FatiguePhase 3NCT00874510

A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

A Phase 3 study testing Mandatory Naps in people with Fatigue, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Fatigue
What is being tested?: Mandatory Naps
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 352 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Dec 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Refusal to consent to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Interventions to Improve Fatigue Management Among Physician Trainees

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.

Read the 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

Conditions: Fatigue
Being tested: Mandatory Naps
Keywords: sleep deprivation, fatigue
Medical subject headings: Fatigue, Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mandatory NapsBehavioural
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 groups in NCT00874510
Study group	Role	What they receive
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. Receives: Behavioral: Mandatory Naps

What is being measured

The primary outcome is the main question the study is designed to answer.

Hours Slept on Overnight Extended Duty Call Shifts
Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Dec 2013

First posted2 Apr 2009 (estimated)
Study startJun 2009
Primary completionJun 2011
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for FatigueStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 352 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00874510
Sponsor's protocol ID: EDU 08-429
Status last verified: Jan 2016
First submitted: 31 Mar 2009
Last updated: 19 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23212498
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.
PubMed 21492159
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.
PubMed 24448046
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.
PubMed 28329124

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventions to Improve Fatigue Management Among Physician Trainees
ClinicalTrials.gov ID: NCT00874510
Acronym / sponsor ID: EDU 08-429
Conditions: Fatigue
Keywords: sleep deprivation, fatigue
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 352 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: University of Pennsylvania
Study start: Jun 2009
Primary completion: Jun 2011 (actual)
Study completion: Dec 2013 (actual)
First posted: 2 Apr 2009 (estimated)
Results: Posted 19 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Status: Recruitment complete, analyses phase only

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard Schedule	No intervention	–interns work standard schedule, being on duty for 30 continuous hours
Mandatory Naps	Experimental	Behavioral: Mandatory Napsinterns 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Refusal to consent to participate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mandatory NapsAs 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	Behavioural	Mandatory Naps

Primary outcome

Hours Slept on Overnight Extended Duty Call Shifts
Time frame: 12 months
Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.

Results and safety

Results posted to the registry on 19 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Schedule	88	88
Mandatory Naps	85	85

Primary outcome: Hours Slept on Overnight Extended Duty Call Shifts

Time frame: 12 months. Mean (95% Confidence Interval). Unit: hours

Measure	Arm 1 - Standard Schedule for Years 1 and Year 2 n = 180	Arm 2 - Mandatory Nap n = 172
Sleep time Year 1 PVAMC	1.98 (1.68 to 2.28)	2.86 (2.57 to 3.10)
Sleep time Year 1 HUP	2.04 (1.79 to 2.24)	3.04 (2.77 to 3.45)
Sleep time Year 2 early shift PVAMC	1.90 (1.71 to 2.10)	2.33 (2.07 to 2.58)
Sleep time Year 2 late shift PVAMC	1.90 (1.71 to 2.10)	2.40 (2.12 to 2.69)
Sleep time Year 2 early shift HUP	1.55 (1.36 to 1.73)	2.40 (2.12 to 2.67)
Sleep time Year 2 late shift HUP	1.55 (1.36 to 1.73)	2.44 (2.17 to 2.71)

Adverse events

Time frame: Adverse event data was collected from time of first shift of intern or resident through the end of the year study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 - Standard Schedule	0 of 180 (0%)	0 of 180 (0%)	Not reported
Arm 2 - Mandatory Naps	0 of 172 (0%)	0 of 172 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23212498Volpp 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 publication: PubMed 21492159Halpern 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 publication: PubMed 24448046Shea 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.
Derived from this study: PubMed 28329124Basner 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kevin G. Volpp, MD PhD principal investigator

VA Medical Center, Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mandatory Naps in people with Fatigue, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hours Slept on Overnight Extended Duty Call Shifts (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00874510, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016; AzTrials last refreshed its copy on 2 Nov 2026.