2276 Development of the expanded access oversight committee at Michigan Medicine

OBJECTIVES/SPECIFIC AIMS: Expanded Access is an avenue for patients with no available treatment options to access investigational drugs and devices for clinical therapy. This process requires physicians treating these patients to submit requests to the FDA and the local IRB, processes which are typically unfamiliar to clinicians. METHODS/STUDY POPULATION: With the goal of reducing burden and ensuring access to investigational products, Michigan Medicine established the Expanded Access Oversight Committee in January 2015. This committee brought together key stakeholders to develop appropriate policy and infrastructure to support these requests. RESULTS/ANTICIPATED RESULTS: Outcomes from this committee have resulted in a uniform process with a single point of entry for interested physicians and patients. With standardized policy implemented across the institution, a revised IRB application has been developed that is more tailored to Expanded Access and an informed consent document has been developed specific to the clinical use of investigational therapies. To ensure timely execution of these agreements, the contracts office has streamlined the process for negotiating Expanded Access agreements with manufacturing companies. Further development has begun with the Michigan Clinical Research Unit to provide space for clinical visits in Expanded Access cases, allowing for initiation of outpatient therapy. These changes have allowed Michigan Medicine to support triple the number of Expanded Access requests, including more than 45 Expanded Access requests in fiscal year 2018. DISCUSSION/SIGNIFICANCE OF IMPACT: Institutional support for Expanded Access requests within a large academic medical center is feasible and can increase access to investigational therapies bfor patients.

used to assess patient health status. There is an emerging trend of using morphomic variables such as muscle mass and bone mineral density to predict surgical and medical outcomes. In certain cases, it has been shown to predict cancer survival more accurately than conventional staging methods. With the growing popularity of morphomic analysis, it is vital to establish baseline variability against which patient populations can be validated. Of populations receiving radiographic imaging, trauma patients are approximately representative of the general population. We created a reference population of morphomic variables from over 6000 University of Michigan patients presenting with trauma. METHODS/STUDY POPULATION: Computed tomography (CT) scans were obtained for all patients who underwent scans for trauma indications at the University of Michigan starting from April 1998. High throughput image processing algorithms written in MATLAB 2015a were used to semi-automatically process chest, abdomen, and pelvis CT scans. Scans were referenced to a common coordinate system based on vertebral levels and body anatomy. Measurements of adiposity, muscle group, and bone density measurements were performed at each level. Percentile curves of morphomic measures of body composition by age and sex were created. The reference population dataset is periodically updated and is publicly accessible. RESULTS/ANTICIPATED RESULTS: As of July 2017, over 6000 patients aged 1-81 years have been included in the Reference Analytics Morphomics Population. Patient CT scans were analyzed at the T10, T11, T12, L1, L2, L3, and L4 vertebral levels. Morphomic measures analyzed include body depth, body cross-sectional area, vertebral trabecular bone density, visceral fat area, fascia area, subcutaneous fat area, central back fat, and psoas muscle area. DISCUSSION/SIGNIFICANCE OF IMPACT: We created reference curves for several morphomic variables from a Reference Analytic Morphomics Population of over 6000 University of Michigan patients presenting with trauma.

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Development of the expanded access oversight committee at Michigan Medicine Kevin Weatherwax, Ray Hutchinson, George Mashour and Misty Gravelin University of Michigan School of Medicine OBJECTIVES/SPECIFIC AIMS: Expanded Access is an avenue for patients with no available treatment options to access investigational drugs and devices for clinical therapy. This process requires physicians treating these patients to submit requests to the FDA and the local IRB, processes which are typically unfamiliar to clinicians. METHODS/STUDY POPULATION: With the goal of reducing burden and ensuring access to investigational products, Michigan Medicine established the Expanded Access Oversight Committee in January 2015. This committee brought together key stakeholders to develop appropriate policy and infrastructure to support these requests. RESULTS/ANTICIPATED RESULTS: Outcomes from this committee have resulted in a uniform process with a single point of entry for interested physicians and patients. With standardized policy implemented across the institution, a revised IRB application has been developed that is more tailored to Expanded Access and an informed consent document has been developed specific to the clinical use of investigational therapies. To ensure timely execution of these agreements, the contracts office has streamlined the process for negotiating Expanded Access agreements with manufacturing companies. Further development has begun with the Michigan Clinical Research Unit to provide space for clinical visits in Expanded Access cases, allowing for initiation of outpatient therapy. These changes have allowed Michigan Medicine to support triple the number of Expanded Access requests, including more than 45 Expanded Access requests in fiscal year 2018. DISCUSSION/SIGNIFICANCE OF IMPACT: Institutional support for Expanded Access requests within a large academic medical center is feasible and can increase access to investigational therapies bfor patients.

