OBJECTIVES/GOALS: The Dixon up-and-down method (U/D), original developed for testing explosives, is especially common in anesthesia research studies. The objective of this research is to compare the performance of the U/D method for obtaining and analyzing sensitivity data with that of the Bayesian Optimal Interval (BOIN) method. METHODS/STUDY POPULATION: A simulation study will compare the performance of the U/D method with the BOIN design. The two study designs offer alternative decision-making algorithms with respect to the dose at which the next experimental unit is treated. These alternative decisions may impact the precision of point estimates of the mean and standard deviation of the effective dose to elicit a response. Transition probability matrices are developed, and maximum likelihood estimates of the unknown parameters assessed for accuracy. For simulation, the effective dose is assumed to be randomly distributed with a known mean and standard deviation. Fixed dose levels are defined, and decisions for what level the next experimental unit should be treated at are defined by the Dixon up-and-down method and the BOIN design. For the U/D method, the stimulus is increased by one level in the absence of a response or decreased if a response occurs from an initial stimulus. A target toxicity probability of 0.50 is used to define the dose escalation or de-escalation rules for the application of the BOIN design. RESULTS/ANTICIPATED RESULTS: A feature of both methods is that the consecutive observations are concentrated about the mean value of the effective dose. However, the BOIN design tends to be more concentrated between these two dose levels. In the presence of severe adverse events, the BOIN design can choose to eliminate doses that are too toxic whereas the U/D design cannot eliminate any dose levels. Transition probability matrices are defined and parameters for the distribution of the effective dose are estimated using maximum likelihood estimation. Mean squared errors for the estimated mean and standard deviations compare the two study designs. DISCUSSION/SIGNIFICANCE OF IMPACT: The BOIN design offers an alternative method for decision-making compared with the U/D method. The BOIN design tends to concentrate dose levels about the mean more than the U/D. This may provide better estimates of the mean and standard deviation of the effective dose for eliciting a response in some circumstances.

OBJECTIVES/GOALS: To date, no reviews have been published combining the topics of pre-operative mental illness and postoperative atrial fibrillation (POAF). For adult cardiac surgical procedures, therefore, this scoping review provides an overview of the published evidence for this novel topic. METHODS/STUDY POPULATION: A combination of MESH terms and text words were used to capture all papers analyzing any risk factors for atrial fibrillation development after any cardiovascular surgery, and thus, 4,203 search results were initially identified. Papers were manually screened for relevance, resulting in 69 articles that analyzed risk factors associated with POAF. As a separate analytical step, all included publications were used to identify additional citations and Web of Science PubMed identification number-based (i.e., PMID) specific backwards citation searches were performed to ensure comprehensive coverage. For each of the three articles analyzed, moreover, these PMIDs were further evaluated using individual google scholar searches to assure no other relevant literature was inadvertently found. RESULTS/ANTICIPATED RESULTS: For the 69 relevant articles found with multivariable risk models predicting new onset POAF during this scoping review, a wide variety of patient risk factors were reported. The statistically significant predictors reported for new POAF included age (57 papers), hypertension (22 papers), tobacco use (15 papers), LVEF-related characteristics (14 papers), COPD (13 papers), and patient gender (13 papers). All other factors were found to be significant 10 times or fewer; importantly, no multivariable models evaluated mental illness-related factors as predictors of new onset POAF. Only 3 articles even considered the potential influence of mental illnesses. DISCUSSION/SIGNIFICANCE: Mentally ill patients have been documented to have increased incidence of cardiovascular disease and adverse cardiac outcomes, however, very few articles evaluated mental illness associations with POAF. This comprehensive review has demonstrated the urgent need for new research focused on mental illness impacts.

