The Mountain West Clinical and Translational Infrastructure Network Community Engagement and Outreach (CEO) Core has fostered academic-community engagement since 2018. States historically receiving lower levels of NIH funding are characterized by significantly higher proportions of rural and remote populations, as well as uniquely elevated percentages of Native American/Alaska Native and Native Hawaiian/Pacific Islander populations compared to most other states. This case study highlights the Core’s efforts in advancing community-engaged research. Key initiatives included forming a CEO Core Steering Committee to recruit interdisciplinary investigators, establishing regional community advisory boards to identify research priorities, and creating a Resource Library and Training Portal for stakeholders. The Core also collaborated with other Cores to provide training, mentorship, and funding for community-engaged research. Despite these achievements, geographical and cultural diversity presented engagement challenges. Regular meetings between investigators and stakeholders ensured bidirectional communication and aligned goals. The Core transformed transactional engagement into meaningful collaboration, emphasizing the need for interdisciplinary teams who understand community needs. Future goals include training academic teams, clinical providers, and community members, empowering early-stage investigators to share findings with partners, leveraging health records for research, and developing strategies to protect investigators’ time.

Exclusion of special populations (older adults; pregnant women, children, and adolescents; individuals of lower socioeconomic status and/or who live in rural communities; people from racial and ethnic minority groups; individuals from sexual or gender minority groups; and individuals with disabilities) in research is a pervasive problem, despite efforts and policy changes by the National Institutes of Health and other organizations. These populations are adversely impacted by social determinants of health (SDOH) that reduce access and ability to participate in biomedical research. In March 2020, the Northwestern University Clinical and Translational Sciences Institute hosted the “Lifespan and Life Course Research: integrating strategies” “Un-Meeting” to discuss barriers and solutions to underrepresentation of special populations in biomedical research. The COVID-19 pandemic highlighted how exclusion of representative populations in research can increase health inequities. We applied findings of this meeting to perform a literature review of barriers and solutions to recruitment and retention of representative populations in research and to discuss how findings are important to research conducted during the ongoing COVID-19 pandemic. We highlight the role of SDOH, review barriers and solutions to underrepresentation, and discuss the importance of a structural competency framework to improve research participation and retention among special populations.

OBJECTIVES/SPECIFIC AIMS: Cancer related pain presents a significant risk for opioid abuse among cancer survivors and contributes to the current opioid crisis. Nearly 90% of breast cancer patients have been reported to have cancer-related pain requiring treatment. Opioids, in combination with NSAIDs, have been widely used for pain management in this population despite the risk of abuse. Long-term NSAID use due to their antineoplastic and neuroprotective effects may offer additional protective effects against opioid abuse. Here, we assess the relationship between NSAID use and opioid abuse among breast cancer patients. METHODS/STUDY POPULATION: Using ICD-9-CM codes, we identified and selected women aged >18 years with breast cancer from the National Inpatient Sample (NIS). Our primary predictor was a history of long-term NSAID use. Opioid abuse was the primary outcome of interest. Secondary outcomes were inpatient mortality and length of stay. Multivariable regression models were employed in assessing the association between predictors and outcomes while adjusting for relevant covariates. RESULTS/ANTICIPATED RESULTS: Among 170,644 women with breast cancer, 7,838 (4.6%) reported a history of long-term NSAID use. Patients with a history of long-term NSAID use had lower odds of opioid abuse (aOR 0.53; 95% CI [0.32-0.88]) and in-hospital mortality (aOR 0.52; 95% CI [0.45-0.60]) and were likely to have shorter hospital stay (7.12 vs. 8.11 days) compared to women with no history of long-term NSAID use. DISCUSSION/SIGNIFICANCE OF IMPACT: Long-term NSAID use may offer a protective effect against opioid abuse and improve in-hospital outcomes translating to better quality of life and healthcare utilization indices among breast cancer patients.

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/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/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.

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/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.

