A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fatigue Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandatory Naps

Behavioral

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

Primary outcomes

Hours Slept on Overnight Extended Duty Call Shifts

Time frame: 12 months

Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

University of Pennsylvania

Registry information

Official study title

Interventions to Improve Fatigue Management Among Physician Trainees

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2013
First posted: Apr 2, 2009
Registry last updated: Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed