Pilot Project for the DTMI CRA Program

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DESCRIPTION (provided by applicant): The overall goal of this pilot study is to evaluate the feasibility, methodology, and economics of setting up a Research Associates Organization (RAO) within the Duke University Translational Medicine Institute (DTMI). The DTMI Community Research Associates (DTMI CRA) program aims to remove administrative burdens to performing clinical research within community practices, increase participation of community providers in generating findings to support evidence-based practices, and enhance the generalizability of research findings to a broader population. This will be accomplished through establishing an educational program and developing a research infrastructure that meets the needs of the community providers. The DTMI CRA program will encompass the entire spectrum of healthcare with representation of hospitals, provider offices, public health clinics, and community participants. To address these goals, the study proposes the following specific aims to: 1) assess the proportion of community providers with an interest in clinical research participation at different levels via a mailed and online survey; 2) compile online training modules on good clinical practices, research ethics, and community health tailored for community providers, followed by an assessment of the time for completion, feedback, and satisfaction with training; 3) assess the components of clinical research support required by practice sites, then tailor clinical research support to the needs of the community practice; 4) inventory the number and type of clinical research studies available throughout the Duke University enterprise that would be appropriate for community provider involvement; 5) summarize the feasibility, methodology, and costs; 6) assess current participation of community practitioners in ongoing research projects, and initiate a new community-based clinical trial for evaluation relative to the findings of Aims 1-5; and 7) participate actively in the network created by this Cooperative Agreement to create a national system.