Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
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)


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: constant CPAP devices | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Device: automatic CPAP devices | Intervention Type: DEVICE; Name: constant CPAP devices; Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: automatic CPAP devices; Assigned to Arm(s): 2
B: Arm Label: Provent; Type: ACTIVE_COMPARATOR; Interventions: Device: Provent® | Arm Label: Placebo-Provent; Type: PLACEBO_COMPARATOR; Interventions: Device: Provent®, Device: Placebo-Provent® | Arm Label: CPAP; Type: ACTIVE_COMPARATOR; Interventions: Device: Provent®, Procedure: CPAP | Intervention Type: DEVICE; Name: Provent®; Assigned to Arm(s): CPAP, Placebo-Provent, Provent | Intervention Type: DEVICE; Name: Placebo-Provent®; Assigned to Arm(s): Placebo-Provent | Intervention Type: PROCEDURE; Name: CPAP; Assigned to Arm(s): CPAP
C: Arm Label: Standard Duty Hour Schedule; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Flexible Duty Hour Schedule; Type: EXPERIMENTAL; Interventions: Behavioral: Flexible Duty Hour Schedule | Intervention Type: BEHAVIORAL; Name: Flexible Duty Hour Schedule; Assigned to Arm(s): Flexible Duty Hour Schedule
D: Arm Label: Intervention cohort; Type: EXPERIMENTAL; Interventions: Other: SCS intervention schedule | Arm Label: Control cohort; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: SCS intervention schedule; Assigned to Arm(s): Intervention cohort

Answer: D