OBJECTIVES/GOALS: We aim to extend a novel statistical method called the Semi-Supervised Mixture Multisource Exchangeability Model (SS-MIX-MEM) and to implement the SS-MIX-MEM approach to supplement ALPS-COVID data with N3C data to achieve analyses with greater precision and actionable conclusions. METHODS/STUDY POPULATION: We will apply the SS-MIX-MEM to supplement the Angiotensin receptor blocker-based Lung Protective Strategy for COVID-19 (ALPS-COVID) RCTs with the National COVID Cohort Collaborative (N3C) database. ALPS-COVID includes both an inpatient and outpatient trial, which investigate losartan as a treatment for COVID-19. The outpatient trial sought to randomize 580 individuals but only enrolled 117, whereas the inpatient trial met its enrollment target and randomized 205 individuals. The N3C database has 3,237,344 COVID-19 cases alongside demographics, lab values, and more. RESULTS/ANTICIPATED RESULTS: In simulation studies, the proposed SS-MIX-MEM approach effectively leveraged a subgroup of supplemental real world data for RCT analyses, improving trial efficiency by increasing precision of treatment effect estimates, decreasing necessary sample size, and introducing minimal bias. In an influenza trial real world data application, the SS-MIX-MEM approach was able to effectively provide insight into treatment effect heterogeneity found in an RCT analogous to incorporating around 80 individuals into a subgroup analysis. We anticipate that leveraging external real world data in a re-analysis of the ALPS-COVID RCTs could provide new insights into losartan, a readily available, potentially beneficial therapeutic for COVID-19. DISCUSSION/SIGNIFICANCE: The high blood pressure drug, losartan, is readily available, has an established safety profile, and might be effective as a treatment for COVID-19. Given that we have very few effective treatment options and are still in the midst of a global pandemic, patients with COVID-19 would greatly benefit from a repurposed, readily available treatment.

OBJECTIVES/GOALS: The Clinical Research Professionals (CRP) at Cincinnati Children’s Hospital Medical Center (CCHMC) identified and addressed gaps in a static on boarding material by transforming it into an interactive, centralized, and customizable REDCap checklist to better meet researcher needs across the institution. METHODS/STUDY POPULATION: The CRP On boarding Checklist is a tool designed to assist clinical researchers in their onboarding process at CCHMC. This tool helps CRPs determine the required/recommended trainings available to assist with skill-building and establishing job role competency. CRP supervisorsand subject matter experts were included incontent revisions, format, and transition to a RED Capsurvey. The new checklist is interactive, targets training requirements by job function, and clearly labels mandatory training. A companion document allows new CRPs to create and track their own individualized training plan. RESULTS/ANTICIPATED RESULTS: The revised CRP On boarding Checklist was launched in April 2022 and announced via email communication. Alive demonstration was presented to all CRPs during the May 2022 CRP Monthly Meeting. The checklist and companion document are linked to the internal CRP website, which is accessible institutionally. Sincelaunch, almost 100 new and internally transferring CRPs have utilized the online tool to guide their training needs. The checklist is intended to reflect real-time changes in educational offerings. In addition to feedback and change requests from the CRP community, the checklist is updated as necessary and routinely reviewed on a biannual basisby the CRP Education Committee. DISCUSSION/SIGNIFICANCE: The creation and maintenance of the CRP Onboarding Checklist is a modern and accessible way for CRPs and supervisors to explore role-applicable training and take active roles in the on boarding process. The RED Capformat allows easy sharing and adoptability to other institutions via data dictionary.

