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

Tracking Information

First Received Date ^ICMJE

March 31, 2009

Last Updated Date

November 13, 2012

Start Date ^ICMJE

June 2009

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00874510 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

Official Title ^ICMJE

Interventions to Improve Fatigue Management Among Physician Trainees

Brief Summary

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Fatigue

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

192

Estimated Completion Date

December 2012

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00874510

Other Study ID Numbers ^ICMJE

EDU 08-429

Has Data Monitoring Committee

Yes

Responsible Party

Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

University of Pennsylvania

Investigators ^ICMJE

Principal Investigator:

Kevin G. Volpp, MD PhD

VA Medical Center, Philadelphia

Information Provided By

Department of Veterans Affairs

Verification Date

November 2012

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

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