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NCT02134847 · ClinicalTrials.gov registry record · NA
Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 413
- Enrollment target
NCT02134847 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 413 participants.
The verdict
NCT02134847, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 413 participants
- Enrollment target
Study 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)
Interventions
- OTHER SCS intervention schedule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2013-07-01 |
| Est. Completion | 2017-03-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02134847
The ClinicalTrials.gov registry entry for NCT02134847 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SCS intervention schedule is the first listed.
NCT02134847 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02134847 about?
NCT02134847 is a clinical study titled "Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety". 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. Th...
What is the current status of trial NCT02134847?
This trial is currently completed. It is a NA study. The enrollment target is 413 participants. The study started on 2013-07-01. Estimated completion is 2017-03-05.
What interventions are being tested in trial NCT02134847?
The interventions under investigation include: SCS intervention schedule (OTHER).
Who is sponsoring clinical trial NCT02134847?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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