OBJECTIVES/SPECIFIC AIMS: Background: Delirium is a well described form of acute brain organ dysfunction characterized by decreased or increased movement, changes in attention and concentration as well as perceptual disturbances (i.e., hallucinations) and delusions. Catatonia, a neuropsychiatric syndrome traditionally described in patients with severe psychiatric illness, can present as phenotypically similar to delirium and is characterized by increased, decreased and/or abnormal movements, staring, rigidity, and mutism. Delirium and catatonia can co-occur in the setting of medical illness, but no studies have explored this relationship by age. Our objective was to assess whether advancing age and the presence of catatonia are associated with delirium. METHODS/STUDY POPULATION: Methods: We prospectively enrolled critically ill patients at a single institution who were on a ventilator or in shock and evaluated them daily for delirium using the Confusion Assessment for the ICU and for catatonia using the Bush Francis Catatonia Rating Scale. Measures of association (OR) were assessed with a simple logistic regression model with catatonia as the independent variable and delirium as the dependent variable. Effect measure modification by age was assessed using a Likelihood ratio test. RESULTS/ANTICIPATED RESULTS: Results: We enrolled 136 medical and surgical critically ill patients with 452 matched (concomitant) delirium and catatonia assessments. Median age was 59 years (IQR: 52–68). In our cohort of 136 patients, 58 patients (43%) had delirium only, 4 (3%) had catatonia only, 42 (31%) had both delirium and catatonia, and 32 (24%) had neither. Age was significantly associated with prevalent delirium (i.e., increasing age associated with decreased risk for delirium) (p=0.04) after adjusting for catatonia severity. Catatonia was significantly associated with prevalent delirium (p<0.0001) after adjusting for age. Peak delirium risk was for patients aged 55 years with 3 or more catatonic signs, who had 53.4 times the odds of delirium (95% CI: 16.06, 176.75) than those with no catatonic signs. Patients 70 years and older with 3 or more catatonia features had half this risk. DISCUSSION/SIGNIFICANCE OF IMPACT: Conclusions: Catatonia is significantly associated with prevalent delirium even after controlling for age. These data support an inverted U-shape risk of delirium after adjusting for catatonia. This relationship and its clinical ramifications need to be examined in a larger sample, including patients with dementia. Additionally, we need to assess which acute brain syndrome (delirium or catatonia) develops first.

ABSTRACT IMPACT: Investigation of tumor-associated blood vessels may serve as an imaging biomarker of response to systemic therapy and cancer outcomes. OBJECTIVES/GOALS: Aberrancies in the tumor microvasculature limit the systemic delivery of anticancer agents, which impedes tumor response. Using human intravital microscopy (HIVM), we hypothesized that HIVM would be feasible in patients with peritoneal carcinomatosis (PC) and generate clinical utility. METHODS/STUDY POPULATION: During cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for PC, HIVM was performed in both tumor and non-tumor areas. The primary outcome was HIVM feasibility to measure vessel characteristics. We secondarily evaluated associations between HIVM vessel characteristics and oncologic outcomes (RECIST response to neoadjuvant therapy and disease-specific survival). RESULTS/ANTICIPATED RESULTS: Thirty patients with PC were enrolled. Nineteen patients (63.3%) received neoadjuvant therapy. HIVM was feasible in all patients. Compared to non-tumor (control) areas, PC areas had a lower density of functional vessels, higher proportion of non-functional vessels, smaller lumenal diameters, and lower blood flow velocity. Qualitative differences in these vessel characteristics were observed among patients who had partial response, stable disease, or progressive disease after receiving neoadjuvant therapy. However, no statistically significant relationships were found between HIVM vessel characteristics and oncologic outcomes. DISCUSSION/SIGNIFICANCE OF FINDINGS: These novel findings comprise the first-in-human, real-time evidence of the microscopic differences between normal and tumor-associated vessels and form the basis for our larger, ongoing clinical trial appropriately powered to determine the clinical utility of HIVM (NCT03823144).

ABSTRACT IMPACT: The findings from this study will inform the development of an FDA-approved patient-rated outcome measure of drug and alcohol craving that can be used in clinical trials aimed at developing or testing effective treatments for substance use disorder. OBJECTIVES/GOALS: Craving is a potential target of investigative medications to reduce drug use due to the strong link between craving and drug use. We will identify all existing craving measures as the first step for developing an FDA-approved patient-rated outcome measure for use in clinical trials. METHODS/STUDY POPULATION: Following PRISMA guidelines, we will update Rosenberg’s (2009) craving review by conducting a systematic review of all existing published and unpublished measures of craving for alcohol, nicotine, cannabis, opioid, and stimulant use. Electronic database (i.e., Ovid MEDLINE, Embase, PsycINFO, Web of Science, Cochrane), forward, backward, and author searches will be conducted. We will also request unpublished craving measures on major listservs (e.g., Research Society on Alcoholism, the Collaborative Perspectives on Addiction, and the College on Problems of Drug Dependence). All papers included in Rosenberg’s (2009) review through September 2020 will be included. RESULTS/ANTICIPATED RESULTS: The findings from this review will provide a comprehensive summary of the construct of craving and its hypothesized and tested domains. This review will elucidate whether the literature suggests there are components of craving unique to alcohol, nicotine, cannabis, opioid, and/or stimulant use, and whether there are key elements of craving common across the disorders. Therefore, these findings will inform whether a single patient-rated outcome measure of craving can be developed for use across substances or if unique patient-rated outcome measures of craving need to be developed for each substance. DISCUSSION/SIGNIFICANCE OF FINDINGS: While many different measures of craving exist, none have gone through the developmental steps required to qualify as an FDA-approved patient-rated outcome measure on which drug treatment labeling can be based. Completing this systematic review is the first step in this process.