OBJECTIVES/GOALS: Inflammation following traumatic injury to the spinal cord persists long after the primary insult and is known to increase complication rates and prolong recovery time. We investigated the effects of Erythropoietin (EPO) in combination with Glucocorticoids on the levels of erythrocyte sedimentation rate (ESR), an overall measure of inflammation. METHODS/STUDY POPULATION: Electronic medical records from approximately 38 million patients in 27 Healthcare Organizations were analyzed using the TriNetX Analytics platform. Patients with spinal cord injuries (SCI) were defined with the ICD-10 code, G95 and two unique cohorts were defined for patients treated with injectable EPO in combination with injectable Glucocorticoids within 6 months of SCI or only injectable Glucocorticoids with no injectable EPO. ESR rates were queried from patient cohorts to evaluate the potential effects of the two treatment pathways on the ESR. Most recent lab results within 6 months before initiating treatment and 1-year post-treatment were defined as “before” and “after” treatment, respectively. Changes in ESR lab results were evaluated using unpaired t-test with Welch’s Correction. RESULTS/ANTICIPATED RESULTS: A total of 14,370 patients satisfied the inclusion criteria. 89 patients were treated with injectable EPO in combination with Glucocorticoids within 6 months of SCI. The ESR lab results were available for 33 patients before treatment with a mean of 63±33 mm/h. The ESR lab results were available for 22 patients after treatment with a mean of 51.7±34.1 mm/h. 14,281 patients were treated with Glucocorticoids (no injectable EPO) within 6 months of SCI. The ESR lab results were available for 2,042 patients before treatment with a mean of 29.2±30.5 mm/h. The ESR lab results were available for 2,184 patients after treatment with a mean of 32.6±30 mm/h. Patients treated with combinational therapy showed a reduction in ESR of 11.3 mm/h, while those treated with only Glucocorticoids showed an increase in ESR of 3.4 mm/h. DISCUSSION/SIGNIFICANCE OF IMPACT: The present results demonstrated that combinational therapy with injectable, EPO and glucocorticoids exhibited a significant reduction in ESR level. The study suggests that EPO and glucocorticoid might have a synergistic effect on reducing the inflammation following SCI. This approach might help reduce the therapeutic dose of glucocorticoids. Conflict of Interest Description: The authors declare that they have no competing interests. CONFLICT OF INTEREST DESCRIPTION: The authors declare that they have no competing interests.

OBJECTIVES/SPECIFIC AIMS: The University of Washington (UW) CTSA Hub Liaison Team has directed and facilitated work required to bring TIN multisite trials to the CTSA hub and its affiliates by: (1) Connecting hub and affiliate investigators with the services offered by the Trial and Recruitment Innovation Centers, (2) identifying investigators at academic and non-academic institutions to act as co-investigators on multisite trials, (3) supporting the local and affiliate human research protection programs and investigators throughout the life-cycle of the study, (4) maximizing CTSA and local study team resources to develop and monitor study-specific volunteer recruitment and retention plans. The UW CTSA TIN Hub Liaison Team has worked to achieve these objectives via the following methods designed for generalization and dissemination. METHODS/STUDY POPULATION: (1) Providing consultations to investigators interested in the services offered by the Trial and Recruitment Innovation Centers. (2) Hub and affiliate investigators at academic and non-academic institutions are identified by a variety of approaches, including the engagement of existing CTSA hub regional collaboration networks, utilizing EHR data from CTSA developed phenotypes and targeted “Investigator Engagement Packets”. (3) Ensuring regulatory oversight and compliance is challenging in the new age of single IRB review. Establishing a flexible reliance office, engaging with the central TIN IRBs and providing guidance and resources to local study teams ensures investigator confidence in the integrity of the protocol approval and study activity processes. (4) The CTSA Hub Liaison team has developed a Recruitment and Retention Plan template and holds recruitment and retention planning meetings with the CTSA study teams engaging in TIN studies. RESULTS/ANTICIPATED RESULTS: It is anticipated that The Hub Liaison Team: (1) Will contribute to the TIN’s process improvement to bring regionally appropriate studies to the CTSA hub and affiliates. (2) Identify ideal investigators to engage both in proposal submission and co-investigating multisite trials. (3) Collect, compare and improve regulatory and contract approval cycle times. (4) Monitor and support screening, accrual and retention of study volunteers. DISCUSSION/SIGNIFICANCE OF IMPACT: Due to low prevalence of disease, challenges related to identifying and randomizing study volunteers and urgency to address clinical and public health issues, multisite study design is an essential option for NCATS. The Trial Innovation Network is an exciting approach to leverage local and national resources to provide infrastructure to improve multisite clinical and observational trial conduct. The University of Washington CTSA hub has developed and piloted methods to achieve the mission of the TIN, by recruiting investigators and realizing trial objectives, with the hope that these methods could be utilized by other CTSA TIN Hub Liaison Teams.

