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A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

This study is ongoing, but not recruiting participants.
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: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fatigue
 Behavioral: Mandatory Naps
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Hours slept on overnight extended duty call shifts [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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: 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874510

Locations
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Department of Veterans Affairs
University of Pennsylvania
Investigators
Principal Investigator: Kevin G. Volpp, MD PhD VA Medical Center, Philadelphia
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00874510     History of Changes
Other Study ID Numbers: EDU 08-429
Study First Received: March 31, 2009
Last Updated: November 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
sleep deprivation
fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013