NCT02134847: ROSTERS

Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety

Completed NA Last updated 30 April 2019

What this trial tests

NA trial testing SCS intervention schedule in Physician Fatigue in 413 participants. Completed in 5 March 2017.

Timeline

1 July 2013

Primary endpoint
5 March 2017

5 March 2017

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	health services research
Enrollment	413
Start date	1 July 2013
Primary completion	5 March 2017
Estimated completion	5 March 2017
Sites	6 locations across United States

Drugs / interventions tested

• SCS intervention schedule

Conditions studied

• Physician Fatigue — all drugs for Physician Fatigue →

Sponsor

Brigham and Women's Hospital

Who can join

21 and older, any sex, with Physician Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:

1. To test the hypothesis that PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses)
2. To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses)
3. To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks \[Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses\] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.
   Landrigan CP, Rahman SA, Sullivan JP, Vittinghoff E, et al · · 2020 · cited 79× · PMID 32579812 · DOI 10.1056/nejmoa1900669
2. Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS).
   Barger LK, Sullivan JP, Blackwell T, O'Brien CS, et al · · 2019 · cited 32× · PMID 31106381 · DOI 10.1093/sleep/zsz110
3. Extended Work Shifts and Neurobehavioral Performance in Resident-Physicians.
   Rahman SA, Sullivan JP, Barger LK, St Hilaire MA, et al · · 2021 · cited 31× · PMID 33619044 · DOI 10.1542/peds.2020-009936
4. Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study.
   Blackwell T, Kriesel DR, Vittinghoff E, O'Brien CS, et al · · 2019 · cited 9× · PMID 30885799 · DOI 10.1016/j.cct.2019.03.005
5. Predicting neurobehavioral performance of resident physicians in a Randomized Order Safety Trial Evaluating Resident-Physician Schedules (ROSTERS).
   Phillips AJK, St Hilaire MA, Barger LK, O'Brien CS, et al · · 2024 · cited 3× · PMID 38007304 · DOI 10.1016/j.sleh.2023.10.018