OBJECTIVES/GOALS: We developed institution-wide RCR training to include all required elements; support trainees to identify key ethical questions that arise in research; and to identify methods to identify a solution; and disseminate results. METHODS/STUDY POPULATION: In 2011, we participated in developing an experimental model of RCR training led by the University of Michigan. We continue to offer this training model to career development awardees in clinical and translational research at OHSU across the institution. Interactive discussion in faculty and trainee groups includes responsibilities of a researcher and a systematic process to address real world research ethics issues. Each participant identifies a key research issue they have encountered and presents a poster at the final session. We have tracked post-training assessment of participant confidence in ethical decision making and in the range of topics identified by participants. RESULTS/ANTICIPATED RESULTS: Since 2012, 227 scholars and trainees have participated in the program with 44 faculty mentors facilitating. We will describe the current curriculum as it has evolved over the past 12 years, presenting trainees with an approach to identify ethical challenges that arise in their research and identify approaches to find a practical solution. We will report on the specific challenges in research ethics identified by participants over this period and how they have evolved. We will also present pre- and post-training data about confidence in ethical decision making. DISCUSSION/SIGNIFICANCE: This approach to RCR training is well-received, has evolved over time, and has led to dissemination. Success is attributed to allowing choice in topics relevant to trainees and practicality of the stepwise approach that is transferable to any situation.

OBJECTIVES/GOALS: Tobacco use remains a significant public health problem in rural America. Community health centers (CHCs) can help reduce the burden of tobacco use in rural areas, but we know little about their knowledge and implementation of best practices for tobacco control. This study assessed the knowledge and existence of tobacco control practices in rural CHCs. METHODS/STUDY POPULATION: Using a cross-sectional study design, we electronically surveyed health administrators and providers (n=64) in six rural CHCs in Louisiana between March 2021 and June 2023. The assessment measured 1) knowledge of the U.S. Public Health Service Clinical Practice Guideline for Treating Tobacco Use, 2) the priority given to smoking cessation programming, 3) the presence of best practices for tobacco control programming, such as having a tobacco control champion and team, 4) establishment of treatment and smoke-free campus policies, and 5) existence of referral procedure to external cessation services. We used descriptive statistics to characterize survey participants and responses. RESULTS/ANTICIPATED RESULTS: Most of the respondents were female (80%), White (61.8%), between 35 and 49 years of age (48.1%), and non-smokers (72.7%). Only half (51.6%) reported knowledge of the guideline for treating tobacco use among all respondents. Only a third (32.8%) said their health center gave smoking cessation high priority relative to other health priorities. Only a third (35.9%) reported having a tobacco champion; less than a fifth (18.8%) said they had a tobacco control team at their health center. Although all health centers had a smoke-free campus policy, about a quarter (23.4%) were unaware of the policy. Less than a quarter (23.4%) reported having a written policy for smoking cessation treatment at their health center, and less than half (46.7%) knew about cessation services to which they could refer patients. DISCUSSION/SIGNIFICANCE: Rural CHCs had limited knowledge of the guideline for tobacco use treatment. Smoking cessation lacked priority, and the prevalence of tobacco control best practices implementation was low. Rural CHCs must improve their implementation of guideline-recommend policies and clinical strategies to promote treatment and reduce the burden of tobacco use.

