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. 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)