OBJECTIVES/SPECIFIC AIMS: To develop a regulatory science case study as an educational resource to inform the regulatory science considerations in medical product development for a range of scientific priority areas and emerging technologies. METHODS/STUDY POPULATION: Precision medicine represents one of the major regulatory science priority areas and the use of biomarkers holds promise for predicting the response to individual treatment strategies. Although progress has been made toward developing biomarkers, the development and validation of clinically useful biomarkers has presented significant regulatory science challenges, including the utilization of biomarkers in predicting responses to different cancer therapies. This case study reviews the technical, regulatory, and policy issues related to the development and use of lung cancer drugs Opdivo® and Keytruda® and an understanding of the codevelopment and utilization of their associated biomarkers. RESULTS/ANTICIPATED RESULTS: A detailed instructor guide with extensive resources such as diagrams and timelines will accompany the case study and will be used to highlight the development and approval process of 2 competing drugs and their associated biomarkers. The resources will provide a better understanding of their progression through the FDA regulatory process and opportunities and challenges for their use. DISCUSSION/SIGNIFICANCE OF IMPACT: Building on the case study framework we have developed, the detailed timelines and a collection of available resources, an extensive and modular case study will be finalized and made available to academic institutions, industry, regulatory agencies, and the public. The full case study and links to a series of resources will be disseminated as a standalone resource for integration into courses or programs interested in learning about specific regulatory science needs and opportunities to enhance medical product development and approval.

OBJECTIVES/GOALS: 1. To characterize domains of maternal psychosocial stress from the Edinburgh Postnatal Depression Scale (EPDS) and Cohens Perceived Stress Scale (PSS) administered during pregnancy using principal components analysis (PCA). 2. To identify sociodemographic, perinatal, and lifestyle correlates of maternal psychosocial stress domains. METHODS/STUDY POPULATION: Using data from 1,079 pregnant women in the Healthy Start Study who completed both the EPDS and PSS in early pregnancy, we ran PCA and retained factors representative of uncorrelated domains of maternal psychosocial stress based on the Scree plot and Eigenvalues >1. We then used linear regression to identify sociodemographic, perinatal, and lifestyle correlates of each maternal stress domain, followed by multivariable models that mutually adjusted for all characteristics that were statistically significant at alpha = 0.10. RESULTS/ANTICIPATED RESULTS: We identified three domains of maternal psychosocial stress based on PCA results: Feeling Overwhelmed (Domain 1), Anhedonia (Domain 2), and Lack of Control (Domain 3). In unadjusted analyses, lower household income and poor diet quality were associated with higher scores for all three domains. In adjusted analyses, lower household income, being multiparous, inadequate or excessive GWG, and poor diet quality were associated with Feeling Overwhelmed. Older age, Hispanic ethnicity, and poor diet quality were associated with Anhedonia. Non-Hispanic, Black race/ethnicity, lower educational attainment, having a partner born outside the US, larger household size, receiving public assistance, and smoking during pregnancy were associated with Lack of Control. DISCUSSION/SIGNIFICANCE: We identify three unique domains of maternal psychosocial stress that are differentially related to sociodemographic, perinatal, and lifestyle characteristics. Correlates of stress domains shed light on upstream determinants and biological and psychosocial mechanisms through which experiences of stress manifest.

OBJECTIVES/GOALS: Research in Action is an on-demand, interactive curriculum designed to increase the ability of clinicians to advance the Academic Learning Health System (aLHS). The 7-module course provides clinicians with the knowledge and skills to lead rigorous quality improvement (QI) projects, translating research evidence into practice. METHODS/STUDY POPULATION: We engaged nurses, physicians, and advanced practice providers (APPs) working in the health system to participate in focus group and advise us in the creation of the curriculum. We conducted focus groups with these stakeholders on the proposed learning objectives, course content, and mode of delivery (in person, virtual, hybrid). Informed by the focus groups, the course was designed for hybrid format so participants could either (1) access the modules on-demand, or (2) learners could participate in a facilitator moderated course where the modules served as the curriculum to guide development of a QI project. The Iowa Model of Evidence-Based Practice was the framework for curriculum development. Upon completion of the modules, stakeholders reviewed each module and provided feedback for improvement. RESULTS/ANTICIPATED RESULTS: Research in Action is a 7-module course, with modules addressing the following topics: (1) Introduction to Quality Improvement, (2) Identify the Problem and Write a Purpose Statement, (3) Form a Team, (4) Appraise and Synthesize the Literature, (5) Design and Pilot the Project, (6) Integrate and Sustain Practice Change, (7) Disseminate the Results. The curriculum is being piloted with multiple clinician groups in the health system. In the next phase of development, a facilitator guide will be created to guide a cohort of clinicians to apply knowledge through discussion sessions and completion of a QI project in the healthcare setting. We anticipate scaling the program for spread to diverse clinician groups in the health system. Pre- and post-implementation data are being collected from current pilot sites. DISCUSSION/SIGNIFICANCE: The aLHS is an essential means for improving healthcare delivery. Research in Action, a hybrid training curriculum, engages frontline clinicians in creating and leading QI projects that implement research evidence into practice to solve problems commonly encountered in the healthcare setting; thus, supporting the advancement of the aLHS.