OBJECTIVES/SPECIFIC AIMS: The proposed pilot study seek to enhance the network of CTSAs at Rockefeller University, NYU, ISMMS, and other community members to support translational workforce development of clinical research nurses and establish a standardized nurse-specific training curriculum in GCP for use within the CTSA network, in other research centers, and in nursing school curricula. This will be coupled with a rigorous evaluation study to test the impact of the training and a comprehensive dissemination plan to make the training available to all nurses and nursing students via modern e-learning method. Aim 1. To create an integrated network of local CTSAs and community partners to develop, validate, and refine a pilot e-learning GCP educational and training program and content and outcomes dissemination plan. It is vital to integrate the efforts of CTSA leaders, community partners, and nursing educators to develop a pilot e-learning nurse workforce training curriculum and the associated evaluation measures and assessment plan. Delphi methods will be employed, coupled with rigorous assessment of face validity, content validity, and item reliability. The resulting educational training program will then be used for an e-learning educational intervention study in CTSAs, other sites, and nursing schools. Aim 2. To test the effect of the pilot GCP education and evaluation program for practicing clinical research nurses (CRNs) within the collaborating CTSAs and community partners, we will perform a randomized controlled trial using a Solomon 4 group design. For the student nurse population, we will develop a randomized control trial using a Solomon 4 group design blocked on course section. As this is a pilot study, descriptive statistics and confidence intervals around parameter estimates will be constructed. In addition, inferential statistics will be calculated on primary outcome of interest (change scores in knowledge of GCP) and measures of heterogeneity of data, patterns of missing data, and reliability of evaluative tools will be analyzed. Aim 3. To implement a dissemination plan to reach both nurses practicing the CRN specialty within CTSAs and other community settings. We will disseminate the program to other CTSAs through the CTSA network communication resources. To broaden the reach to a population of nurses and student nurses with limited prior education or training in nurse-specific GCP competencies, but who provide care to research participants in nontraditional research settings, we will craft a novel set of dissemination methods, including the CITI Program electronic platform that can be accessed by nurses and nursing students across settings. In addition, dissemination will be at nursing education meetings and in nursing journals.METHODS/STUDY POPULATION: There are several components to this pilot program. The component that includes a research strategy is the testing of the effectiveness of the training and educational interventions on GCP knowledge and efficacy. Study cohort: Recruitment of study subjects will be in coordination with 3 CTSA collaborators and community partners for 2 samples: (1) nurses who provide care to clinical research participants across a variety of settings (health care systems, research hospitals, and care provider networks) and who are already trained according to current standard in GCP, (2) nursing students from the collaborative network of the 3 CTSAs, NYU School of Nursing has agreed to pilot test the introductory student module. The methodological approach will be a random assignment control trial Solomon 4 group design for practicing CRNs within the collaborating CTSAs and community partners. For student nurse population, the methodological approach will be a randomized-control trial Solomon 4 group design blocked on course section. Survey measures of CRN GCP knowledge and efficacy will be obtained pre and post educational intervention. RESULTS/ANTICIPATED RESULTS: Aim 1. Expected outcomes are pilot e-learning nurse workforce training modules curriculum, and evaluation measures and plan appropriate for CTSAs, community sites, and nursing schools. Specifically, 14 modules (averaging 30 minutes each) for practicing CRNs, and one 45 minute module for nursing students. The significance of these findings will provide a framework for the e-learning educational intervention study. CITI Program is enthusiastic about the module development and refinement and will provide direction for consistency in formatting with current CITI Program modules, set-up of learner groups for comparison, and evaluative measures such as completion data and scoring. Aim 2. Expected outcomes are an effective pilot educational intervention for practicing nurses and students and valid and reliable evaluation tools and plan that can be generalized to the larger CRN and nursing community. Aim 3. Expected outcomes are an enhanced CTSA dissemination plan that includes non-CTSA resources and reaches non-CTSA employed nurses and nursing students. DISCUSSION/SIGNIFICANCE OF IMPACT: The expected outcomes of this pilot study are: (1) an enduring GCP education that can be continually updated and training structure for CRNs, and nurses and nursing students throughout the United States; (2) a reproducible effective standardized basic nurse-specific GCP curriculum for dissemination; (3) assessment tools to evaluate programmatic success, nurse and nursing student knowledge and efficacy on nurse-specific GCP; (4) and a CTSA dissemination plan that to reach non-CTSA nurses and nursing students. Our ultimate goal is the development of a translational workforce educated and competent in GCP at CTSA sites, at non-CTSA sites, and in nursing schools so as to improve the quality of clinical research.

Objectives/Goals: To assess the impact of UCLA’s Clinical and Translational Science Institute Research Associates Program (CTSI-RAP), a student-led undergraduate clinical research initiative, on current members’ career interests and development. Methods/Study Population: To evaluate CTSI-RAP’s impact, we surveyed students using the REDCap platform between May and June 2023. The survey captured data on demographics, academic background, motivations for joining, and engagement in clinical research activities. Students also provided self-assessments of how the program influenced their career interests. Both descriptive and qualitative analyses were then used to assess key factors influencing students’ experiences, including the program’s impact on career decisions in healthcare and clinical research. Results/Anticipated Results: Out of 43 students surveyed, 40 responded (93%). Before entering, 84.2% of students had less than one year of research experience, and most students (73.6%) did not have family members in healthcare or research professions. Top reasons for joining were gaining clinical research exposure, healthcare setting experience, and pursuing healthcare careers. Overall, 97% of students stated CTSI-RAP “definitely” or “most probably” confirmed their interest in medicine and 76% of students reported CTSI-RAP has “definitely” or “most probably” solidified their interest in clinical research. 100% of students who have applied for a job, professional school, scholarship, or internship included CTSI-RAP as a meaningful experience, reflecting the program’s mission to provide motivations for a career in medicine and science. Discussion/Significance of Impact: Since its establishment in 2013, CTSI-RAP has expanded from 15 students to more than 50 annually, providing hands-on clinical research and professional development opportunities. The program’s peer-mentorship and student-led approach have proven effective in preparing students for diverse healthcare and research pathways.

