scholars, 52% are female and 38% are underrepresented minorities (URM)–significantly higher than the 12% URM for overall CTSA KL2 scholars. Scholars have 176 total publications related to their KL2 projects and have received $52.4m in total research funding. In addition, 50% of the projects focused on health disparities. Overall, 48% of KL2 scholars have received large subsequent federal awards including three NIH K awards and six NIH R awards. Scholars actively utilized CTSI services during and after graduation. Programmatic enhancements such as adding institutional scholars and using scholar feedback to improve program resources were also implemented. DISCUSSION/SIGNIFICANCE: Miami CTSI’s KL2 program has demonstrated success in fulfilling its program goals. The process and outcome evaluation has provided a better understanding of program performance and progress and has demonstrated alignment with CTSI’s overall goals on addressing health disparities and its commitment to diversity and equity.

OBJECTIVES/GOALS: Faculty pursuing their first independent research grants often struggle to express their ideas in a concise, compelling way. Thus, we developed the “Research and Scholarship Storytelling Bootcamp” to equip these faculty with narrative development skills applicable across disciplines and mechanisms. METHODS/STUDY POPULATION: Early-career researchers who were preparing either their first NIH R-series application or an NSF CAREER award proposal were invited to participate. Enrollment was limited to 20 participants. Those accepted learned the “And-But-Therefore” narrative framework by reading a short book and attending 4 synchronous lectures. Between sessions, they applied the framework by drafting abstracts and Specific Aims/Project Summary documents and reviewing their fellow participants’ work. We assessed participants' comfort with storytelling, perceptions of preparedness, and confidence regarding funding chances, before and after the program using a visual analog scale (max 100 points) and calculated Cohen’s d to evaluate the effect size of any changes. RESULTS/ANTICIPATED RESULTS: Thirty people applied for 20 slots, indicating strong demand. Eleven NIH applicants and 9 NSF applicants enrolled. Before the program, participants rated their comfort with storytelling at 45 ± 25, their preparedness at 39 ± 24, and their funding confidence at 39 ± 26. Nine total participants completed all sessions, assignments, and surveys. Completion rates were comparable for NIH- and NSF-targeting participants. After the program, completing participants reported increases in their comfort with storytelling (68 ± 14 post vs 32 ± 20 pre, d = 1.46), perceived preparedness (64 ± 20 post vs 48 ± 26 pre, d=0.58), and confidence in funding chances (56 ± 19 post vs 40 ± 27 pre, d=0.75). DISCUSSION/SIGNIFICANCE: This program was the first of its kind for multidisciplinary early-career faculty at our institution. The program successfully achieved its objectives for those who completed all activities. Future analysis of survey comments and proposal success rates will reveal barriers to full program engagement and opportunities for further training.

ABSTRACT IMPACT: ReacStick concussion testing and monitoring can serve as a 'vital sign for the brain', allowing for an immediate, objective assessment on the field or at the bedside. This project examines the entrepreneuship process from invention to commercialization. OBJECTIVES/GOALS: ReacStick is the first objective, portable, measure of concussion likelihood and severity and uses simple and complex reaction time testing. We detail the entrepreneurship process from product invention through its current mid-stage (patented, 20+ publications, etc.) to future commercialization for diverse applications. METHODS/STUDY POPULATION: ReacStick was invented in 2010 and underwent extensive testing and validation of the underlying innovations. The regulatory landscape of the product was examined, and 510(k) was found to be the best pathway. Competitive analysis was done examining alternative products and comparing against the current gold standards. A customer discovery process was undertaken, and stakeholders were interviewed for feedback and iteration. Testing and validation were completed with athletes, older adults, and people taking medications. An overview of the necessary commercialization concepts is: market opportunity/monetization, intellectual property considerations, regulatory processes, commercialization plan. RESULTS/ANTICIPATED RESULTS: ReacStick accurately predicts concussion and time to recovery and was patented through UM Tech Transfer in 2010, with 10 years currently remaining on the patent. Through customer discovery processes, athletics was determined to be the most viable first market to enter. Next steps include seeking additional patent protection, capital investors, delivery of minimum viable product followed by iteration and improvement for military, emergency medicine and acute care use. The current remaining timeline involves 12-18 months to commercialization and includes regulatory approval, additional patent protection, collaboration with regulatory consultants, capital fundraising and product production. DISCUSSION/SIGNIFICANCE OF FINDINGS: The research team has gone through a lengthy process toward commercialization of ReacStick. Proof of concept and extensive validation of the underlying technology have been completed and the regulatory process has been mapped. Our experience can serve as a model of many of the steps and challenges that lie on the path from lab to sale to end users.

