Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study
| Autor: | 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, ROSTERS Study Group |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Cross-Over Studies Outcome Assessment Prevention Clinical Trials and Supportive Activities Personnel Staffing and Scheduling Randomized Internship and Residency Medical and Health Sciences Work hours Health Care Patient safety Clinical Research Work Schedule Tolerance Humans Medical errors Female Pediatric intensive care unit Health Services Research Public Health Sleep ROSTERS Study Group General Clinical Medicine Work Performance |
| Popis: | IntroductionWhile 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).MethodsROSTERS 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.ResultsThe 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.ConclusionsResults 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. |
| Databáze: | OpenAIRE |
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