OBJECTIVES/GOALS: Quantitative Staff are an essential workforce for biomedical research. While faculty can engage with peers locally and through national organizations, similar opportunities are limited for staff and often do not meet their unique needs and interests. Creating a professional community is valuable for supporting and developing this workforce. METHODS/STUDY POPULATION: We established the Quantitative Scientific Staff National Network (QS2N2) with the mission to provide professional development and networking opportunities, and to serve as an information resource and advocate through the fostering of community among staff quantitative analysts at any career stage. The initial membership outreach was to all Biostatistics, Epidemiology, and Research Design (BERD) programs through members of ACTS BERD Special Interest Group (SIG). We created a Leadership Team and an Advisory Board consisting of staff and faculty biostatisticians with experience working as or managing staff to govern the network. A Core Planning Committee consisting of 15 members guides planning, implementation, and execution of network activities as operationalized through subcommittees. RESULTS/ANTICIPATED RESULTS: The network currently has 131 members from over 30 health science institutions. Subcommittees focused on Education and Training, Membership, Communication and Web Development, and Mentoring were created and are developing events, programs and infrastructure to further the network’s mission. Network events such as webinars will be offered quarterly; with our first event planned for Nov 3rd. Expansion and maturation of QS2N2 will be done through regular remote meetings where members can connect with peers at other institutions, engage in career development activities, and attend technical seminars. Additional membership outreach will seek to connect with staff in government and private sectors. DISCUSSION/SIGNIFICANCE: Knowledgeable, highly skilled collaborative analysts (e.g., biostatisticians, data scientists) are an essential workforce in clinical and translational science and health research centers.The QS2N2 will support professional development, engagement and growth of this critical workforce which is necessary to advance quality research.

OBJECTIVES/SPECIFIC AIMS: To increase knowledge and application of clinical research coordinator competencies among Research Professionals at the University of Minnesota. METHODS/STUDY POPULATION: The UMN’s CTSI developed and piloted a Foundations for Research Professionals training program comprised of: a baseline assessment, 7 online modules, 4 in-person training sessions, video and reading assignments and a post assessment, which totaled 30–35 hours of training and covered the following topics: preparing for a study, study management, participant recruitment and engagement, assessing capacity to consent and the informed consent process. This course also provides valuable resources and connections to online references and materials. The competencies for this program were based on work of the Joint Task Force for Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: 30 clinical research professionals completed the pilot program and averaged an increase of 6.5% from baseline assessment to post assessment. Participants were asked to rate their confidence on a variety of role-based competencies at the time of preassessments and postassessments. Trends show an increase in confidence for all competency areas after completion of the training program. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a workforce of competent research professionals is integral to improve the efficiency, quality, and ethics of research. The Foundations for Research Professionals training program increased knowledge of clinical research coordinator competencies. We will assess impact on application of the competencies 6 months after completion of the program. Our next steps include offering the training program as a 2-week session on an ongoing basis for new coordinators at the University of Minnesota.

ABSTRACT IMPACT: Laying the groundwork for better predictive algorithms to inform clinical decisions and planning. OBJECTIVES/GOALS: Frailty scores predict poor patient outcomes. Validated against highly relevant outcomes, such scores can be used to inform clinical and resource utilization decisions. We generated and validated an electronic Frailty Index (EFI) from real-world EHR data using the Rockwood deficit-accumulation framework to predict patient safety events. METHODS/STUDY POPULATION: To assure that the research approach reflected perspectives of multiple stakeholders, our multidisciplinary group included an implementation scientist, a geriatrician, an internist, and an informatician. From our large academic health center, we accessed EHR data for 14,844 patients randomly sampled from the data warehouse underlying our ACT/SHRINE node. The per-visit EFI scores were calculated using EHR codes in a rolling 2-year time window. EFI was used as the predictor variable in the analytic design. The primary outcomes were preventable patient-safety events derived from ICD-10 codes including hospital-acquired infections, non-operative hospital-acquired trauma, and cardiac complications. Cox proportional hazard models were used to estimate risk for each outcome. RESULTS/ANTICIPATED RESULTS: We found statistically significant associations of EFI with clinically meaningful outcomes from EHR data. For most outcomes, we found significant correlation with EFI and c-statistics indicating good calibration of the models. The EFI was a strong predictor of clinically relevant outcomes without relying on any data other than diagnoses, vital signs, and laboratory results from the EHR. In contrast to previous studies, we treated EFI as a time-varying predictor with multiple follow-ups per patient, which is more realistic than relying on one static time-point. We used a representative sample of the adult patient population rather than limiting it to older individuals and found EFI to be a useful metric even at relatively young ages. DISCUSSION/SIGNIFICANCE OF FINDINGS: The EFI predicted safety events in adult patients using only routine, structured EHR data and can offer a low-effort, scalable method of risk assessment, valuable to clinical decisions. The capability to harness EHR data and rapidly generate clinical knowledge can be transformative for complex care and contributes to Learning Health Systems.