OBJECTIVES/GOALS: Tobacco use remains a significant problem in rural America. Federally Qualified Health Centers (FQHCs) can help reduce the burden of tobacco use in rural areas. Still, we know little about center awareness and implementation of best practices for tobacco control. We assessed the knowledge and existence of tobacco control strategies in rural FQHCs. METHODS/STUDY POPULATION: We electronically surveyed health administrators and providers (n=33) in three rural Louisiana FQHCs between March and April 2021. The assessment measured awareness of the U.S. Public Health Service Clinical Practice Guideline for Treating Tobacco Use, center priority given to smoking cessation programming, the presence of best practices for tobacco control programming such as having a tobacco control champion and team, treatment and smoke-free campus policies, and referral to external cessation services. Descriptive statistics characterize survey respondents and responses. RESULTS/ANTICIPATED RESULTS: The majority of the respondents were female (88.5%), White (53.8%), between 35 and 54 years of age (69.2%), and non-smokers (65.4%). Among all respondents, 69.7% reported awareness of the U.S. Public Health Service Clinical Practice Guideline for Treating Tobacco Use. Less than half (48%) said their health center gave smoking cessation high priority relative to other health priorities. Only a third (36%) reported having a tobacco champion, and a quarter (25%) had a tobacco control team at their facility. Although all centers had a smoke-free campus policy, a quarter (27%) were unaware of the policy. Only a quarter (27%) reported having a written policy for smoking cessation treatment at their center, and a little more than half (56.7%) knew about cessation services to which they could refer tobacco users. DISCUSSION/SIGNIFICANCE: Centers had limited knowledge of the U.S. guideline for tobacco use treatment. Smoking cessation lacked priority, and tobacco control best practices implementation was low. FQHCs serving rural populations can implement guideline-recommend policies and clinical treatments, and future studies should test strategies to increase implementation.

OBJECTIVES/SPECIFIC AIMS: The majority of obese adults do not become obese until adulthood. Although adults spend the equivalent of a 40-hour work week in front of the television (TV), there are mixed data on whether the sedentary behavior of TV viewing is linked with weight gain during adulthood. The purpose of this study was to examine the associations among sedentary behavior, measured as TV viewing and TV in the bedroom, with eating behavior, eating attitudes and cravings, fat gain, and blood pressure in healthy young adults over a 2-year period. METHODS/STUDY POPULATION: The sample included 73 healthy, nonobese adults (56% women, 80% white) who were 26.8±4.5 years of age with a body mass index of 22.9±2.4 kg/m2. Participants completed clinic visits at baseline and 2-years later (Year 2) which assessed weight, height, blood pressure, waist circumference, and total body fat measured by dual energy X-ray absorptiometry. A food frequency questionnaire was used to estimate dietary intake, and the eating inventory was used to assess dietary restraint, disinhibition, and hunger. At baseline, participants self-reported TV habits including number of hours/week of watching TV (including cable, VCR, DVD) and presence of a TV in the bedroom. For the analysis, participants were stratified by quartiles of TV viewing time. T tests were used to examine the association between TV viewing and bedroom TV. Linear regression models were used to examine the association between TV viewing and each anthropometric and body composition measure and change over the 2-year period, as well as with the dietary constructs. Models controlled for age, sex, and baseline body fat. Separate models were used to investigate the associations between bedroom TV and the same dependent variables. RESULTS/ANTICIPATED RESULTS: Participants reported an average of 13.3±10.8 hours/week of TV viewing, with 33.3% reporting a TV in the bedroom. There were no differences in age, sex, or race among the quartiles of TV viewing or between those who did and did not have a bedroom TV. Adults with a bedroom TV did not differ in hours/week of TV viewing compared with those without a bedroom TV. Amount of TV viewing was associated with higher systolic blood pressure at baseline (p=0.05) but with no other anthropometric or body composition indices nor with change in body composition over the 2-year period. Adults with a bedroom TV reported higher craving for sweets at baseline (p=0.03). Amount of TV viewing was related to lower consumption of vegetables (p=0.04) and fruit or fruit juice (p=0.03) at Year 2, but there was no association with total calorie consumption. TV viewing and bedroom TV were not related to dietary restraint, disinhibition, or hunger at either time point. DISCUSSION/SIGNIFICANCE OF IMPACT: Adults who watched more TV consumed fewer fruits and vegetables, and those with a TV in the bedroom reported higher craving for sweets. Though there were no observed relationships between TV habits and body composition change, the associations with cravings and food consumption warrant further exploration. Querying young adults’ TV and media use habits in clinical settings may alert physicians to those at risk of developing poor dietary habits.

