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):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00874510
First received: March 31, 2009
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: September 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Fatigue
Intervention: Behavioral: Mandatory Naps

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard Schedule interns work standard schedule, being on duty for 30 continuous hours
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.

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


Participant Flow for 2 periods

Period 1:   Year 1
    Standard Schedule     Mandatory Naps  
STARTED     88     85  
COMPLETED     88     85  
NOT COMPLETED     0     0  

Period 2:   Year 2
    Standard Schedule     Mandatory Naps  
STARTED     92     87  
COMPLETED     92     87  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Characteristics of control and intervention groups comprised of medicine interns participating in a randomized trial of a Year 1 5-hour and Year 2 3-hour protected nap period at the Philadelphia Veterans Administration Medical Center ( PVAMC) and the Hospital of the University of Pennsylvania

Reporting Groups
  Description
Standard Schedule interns work standard schedule, being on duty for 30 continuous hours
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.

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

Total Total of all reporting groups

Baseline Measures
    Standard Schedule     Mandatory Naps     Total  
Number of Participants  
[units: participants]
  180     172     352  
Age, Customized  
[units: years]
Mean (Standard Deviation)
     
Year 1 PVAMC     27.5  (2.3)     27.3  (2.3)     27.4  (2.3)  
Year 1 HUP     28.1  (2.2)     27.7  (2.0)     27.9  (2.1)  
Year 2 PVAMC     27.9  (2.4)     27.9  (3.5)     27.9  (2.9)  
Year 2 HUP     28.1  (2.9)     28.3  (3.0)     28.2  (3.0)  
Gender  
[units: participants]
     
Female     93     85     178  
Male     87     87     174  
Region of Enrollment  
[units: participants]
     
United States     180     172     352  



  Outcome Measures

1.  Primary:   Hours Slept on Overnight Extended Duty Call Shifts   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kevin Volpp, MD, PhD
Organization: Center for Health Incentives and Behavioral Economics
phone: 215.573-0270
e-mail: volpp70@exchange.upenn.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00874510     History of Changes
Other Study ID Numbers: EDU 08-429
Study First Received: March 31, 2009
Results First Received: September 15, 2014
Last Updated: January 22, 2016
Health Authority: United States: Federal Government