A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

NCT00874510 | Completed Phase 3 Results DMC

• 1 other identifier: EDU 08-429
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

sleep deprivation; fatigue

Outcome Measures

Primary Outcomes (1)

• Hours Slept on Overnight Extended Duty Call Shifts

  Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.

  12 months

Study Arms (2)

Standard Schedule

NO INTERVENTION

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

Mandatory Naps

EXPERIMENTAL

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

Interventions

Mandatory Naps BEHAVIORAL

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

Mandatory Naps

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal to consent to participate

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Pennsylvania: collaborator

Study Sites (1)

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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.

  PMID: 23212498 RESULT

• 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.

  PMID: 21492159 RESULT

• 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.

  PMID: 24448046 RESULT

• 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.

  PMID: 28329124 DERIVED

MeSH Terms

Conditions

Fatigue; Sleep Deprivation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Results Point of Contact

• Title: Kevin Volpp, MD, PhD
• Organization: Center for Health Incentives and Behavioral Economics

volpp70@exchange.upenn.edu

215.573-0270

Study Officials

• Kevin G. Volpp, MD PhD

  VA Medical Center, Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 2, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2013
• Last Updated: February 19, 2016
• Results First Posted: February 19, 2016

Record last verified: 2016-01

Locations

US (1)