OBJECTIVES/GOALS: Penn State CTSI supports KL2 career development awards for faculty seeking to become leaders in clinical and translational research. CTSAs can benefit from a better understanding of KL2 applicant profiles and trainee outcomes. Predictive modeling of KL2 records provides insights into institutional processes and continuous improvement goals. METHODS/STUDY POPULATION: Collecting KL2 application records at Penn State CTSI from 2017 to 2023, comprising both accepted and not accepted candidate profiles, this study used a generalized logistic mixed model with binomial distribution to understand the factors predictive of KL2 trainee acceptance, (n=47). The following factors were modeled as potentially predictive of scholars’ acceptance: Institution-specific Processes—Campus; Terminal Degree Type; College of Residency, Applicant Demographics and Portfolio—Minoritized or Protected Groups; Mean Application Score; Rurality Focus; Gender, and Outcomes—Post-Program h-index. RESULTS/ANTICIPATED RESULTS: Only Campus and Degree were significant factors predictive of trainee acceptance (r<.0001), with a particular campus and the MD degree-designation both exerting selectional pressures on acceptance rates. Applicant demographics were not significant historical factors in selection despite the most recent trainee cohort comprised of all women. Similarly, while our CTSA focuses on rural inequality and accessibility, a research proposal focused on rurality was not a significant factor for acceptance. Notably, NIH-scaled application scores and post-program h-indices were not significant for accepted and non-accepted applicants. DISCUSSION/SIGNIFICANCE: The absence of applicant-focused selectional pressure is striking—Penn State CTSI does not significantly select for gender, URM, or URP status. Administration is now empowered to intentionally engage, recruit, and retain from our other affiliated campuses and colleges.

OBJECTIVES/GOALS: Prostate cancer treatment is associated with significant genitourinary side effects. There is a critical need for treatment with decreased morbidity. We report the development of a novel treatment paradigm combining irreversible electroporation and lower dose radiation to provide prostate cancer patients with a less morbid treatment. METHODS/STUDY POPULATION: Intermediate risk prostate cancer patients will undergo focal irreversible electroporation followed by low dose, whole gland radiation therapy. The primary endpoint is freedom from clinically significant cancer on biopsy at 12-month follow up. Secondary endpoints include safety profile, oncologic efficacy, effectiveness of RT and need for secondary treatment. This trial (NCT05345444) and currently actively recruiting patients after initial feasibility trial. Sample size is calculated to detect an increase in the proportion of patients who are cancer free at 1-year, from 0.80 to 0.95. An exact binomial test with a 10% one-sided significance level will have 94.3% power to detect the difference between the null and alternative hypothesis when the sample size is 42. RESULTS/ANTICIPATED RESULTS: This is a clinical trial in progress. DISCUSSION/SIGNIFICANCE: Combined irreversible electroporation (IRE) and a lower dose radiotherapy (RTIRE) may provide prostate cancer patients a treatment with minimal side effects.

OBJECTIVES/GOALS: Our project aims to assess the composition or characteristics of research papers that score high on alternative metrics. These alternative metrics including the number of newspaper mentions, social media mentions, and the attention score as catalogued on Altmetric, a tool used to document community attention for a given research paper. METHODS/STUDY POPULATION: Our study intends to 1) Utilize topic modeling to identify prevalent themes on Altmetric, and 2) Apply network analysis to elucidate the interconnectedness among universities, funding sources, journals, and publishers associated with high-attention papers. 3) Examine how these patterns vary when attention metrics shift, such as social media mentions, newspaper mentions, or the Altmetric score. We'll first perform this analysis on all types of papers and then limit the networks to Biomedical and Clinical Sciences, and Public and Allied Health Sciences to help inform what health topics garner attention. RESULTS/ANTICIPATED RESULTS: Our initial Altmetric topic models revealed sustained attention for COVID-19 and vaccination-related publications well beyond the pandemic (specifically, papers from January 2023). Health topics like cancer, dementia, and obesity also garnered high attention. Additionally, political papers (elections, democracy), climate change, and battery research had notable attention values. Further analysis needs to be done to explain why these topics gain attention and the type of attention they garner. We will construct networks to see the relationship between attention and entities like universities, funding sources, journals, and publishers. This will identify whether certain clusters of these entities produce papers with high attention or if attention is distributed evenly amoung them. DISCUSSION/SIGNIFICANCE: To gauge the broader impact of scholarly research alternative metrics beyond citations are needed. Altmetric is used widely by CTSA’s to measure the community interest in research. Understanding the types of research that gain traction on Altmetric can help researchers understand how to garner interest from the community.

