A Randomized Controlled Trial of Mandatory Naps for Physicians in Training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Interventions to Improve Fatigue Management Among Physician Trainees|
- Hours slept on overnight extended duty call shifts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||December 2013|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
No Intervention: Arm 1
interns work standard schedule, being on duty for 30 continuous hours
Experimental: Arm 2
interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.
Behavioral: Mandatory Naps
As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am
Background: The release of the Institute of Medicine report on resident work hours and patient safety highlighted the risks to patient and resident safety of extended duty on-call shifts.
Objectives: The purpose of this study is to test the feasibility and effectiveness of mandatory naps during extended duty overnight shifts for residents.
Methods: 2 2-arm RCTs will be run simultaneously. At each site (PVAMC and HUP), every other month residents will be randomized to either work the standard schedule (which involves interns being on duty for 30 continuous hours) vs. the mandatory nap schedule, which involves interns signing out their beepers for 5 hours in the middle of the night to covering night floats and for 3 hours in Year 2. The primary outcome will be the amount slept as measured by actigraphs, with secondary outcomes of cognitive alertness measured by 3-minute psychomotor vigilance testing (PVT), Stanford sleepiness Scale, and other measures of resident and patient well-being. The trial will run in two phases, each lasting 12 months.
Status: Recruitment complete, analyses phase only
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874510
|United States, Pennsylvania|
|VA Medical Center, Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Kevin G. Volpp, MD PhD||VA Medical Center, Philadelphia|