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Early findings from a real-world RCT: Acceptance and commitment therapy (ACT) for persistent pain in an integrated primary care setting This study seeks to test the feasibility and effectiveness of a brief Acceptance and commitment therapy (ACT) treatment for patients with persistent pain in a patient-centered medical home. METHODS/STUDY POPULATION: Participants are recruited via secure messaging, clinic advertisements and clinician referral. Primary care patients age 18 and older with at least 1 pain condition for 12 weeks or more in duration are stratified based on pain severity ratings and randomized into (a) ACT intervention or (b) control group [Enhanced Treatment as Usual (E-TAU)]. Participants in the ACT arm attend 1 individual visit with an integrated behavioral health provider, followed by 3 weekly ACT classes and a booster class 2 months later. E-TAU participants will receive usual care plus patient education handouts informed by cognitive behavioral science. Currently, 17% of our overall goal of 60 patients have completed ACT or enhanced treatment as usual. Average participant age is 49 years old, 70% female, and 70% Hispanic/Latino. Most report multisite pain conditions (e.g., musculoskeletal, fibromyalgia) and 30% are taking opioid medications. Data analysis in this presentation will include early correlational findings from baseline assessments. Upon study completion, we will analyze data using a general linear mixed regression model with repeated measures. RESULTS/ANTICIPATED RESULTS: The overall hypothesis is that brief ACT treatment reduces physical disability in patients with persistent pain when delivered by an integrated behavioral health provider in primary care. By examining a subset of patients on opioid medications, we also anticipate a reduction in opioid misuse behaviors. Additionally, it is anticipated that improvements in patient functioning will be mediated by patient change in pain acceptance and patient engagement in values-consistent behaviors. DISCUSSION/SIGNIFICANCE OF IMPACT: This pilot study will establish preliminary data about the feasibility and effectiveness of addressing persistent pain in a generalizable, "real-world" integrated primary care setting. Data will help support a larger trial in the future. If effective, findings could improve treatment methods and quality of life for patients with persistent pain using a scalable approach.

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Evolution of the interdisciplinary co-citation network supported by the Georgia Clinical and Translational Science Alliance Program from 2006 through 2016 Dorothy R. Carter 1 , Nicole Llewellyn 2 , Eric Nehl 2 and Latrice Rollins 3 1 The University of Georgia; 2 Emory University; 3 Moorehouse School of Medicine OBJECTIVES/SPECIFIC AIMS: The National Institutes of Health (NIH) has provided continual support for the Georgia Clinical and Translational Science Alliance (CTSA) since 2006. An overarching goal of the Georgia CTSA is to accelerate clinical and translational research to impact health in Georgia and beyond. Toward these ends, a primary objective has been to support interdisciplinary research projects encompassing 2 or more disciplinary domains. The goal of the present study is to evaluate the degree to which interdisciplinary research projects increased in prevalence during the first decade of funding. METHODS/STUDY POPULATION: We began by using PubMed to identify all publications citing the Georgia CTSA hub (n = 1865), categorizing each article as encompassing 1 or more research domain using a taxonomy derived from the Web of Science. We created 1 network for each of the 10 years with nodes representing research areas and ties between pairs of nodes representing the presence of 1 or more publication integrating both research areas. We conducted longitudinal network analyses using an approach called MCMC MLE Temporal Exponential Random Graph Models, which models the antecedents of networks over time. RESULTS/ANTICIPATED RESULTS: Supporting Georgia CTSA objectives, results suggest the probability of publications connecting multiple research areas increased over time, with substantially greater increases appearing initially as compared to later years. DISCUSSION/SIGNIFICANCE OF IMPACT: This study advances an innovative approach to modeling the system-wide impact of CTSA hub funding.

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Exploring the relationships between acculturation, discrimination and function in older African immigrants: A dissertation study Manka Nkimbeng, Yvonne Commodore-Mensah and Sarah Szanton Johns Hopkins University School of Medicine OBJECTIVES/SPECIFIC AIMS: Acculturation and discrimination are associated with negative health outcomes including functional disability. The effect of these on functional disability in older African immigrants in the United States is not well understood. The purpose of this study is to describe and examine the experiences of acculturation, racial discrimination and functional disability in older African immigrants. METHODS/STUDY POPULATION: This study will use cross-sectional quantitative and qualitative mixed methods design. We plan cambridge.org/jcts 81