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

Study Overview
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Brief Summary
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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: 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) 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) 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)

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

Conditions
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Physician Fatigue

Intervention / Treatment
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* Other: SCS intervention schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a second or third year resident of pediatrics or a combined pediatrics program Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention cohort<br>This cohort will work on the SCS intervention schedule | Other: SCS intervention schedule<br> <br> |
| No Intervention: Control cohort<br>This group will work on a traditional schedule | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical errors, Resident, Fatigue, Sleep deprivation