UH3 Project: Time to Reduce Mortality in End-Stage Renal Disease (TiME)
Principal Investigator: Laura Dember, MD
Sponsoring Institution: University of Pennsylvania
NIH Institute Providing Oversight: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Program Official: Paul Kimmel (NIDDK)
Project Scientist: Kevin Abbott (NIDDK)
ClinicalTrials.gov Identifier: NCT02019225
Study Locations: Dialysis facilities throughout the United States
Trial Status: Terminated
TiME is a large pragmatic, cluster-randomized clinical trial testing a simple intervention to improve survival and quality of life for patients with kidney failure who require chronic treatment with dialysis. The trial evaluates a minimum hemodialysis session duration of 4.25 hours compared with usual care for patients with end-stage renal disease initiating treatment with thrice weekly maintenance hemodialysis.
The TiME trial is conducted through a partnership between academic investigators and 2 large dialysis provider organizations in approximately 320 dialysis facilities. The pragmatic design of the trial, the use of multiple electronic health record systems for trial implementation, and the partnership between academia and industry will establish a framework for conducting research within health care delivery systems that will be relevant to a broad range of diseases and research questions.
Ethical issues in pragmatic cluster-randomized trials in dialysis facilities. Am J Kidney Dis. 2019;74(5):659-666.
The TiME trial: a fully embedded, cluster-randomized, pragmatic trial of hemodialysis session duration. J Am Soc Nephrol. 2019;30(5):890-903.
Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach. Trials. 2017;18(1):474.
Pragmatic trials in maintenance dialysis: perspectives from the Kidney Health Initiative. J Am Soc Nephrol. 2016;27(10):2955-2963.
Patient and physician views about protocolized dialysis treatment in randomized trials and clinical care. AJOB Empir Bioeth. 2016;7(2):106-115.
5/1/2019: Presentation to NIH Collaboratory Steering Committee (slides)
5/14/2018: Presentation to NIH Collaboratory Steering Committee (slides)
5/23/2017: Presentation on Top Barriers/Challenges and Recent Generalizable Lessons to NIH Collaboratory Steering Committee (slides)
5/9/2016: Presentation on Data Governance and Data Sharing to NIH Collaboratory Steering Committee (slides)
5/9/2016: Presentation on Generalizable Lessons Learned to NIH Collaboratory Steering Committee (slides)
4/21/2015: Presentation to NIH Collaboratory Steering Committee (slides)
8/20/2014: Presentation on Lessons Learned to NIH Collaboratory Steering Committee (slides)
2/14/2014: Presentation of "Decision Autonomy in Pragmatic Clinical Trials—Supplement to TiME Presentation" to NIH Collaboratory Steering Committee Meeting (slides)
2/24/2014: Presentation on Data Sharing to NIH Collaboratory Steering Committee (slides)