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/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: Syncope is a common diagnosis in observation medicine, and characterization of observation patients is often limited to single unit, single center, or single payer systems. TriNetX, a federated deidentified multicenter national public database, provides an opportunity to study these patients from across the USA. Methods/Study Population: This retrospective cohort study queried data from 56 health care organizations (HCO) in TriNetX to examine differences between observation patients with syncope who required admission vs. those who were discharged. All observation stays with a diagnosis of syncope, defined by ICD-10, CPD, and SNOWMED codes, were queried. A total of 281,162 observation encounters were included in analysis, of which 46.4% (n = 130,357) were admitted and 53.6% (n = 150,805) were discharged. Data on age, gender, race, ethnicity, presence of congestive heart failure, EKG, and serum labs were collected for comparative analysis. T-test and Chi-square analyses were deployed with significance  =  p Results/Anticipated Results: The cohorts demonstrated statistically significant differences across all demographic factors, however, they were not clinically meaningful. Clinically significant differences include that only 72.8% of admitted patients and 68.3% of discharged patients had an EKG recorded in TriNetX during the period of observation (p Discussion/Significance of Impact: Patients admitted from observation status were more likely to have CHF, higher BNP, and pro-BNP values. TriNetX is a powerful tool to study patients across multiple hospital systems and payer types. Limitations, however, include incomplete data and inaccuracies among claims records.

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/Goals: The Wake Forest Clinical and Translational Science Institute (WF CTSI) provides many services, but little is known about how utilization of services affects research outcomes. Our goal is to understand long-term outcomes of recurrent service use from existing resources with an eye towards creating new processes to track research outcomes. Methods/Study Population: The Dissemination, Implementation, and Continuous Quality Improvement team partnered with the Biostatistics, Epidemiology, and Research Design (BERD) program for this project. Initially, we aimed to track abstract and paper publications, and grant submissions (unfunded and funded) for all service requests coming through the BERD from 2017-2024. This was quickly deemed infeasible using prior CTSI data collection processes; however, detailed follow-up data did exist on funded CTSI pilots in the same time window. Consequently, we aimed to test associations between project attributes provided on the service request form and downstream research outcomes, including peer-reviewed publications and grant funding. We used chi-squared tests in the Python package “tableone” to test these associations. Results/Anticipated Results: Our sample only included WF CTSI pilot-funded projects; though, unexpectedly we found information on pilot projects funded by different sources including center/institutional pilots, federal funding, foundation grants, and internal/departmental funding. We found it most effective to link service requests with IRB numbers, because different principle investigators can submit requests on behalf of the same project. N=206 total projects were included in the analysis. Regarding peer-reviewed publications, associations were found with type of service, principal investigator rank, and IRB approval status. Regarding grant funding, associations were found with service type, principal investigator career stage, and previous principal investigator grant funding. Discussion/Significance of Impact: As part of a large academic learning health system, the WF CTSI provides support to various investigators and tracking long-term research outcomes is a priority. This investigation identified important predictors of successful publications and grants in pilot projects, though it also identified gaps in processes to track research outcomes.

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/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: Community-based practices have limited research opportunities for providers. As a rural community-based health system, Mayo Clinic Health System (MCHS) sought to create intramural funding mechanisms to help early-stage researchers conduct pilot research so they are more competitive to compete for more robust extramural funding opportunities. Methods/Study Population: We created a Research Seed Grant Program infrastructure across our four MCHS regions (Southwest and Southeast Minnesota, Northwest and Southwest Wisconsin). This model program featured an initial research funding announcement call based on 6 prioritized programs (AI Validation & Stewardship, Cancer, Health Equity, Population Health, Rural Health, Learning Healthcare System [LHS]), with submissions uploaded to a central electronic repository. Proposal review and ranking was organized on a regional basis, with ranking of all proposals by at least 2 clinical scientist reviewers according to the NIH domain-specific framework (i.e., 1.0 best > 9.0 worst). Awards were competitively selected by conformity to prioritized research areas and through ranking of most competitive overall application scores. Results/Anticipated Results: For our inaugural RFA, we received 55 grant application submissions across the MCHS regions. Fifteen of the most highly ranked applications were selected for awards on a per region basis, providing direct funding as well as protected investigator research time of 10% for up to six months. The selected projects address several research priorities including improving access, reducing health disparities, improving behavioral health in our communities, increasing cancer screening and prevention, and community-based pragmatic trials and interventions. Outcomes from these now completed pilot projects remain pending at this time. Funding for this seed grant program was supported by philanthropy, Mayo Clinic Research Administration, Mayo Clinic Comprehensive Cancer Center, and the Mayo Clinic CCaTS Rural Core. Discussion/Significance of Impact: We present this framework for a LHS-focused Seed Grant program model for consideration of adoption by other national/international LHS. Future plans include tracking of outcome metrics (e.g., published peer review articles, extramural grant applications) of this initial cycle and future expansion of this program to support the goals of our LHS.

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.