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

Physician Fatigue Clinical Trial

— ROSTERS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134847
• Other study ID #: 2010P001346
• Status: Completed
• Phase: N/A
• Start date: July 1, 2013
• Est. completion date: March 5, 2017

Study information

• Verified date: April 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: March 5, 2017
• Est. primary completion date: March 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Fatigue
• Physician Fatigue

Intervention

Other:
• SCS intervention schedule

Locations

Country	Name	City	State
United States	Childrens Hospital of Colorado	Aurora	Colorado
United States	Childrens Hospital Boston	Boston	Massachusetts
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Cincinnati Childrens Hospital	Cincinnati	Ohio
United States	University of Iowa Hospital	Iowa City	Iowa
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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.
Secondary	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.