A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

Study Overview
=================
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

Official Title
-----------------
Interventions to Improve Fatigue Management Among Physician Trainees

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Behavioral: Mandatory Naps


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Schedule<br>interns work standard schedule, being on duty for 30 continuous hours | |
| Experimental: Mandatory Naps<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep deprivation, fatigue