Pragmatic Trials in Maintenance Hemodialysis

维持性血液透析的实用试验

• 批准号: 8737895
• 负责人: Laura M Dember
• 金额: $ 135.48万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8737895
• 关键词: Academia; Businesses; Chronic; Clinical Research; Clinical Trials; Clinical Trials Design; Collection; Communities; Data; Data Coordinating Center; Dialysis procedure; Disease; Effectiveness of Interventions; Electronic Health Record; Eligibility Determination; End stage renal failure; Health; Health Personnel; Healthcare Systems; Hemodialysis; Hospitalization; Hour; Individual; Industry; Information Systems; Intervention; Kidney Failure; Maintenance; Metric; Modeling; Outcome; Patients; Pennsylvania; Phase; Provider; Quality of life; Randomized; Research; Research Personnel; System; Testing; Time; United States; United States National Institutes of Health; Universities; clinical care; collaboratory; cost effective; data exchange; electronic data; health care delivery; health related quality of life; implementation trial; improved; innovation; mortality; pragmatic trial; programs; systems research; tool; treatment as usual

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.

描述（由申请人提供）：本申请旨在在NIH医疗保健系统（HCS）研究合作社内进行大型的，实用的临床试验演示项目。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议“减少末期肾脏疾病（时间）死亡率的时间”试验。计时试验是一项大型，群集的，务实的试验，将评估系统性实施至少四个小时的血液透析会话持续时间至少四个小时的患者的生存，住院和与健康相关的生活质量的影响他们正在使用维持血液透析进行治疗。该试验将在美国两个最大的透析提供者组织拥有的大约320个透析设施中进行。透析提供商组织的电子数据系统将用于识别参与的透析设施，用于收集F试验数据和结果，以及将数据传输到宾夕法尼亚大学临床研究计算单元，该计算将作为数据协调中心试验。该项目将分为两个阶段：UH2计划阶段和UH3实施阶段，每个阶段都有特定的进度和指标里程碑，以评估用于试验的创新方法。透析研究网络应用程序实现了NIH HCS研究合作实用临床试验演示项目计划的目标。计时试验是务实的：1）评估在通常的护理环境中实施的干预措施，2）它利用用于Routie临床护理的数据，3）它对资格的限制很小，4）不需要特定的专家从业者。从临床和患者的角度来看，结果在临床上都很重要。该试验将通过学术研究人员与两个具有不同业务模型，文化和电子数据系统的医疗保健提供者组织之间的合作伙伴关系进行。在广泛的医疗保健系统和疾病中相关且适用的创新方法将用于高度集中的试验执行，并且将开发并与更广泛的研究社区共享工具。因此，除了有效地测试肾衰竭患者的简单但潜在的高影响干预外，Tim试验示范项目还将为进行具有成本效益的大规模临床试验而产生重要的进步，以评估实际干预措施的有效性” - 世界设置。