Pragmatic Trials in Maintenance Hemodialysis

描述(由申请人提供)：此申请寻求在NIH医疗保健系统(HCS)研究合作实验室内进行一个大型、务实的临床试验示范项目。由学术研究人员和透析提供者组织组成的透析研究网络正在提出“减少终末期肾病死亡率(TIME)”试验。TIME试验是一项大型、整群随机、务实的试验，将评估系统性实施至少4小时的血液透析疗程对开始维持性血液透析治疗的不可逆性肾功能衰竭患者的存活率、住院率和与健康相关的生活质量的影响。这项试验将在美国两家最大的透析提供商组织拥有的大约320个透析设施中进行。透析提供者组织的电子数据系统将用于识别参与的透析设施，收集试验数据和结果，并将数据传输到宾夕法尼亚大学临床研究计算单位，该单位将作为试验的数据协调中心。该项目将分两个阶段实施：UH2规划阶段和UH3实施阶段，每个阶段都有具体的进展里程碑和评估试验所用创新方法的指标。透析研究网络的应用实现了NIH HCS研究合作实验室务实临床试验示范项目计划的目标。时间试验是务实的：1)它评估在通常护理环境中实施的干预措施，2)它利用为常规临床护理获得的数据，3)它对资格有最小的限制，4)它不需要从业人员的特定专家。无论是从临床还是从患者的角度来看，结果都是重要的。这项试验将通过学术研究人员和两个拥有不同商业模式、文化和电子数据系统的医疗保健提供者组织之间的合作进行。将使用在广泛的卫生保健系统和疾病中相关和适用的创新方法来高度集中地执行试验，并将开发工具并与更广泛的研究界共享。因此，除了对肾衰竭患者有效地测试一种简单但可能产生高影响的干预措施外，TIM试验示范项目还将在进行具有成本效益的大规模临床试验方面取得重要进展，这些临床试验在“现实世界”环境中评估干预措施的有效性。

DESCRIPTION (provided by applicant): This application seeks to conduct a large, pragmatic clinical trial demonstration project within the NIH Health Care Systems (HCS) Research Collaboratory. The Dialysis Research Network, comprised of academic investigators and dialysis provider organizations, is proposing the "Time to Reduce Mortality in End-Stage Renal Disease (TiME)" trial. The TiME trial is a large, cluster-randomized, pragmatic trial that will evaluate the effects on survival, hospitalizations, and health-related quality of life of a systemaic implementation of a hemodialysis session duration of at least four hours for individuals with irreversible kidney failure who are initiating treatment with maintenance hemodialysis. The trial will be conducted in approximately 320 dialysis facilities owned by the two largest dialysis provider organizations in the United States. The electronic data systems of the dialysis provider organizations will be used for identification of participating dialysis facilities, for collection f trial data and outcomes, and for transmission of data to the University of Pennsylvania Clinical Research Computing Unit which will serve as the data coordinating center for the trial. The project will be implemented in two phases: the UH2 planning phase and the UH3 implementation phase, each of which has specific milestones for progress and metrics for evaluating the innovative approaches used for the trial. The Dialysis Research Network application fulfills the objectives of the NIH HCS Research Collaboratory Pragmatic Clinical Trials Demonstration Projects program. The TiME trial is pragmatic: 1) it evaluates an intervention implemented in the usual care setting, 2) it utilizes data that are obtained for routie clinical care, 3) it has minimal restrictions on eligibility, and 4) it requires no specific expertse of practitioners. The outcomes are important both clinically and from the perspective of the patient. The trial will be conducted through a partnership between academic investigators and two health care provider organizations with different business models, cultures, and electronic data systems. Innovative approaches that are relevant and applicable across a broad range of health care systems and diseases will be used for highly centralized execution of the trial, and tools wil be developed and shared with the broader research community. Thus, in addition to efficiently testing a simple but potentially high-impact intervention for patients with kidney failure, the TiM trial demonstration project will generate important advances for conducting cost-effective, large-scale clinical trials that assess the effectiveness of interventions in "real-world" settings.