OBJECTIVES/GOALS: Individuals with intellectual and developmental disabilities (IDD) have lower levels of moderate-to-vigorous physical activity (MVPA) and a greater risk for sedentary-related comorbidities compared to their typically developing peers. Understanding activity patterns may provide opportunities for targeted physical activity interventions. METHODS/STUDY POPULATION: Secondary analyses were performed on baseline accelerometer data pooled from 2 clinical trials and a pilot study in adolescents (11-17 years) and young adults (18-21 years) with IDD. MVPA was assessed using accelerometers worn on the non-dominant hip during waking hours over 7 consecutive days. Data were collected at 60 hertz and activity counts were aggregated over 60 second epochs. Wear time was determined with the Choi algorithm and MVPA was classified using the Troiano adult or Freedson age-specific child cut-points. Mixed effects linear regressions were used to determine the effects of day of the week, time of the day, and season on MVPA. Diagnosis, gender, and age were used as fixed effect covariates with random intercepts varying among the participants and days of observation within each participant. RESULTS/ANTICIPATED RESULTS: There were 231 individuals (15.6 ± 2.8 years, 51.5% female) who had IDD (36.8% Autism, 48.1% Down syndrome) with 22,498 minutes of MVPA. Individuals with IDD wore the accelerometers an average of 592 ± 254 min./day and completed 13.5 ± 17.9 min./day of MVPA. Average MVPA was lowest in individuals with Autism (12.6 ± 11.4 min./day) and Down syndrome (13.2 ± 9.3 min./day) when compared to those with other IDDs (16.8 ± 10.8 min./day). Participation in MVPA was similar in males (13.4 ± 10.7 min./day) and females (13.7 ± 9.9 min./day). Mixed effects linear regressions showed that individuals participated in fewer minutes of MVPA on the weekend (β = -0.75, p < 0.001) and from 12-3 pm (reference) when compared to before 12 pm (β = 0.87, p < 0.001) and 3-7 pm (β = 0.66, p=0.007). No significant seasonal effects were found. DISCUSSION/SIGNIFICANCE: Individuals with IDD were significantly less active on the weekend, but they did participate in more minutes of MVPA in the morning and late afternoon/early evening. Physical activity interventions aiming to increase MVPA on the weekend and during the early afternoon may increase the number of weekly minutes of MVPA in individuals with IDD.

OBJECTIVES/GOALS: Learn how the National Organization of Research Development Professionals (NORDP) adapted the Center for Improvement of Mentored Experiences in Research (CIMER) NIH-funded evidenced-based mentor training curriculum for research development professionals and how the curriculum will be further adapted for clinical research professionals. METHODS/STUDY POPULATION: NORDP pioneered the adaptation of the CIMER curriculum for professional research staff. In addition to revamping the case studies and ensuring the curriculum was appropriately staff-centric, the NORDP team developed best practices for adapting the curriculum. This approach included four phases: (1) developing expertise in mentor training, (2) adapting curriculum for staff, (3) creating role-specific case studies, and (4) integrating mentor training with institutional or professional association-based mentoring programs. In collaboration with CIMER and units at the University of Minnesota (UMN), the mentor training model for research development will be further adapted for clinical research staff, i.e. coordinators, regulators, facilitators. RESULTS/ANTICIPATED RESULTS: This poster will discuss the preliminary work of adapting the curriculum for clinical research professionals by the UMN’s Departments of Family Medicine and Community Health and Clinical and Translational Science Institute’s Translational Workforce Development team. The anticipated short to mid-term outcomes of this work include: (1) improved research professionals mentoring knowledge and skills, (2) diversity addressed across research roles, (3) reduced staff turnover and associated costs, (4) increased staff job satisfaction and moral, and (5) research culture changed to value mentoring excellence across the academic enterprise. DISCUSSION/SIGNIFICANCE: Research mentoring has traditionally been focused on faculty and trainees. Given the unique skill sets and increasing complexity of research staff roles, mentoring can increase job satisfaction and reduce the overall costs related to turnover, i.e. research productivity, loss of institutional knowledge, hiring costs, etc.

