A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

This study has been completed.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00874510
First received: March 31, 2009
Last updated: April 18, 2014
Last verified: April 2014

March 31, 2009
April 18, 2014
June 2009
June 2011   (final data collection date for primary outcome measure)
Hours slept on overnight extended duty call shifts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
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 2 randomized controlled trials in which we 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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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: 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.
    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
192
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00874510
EDU 08-429
Yes
Department of Veterans Affairs
Department of Veterans Affairs
University of Pennsylvania
Principal Investigator: Kevin G. Volpp, MD PhD VA Medical Center, Philadelphia
Department of Veterans Affairs
April 2014

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