Randomized Controlled Trial

. 2019 May:80:22-33.

doi: 10.1016/j.cct.2019.03.005. Epub 2019 Mar 15.

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

Terri Blackwell¹, Dana R Kriesel², Eric Vittinghoff³, Conor S O'Brien⁴, Jason P Sullivan⁴, Natalie C Viyaran⁴, Shadab A Rahman⁵, Steven W Lockley⁵, Laura K Barger⁵, Ann C Halbower⁶, Sue E Poynter⁷, Kenneth P Wright Jr⁸, Pearl L Yu⁹, Phyllis C Zee¹⁰, Christopher P Landrigan¹¹, Charles A Czeisler⁵, Katie L Stone¹²; ROSTERS Study Group

Affiliations

¹ California Pacific Medical Center Research Institute, San Francisco, CA, USA. Electronic address: tblackwell@sfcc-cpmc.net.
² California Pacific Medical Center Research Institute, San Francisco, CA, USA.
³ University of California, San Francisco, San Francisco, CA, USA.
⁴ Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.
⁵ 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.
⁶ Children's Hospital Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁷ Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.
⁸ Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.
⁹ University of Virginia Children's Hospital, Charlottesville, VA, USA.
¹⁰ Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University, Chicago, IL, USA.
¹¹ 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.
¹² California Pacific Medical Center Research Institute, San Francisco, CA, USA; University of California, San Francisco, San Francisco, CA, USA.

PMID: 30885799
PMCID: PMC6482052
DOI: 10.1016/j.cct.2019.03.005

Randomized Controlled Trial

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

Terri Blackwell et al. Contemp Clin Trials. 2019 May.

. 2019 May:80:22-33.

doi: 10.1016/j.cct.2019.03.005. Epub 2019 Mar 15.

Authors

Affiliations

¹ California Pacific Medical Center Research Institute, San Francisco, CA, USA. Electronic address: tblackwell@sfcc-cpmc.net.
² California Pacific Medical Center Research Institute, San Francisco, CA, USA.
³ University of California, San Francisco, San Francisco, CA, USA.
⁴ Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, USA.
⁵ 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.
⁶ Children's Hospital Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁷ Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.
⁸ Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.
⁹ University of Virginia Children's Hospital, Charlottesville, VA, USA.
¹⁰ Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University, Chicago, IL, USA.
¹¹ 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.
¹² California Pacific Medical Center Research Institute, San Francisco, CA, USA; University of California, San Francisco, San Francisco, CA, USA.

PMID: 30885799
PMCID: PMC6482052
DOI: 10.1016/j.cct.2019.03.005

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 Identifier: NCT02134847.

Keywords: Medical errors; Patient safety; Pediatric intensive care unit; Randomized; Sleep; Work hours.

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Figures

**Figure 1.**
Resident-physician Rotation Recruitment and Data Completeness

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References

1. Goel N, Basner M, Rao H, Dinges DF. Circadian rhythms, sleep deprivation, and human performance. Prog Mol Biol Transl Sci. 2013;119:155–90. doi: 10.1016/B978-0-12-396971-2.00007-5. - DOI - PMC - PubMed
1. Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA. Effect of reducing interns’ work hours on serious medical errors in intensive care units. N Engl J Med. 2004. October 28;351(18):1838–48. - PubMed
1. Barger LK, Cade BE, Ayas NT, Cronin JW, Rosner B, Speizer FE, Czeisler CA; Harvard Work Hours, Health, and Safety Group. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005. January 13;352(2):125–34. - PubMed
1. Lockley SW, Cronin JW, Evans EE, Cade BE, Lee CJ, Landrigan CP, Rothschild JM, Katz JT, Lilly CM, Stone PH, Aeschbach D, Czeisler CA; Harvard Work Hours, Health and Safety Group. Effect of reducing interns’ weekly work hours on sleep and attentional failures. N Engl J Med. 2004. October 28;351(18):1829–37. - PubMed
1. Ayas NT, Barger LK, Cade BE, Hashimoto DM, Rosner B, Cronin JW, Speizer FE, Czeisler CA. Extended work duration and the risk of self-reported percutaneous injuries in interns. JAMA. 2006. September 6;296(9):1055–62. - PubMed

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

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

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