OBJECTIVES/GOALS: The rib construct is a novel device for treating childhood hyperkyphosis and kyphoscoliosis. The purpose of this study was to investigate the biomechanics, mechanism, and clinical outcomes of this device. The overarching hypothesis was that the rib construct is safe and effective for correcting hyperkyphotic spinal deformity. METHODS/STUDY POPULATION: Biomechanical evaluation: An ex vivo porcine spine biomechanical study compared traditional pedicle screw proximal fixation to the rib construct in terms of proximal fixation strength and construct stiffness. Porcine model hyperkyphosis correction with rib construct: An in vivo hyperkyphotic porcine model was used to study the ability of the rib construct to correct hyperkyphosis in the developing porcine spine. Human hyperkyphotic correction with rib construct: A retrospective study was conducted to examine the radiographic outcomes, complication rates, procedure times, and blood losses experienced by human patients that received rib construct surgery. RESULTS/ANTICIPATED RESULTS: Biomechanical evaluation: The rib construct was significantly less prone to proximal fixation failure and less stiff compared to pedicle screws. Porcine model hyperkyphosis correction with rib construct: The average T6-T14 thoracic kyphosis was 35.8 ± 3.2° at the time of hyperkyphosis creation surgery. In response to corrective surgery with the rib-hook construct, T6-T14 thoracic hyperkyphosis decreased immediately post-op to 11.3 ± 7.8° and continued to decrease to 7.8 ± 7.6° until final follow-up 8 weeks post-op (n = 3). Human hyperkyphosis correction with rib construct: Pre-op sagittal Cobb angle was 81 ± 31° and fell to 43 ± 24° post-op and to 38 ± 24° at final follow-up; indicating ~100% correction (normal thoracic kyphosis is 40°). DISCUSSION/SIGNIFICANCE OF IMPACT: The results suggest that the rib construct is a highly effective technique and superior to existing methods.

OBJECTIVES/SPECIFIC AIMS: This study sought to develop a mHealth application which was capable of predicting the spread of infectious diseases during the height of the Ebola outbreak in Lagos, Nigeria. Following the success of this primary task, the research then sought to understand behavioral health issues which are indicative of chronic diseases, such as sedentary behaviors and where they occur at a geospatial level in real-time. The results of this study are now being used to develop a larger scale 500 person study in Rochester, NY, USA. METHODS/STUDY POPULATION: During a 3-month period individuals were asked to install a mobile health application known as Node onto the their android device. Consent was done remotely, individuals were recruited through the Lagos University Teaching Hospital, Nigeria Institute of Medical Research, and the University of Lagos. Participants were paid 50 USD/month for each month of study completion, while continuous location data was collected in addition to survey information about participants. RESULTS/ANTICIPATED RESULTS: During the study period 70 individuals enrolled, using this data we were able to create network based models which indicated that diseases were more likely to spread at the beginning of the week, and also indicated who would be most susceptible to being patient zero. In phase 2 we have started to look at behavioral patterns to determine the risk of chronic disease among our study population, by examining their human mobility patterns, since we can determine average sleep patterns, activity patterns using machine learning classifiers, and time spent in traffic—all of which we can visualize in a real-time geospatial manner with higher objectivity than traditional mechanisms for data collection. DISCUSSION/SIGNIFICANCE OF IMPACT: In developing countries, using Nigeria as our example most chronic disease and household studies only enroll a few thousand participants for a country numbering 150 million plus. Using our rapidly available application we were able within 1 week to enroll 70 participants on 1 year of funding, this creates a framework for larger scale public health studies which can be done in developing countries and also demonstrates the value in mHealth which can both answer questions of infectious disease and chronic diseases at the same time. Our results indicate that at an infectious disease level in city environments diseases may be prevented by targeting events early in the week. While at a chronic disease level the lack of reliable power results in less sedentary behavior as individuals seek locations to charge phones, while those with more stable western-like lifestyles have started to exhibit the conditions which cause such outcomes as obesity, which has begun to rise in developing countries. Ultimately, these results serve as a staging point to launch a more wide scale study both in the United States and Nigeria within the year, now that feasibility has been established.