OBJECTIVES/SPECIFIC AIMS: This study seeks to evaluate the role of PCOS in insulin resistance and sleep apnea in adolescents. METHODS/STUDY POPULATION: 37 adolescent patients 13-21 with PCOS (27 obese, 11 lean), along with 8 controls ages 18-21 were recruited. Subjects underwent a hyperinsulinemic euglycemic clamp study and a proportion of the PCOS subjects also underwent polysomnography. Baseline parameters were compared and M/I (index of insulin sensitivity), and GIR were compared. RESULTS/ANTICIPATED RESULTS: M/I was only statistically significantly different between obese PCOS subjects vs control (0.056 vs 0.17, p=0.0061). GIR was higher in the obese PCOS group compared to the lean PCOS group (2.48 vs 6.79, p=0.0001). There were no differences in GIR between the lean PCOS subjects and control (6.79 vs 9.08, p=0.30). 21 obese PCOS subjects and 10 lean PCOS underwent polysomnography. None of the lean PCOS subjects had obstructive sleep apnea (OSA). 8 of the obese subjects had OSA. DISCUSSION/SIGNIFICANCE OF IMPACT: More studies are needed to assess insulin sensitivity and sleep apnea in adolescents with lean PCOS. Our study did not find more insulin resistance in adolescents with PCOS compared to lean controls apart from what would be expected from obesity. Of adolescent obese subjects with PCOS, OSA seems quite prevalent and providers should consider screening and referral for these patients.

OBJECTIVES/GOALS: Older patients with HL have worse outcomes than younger patients, which may reflect treatment selection, including fewer chemotherapy cycles. Immortal time bias exists when patients must survival to initiation, and even completion, of treatment. We described treatment length and death to evaluate the extent of immortal time bias. METHODS/STUDY POPULATION: This retrospective cohort study utilized SEER-Medicare data from 1999-2014. Patients diagnosed with incident advanced stage HL at age ≥65 years and enrolled in Medicare Part A and B fee for service were included. Chemotherapy or radiotherapy treatment initiated within 4 months of diagnosis was determined from inpatient, outpatient, and physician/supplier claims. No treatment was defined by lack of treatment claims. Dates from claims were used to define length of treatment; ≥4 months of treatment indicated complete chemotherapy cycles. Date of death was obtained from Medicare data. Analyses were limited to 1 year post-diagnosis. Summary statistics were used to describe treatment length and subsequent death. RESULTS/ANTICIPATED RESULTS: We included 1492 advanced stage HL patients with a mean age of 76 years (SD = 7). 428 (29%) patients had no documented treatment; 397 (27%) were treated <4 months indicating fewer chemotherapy cycles; and 667 (45%) were treated for ≥4 months indicating complete chemotherapy cycles. Among those with no documented treatment, 15% died within 1 month of diagnosis with 78% dying by 1 year post-diagnosis. Among those treated <4 months, 36% died within 1 month of their last treatment claim with 64% dying by 1 year post-diagnosis. Among those treated ≥4 months, 7% died within 1 month of their last treatment claim with 14% dying by 1 year post-diagnosis. DISCUSSION/SIGNIFICANCE OF IMPACT: Few untreated patients died within 1 month of diagnosis. One-third of patients treated <4 months died soon after completion of treatment, while patients treated longer survived longer, suggesting some patients did not survive to complete treatment. To account for this immortal time bias, landmark analysis will be used to assess the relationship between treatment and survival.

