Abstract
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
Original language | English (US) |
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Pages (from-to) | 22-33 |
Number of pages | 12 |
Journal | Contemporary Clinical Trials |
Volume | 80 |
DOIs | |
State | Published - May 2019 |
Funding
Dr. Wright Jr. reports grants from National Institutes of Health, during the conduct of the study; personal fees from Circadian Therapeutics, LTD, grants, personal fees, non-financial support and other from CurAegis Technologies, personal fees from Kellogg's, non-financial support from Somalogic, Inc., personal fees from American Academy of Sleep Medicine, personal fees from American College of Chest Physicians, personal fees from American College of Sports Medicine, personal fees from,American Diabetes Association, personal fees from Associated Professional Sleep Societies, grants from Philips Inc., personal fees from Obesity Medicine Association, outside the submitted work. Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) is supported by National Heart, Lung, and Blood Institute ( U01-HL-111478 and U01-HL-111691 ). Drs. Barger, Lockley, and Czeisler were supported in part by funding from the National Institute of Occupational Safety and Health R01-OH-010300 . Dr. Lockley reports commercial interests from the last 3 years (2015–2018), unrelated to the work, that are listed below. Dr. Lockley has received consulting fees from the Atlanta Falcons, Atlanta Hawks, Delos Living LLC, Noble Insights, OpTerra Energy Services Inc., Pegasus Capital Advisors LP, Serrado Capital, Slingshot Insights and Team C Racing. He has current consulting contracts with Akili Interactive, Apex 2100 Ltd., BHP Billiton, Consumer Sleep Solutions, Headwaters Inc., Hintsa Performance AG, Light Cognitive, Lighting Science Group Corporation, Mental Workout, McCullough Hill Leary PS, Paul, Weiss, Rifkind, Wharton & Garrison LLP, PlanLED, Six Senses, Stantec and Wyle Integrated Science and Engineering. Dr. Lockley has received unrestricted equipment gifts from Biological Illuminations LLC, Bionetics Corporation and F.LUX Software LLC; has equity in iSLEEP, Pty; royalties from Oxford University Press; honoraria plus travel, accommodation and/or meals for invited seminars, conference presentations or teaching from BHP Billiton, Estee Lauder, Informa Exhibitions (USGBC), and Teague; travel, accommodation and/or meals only (no honoraria) for invited seminars, conference presentations or teaching from IES, Lightfair, USGBC, DIN and SLTBR. Dr. Lockley has completed investigator-initiated research grants from Biological Illumination LLC and has an ongoing investigator-initiated grant from F. Lux Software LLC; He is a Program Leader for the non-profit CRC for Alertness, Safety and Productivity, Australia, through an adjunct faculty position at Monash University and unpaid Member of the Scientific Advisory Board for the non-profit Midwest Lighting Institute. Dr. Lockley holds a process patent for ‘Systems and methods for determining and/or controlling sleep quality’, which is assigned to the Brigham and Women's Hospital per Hospital policy. Dr. Lockley has also served as a paid expert in legal proceedings related to light and health.
Keywords
- Medical errors
- Patient safety
- Pediatric intensive care unit
- Randomized
- Sleep
- Work hours
ASJC Scopus subject areas
- Pharmacology (medical)