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

NCT ID: NCT02134847

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-01
• Study Completion Date: 2017-03-05

Brief Summary

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)

Conditions

Physician Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention cohort

This cohort will work on the SCS intervention schedule

Group Type: EXPERIMENTAL

SCS intervention schedule

Intervention Type: OTHER

Control cohort

This group will work on a traditional schedule

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SCS intervention schedule

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christopher P. Landrigan, MD, MPH

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Landrigan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Charles A Czeisler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Childrens Hospital of Colorado

Aurora, Colorado, United States

University of Iowa Hospital

Iowa City, Iowa, United States

Childrens Hospital Boston

Boston, Massachusetts, United States

Cincinnati Childrens Hospital

Cincinnati, Ohio, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33619044 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32579812 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31106381 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30885799 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2010P001346

Identifier Type: -

Identifier Source: org_study_id