OBJECTIVES/GOALS: A qualitative study was performed to characterize experiences of Black and White women going through menopause, as well as identify barriers and facilitators for participating in a lifestyle program targeting weight management during menopause. This abstract includes data from Black women. Results from White women will be available by ACTS 2022. METHODS/STUDY POPULATION: Perimenopausal and postmenopausal Black women with a self-reported desire to lose or maintain weight during menopause participated in a total of six focus groups. Women were asked about their past experiences with diet, exercise, and weight management; their menopause experiences; as well as specific components and considerations for developing a lifestyle program for weight management. Thematic analysis was conducted on coded transcripts and four main themes emerged, each containing three to seven subthemes. RESULTS/ANTICIPATED RESULTS: Twenty-seven Black women (age 54±4 years, BMI 35.1±9.0 kg/m2) were enrolled. Overall, women felt unprepared for the changes they experienced during menopause and had difficulty maintaining or losing weight. While women were receptive to trying different diets and exercises, they wanted a diet that was flexible with their lifestyle and exercises that considered their existing health status. Women were also interested in learning about menopause alongside other women, stating that medical professionals did not provide them with adequate information or help. Social support, accountability, and seeing results were perceived critical to achieve long-lasting behavioral change. DISCUSSION/SIGNIFICANCE: Women were interested in receiving menopause information and improving their overall health as part of a lifestyle program during menopause. Associating with other women affected by menopause will allow for the creation of more sustainable lifestyle programs during menopause.

OBJECTIVES/GOALS: Racial/ethnic minoritized children experience poorer cancer outcomes, which may be driven by structural racism. We apply an index that combines segregation and neighborhood vulnerability to a pediatric oncology population and assesses its association with acuity of illness at initial presentation. METHODS/STUDY POPULATION: A retrospective analysis will be performed in a cohort of pediatric patients diagnosed with solid tumors at Children’s Healthcare of Atlanta (CHOA) from 2010-2018 (N=1149). The sample will be linked to a structural racism index (SRI) that has been established in our prior work. We abstract data from medical records to quantify initial acuity of illness based on the need for ICU-level resources. Differences in sociodemographic characteristics will be analyzed by the SRI, using chi-squared, Student t-tests, and ANOVA where appropriate. Logistic regression models will be used to assess the association of the SRI with acuity of illness. RESULTS/ANTICIPATED RESULTS: We anticipate that relevant sociodemographic characteristics (e.g., race/ethnicity, insurance status) differ by the SRI. The CHOA Cancer Registry includes a racially and ethnically diverse group of patients: 63% of the cohort is White, 30% is Black,10% are Other, and 15% are Hispanic/Latino. Furthermore, we anticipate that pediatric patients with solid tumors living in counties with greater levels of structural racism as measured by the SRI experience an increased acuity of illness at initial presentation. DISCUSSION/SIGNIFICANCE: By applying a novel index quantifying structural racism, we will provide new information about the structural barriers patients and families face prior to a pediatric cancer diagnosis. This work will allow us to identify areas for potential interventions in this vulnerable young patient population.

OBJECTIVES/SPECIFIC AIMS: Existing GCP training is geared primarily towards researchers conducting drug, device, or biologic clinical trials, and largely ignores the unique needs of researchers conducting social and behavioral clinical trials. The purpose of this project was to develop a comprehensive, relevant, interactive, and easy to administer GCP eLearning course for social and behavioral researchers. METHODS/STUDY POPULATION: As part of the ECRPTQ project funded by the National Center for Advancing Translational Sciences (NCATS), a Social and Behavioral Work Group of ~30 experienced social and behavioral investigators and study coordinators was formed to develop GCP training for social and behavioral researchers. Existing GCP training programs were reviewed to identify relevant content that should be included as well as gaps specific to social and behavioral clinical trials where new content would need to be developed. In total, 9 specific modules—Introduction, Research Protocol, Roles and Responsibilities, Informed Consent Communication, Confidentiality/Privacy, Recruitment/Retention, Participant Safety/Adverse Event Reporting, Quality Control/Assurance, and Research Misconduct—were identified by the work group and the content was mapped to competency domains defined by the ECRPTQ project, as well as International Council for Harmonisation (ICH) GCP principles. Several investigators and study coordinators were identified as content experts for each module topic. Working with an instructional designer, these experts defined learning objectives and outlined content relevant for both study coordinators and investigators for inclusion in the modules. The curriculum was developed using Articulate Storyline that is SCORM 1.2 compliant making the course usable to the widest audience. The course was designed to be administered on laptop or desktop computers and is accessible for individuals with hearing or viewing impairments. To maximize learning, instructional designers used creative treatments including: narration to guide learners or offer tips; short video scenarios to introduce topics; interactive activities, such as drag and drop games and “click to learn more information”; knowledge checks with feedback; resources, including downloadable job aids; end of module quizzes, and documentation of course completion. The full curriculum takes 2–4 hours to complete, with individual modules taking 30 minutes to complete. RESULTS/ANTICIPATED RESULTS: Pilot testing to evaluate the effectiveness of the eLearning course is underway at 5 sites: University of Michigan, Boston University, University of Rochester, University of Florida, and SUNY Buffalo. DISCUSSION/SIGNIFICANCE OF IMPACT: This eLearning course provides relevant, comprehensive GCP training specifically for social and behavioral researchers. Unlike existing GCP training that is geared towards drug and device researchers, this course includes scenarios and examples that are relevant to social and behavioral researchers. The engaging, interactive nature of this course is designed to improve learning and retention, resulting in improved job performance. In addition, the modules are designed for both investigators and clinical research coordinators, thus eliminating the need for different training modules for different study team members.

