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Clinical Research
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The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration

Laura M. Dember, Eduardo Lacson, Steven M. Brunelli, Jesse Y. Hsu, Alfred K. Cheung, John T. Daugirdas, Tom Greene, Csaba P. Kovesdy, Dana C. Miskulin, Ravi I. Thadhani, Wolfgang C. Winkelmayer, Susan S. Ellenberg, Denise Cifelli, Rosemary Madigan, Amy Young, Michael Angeletti, Rebecca L. Wingard, Christina Kahn, Allen R. Nissenson, Franklin W. Maddux, Kevin C. Abbott and J. Richard Landis
JASN May 2019, 30 (5) 890-903; DOI: https://doi.org/10.1681/ASN.2018090945
Laura M. Dember
1Renal, Electrolyte and Hypertension Division, Department of Medicine,
2Department of Biostatistics, Epidemiology, and Informatics,
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Eduardo Lacson Jr.
3Division of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts;
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Steven M. Brunelli
4DaVita Clinical Research, Minneapolis, Minnesota;
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Jesse Y. Hsu
5Department of Biostatistics, Epidemiology, and Informatics, and
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Alfred K. Cheung
6Division of Nephrology and Hypertension, Department of Internal Medicine, University of Utah and Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, Utah;
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John T. Daugirdas
7Division of Nephrology, Department of Medicine, University of Illinois College of Medicine at Chicago, Chicago, Illinois;
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Tom Greene
8Departments of Population Health Science and Internal Medicine, University of Utah, Salt Lake City, Utah;
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Csaba P. Kovesdy
9Division of Nephrology, Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee;
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  • ORCID record for Csaba P. Kovesdy
Dana C. Miskulin
10Division of Nephrology, Tufts Medical Center, Boston, Massachusetts;
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Ravi I. Thadhani
11Division of Nephrology, Massachusetts General Hospital, Boston, Massachusetts;
12Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California;
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Wolfgang C. Winkelmayer
13Selzman Institute for Kidney Health, Section of Nephrology, Department of Medicine, Baylor College of Medicine, Houston, Texas;
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Susan S. Ellenberg
5Department of Biostatistics, Epidemiology, and Informatics, and
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Denise Cifelli
14Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;
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Rosemary Madigan
14Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;
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Amy Young
4DaVita Clinical Research, Minneapolis, Minnesota;
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Michael Angeletti
3Division of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts;
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Rebecca L. Wingard
3Division of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts;
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Christina Kahn
3Division of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts;
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Allen R. Nissenson
15DaVita Kidney Care, El Segundo, California;
16David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California; and
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Franklin W. Maddux
3Division of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts;
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Kevin C. Abbott
17National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland
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J. Richard Landis
5Department of Biostatistics, Epidemiology, and Informatics, and
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Significance Statement

Routine incorporation of pragmatic trials into clinical care delivery has potential to generate answers to important questions, such as optimal approaches for fundamental components of maintenance hemodialysis. The Time to Reduce Mortality in ESRD (TiME) trial was a large pragmatic trial demonstration project designed to determine if a hemodialysis session duration longer than many patients in the United States currently receive improves clinical outcomes. Although the trial accomplished many of its demonstration project objectives, including rapid enrollment of >7000 patients, use of an opt-out consent approach, and complete reliance on clinically acquired data, uptake of the intervention was insufficient to determine whether longer sessions improve outcomes. Embedding trials into hemodialysis clinical care will require more effective strategies for engaging clinical personnel and patients.

Abstract

Background Data from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established.

Methods To develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients.

Results The trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care.

Conclusions Although a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.

  • TiME Trial
  • dialysis session duration
  • learning health system
  • NIH Health Care Systems Research Collaboratory
  • opt-out consent
  • consent waiver
  • Copyright © 2019 by the American Society of Nephrology
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Journal of the American Society of Nephrology: 30 (5)
Journal of the American Society of Nephrology
Vol. 30, Issue 5
May 2019
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The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration
Laura M. Dember, Eduardo Lacson, Steven M. Brunelli, Jesse Y. Hsu, Alfred K. Cheung, John T. Daugirdas, Tom Greene, Csaba P. Kovesdy, Dana C. Miskulin, Ravi I. Thadhani, Wolfgang C. Winkelmayer, Susan S. Ellenberg, Denise Cifelli, Rosemary Madigan, Amy Young, Michael Angeletti, Rebecca L. Wingard, Christina Kahn, Allen R. Nissenson, Franklin W. Maddux, Kevin C. Abbott, J. Richard Landis
JASN May 2019, 30 (5) 890-903; DOI: 10.1681/ASN.2018090945

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The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration
Laura M. Dember, Eduardo Lacson, Steven M. Brunelli, Jesse Y. Hsu, Alfred K. Cheung, John T. Daugirdas, Tom Greene, Csaba P. Kovesdy, Dana C. Miskulin, Ravi I. Thadhani, Wolfgang C. Winkelmayer, Susan S. Ellenberg, Denise Cifelli, Rosemary Madigan, Amy Young, Michael Angeletti, Rebecca L. Wingard, Christina Kahn, Allen R. Nissenson, Franklin W. Maddux, Kevin C. Abbott, J. Richard Landis
JASN May 2019, 30 (5) 890-903; DOI: 10.1681/ASN.2018090945
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Keywords

  • TiME Trial
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  • learning health system
  • NIH Health Care Systems Research Collaboratory
  • opt-out consent
  • consent waiver

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