OBJECTIVES/GOALS: The aim of this study was to evaluate current and new anatomical approaches to treating obstructive sleep apnea (OSA) in patients who fail continuous positive airway pressure (CPAP). Understanding the breadth of devices and procedures increases clinical scope of practice and innovator opportunities. METHODS/STUDY POPULATION: A comprehensive review of literature, FDA approvals, patents, and commercially available technologies was undertaken with regards to anatomical approaches for treating OSA. These include experimental therapies, surgical approaches, and non-surgical ablative procedures. Oral appliances, positive airway pressure devices, and therapeutics were excluded. Key search terms included obstructive sleep apnea,’ anatomy,’ surgery,’ devices,’ experimental therapy,’ innovation,’ technology,’ and translational research.’ Publications were limited to the last five years. Innovations were evaluated for relevance to OSA treatment and then assessed in greater depth based on scientific literature. RESULTS/ANTICIPATED RESULTS: Numbers of preclinical and commercially available innovations pertinent to the anatomical treatment of OSA were reported along with clinically relevant outcome metrics. The greatest number of innovations was found in surgical approaches, including soft-tissue removal, orthognathic surgery, and electrical stimulation. Outcome parameters included safety, efficacy, patient compliance, and mean disease alleviation as a ratio of efficacy to compliance. Innovations were grouped by their intended anatomical targets including retrolingual, palatal, oropharyngeal, epiglottic, nasal, and complete concentric collapse, making special note of gaps in the treatment armamentarium. DISCUSSION/SIGNIFICANCE: In the last decade, sleep surgery has trended toward innovative CPAP alternatives. Nerve stimulation and ablative procedures have grown, but some anatomical presentations have been frequently excluded. These developments present opportunities for innovators to fill persistent gaps in treatment.

OBJECTIVES/SPECIFIC AIMS: Millions of diverse, older adults live with serious and chronic illness for which they will face complex, ongoing medical decisions. Advance care planning (ACP) has been conceptualized as a health behavior that supports adults in understanding and sharing their values, goals, and preferences for future medical care. Depression and anxiety are known barriers to participation in health behaviors. It is unknown whether depression and anxiety are associated with ACP participation or with patients’ values for future medical care. Understanding whether depression and anxiety are associated with ACP would be important to tailor ACP interventions. METHODS/STUDY POPULATION: In total, 908 English-speaking and Spanish-speaking participants ≥55 years of age were recruited from a San Francisco county hospital. We measured depression (Patient Health Questionnaire 8-item scale) and anxiety (Generalized Anxiety Disorder 7-item scale), dichotomized into none-to-mild Versus moderate-to-severe. We measured ACP engagement using a validated survey of Behavior Change Processes (e.g., knowledge, self-efficacy, readiness; 5-point Likert) and Action Measures (e.g., ask, discuss, and document one’s wishes; yes/no). We elicited values concerning life extension categorized as “life is always worth living no matter the health situation” Versus “some health situations would make life not worth living.” To explore associations, we usedχ2, Mann-Whitney tests, linear and logistic regressions. RESULTS/ANTICIPATED RESULTS: Mean participant age was 64 years±6, 80% were non-White, 40% had limited literacy, 45% were Spanish-speaking, and the prevalence of depression and anxiety was 12% and 10%, respectively. Depression and anxiety were not associated with ACP Engagement, p>0.05. However, participants with depression had an increased odds of reporting “some health situations would make life not worth living” than those not depressed, p=0.02. In multivariate linear and logistic regression, controlling for age, gender, literacy, and health status, having depression increased the odds of not valuing life extension OR 2.9 (CI: 1.7–4.9). Anxiety was not associated with values concerning life extension, p>0.05. DISCUSSION/SIGNIFICANCE OF IMPACT: Depression and anxiety were not associated with prior ACP engagement suggesting engaging patients in ACP does not increase these conditions. However, depression was associated with an increased odds of not valuing life extension and, therefore, may influence treatment choices. Longitudinal randomized controlled trials of an ACP intervention are currently underway to investigate these associations further.