OBJECTIVES/SPECIFIC AIMS: Our objectives with this project are to engage communities through technology creating a communication channel with affected communities and stakeholders about mosquito-borne illness, vector control and environmental health risk. Furthermore, engaging communities to electronically map ecological risks that impact mosquito-borne illness with the goal of creating a mobile application that will work as an ecological surveillance against mosquito proliferation and potential mosquito population reduction, and finally pilot test and evaluate potential benefits in communities where the application was used. METHODS/STUDY POPULATION: We propose a methodology to perform formative community work that will underscore a distributed, democratized ecological surveillance through an integration of multidimensional health behavior theories that address the challenges of ZIKV in Culebra, a marginalized island community off the coast of the main island of Puerto Rico. Using participatory design, we will develop, test, and evaluate users’ experiences towards mobile applications using qualitative (interviews) and quantitative (survey) methodologies. A mobile application with the capacity of mapping, use of social-media, crowdsourcing, and photo-voice in a dynamic and simple way will allow community members to alert “hot-zone” locations to the stakeholders interested in creating ecological action in their community. This multidimensional concept integrates explanatory and prospective approaches and will generate systematic short-term solutions for mosquito control and long-term solutions providing the necessary tools for community empowerment. RESULTS/ANTICIPATED RESULTS: Our proposed design will facilitate better understanding of the interactions between community members and socio-environmental determinants of mosquito-borne diseases. Furthermore, our proposed project will not only facilitate communication among members of a community, but also it will provide a platform for engagement and empowerment, establishing a change in the preventive paradigm of how communities face the negative impacts of micro-ecologies that surround them. DISCUSSION/SIGNIFICANCE OF IMPACT: Our proposed community collaboratory mHealth tool mZAP! (Zonas, Accion y Proteccion) will address the lack of community participation efforts against mosquito-borne diseases contributed simultaneously by the disengagement and disempowerment of community members. mZAP! will serve as an innovative tool to engage marginalized and communities made vulnerable in Puerto Rico. This approach should be successful as Puerto Rico is one of the most digitally connected countries in Latin America, with high mobile phone usage rates and social media use. Using mZAP!, communities will report and map breeding sites, use social media and crowd sensing, targeting against powerful tools against mosquito ecologies in their own environments. This application could result in an effective way to change the paradigms for public health approaches to use Information Communications Technologies (ICTs) to empower communities.

OBJECTIVES/SPECIFIC AIMS: Chronic obstructive pulmonary disease (COPD) is a leading cause of both hospitalizations and readmissions in the United States, and about 1 in 5 hospitalized patients with COPD will be readmitted within 30 days. COPD-focused self-management programs are frequently used to help patients better manage their symptoms and prevent hospitalization. However, while the majority of patients with COPD have at least one comorbidity, most trials of COPD self-management programs either excluded patients with significant comorbidities or did not analyze the impact of comorbidities on patient outcomes. Using data from the BREATHE trial of a COPD self-management program, this study aims to determine if patient post-intervention outcomes differ based on the intensity and type of patient comorbidities. METHODS/STUDY POPULATION: In total, 240 patients hospitalized for COPD were randomly assigned to either a comprehensive self-management intervention or usual transitional care. Primary outcomes for this trial were the number of COPD-related hospitalizations and emergency department visits at 6 months and changes in COPD-specific quality of life. To determine whether patient comorbidities modify the effect of the self-management intervention on readmission and quality of life outcomes, we will compare patient outcomes across groups stratified by comorbidity burden (Charlson Comorbidity Index) and type (baseline diagnosis of congestive heart failure, diabetes, and depression). In addition, we will use regression analysis with interaction terms to test for interaction between comorbidity burden/type and intervention assignment. RESULTS/ANTICIPATED RESULTS: We hypothesize that the effect of the self-management intervention will differ in patients with greater comorbidity burden due to competing medical demands for patients with multimorbidity. DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this study will help clinicians better target disease-specific self-management programs to the groups of patients with COPD who are likely to receive the greatest benefit from this type of intervention.

