Evaluation and Administration Support for Pragmatic Trials

实用试验的评估和管理支持

• 批准号: 9317526
• 负责人: Paula Darby Lipman
• 金额: $ 17.69万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9317526
• 关键词: Achievement; Area; Award; Awareness; Case Study; Clinical Research; Clinical Trials; Collaborations; Communication; Communities; Complement; Coordinating Center Administration; Data; Doctor of Philosophy; Documentation; Effectiveness; Elements; Ensure; Environment; Evaluation; Evidence based practice; Funding; Goals; Health; Institutes; Institutional Review Boards; Intervention; Intervention Trial; Interview; Investigation; Knowledge; Lead; Life Cycle Stages; Link; Logistics; Measures; Mediation; Medical Technology; Medical center; Methods; Patients; Phase; Policies; Principal Investigator; Process; Program Evaluation; Protocols documentation; Provider; Randomized Clinical Trials; Randomized Controlled Trials; Readiness; Recruitment Activity; Research; Research Personnel; Risk; Role; Source; Specific qualifier value; Time; Translational Research; U-Series Cooperative Agreements; United States National Institutes of Health; Work; clinical practice; comparative; comparative effectiveness; contextual factors; cost; design; directed attention; health information technology; improved; innovation; meetings; patient oriented; pragmatic trial; programs; public health relevance; social organization; success

DESCRIPTION (provided by applicant): Funders and olicymakers have become increasingly aware of the need to support studies that reflect the real world, comparative effectiveness of health interventions (CBO, 2007). Investigators striving to generate more "practice-based evidence" (Green, 2006) may be faced with unexpected and difficult challenges as they collaborate with community partners, seek to conduct high-impact, patient-centered research in clinical practice settings, and negotiate an increasingly integrated health information technology environment. However, the multiple barriers to research translation are potentially within the control of researchers and program developers (Glasgow and Emmons, 2007).Tracking critical trial metrics and milestones, and working closely with investigators to understand their progress, can direct attention to social, organizational, and ecological factors linked to more efficient and effective trial planning and implementation. The National Institutes of Health (NIH) initiative to support a group of 12 varied (across six NIH institutes) low-cost, pragmatic, patient-centered RCTs provides the opportunity to improve our current knowledge of "what works" when conducting these potentially high-impact trials and to systematically evaluate the impact of the required design elements on key metrics such as trial efficiency, cost, and impact. The NIH is seeking an evaluation and administration coordinating center to assess methods and processes that contribute to success during the UH2 planning phase (Year 1) and the UH3 implementation phase (Years 2 to 5). The UH2 planning phase will focus on how efficiently each grantee achieves start-up and planning milestones, assess time required for trial readiness, and evaluate strategies associated with success. During the UH3 implementation phase, the evaluation will consider the timeliness of recruitment, patient retention, success using integrated electronic sources, and the ability to answer key research questions. The evaluation and administrative coordinating center will (1) conduct a utilization-focused, mixed-methods program evaluation of the readiness and success of the trials funded under RFA-HL-14-019; and (2) support the NIH by providing administrative support for trials funded under RFA-HL-14-019, including assisting grantees with documentation of milestones, communication tasks, and meeting logistics.

描述（由申请人提供）：资助者和政策制定者越来越意识到需要支持反映真实的世界的研究，卫生干预措施的比较有效性（CBO，2007）。努力产生更多“基于实践的证据”（绿色，2006）的研究者可能会面临意想不到的困难挑战，因为他们与社区合作伙伴合作，寻求在临床实践环境中进行高影响力，以患者为中心的研究，并谈判日益一体化的卫生信息技术环境。然而，研究转化的多重障碍可能在研究人员和项目开发人员的控制范围内（格拉斯哥和埃蒙斯，2007年）。跟踪关键的试验指标和里程碑，并与研究人员密切合作以了解其进展，可以将注意力集中在与更有效和更安全相关的社会，组织和生态因素上。 有效的审判规划和实施。美国国立卫生研究院（NIH）倡议支持一组12个不同的（跨6个NIH研究所）低成本，务实，以患者为中心的随机对照试验，提供了机会，以提高我们目前的知识“什么是有效的”当进行这些潜在的高影响力的试验，并系统地评估所需的设计元素对关键指标的影响，如试验效率，成本和影响。NIH正在寻求一个评估和管理协调中心，以评估有助于在UH 2规划阶段（第1年）和UH 3实施阶段（第2年至第5年）取得成功的方法和流程。UH 2规划阶段将重点关注每个受赠方实现启动和规划里程碑的效率，评估试验准备所需的时间，并评估与成功相关的策略。在UH 3实施阶段，评价将考虑招募的及时性、患者保留、使用集成的成功性 电子资源，以及回答关键研究问题的能力。评价和行政协调中心将（1）对RFA-HL-14-019资助的试验的准备和成功进行以利用为重点的混合方法项目评价;（2）通过为RFA-HL-14-019资助的试验提供行政支持来支持NIH，包括协助受资助者记录里程碑、沟通任务和会议后勤。