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

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ClinicalTrials.gov Identifier: NCT02134847
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher P. Landrigan, MD, MPH, Brigham and Women's Hospital

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)

Condition or disease Intervention/treatment Phase
Physician Fatigue Other: SCS intervention schedule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : March 5, 2017
Actual Study Completion Date : March 5, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. resident-related preventable adverse events and near misses. [ Time Frame: Each resident (subject) will be observed for 1 month. ]
    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)


Secondary Outcome Measures :
  1. ICU-wide preventable adverse events and near misses [ Time Frame: Each participating PICU will be studied for 8 months on each of the schedules (16 months total). ]
    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.

  2. resident neurobehavioral performance. [ Time Frame: Subjects will be tested 3-5 times per week for 1 month. ]
    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.

  3. Risk of resident motor vehicle crashes (MVC) [ Time Frame: Subjects will be monitored while they drive to/from work for 1 month. ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134847


Locations
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United States, Colorado
Childrens Hospital of Colorado
Aurora, Colorado, United States, 80045
United States, Iowa
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Ohio
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229-3026
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22911
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Christopher Landrigan, MD, MPH Brigham and Women's Hospital
Principal Investigator: Charles A Czeisler, MD, PhD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Christopher P. Landrigan, MD, MPH, Brigham and Women's Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christopher P. Landrigan, MD, MPH, Dr., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02134847    
Other Study ID Numbers: 2010P001346
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Keywords provided by Christopher P. Landrigan, MD, MPH, Brigham and Women's Hospital:
Resident
Fatigue
Sleep deprivation
medical errors
Additional relevant MeSH terms:
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Fatigue