OBJECTIVES/SPECIFIC AIMS: The American Academy of Pediatrics (AAP) recommends that preschool-aged children spend no more than 2 hours/day using digital screens such as TVs. However, there is a proliferation of digital screens in children’s daily lives both at school and at home. The purpose of this study was to examine factors that contribute to children’s screen-time, including their demographic characteristics and whether or not they have screen-time at school. METHODS/STUDY POPULATION: In total, 59 children (3.3±0.4 years of age; 47% female) enrolled in 3 child care centers participated. Center directors reported school screen-time; 1 center was classified as not providing screen-time and 2 centers were classified as providing screen-time. Parents reported child’s age, sex, and maternal education as a proxy for socio-economic status. Parents reported child’s out-of-school screen-time by responding to the question “During the past 30 days, on average how many hours per day did your child sit and watch TV or videos outside of school?” Additional questions queried how many hours per day did the child “use a computer or play computer games,” “play video games,” “use a smartphone,” and “use an iPad or tablet.” Children’s height and weight were collected using standard clinic procedures and body mass index (BMI) was calculated. T tests were used to examine differences in screen-time by age, sex, and school screen-time. General linear models were used to examine the influence of school screen-time (1=no screen-time, 0=between 1 and 60 min/day of screen-time), age, BMI, and maternal education on out-of-school screen-time and time spent with each device. Logistic regression analysis was used to examine likelihood of meeting screen-time recommendations based on the same characteristics. RESULTS/ANTICIPATED RESULTS: Parent-reported total screen-time was 6.3±3.6 hours/day (h/d); specifically, 2.5±1.1 h/d watching TV, 1.5±2.2 h/d using a smartphone, 1.1±0.9 h/d using a tablet, 0.8±1.0 h/d on a computer, and 0.5±0.7 h/d playing video games. Based on total screen-time, 15% of children met AAP recommendations; based on TV viewing only, 52% met AAP recommendations. The 4-year-old children viewed more screen-time overall compared to the 3-year-old children including on TV, computer, and tablet (p<0.05), but there were no sex differences. In fully adjusted linear models, out-of-school screen-time was lower among those who had no screen-time at school (p=0.02) and higher among older children (p<0.01). Computer use was higher among older children (p=0.02). Older children and those with lower maternal education were less likely to meet clinical recommendations based on TV viewing (p<0.05). There were no observed associations with likelihood of meeting clinical recommendations based on total screen-time. BMI was not a significant predictor of screen-time. DISCUSSION/SIGNIFICANCE OF IMPACT: The majority of children exceeded AAP screen-time limits, with screen-time sharply higher among older children, and the associations did not vary by weight status. Children who attended schools that allowed screen-time had higher amounts of out-of-school screen-time. Pediatricians and healthcare providers should query parents on children’s screen-time practices at home and at school and offer strategies to help families meet the clinical recommendations.

OBJECTIVES/GOALS: This project has two linked aims. (1) It seeks to integrate the TSBM into specific practices and processes to advance its integration into translational research and translational science processes. (2) Via this integration, it aims to determine ways to expand the TSBM as a conceptual model. Ultimately, we aim to advance the TSBM framework and use. METHODS/STUDY POPULATION: We developed a process that implemented and integrated the TSBM within three intentionally-distinct processes. First, we expanded the use of the TSBM case study from a focus on research studies to a focus on translational research programs, and specifically workforce development programs. Second, we integrated TSBM domains and indicators into a new Duke CTSA-wide database used to track, monitor, and assess activities and achievements across the CTSA. Third, we embedded TSBM and its indicators into our Pilots projects application and review process as well as ongoing reporting. RESULTS/ANTICIPATED RESULTS: We were able to successfully integrate the TSBM model into the processes indicated in methods, yet this integration identified opportunity to improve the model to enhance its applicability and value. We found the TSBM applies in distinct ways to translational science programs compared to research studies, with added indicators better accommodating TSBM application to programs. To properly integrate TSBM into progress monitoring systems, we found added needs to ensure comprehensibility for a wide array of researchers and program implementers. Across uses, we identified challenge distinguishing between TSBM benefits as demonstrated versus potential and ambiguity in potential as based on time to benefit realization, likelihood of realization, or centrality of a specific project to realization. DISCUSSION/SIGNIFICANCE: Our session contributes significantly to the field of translational research and science through its focus on advancement and implementation of an innovated model in its early stages, including how researchers and translation science entities can incorporate this model into their own work beyond the traditional use of case studies.

OBJECTIVES/SPECIFIC AIMS: Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences.The objective was to test the effectiveness of a prediabetes SDM intervention. METHODS/STUDY POPULATION: This was a cluster-randomized controlled trial in 20 primary care clinics within a large regional health system. Participants were overweight/obese adults with prediabetes (BMI>24 kg/m2 and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics.Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention; DPP, DPP +/− metformin, metformin only, or usual care. RESULTS/ANTICIPATED RESULTS: Uptake of DPP and/or metformin was higher among SDM participants (n=351) than controls receiving usual care (n = 1,028; 38% vs. 2%, p<.001). At 12-months follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (−5.3 vs. −0.2, p < .001). DISCUSSION/SIGNIFICANCE OF IMPACT: A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4-months and weight loss at 12-months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk.