OBJECTIVES/GOALS: Diabetic ketoacidosis (DKA) is a life-threatening complication of diabetes. Though largely preventable, DKA is one of the most common acute complications of diabetes. In the US, rates of DKA hospitalization and associated costs have been increasing over the past two decades. METHODS/STUDY POPULATION: In this study, we used the Kentucky Statewide Inpatient Database (2010-2019) and the Nationwide Readmission Database (2010-2018) to explore variation in rates of DKA hospitalization across key sociodemographic subgroups (age, sex, race/ethnicity, rural/urban, insurance coverage, and county-level poverty index) and identify clinical predictors of DKA hospitalization. The primary outcome was hospitalization with a first diagnosis of DKA identified using ICD-9 and -10 codes. Crude rates were calculated using state- and county-level population estimates obtained from the US Census Bureau and are presented as the total number of events per 10,000 people. Regression models will be used to examine the associations between DKA hospitalization and clinical predictors. RESULTS/ANTICIPATED RESULTS: In Kentucky, from 2010-2019, rates of DKA hospitalization increased by 45% (from 65.5 to 94.8 per 100,000). The largest variation was observed by age, race/ethnicity, and insurance. In those aged 15-44, rates of DKA hospitalization were three times higher than rates in the youngest (<15) and oldest (>75) groups (>130 vs <45 per 100,000). Non-Hispanic Blacks experienced rates of DKA hospitalization that were 2x higher than rates observed in non-Hispanic Whites (183.9 vs 92.6 per 100,000). Those covered by Medicaid had the highest rates of DKA hospitalization (171.3 vs 32.4 per 100,000 in commercially insured). Small, but consistent, disparities were observed in rural vs urban counties and higher poverty rates. Predictors of DKA hospitalization are being examined in the Nationwide Readmission Database. DISCUSSION/SIGNIFICANCE: Our findings underscore significant variation in DKA risk across key sociodemographic subgroups and will examine and confirm previously identified clinical predictors of DKA. Because DKA is largely preventable, identifying individuals at higher risk and targeting interventions and services to these individuals may help reduce DKA rates.

OBJECTIVES/GOALS:

1. 1. analyze urinary protein exosome content pattern before and during DASH diet.

2. 2. characterize urine electrolyte changes associated with changes in protein profiles, and hormonal changes before/after DASH diet.

3. 3. analyze the association of these changes to the DASH-related BP response.

METHODS/STUDY POPULATION: In this proof of concept study, hypertension stage 1 volunteers will receive a DASH based menu during 14 consecutive days of elective admission to the RU research hospital. Participants will complete a food frequency questionnaire (VioScreen) with a bionutritionist. Throughout the intervention period, participants will be assessed for blood pressure, plasma renin and aldosterone, and 24 hour urines for electrolytes, creatinine, protein, albumin and first morning urine collected for exosomes. Exosome analysis will be performed by a commercial lab. Proteome analysis will be conducted in the RU Mass-spectrometry service. RESULTS/ANTICIPATED RESULTS: The causal pathway we will elucidate hypothesizes that: 1) changes in diet affect blood electrolytes, and through these, aldosterone. 2) Aldosterone alters the expression of specific transporter proteins in the renal tubule; protein expression will be reflected in the urine exosome. 3) These transporters affect the excretion of electrolytes, as reflected by urinary ratio of sodium (Na) to Potassium (K). During consumption of the Western diet, the Na/K ratio is approximately 2-2.5, whereas we expect the urinary sodium/potassium ratio to be <1, when the participant is eating a DASH based diet. DISCUSSION/SIGNIFICANCE OF IMPACT: This assay provides a clinical tool to assess dietary adherence, and the project will provide insights into the mechanism whereby DASH reduces blood pressure.