OBJECTIVES/GOALS: Specialty care for asthmatic children should prevent adverse asthma outcomes. This study of children receiving care in the Arkansas Medicaid program used a comparative effectiveness research design to test whether allergy specialty care was associated with reduced adverse asthma outcomes. METHODS/STUDY POPULATION: Using the Arkansas All Payer Claims Database we studied Medicaid-enrolled children with asthma using a propensity score greedy nearest neighbor one-to-one matching algorithm. We matched children with (treatment) and without (comparison) an allergy specialist visit in 2018. The propensity score model included 26 covariates (demographic, clinical, and social determinants of health). Multivariable adjusted logistic regression was used to estimate adverse asthma events (AAE: emergency department visit or inpatient hospitalization with a primary or secondary diagnosis of asthma in 2019). RESULTS/ANTICIPATED RESULTS: We identified 3,031 children with an allergy specialist visit in 2018, and successfully propensity-score matched 2,910 of the treatment group with a non-allergy specialist visit comparison group. The rate of AAEs in 2019 was 9.5% for individuals with an allergy specialist visit versus 10.1% among those without a specialist visit (p=0.450). The adjusted regression analysis showed 20.3% lower rates of AAEs (aOR: 0.797; 95% Confidence Interval: 0.650, 0.977; p=0.029) in 2019 for children with an allergy specialist visit in 2018 compared to those that did not. DISCUSSION/SIGNIFICANCE: Utilizing allergy specialist care was associated with better asthma outcomes in our statewide study of Arkansas Medicaid-enrolled children with asthma. Asthma quality metrics based on guideline-based recommendations for allergy specialist care should be considered in population health management programs.

Medical researchers are increasingly prioritizing the inclusion of underserved communities in clinical studies. However, mere inclusion is not enough. People from underserved communities frequently experience chronic stress that may lead to accelerated biological aging and early morbidity and mortality. It is our hope and intent that the medical community come together to engineer improved health outcomes for vulnerable populations. Here, we introduce Health Equity Engineering (HEE), a comprehensive scientific framework to guide research on the development of tools to identify individuals at risk of poor health outcomes due to chronic stress, the integration of these tools within existing healthcare system infrastructures, and a robust assessment of their effectiveness and sustainability. HEE is anchored in the premise that strategic intervention at the individual level, tailored to the needs of the most at-risk people, can pave the way for achieving equitable health standards at a broader population level. HEE provides a scientific framework guiding health equity research to equip the medical community with a robust set of tools to enhance health equity for current and future generations.

OBJECTIVES/GOALS: Scaffolding aids learning by gradually removing assistance to encourage independence (Bickhard, 2013; Gross, 2015). Mightier is a commercially available biofeedback game that fosters emotion regulation (ER) skill practice through play. This study aims to evaluate the ability of Mightier to scaffold the learning of ER and reduce irritability. METHODS/STUDY POPULATION: Data were collected via online caregiver report. Inclusion criteria were age of child (<= 18 years) and study enrollment prior to the child engaging with Mightier. Children wear a heart rate (HR) monitor while playing games in the Mightier app library. As their HR increases, play becomes more difficult. Children can pause the game to use a scaffolded ER activity or regulate independently to return the game to normal difficulty levels. Caregivers were instructed to use the game ad libitum. Participants included caregivers of 195 children (Mage = 7.84 years old; range = 4-18 years old; 24.28% female; 74.57% male); the sample was predominantly White (56%). Caregivers completed the Affective Reactivity Index, a measure of their child’s irritability, before and after playing Mightier for 8-12 weeks. RESULTS/ANTICIPATED RESULTS: A first Wilcoxon Signed Rank Test revealed a significant reduction in the ratio of scaffolded cooldowns (using a guided activity to regulate) to total cooldowns on the first play day (Md =.50) versus the last play day (Md = .22), z = –6.51, p < .001. A second test revealed a statistically significant increase in the ratio of independent cooldowns (regulating on their own) to total cooldowns on the first play day (Md = .50) versus the last day of play (Md = .80), z = 6.34, p < .001. Given the significant, inverse relationships between scaffolded and independent ER on the first play day versus the last play day, further analyses will examine potential mediation and moderation effects of game engagement (play minutes, total cooldowns, scaffolded cooldowns, and independent cooldowns) on changes in irritability. DISCUSSION/SIGNIFICANCE: ER is vital for healthy development and protects against mental health challenges (LeBlanc etal., 2017). Across domains, scaffolded practice promotes learning (Vygotsky, 1978). Results reveal that scaffolded practice leads to independent ER during play. Future research should explore whether this pathway leads to independent ER outside of play.

