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

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)

Study Overview

• Status: Completed
• Conditions: Physician Fatigue
• Intervention / Treatment: Other: SCS intervention schedule

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital of Colorado
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Childrens Hospital Boston
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3026
      • Cincinnati Childrens Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • University of Virginia Health System
  • Washington
    • Seattle, Washington, United States
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be a second or third year resident of pediatrics or a combined pediatrics program

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention cohort; This cohort will work on the SCS intervention schedule	Other: SCS intervention schedule
No Intervention: Control cohort; This group will work on a traditional schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
resident-related preventable adverse events and near misses.	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)	Each resident (subject) will be observed for 1 month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU-wide preventable adverse events and near misses	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.	Each participating PICU will be studied for 8 months on each of the schedules (16 months total).
resident neurobehavioral performance.	Resident physicians' risk of neurobehavioral performance failures as assessed through simple visual reaction time tasks [Psychomotor Vigilance Task (PVT) lapses] - will be lower on the SCS intervention schedule than on the traditional schedule.	Subjects will be tested 3-5 times per week for 1 month.
Risk of resident motor vehicle crashes (MVC)	Fatigue during the commute to and from work, as assessed by the John's drowsiness scale (JDS), will be lower on the SCS schedule than the traditional schedule, making MVC's less likely during the time on the SCS schedule.	Subjects will be monitored while they drive to/from work for 1 month.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Christopher Landrigan, MD, MPH, Brigham and Women's Hospital; Principal Investigator: Charles A Czeisler, MD, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Rahman SA, Sullivan JP, Barger LK, St Hilaire MA, O'Brien CS, Stone KL, Phillips AJK, Klerman EB, Qadri S, Wright KP Jr, Halbower AC, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Sanderson AL, Zee PC, Landrigan CP, Czeisler CA, Lockley SW; ROSTERS STUDY GROUP. Extended Work Shifts and Neurobehavioral Performance in Resident-Physicians. Pediatrics. 2021 Mar;147(3):e2020009936. doi: 10.1542/peds.2020-009936. Epub 2021 Feb 22.
• Landrigan CP, Rahman SA, Sullivan JP, Vittinghoff E, Barger LK, Sanderson AL, Wright KP Jr, O'Brien CS, Qadri S, St Hilaire MA, Halbower AC, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Zee PC, Lockley SW, Stone KL, Czeisler CA; ROSTERS Study Group. Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts. N Engl J Med. 2020 Jun 25;382(26):2514-2523. doi: 10.1056/NEJMoa1900669.
• Barger LK, Sullivan JP, Blackwell T, O'Brien CS, St Hilaire MA, Rahman SA, Phillips AJK, Qadri S, Wright KP, Segar JL, McGuire JK, Vitiello MV, de la Iglesia HO, Poynter SE, Yu PL, Zee P, Sanderson AL, Halbower AC, Lockley SW, Landrigan CP, Stone KL, Czeisler CA; ROSTERS Study Group. Effects on resident work hours, sleep duration, and work experience in a randomized order safety trial evaluating resident-physician schedules (ROSTERS). Sleep. 2019 Aug 1;42(8):zsz110. doi: 10.1093/sleep/zsz110.
• Blackwell T, Kriesel DR, Vittinghoff E, O'Brien CS, Sullivan JP, Viyaran NC, Rahman SA, Lockley SW, Barger LK, Halbower AC, Poynter SE, Wright KP Jr, Yu PL, Zee PC, Landrigan CP, Czeisler CA, Stone KL; ROSTERS Study Group. Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study. Contemp Clin Trials. 2019 May;80:22-33. doi: 10.1016/j.cct.2019.03.005. Epub 2019 Mar 15.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): March 5, 2017
• Study Completion (Actual): March 5, 2017

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Fatigue; Sleep deprivation; Resident; medical errors
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 2010P001346