Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study.

Autor: Blackwell T; California Pacific Medical Center Research Institute, San Francisco, CA, USA. Electronic address: tblackwell@sfcc-cpmc.net., Kriesel DR; California Pacific Medical Center Research Institute, San Francisco, CA, USA., Vittinghoff E; University of California, San Francisco, San Francisco, CA, USA., O'Brien CS; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA., Sullivan JP; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA., Viyaran NC; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA., Rahman SA; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA., Lockley SW; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA., Barger LK; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA., Halbower AC; Children's Hospital Colorado Anschutz Medical Campus, Aurora, CO, USA., Poynter SE; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA., Wright KP Jr; Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA., Yu PL; University of Virginia Children's Hospital, Charlottesville, VA, USA., Zee PC; Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University, Chicago, IL, USA., Landrigan CP; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA; Division of General Pediatrics, Department of Medicine, Boston Children's Hospital, Boston, MA, USA., Czeisler CA; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA; Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA., Stone KL; California Pacific Medical Center Research Institute, San Francisco, CA, USA; University of California, San Francisco, San Francisco, CA, USA.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2019 May; Vol. 80, pp. 22-33. Date of Electronic Publication: 2019 Mar 15.
DOI: 10.1016/j.cct.2019.03.005
Abstrakt: Introduction: While the Accreditation Council for Graduate Medical Education limited first year resident-physicians to 16 consecutive work hours from 2011 to 2017, resident-physicians in their second year or higher were permitted to work up to 28 h consecutively. This paper describes the Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) study, a clustered-randomized crossover clinical trial designed to evaluate the effectiveness of eliminating traditional shifts of 24 h or longer for second year or higher resident-physicians in pediatric intensive care units (PICUs).
Methods: ROSTERS was a multi-center non-blinded trial in 6 PICUs at US academic medical centers. The primary aim was to compare patient safety between the extended duration work roster (EDWR), which included shifts ≥24 h, and a rapidly cycling work roster (RCWR), where shifts were limited to a maximum of 16 h. Information on potential medical errors was gathered and used for classification by centrally trained physician reviewers who were blinded to the study arm. Secondary aims were to assess the relationship of the study arm to resident-physician sleep duration, work hours and neurobehavioral performance.
Results: The study involved 6577 patients with a total of 38,821 patient days (n = 18,749 EDWR, n = 20,072 RCWR). There were 413 resident-physician rotations included in the study (n = 203 EDWR, n = 210 RCWR). Resident-physician questionnaire data were over 95% complete.
Conclusions: Results from data collected in the ROSTERS study will be evaluated for the impact of resident-physician schedule roster on patient safety outcomes in PICUs, and will allow for examination of a number of secondary outcome measures. ClinicalTrials.gov Identifier: NCT02134847.
(Copyright © 2019 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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