OBJECTIVES/GOALS: The United States is experiencing an epidemic of firearm deaths and injuries. Poverty and other socioeconomic factors have been linked to firearm injuries on the national level. The goal of this study is to examine the relationship between county level poverty and firearm injuries in the State of Maryland. METHODS/STUDY POPULATION: This is a cross sectional study assessing fatal and non-fatal firearm injuries of all ages between 2018-2020 utilizing data from the State of Maryland’s Health Services Cost Review Commission. Our primary analysis will involve calculating injury and mortality rates to assess if fatal and non-fatal firearm injuries are associated with county-level poverty, defined as the percentage of the population living below the federal poverty line. Rates will be calculated by determining county level population within subgroups using the National Historical Geographical Information System database. We will also conduct regression analyses to adjust for confounding variables selected based on evidence from prior research. Some of these variables include age, sex, race, urbanicity, and the social vulnerability index. RESULTS/ANTICIPATED RESULTS: An abundance of prior research has demonstrated differences in firearm injury by age, sex, and race. Prior studies have also shown that poverty is associated with higher rates of firearm-related deaths among youth. Based on that foundational data, we anticipate that regression analyses will demonstrate that counties with higher poverty levels will have higher rates of fatal and non-fatal firearm injuries, even after controlling for other known risk factors. DISCUSSION/SIGNIFICANCE: Findings from this study will contribute to growing evidence on the role of poverty in the burden of firearm injuries and mortality. This will have policy implications regarding the allocation of public health resources and interventions aimed at reducing firearm-related injuries and deaths in Maryland.

OBJECTIVES/SPECIFIC AIMS: This study aims to assess the safety, feasibility, clinical benefits and pharmacodynamics of adding allopurinol to standard maintenance therapy that includes 6-mecaptopurine (6-MP) in pediatric patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. Our goal is to investigate if allopurinol improves hepatotoxicity and GI toxicity, if it safely decreases acute neutrophil count (ANC), if it reduces the 6-MP dose required during chemotherapy, and if it works through our hypothesized mechanism by lowering the levels of the toxic metabolite, 6-methylmecaptopurine (6-MMP) and by raising the levels of the active metabolite, 6-thioguanine (6-TGN). METHODS/STUDY POPULATION: This is a single arm, nonblinded pilot study of patients under age 30 years who were being treated in the maintenance phase of therapy for ALL or lymphoblastic lymphoma, and had adverse effects such as high 6-MMP:6-TGN ratio, high ANC, and high liver enzymes. Patients enrolled were started with allopurinol in addition to ongoing oral chemotherapy. Data from beginning maintenance to end of chemotherapy was collected in the electronic medical record, EPIC for the 13 patients enrolled at Johns Hopkins, and data analysis was conducted using STATA and Excel. RESULTS/ANTICIPATED RESULTS: Initial data analysis reveals that the required dose of 6-MP after addition of allopurinol to the chemotherapy regimen was significantly lower compared with that before the addition of allopurinol in 11 out of the 12 patients assessed (p<0.05). Among the 10 patients that were assessed for 6MMP:6TG ratio, all had lower average 6MMP:6TGN ratios after allopurinol compared to before allopurinol; the percentage of weeks that goal 6MMP:6TGN ratio (<40) were maintained were statistically significant in 6 patients (p<0.05) and close to significance in 2 other patients (p=0.057). The percentage of weeks that patients maintained alanine aminotransferase levels below 120 was significantly greater after addition of allopurinol compared to before the addition of allopurinol in 9 out of 13 patients assessed, suggesting that allopurinol may be associated with reduced hepatotoxicity. Further data analysis is ongoing to assess the percentage of weeks that patients maintained goal total bilirubin, direct bilirubin, and ANC, as well as average number of admissions for infections and average number of therapy holds after allopurinol addition compared to before allopurinol addition. DISCUSSION/SIGNIFICANCE OF IMPACT: Allopurinol is associated with reduction in required 6-MP dose, decrease in the percentage of weeks that patients have hepatotoxicity, and reduction in the ratio of toxic metabolite to active anti-leukemic metabolite in several patients. We hope that the results of this study can be used for further research and for guiding clinical practice since there are no established guidelines in pediatric oncology regarding addressing side effects of oral chemotherapy using 6-MP. If allopurinol indeed is safe and effective, adding it to the standard chemotherapy regimen can lead to better tolerance and compliance to oral maintenance chemotherapy, and hopefully improved outcomes for children with ALL and lymphoblastic leukemia.