OBJECTIVES/GOALS: Cannabis laws may impact cannabis and tobacco use, given high prevalence of co-use of these products among young adults (YAs). The objective of this study was to examine trends in YA any cannabis, blunt, cigarette, and cigar use from 2002-2018 in states that passed adult and medical use (AMU) or medical use only (MUO) cannabis laws during that time (N=16). METHODS/STUDY POPULATION: Using data from the National Survey on Drug Use and Health, we conducted a segmented regression analysis to calculate absolute percent change (APC) in past 30-day cannabis and tobacco use between time points. The National Cancer Institute’s Joinpoint software was used to also estimate points of inflection (Joinpoints) when the slope of a trend significantly (p<0.05) changes. Separate models were estimated for each state, with time as the independent variable measured in years. Up to three Joinpoints per model were allowed. The model with optimal Joinpoints was determined using a model selection criterion via a permutation test. Joinpoints and APCs were compared with key legalization dates to describe patterns within and across states with varying cannabis policies. RESULTS/ANTICIPATED RESULTS: Generally, the 16 states showed a steady decline in YA cigarette smoking over time, a slight decline in cigar smoking, and increases in cannabis and blunt use. AMU states had lower average 2018 prevalence of cigarette smoking than MUO states (18.3% vs. 21.5%) and higher cannabis use (32.3% vs. 21.3%). Cannabis use consistently increased following opening of MUO retail outlets. Generally, there appears to be a slight delay in cannabis use increases following AMU laws, and in some states temporary declines. For example, Washington experienced an initial decrease (-20.3%) following AMU passage (2012) then increase (+16.3%) after retail dispensaries opened in 2014. In AMU states, blunt use has surpassed cigar smoking, while in MUO states, the prevalence of blunt and cigar use is similar. DISCUSSION/SIGNIFICANCE: Introduction of cannabis laws are correlated with increases in YA cannabis and blunt use, with higher cannabis use in AMU states. Trends may also correlate other state political, economic, or social factors. Joinpoint regression can assess changes in a policy’s target behavior with no a priori assumptions regarding timing of policy effects.

Given the dramatic growth in the financial burden of cancer care over the past decades, individuals with cancer are increasingly susceptible to developing social needs (e.g., housing instability and food insecurity) and experiencing an adverse impact of these needs on care management and health outcomes. However, resources required to connect individuals with needed social and community services typically exceed the available staffing within clinical teams. Using input from focus groups, key informant interviews, user experience/user interface testing, and a multidisciplinary community advisory board, we developed a new technology solution, ConnectedNest, which connects individuals in need to community based organizations (CBOs) that provide services through direct and/or oncology team referrals, with interfaces to support all three groups (patients, CBOs, and oncology care teams). After prototype development, we conducted usability testing, with participants noting the importance of the technology for filling a current gap in screening and connecting individuals with cancer with needed social and community services. We employ a patient-empowered approach that engages the support of an individual’s healthcare team and community organizations. Future work will examine the integration and implementation of ConnectedNest for oncology patients, oncology care teams, and cancer-focused CBOs to build capacity for effectively addressing distress in this population.