Objectives/Goals: This study aims to evaluate diversity of participants in GLP-1 T2DKM clinical research with regard to sex, race, and ethnicity by using results data available through the ClinicalTrials.gov database. Sample population estimates for studies were calculated using the 2020 Census and compared within groups with respect to sex, race, and ethnicity. Methods/Study Population: The public ClinicalTrials.gov database was searched for interventional studies with GLP1 inclusion as treatment (n = 2,397). This search was then filtered to studies where results were reported (n = 772). From these studies, 466 studies focused on type 2 diabetes as a condition and thus became the analysis dataset. Participant and protocol information for these 466 studies were obtained from the clinical trials transformation initiative (CTTI) as an AACT data download. Observed to expected ratios were calculated for each subgroup-based population estimates from the 2020 Census and using the baseline counts of participants for studies where sex, race, and ethnicity were provided. In addition to within group comparisons, study characteristics (e.g. phase) were included in models to assess influence of covariates. Results/Anticipated Results: Of the 466 studies, 430 (92%) reported sex, 171 (37%) reported race, and 145 (31%) reported Hispanic ethnicity. Among those found to be underrepresented in studies (defined as a ratio < 1): females (mean  =  0.89, median  =  0.92); Black/African Americans (mean  =  0.88, median  =  0.39). Hispanic or Latinos mean ratio was 1.16 (95% CL: 0.97, 1.35) but had the least available data. When including covariates in the models, there were statistically significant differences in ratios with respect to sex as females had significantly lower odds compared to males (ratio > =  1), with the odds being about 21% of those for males. With respect to race, Black or African American individuals had significantly lower odds (about 32% of those of White individuals) (ratio > =  1). Discussion/Significance of Impact: This study reveals significant underrepresentation of females (mean ratio 0.89) and Black/African Americans (mean ratio 0.88) in clinical trials for GLP-1 drugs in type 2 diabetes. These disparities highlight the need for more inclusive research to ensure diverse populations benefit equally from medical advancements.

OBJECTIVES/GOALS: This study examined patient perceptions on the benefits, barriers, and facilitators of conventional and complementary/behavioral pain strategies that can be offered in the ED setting including physical therapy, mindfulness, acupuncture, and yoga. METHODS/STUDY POPULATION: We conducted and recorded semi-structured interviews with 30 patients who presented to the ED with musculoskeletal pain. Interviews focused on patients’ perceptions of NP pain treatments, barriers/facilitators to utilization, and recommendations that would promote engagement. A hierarchical coding system was developed and refined using the interview guide, the Theory of Planned Behavior, and preliminary review of the transcripts. The iterative process of developing the coding system allowed us to identify preliminary themes. RESULTS/ANTICIPATED RESULTS: Patients believe education on pain and the mind-body connection would give a sense of pain control. Likely barriers to engaging at the ED include lights, noise, interruptions, and uncertainty of their medical status. Post-discharge NP treatment barriers are financial and logistical. Engagement can be facilitated by a desire to avoid opioids, familiarity with meditation practices, and consistent positive communication with the health care team. Patients desire evidence on effectiveness, including testimonials, and suggested NP techniques should be introduced early, with written materials used for post-discharge referral. Patients prefer in-person treatment but would appreciate a virtual option. The initial session should occur in-person to build trust and facilitate virtual session engagement. DISCUSSION/SIGNIFICANCE: Patients are willing to engage in nonpharmacological pain treatment, however the unpredictable ED environment, uncertainty of their medical status, and financial and time constraints are significant barriers.