ABSTRACT IMPACT: Our research has the potential to impact human health by identifying gender specific neural markers of emotion regulation in alcohol use disorder. OBJECTIVES/GOALS: Emotion dysregulation is known to be mediated by altered functional organization of the limbic system in addiction. This preliminary study sought to identify gender effects in the association between emotion regulation and resting-state functional connectivity (rsFC) of a negative affect network. METHODS/STUDY POPULATION: 55 individuals receiving treatment for alcohol use disorder (˜2 weeks of abstinence) were recruited for this study and included in this analysis (N=55; Age: M=41.78, SD=10.66; 21 females). RsFC within a network involved in the withdrawal/negative affect stage of addiction and Personality Inventory for DSM-5 (PID-5) metrics were collected from all participants. RsFC data were preprocessed using the Human Connectome Project pipelines. Correlations between (a) rsFC within the withdrawal/negative affect network and the (b) scores of the negative affect subscale of the PID-5 instrument were conducted for each gender separately. RESULTS/ANTICIPATED RESULTS: Independent samples t-test showed a statistically significant gender difference in the PID-5 negative affect scores (Males: M=1.02, SD=0.66; Females: M=1.53, SD=0.51); t(55)=-3.002, p=0.004. Only females showed a significant correlation between rsFC within the withdrawal/negative affect network and negative affect scores of the PID-5 (r=0.51, p<0.05). Fisher r-to-z test showed significant gender differences (z=-1.91; p=0.03, 1-tailed) in correlations coefficients representing the relationship between rsFC of the withdrawal/negative affect network and negative affect (PID-5 subscale). DISCUSSION/SIGNIFICANCE OF FINDINGS: Preliminary findings suggest that the relationship between neural networks mediating emotion regulation and negative affect is only found in females. These results provide valuable data to inform personalized chemical dependency treatment that targets emotion regulation specific to females.

OBJECTIVES/GOALS: The purpose of this report is to describe the role of Periodontal Disease (PD) in Coronary Artery Disease (CAD) in a Hispanic country. METHODS/STUDY POPULATION: Literature and Puerto Rican experience was reviewed and will be discussed. RESULTS/ANTICIPATED RESULTS: PD produces inflammatory disease by bacterial infection in the gingiva. This factor PD activates an inflammatory process affecting the CAD cascade inducing myocites, endothelial cells activation and cytokines. The incidence of gingival disease in the Puerto Rican population (P) is around 50%; of this group 80% will develop periodontal disease. Including this factor and diabetes mellitus Type 2, still the incidence of CAD is 20-30% less than the U.S.A. DISCUSSION/SIGNIFICANCE OF IMPACT : CAD is a systemic disease related to genetic factors and inflammation. PD is related to an inflammatory process, which will activate the CAD process, producing tissue infarcts. The daily use of resolving or liquid Omega 3 in the gingival tissue is useful in the prevention of gingival and periodontal disease. CONFLICT OF INTEREST DESCRIPTION: All authors have no relationship with any industry or financial associations in connection with the submitted abstract.

OBJECTIVES/SPECIFIC AIMS: There are currently over a million survivors of childhood, adolescent, and young adult cancer in the United States, many of whom were treated with radiation therapy. Chest radiation with fields including the coronary arteries is a risk factor for cardiovascular disease. Of note, survivors are often unaware of this increased cardiovascular disease risk or, if they are aware, do not know how to mitigate the risk. Visual aids and communicating risk in terms of absolute risk reductions are shown to improve patients’ understanding. The Institute of Medicine recommends use of decision aids to optimize patient discussions of benefits and harms of therapies. Our goal is to develop and pilot test a statin therapy risk communication tool for use in high-risk cancer survivors to improve shared decision making and patient knowledge of coronary artery disease risk. METHODS/STUDY POPULATION: Participants were recruited from the adult long-term follow-up clinic at Sloan Kettering Cancer Center into 2 arms, usual care Versus intervention with the statin risk communication tool. The post-visit assessment used Likert-like scales to explore patient perceptions of statin use. The study was not powered for significance as it was a feasibility study; descriptive statistics were run to compare the 2 groups. RESULTS/ANTICIPATED RESULTS: Participants (n=45) had a mean age of 45. In the intervention group, 92% felt the information given was right compared with 73% of the usual care group. In all, 63% of the intervention arm felt the information was helpful, compared with 47% of those in usual care. And 53% of usual care would recommend the method to other patients and for other treatment choices compared to 67% of those in the intervention arm. DISCUSSION/SIGNIFICANCE OF IMPACT: This risk communication tool was assessed for acceptability and found to be more acceptable compared with usual care. In addition, we will gather further information on knowledge enhancement and decisional conflict as well as qualitative data regarding the shared decision making experience. With this information, a future randomized-controlled trial across institutions could provide information on how childhood, adolescent, and young adult survivors approach shared decision making with risk communication tools.