OBJECTIVES/GOALS: Our objective is to explore the evolving role of evaluators within Learning Health Systems (LHSs) and the implications for evaluation approaches in these dynamic healthcare environments. We aim to disseminate lessons learned to help inform best practices for other CTSA hubs operating under a LHS model. METHODS/STUDY POPULATION: Our investigation builds upon our prior qualitative analysis of the LHS literature and contextualization of unique challenges, and potential remedies, of a LHS in Academic Health Centers. As evaluators, we are particularly interested in understanding how evaluation work is conducted in LHSs and exploring ways to optimize the role of evaluators and their skillset in this context. For this investigation, we examined the competencies necessary for evaluators working in LHS and the specialized evaluation approaches needed to fulfill these requirements. Our approach drew from multi-faceted data and experience. We leveraged insights from our literature review, direct experience within WFUSOM CTSI, and discussions with other evaluators. This combination of data sources provided the foundation for our analysis. RESULTS/ANTICIPATED RESULTS: We expect that as more health systems move toward the LHS model, they will have an increased need for various forms of evaluation, requiring resources well beyond what they are currently dedicating to evaluation. Expectations for evaluators will be enhanced in the following distinct, yet complementary, categories: generating new knowledge and translating research knowledge into practice. Anticipated results include identifying essential competencies for evaluators in LHS, such as data proficiency, clinical understanding, and adaptive skills. We also expect to uncover various evaluation approaches specific to LHS, including quality improvement studies, pragmatic trials, and stakeholder-engaged research. DISCUSSION/SIGNIFICANCE: Understanding the evolving role of evaluators and specialized evaluation approaches in LHS is crucial. It enhances the ability to generate localized evidence, customize interventions, and improve patient care. This knowledge empowers healthcare systems to adapt, innovate and deliver high-quality care for a higher impact on patient outcomes.

OBJECTIVES/GOALS: To develop and validate a tool to systematically identify benefits accruing to research within the Translational Science Benefits Model (TSBM) framework. We used a Delphi panel to reach consensus among a group of experts on criteria required for a clinical, community, economic, or policy benefit to be verified as coming from research. METHODS/STUDY POPULATION: A coding tool with proposed criteria to verify each of the 30 benefits was created at UCI to confirm the TSBM benefits resulting from funded research. We convened 11 experts from 8 CTSA hubs, who consisted of evaluators (faculty and staff) with experience using the TSBM. A web-based survey was used for Round 1, followed by a panel discussion of remaining unvalidated criteria, and a Round 2 survey as the final decision for inclusion of items in the tool. Response options for each criterion were “yes, required” or “no, not required”. Criteria that reached consensus (>70% agreement) were considered validated for inclusion in the final version. Panelist suggested criteria in Round 1 were also incorporated in the Round 2 survey for consideration by the experts. RESULTS/ANTICIPATED RESULTS: In the web-based survey for Round 1, all 11 experts participated and 92% of criteria reached the determined consensus level (N = 157). The remaining 8% of the criteria (N = 13) were discussed during the panel meeting. The discussion, in which 8 experts participated, was moderated by UCI and took place virtually via Zoom. All experts were sent a recording of the discussion and given the opportunity to post comments online about the remaining criteria before, during, and for a day after the discussion. Round 2 will include 50 newly proposed criteria from panelists and the 13 criteria that did not reach consensus in Round 1. Based on the results of Round 2, the criteria that reach consensus will be included in the final version of the coding tool that can be used across all TSBM benefits. DISCUSSION/SIGNIFICANCE: Using the Delphi Methodology, we will have a standardized set of criteria that may be applied to determine whether a TSBM benefit has resulted from a specific research project or program. This standardization will allow for aggregation and comparison of data across CTSA hubs and further multi-level evaluation of impact.

There is increasing recognition of the crucial need for robust community engagement in health research and clinical trials. Despite this awareness, challenges persist in bridging the gap between researchers and communities. Much of the current discourse focuses on addressing issues such as cultural humility and equitable partnerships. To expand this conversation, we conducted community engagement studios, following the model by Joosten et al. We wanted to gather perspectives on research involvement across New Mexico. This process and resultant findings offer valuable insights into effective community engagement practices and advance clinical and translational science by amplifying community voices and needs.