UH3 Project: Time to Reduce Mortality in End-Stage Renal Disease (TiME)

UH3 Project: Time to Reduce Mortality in End-Stage Renal Disease (TiME)

Principal Investigator: Laura Dember, MD

Sponsoring Institution: University of Pennsylvania

Collaborators:

  • Fresenius Medical Care North America

  • DaVita Clinical Research

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.

NIH Project Information

Presentation

5/1/2019: Presentation to NIH Collaboratory Steering Committee (slides)

Interviews

4/20/2015: Interview with principal investigator Dr. Laura Dember (PDF)

Supplementary Material

Regulatory and Ethics Support Documentation

Publications

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.

Presentations

5/1/2019: Presentation to NIH Collaboratory Steering Committee (slides)

5/14/2018: Presentation to NIH Collaboratory Steering Committee (slides)

9/15/2017: PCT Grand Rounds: "Who To Include in a Pragmatic Trial? It Depends" (video; 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)

2/06/2015: PCT Grand Rounds: "The TiME Trial: From Planning to Implementation" (video; 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)

9/27/2013: PCT Grand Rounds: "Pragmatic Trials for Uncommon Conditions" (video; slides)

2/22/2013: PCT Grand Rounds: "Time to Reduce Mortality in End-Stage Renal Disease (TiME)" (video; slides)

 

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Citation:

Demonstration Projects: UH3 Project: Time to Reduce Mortality in End-Stage Renal Disease (TiME). In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/demonstration-projects/uh3-project-time-to-reduce-mortality-in-end-stage-renal-disease-time/. Updated January 13, 2020.