Format

Send to

Choose Destination
J Am Soc Nephrol. 2019 May;30(5):890-903. doi: 10.1681/ASN.2018090945. Epub 2019 Apr 18.

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

Author information

1
Renal, Electrolyte and Hypertension Division, Department of Medicine, ldember@pennmedicine.upenn.edu.
2
Department of Biostatistics, Epidemiology, and Informatics.
3
Division of Nephrology, Fresenius Medical Care North America, Waltham, Massachusetts.
4
DaVita Clinical Research, Minneapolis, Minnesota.
5
Department of Biostatistics, Epidemiology, and Informatics, and.
6
Division of Nephrology and Hypertension, Department of Internal Medicine, University of Utah and Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, Utah.
7
Division of Nephrology, Department of Medicine, University of Illinois College of Medicine at Chicago, Chicago, Illinois.
8
Departments of Population Health Science and Internal Medicine, University of Utah, Salt Lake City, Utah.
9
Division of Nephrology, Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee.
10
Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.
11
Division of Nephrology, Massachusetts General Hospital, Boston, Massachusetts.
12
Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California.
13
Selzman Institute for Kidney Health, Section of Nephrology, Department of Medicine, Baylor College of Medicine, Houston, Texas.
14
Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
15
DaVita Kidney Care, El Segundo, California.
16
David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California; and.
17
National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.

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.

KEYWORDS:

NIH Health Care Systems Research Collaboratory; TiME Trial; consent waiver; dialysis session duration; learning health system; opt-out consent

PMID:
31000566
PMCID:
PMC6493975
[Available on 2020-05-01]
DOI:
10.1681/ASN.2018090945

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center