OBJECTIVES/GOALS: To evaluate the feasibility, acceptability, and appropriateness of a 1:1 peer-delivered psychosocial support intervention to family caregivers of hospice patients with cancer, and determine a range of potential effects of the intervention on psychological distress symptoms and perceptions of the caregiving experience. METHODS/STUDY POPULATION: Quantitative and qualitative data were collected from hospice caregivers of cancer patients who participated in a non-controlled pilot feasibility trial of a 1:1, peer-delivered psychosocial intervention called Peer Caregiver Navigation (PCN). The purpose of this study was to evaluate the feasibility, acceptability, and appropriateness of delivering PCN to hospice family caregivers of cancer patients, and to determine a range of potential effects of PCN on caregivers’ anxiety symptoms, depressive symptoms, self-efficacy, and benefit finding. Qualitative data were analyzed using deductive thematic analysis. For our study outcomes, we used both parametric and nonparametric t-tests to examine mean differences between outcomes at baseline and midpoint, and baseline and endpoint. RESULTS/ANTICIPATED RESULTS: The findings demonstrate that Peer Caregiver Navigation (PCN) is acceptable, appropriate, and feasible to deliver to hospice family caregivers of cancer patients. Appropriateness of our selected target outcomes was determined by confirming expected measurement change in depressive symptoms (lower), anxiety symptoms (lower), benefit finding (higher), and self-efficacy (higher). Exit interviews revealed that participants responded favorably to our selected measures for these outcomes and to our data collection time intervals. Moreover, recruitment and consenting processes, survey completion rates, and attrition outcomes (i.e., study exit due to active withdrawal vs. patient death) were analyzed to inform recruitment and retention feasibility for future studies. DISCUSSION/SIGNIFICANCE: Peer Caregiver Navigation (PCN) was determined to be feasible, acceptable, and appropriate to hospice family caregivers of patients with cancer. Moreover, PCN has the potential to improve caregivers' symptoms of psychological distress by providing them much needed psychoeducation, coping skills training, and emotional support.

OBJECTIVES/SPECIFIC AIMS: To evaluate the ability of various techniques to track changes in body fluid volumes before and after a rapid infusion of saline. METHODS/STUDY POPULATION: Eight healthy participants (5M; 3F) completed baseline measurements of 1) total body water using ethanol dilution and bioelectrical impedance analysis (BIA) and 2) blood volume, plasma volume and red blood cell (RBC) volume using carbon monoxide rebreathe technique and I-131 albumin dilution. Subsequently, 30mL saline/kg body weight was administered intravenously over 20 minutes after which BIA and ethanol dilution were repeated. RESULTS/ANTICIPATED RESULTS: On average, 2.29±0.35 L saline was infused with an average increase in net fluid input-output (I/O) of 1.56±0.29 L. BIA underestimated measured I/O by −3.4±7.9%, while ethanol dilution did not demonstrate a measurable change in total body water. Carbon monoxide rebreathe differed from I-131 albumin dilution measurements of blood, plasma and RBC volumes by +0.6±2.8%, −5.4±3.6%, and +11.0±4.7%, respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: BIA is capable of tracking modest changes in total body water. Carbon monoxide rebreathe appears to be a viable alternative for the I-131 albumin dilution technique to determine blood volume. Together, these two techniques may be useful in monitoring fluid status in patients with impaired fluid regulation.

