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A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874510
First Posted: April 2, 2009
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
VA Office of Research and Development
March 31, 2009
April 2, 2009
September 15, 2014
February 19, 2016
February 19, 2016
June 2009
June 2011   (Final data collection date for primary outcome measure)
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.
Hours Slept on Overnight Extended Duty Call Shifts [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00874510 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomized Controlled Trial of Mandatory Naps for Physicians in Training
Interventions to Improve Fatigue Management Among Physician Trainees
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.

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

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Fatigue
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
  • No Intervention: Standard Schedule
    interns work standard schedule, being on duty for 30 continuous hours
  • Experimental: 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.
    Intervention: Behavioral: Mandatory Naps

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
352
December 2013
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00874510
EDU 08-429
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
University of Pennsylvania
Principal Investigator: Kevin G. Volpp, MD PhD VA Medical Center, Philadelphia
VA Office of Research and Development
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP