A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

Phase 3

Completed

• Conditions: Fatigue
• Interventions: Behavioral: Mandatory Naps

• Registration Number: NCT00874510
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This study will consist of a randomized controlled trial in which the investigators test the feasibility and effectiveness of mandatory nap programs for physicians in training. One site will be the general medical service of the Philadelphia Veterans Affairs Medical Center. The other will be the oncology service of the Hospital of the University of Pennsylvania. The primary outcome will be the amount slept while on call. The first year will test the efficacy of a 5 hour mandatory nap schedule, the second year will test the efficacy of a 3 hour mandatory nap schedule.

Detailed Description

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: For 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.

Status: Recruitment complete, analyses phase only

Study Timeline

• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Study Start: 2009-06
• Primary Completion: 2011-06
• Study Completion: 2013-12
• Results First Submitted: 2014-09-15
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-22
• Last Update Submitted: 2016-01-22
• Results First Posted: 2016-02-19
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

• Residents in the University of Pennsylvania Internal Medicine Training Program who are rotating through either Philadelphia VA Medical Center Medical Service or Hospital of University of Pennsylvania Oncology Service

Exclusion Criteria

• Refusal to consent to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mandatory Naps	Mandatory Naps	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.

Primary Outcome Measures

Name	Time	Method
Hours Slept on Overnight Extended Duty Call Shifts	12 months	Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.

Trial Locations

Locations (1)

VA Medical Center, Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States