OBJECTIVES/GOALS: Harnessing the EHR to support clinical research is critical for the study of rare diseases such as interstitial lung disease (ILD). However no studies have compared EHR and research-quality data in the ILD population. Our objectives were to (1) identify ILD patients and extract clinical data from an EHR system and (2) assess the performance of ILD data capture. METHODS/STUDY POPULATION: Case validated algorithms were implemented to identify patients from the University of California San Francisco EHR and extract key ILD clinical information including, demographic variables, process measures and patient outcomes. Key clinical information were defined based on consensus statements and ILD clinical trials. A subset of ILD patients, had variables recorded in both the EHR and a separate ILD longitudinal research database. The completeness of EHR data capture and level of agreement were compared between three data collection methods: (1) data manually and systematically collected for an ILD research database (gold standard), (2) data automatically extracted from structured fields in the EHR, and (3) data extracted from unstructured data sources. RESULTS/ANTICIPATED RESULTS: We identified 5857 ILD patients in the EHR, of which 2100 patients had data available in the both the EHR and research database. Baseline demographic variables, co-morbidities, use of diagnostic testing, pharmacotherapy were accurately extracted from structured fields. Outcome measures, including lung physiology, radiographic patterns, pathology results, and health related quality of life (HRQoL) were unevenly extracted from structured fields alone. With the exception of HRQoL, these measures were accurately captured in unstructured EHR sources. Notably, certain metrics were better defined in the EHR, including health care resource utilization metrics, acute exacerbations, medication side effects, supplemental oxygen use and specialty care referrals (rheumatology, lung transplant, palliative care, etc). DISCUSSION/SIGNIFICANCE OF IMPACT: A large real-world ILD cohort can be algorithmically extracted from the EHR along with key clinical variables with accuracy comparable to protocol-driven research databases. Rigorous assessment of the types of disease-specific variables that are present in EHR-derived data will inform future interventions to improve the fidelity, accessibility and use of the EHR in clinical research.

Objectives/Goals: The Competency-Based All-Level Training (COBALT) curriculum standardizes learning for clinical research coordinators (CRCs) across multiple institutions within Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI), with flexible, topic-specific training at all experience levels, in both academic and industry-sponsored research. Methods/Study Population: The COBALT curriculum was developed in collaboration with subject matter experts, managers of CRCs, and other clinical research professionals from institutions across the WWAMI region. A thorough assessment of existing training programs within the region helped identify gaps and unmet needs. The curriculum was designed within a user-friendly learning management system that can be accessed across institutions. It has been piloted with diverse groups and committees of CRCs, professionals, and institutional leaders in clinical and translational science. Ongoing evaluation is being conducted qualitatively using built-in assessment surveys, demonstrations, and interviews. Results/Anticipated Results: The anticipated outcome is the creation of a highly standardized and efficient training program for clinical research professionals across multiple institutions in the WWAMI region. This program will be carefully tailored to each professional’s level of experience, ensuring personalized skill development. By aligning training with diverse expertise levels, the initiative aims to significantly elevate the quality, consistency, and overall performance of clinical research efforts across the regional research community. Discussion/Significance of Impact: The COBALT curriculum provides a vetted learning curriculum for CRCs, with a tailorable training plan that helps them collaborate with their supervisors to tailor training to their career goals. This ensures that the curriculum is not only comprehensive but also adaptable to individual needs.

ABSTRACT IMPACT: This review will encourage further development of novel uses of REDCap for the benefit of the research community. OBJECTIVES/GOALS: REDCap is a clinical research data collection platform that is primarily used as intended. However, little is known about its more novel uses, specifically in clinical decision support in patient care and in clinical research management. Thus, the purpose of this review is to examine peer reviewed literature identifying and describing such novel uses. METHODS/STUDY POPULATION: A systematic search was conducted in both PubMed and Google Scholar using the equation ((REDCap) OR ('Research Electronic Data Capture')) AND ((Clinical Trial Management) OR (Clinical Research)).’ Articles were screened by title, then abstract, and then were reviewed in full if they met inclusion criteria. Articles were included if they had potential relevance to the topic of REDCap or if they mentioned activities related to fields of clinical and translational science including operational support in areas such as clinical research management. Articles were excluded if they focused on common clinical research activities relating to data collection software such as survey administration, database building or data collection for clinical trials, registries, and cohort studies. RESULTS/ANTICIPATED RESULTS: The initial search yielded 390 results, of which 40 underwent an abstract review; only 8 of these underwent full text review. Of these, 5 discussed uses of REDCap in the context of operational support in clinical research management; 3 were related to clinical decision support in patient care. For the 5 articles focused on operational support in clinical research management, topics include e-consenting procedures, collection and storage of protected health information (PHI), patient recruitment and tracking stakeholder engagement. The 3 articles about clinical decision support discuss REDCap tools for generating risk predictions for post-surgical clinical outcomes, generating recommendations and STI test orders, and increasing efficiency in hand-offs to enhance care of surgical oncology patients. DISCUSSION/SIGNIFICANCE OF FINDINGS: Considering that only a small percentage of peer reviewed research reports out on novel uses of REDCap, there is a need for the REDCap consortium to do further work to fulfill its mission to adopt, innovate, and suggest novel uses of REDCap, thus expanding the understanding of its functionalities and therefore its utility in the research community.