Design and Recruitment of the Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) Study1

Details

• Alternative Title:
  Contemp Clin Trials
• Personal Author:
  Blackwell, Terri ; Kriesel, Dana R. ; Vittinghoff, Eric ; O’Brien, Conor S. ; Sullivan, Jason P. ; Viyaran, Natalie C. ; Rahman, Shadab A. ; Lockley, Steven W. ; Barger, Laura K. ; Halbower, Ann C. ; Poynter, Sue E. ; Wright, Kenneth P. ; Yu, Pearl L. ; Zee, Phyllis C. ; Landrigan, Christopher P. ; Czeisler, Charles A. ; Stone, Katie L.
• Corporate Authors:
  ROSTERS Study Group
• Description:
  Introduction:
  
  While the Accreditation Council for Graduate Medical Education limited first year resident-physicians to 16 consecutive work hours from 2011–2017, resident-physicians in their second year or higher were permitted to work up to 28 hours 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 hours 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 hours, and a rapidly cycling work roster (RCWR), where shifts were limited to a maximum of 16 hours. 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 38821 patient days (n=18749 EDWR, n=20072 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.
  
  
• Subjects:
  Article Medical Errors Patient Safety Pediatric Intensive Care Unit Randomized Sleep Work Hours
• Source:
  Contemp Clin Trials. 80:22-33
• Pubmed ID:
  30885799
• Pubmed Central ID:
  PMC6482052
• Document Type:
  Journal Article
• Funding:
  R01 OH010300/OH/NIOSH CDC HHS/United States ; U01 HL111478/HL/NHLBI NIH HHS/United States ; U01 HL111691/HL/NHLBI NIH HHS/United States
• Volume:
  80
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:7d5dba7ca0489a9c58b6aca7762ada8ed4dbbea9cd1d0bb18ccbf59ee35727db
• Download URL:
  https://stacks.cdc.gov/view/cdc/77847/cdc_77847_DS1.pdf
• File Type:
  [PDF - 362.91 KB ]