Pilot Project for the DTMI CRA Program

描述(由申请人提供)：这项试点研究的总体目标是评估在杜克大学转化医学研究所(DTMI)内建立一个研究助理组织(RAO)的可行性、方法学和经济性。DTMI社区研究协会(DTMI CRA)计划旨在消除在社区实践中进行临床研究的行政负担，增加社区提供者在生成支持循证实践的研究结果方面的参与，并增强研究结果在更广泛人群中的普适性。这将通过建立教育计划和开发满足社区提供者需求的研究基础设施来实现。DTMI CRA计划将涵盖医疗保健的整个范围，代表医院、服务提供者办公室、公共卫生诊所和社区参与者。 为了达到这些目标，该研究提出了以下具体目标：1)通过邮寄和在线调查，评估不同级别的社区提供者对临床研究参与感兴趣的比例；2)为社区提供者量身定做关于良好临床实践、研究伦理和社区健康的在线培训模块，然后评估完成时间、反馈和对培训的满意度；3)评估实践站点所需的临床研究支持的组成部分，然后根据社区实践的需要定制临床研究支持；4)盘点整个杜克大学企业中适合社区提供者参与的临床研究研究的数量和类型；5)总结可行性、方法和成本；6)评估社区从业者当前参与正在进行的研究项目的情况，并启动一项新的基于社区的临床试验，以针对AIMS 1-5的结果进行评估；以及7)积极参与本合作协议创建的网络，以创建一个国家系统。

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.