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A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

Primary Purpose

Fatigue

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mandatory Naps
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fatigue focused on measuring sleep deprivation, fatigue

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Medical Center, Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Schedule

Mandatory Naps

Arm Description

interns work standard schedule, being on duty for 30 continuous hours

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.

Outcomes

Primary Outcome Measures

Hours Slept on Overnight Extended Duty Call Shifts
Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2009
Last Updated
January 22, 2016
Sponsor
VA Office of Research and Development
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00874510
Brief Title
A Randomized Controlled Trial of Mandatory Naps for Physicians in Training
Official Title
Interventions to Improve Fatigue Management Among Physician Trainees
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
sleep deprivation, fatigue

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Schedule
Arm Type
No Intervention
Arm Description
interns work standard schedule, being on duty for 30 continuous hours
Arm Title
Mandatory Naps
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Mandatory Naps
Intervention Description
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 Outcome Measure Information:
Title
Hours Slept on Overnight Extended Duty Call Shifts
Description
Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin G. Volpp, MD PhD
Organizational Affiliation
VA Medical Center, Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23212498
Citation
Volpp KG, Shea JA, Small DS, Basner M, Zhu J, Norton L, Ecker A, Novak C, Bellini LM, Dine CJ, Mollicone DJ, Dinges DF. Effect of a protected sleep period on hours slept during extended overnight in-hospital duty hours among medical interns: a randomized trial. JAMA. 2012 Dec 5;308(21):2208-17. doi: 10.1001/jama.2012.34490.
Results Reference
result
PubMed Identifier
21492159
Citation
Halpern SD, Kohn R, Dornbrand-Lo A, Metkus T, Asch DA, Volpp KG. Lottery-based versus fixed incentives to increase clinicians' response to surveys. Health Serv Res. 2011 Oct;46(5):1663-74. doi: 10.1111/j.1475-6773.2011.01264.x. Epub 2011 Apr 14.
Results Reference
result
PubMed Identifier
24448046
Citation
Shea JA, Dinges DF, Small DS, Basner M, Zhu J, Norton L, Ecker AJ, Novak C, Bellini LM, Dine CJ, Mollicone DJ, Volpp KG. A randomized trial of a three-hour protected nap period in a medicine training program: sleep, alertness, and patient outcomes. Acad Med. 2014 Mar;89(3):452-9. doi: 10.1097/ACM.0000000000000144.
Results Reference
result
PubMed Identifier
28329124
Citation
Basner M, Dinges DF, Shea JA, Small DS, Zhu J, Norton L, Ecker AJ, Novak C, Bellini LM, Volpp KG. Sleep and Alertness in Medical Interns and Residents: An Observational Study on the Role of Extended Shifts. Sleep. 2017 Apr 1;40(4):zsx027. doi: 10.1093/sleep/zsx027.
Results Reference
derived

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A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

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