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临床试验/NCT00874510
NCT00874510已完成3 期

Interventions to Improve Fatigue Management Among Physician Trainees

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2009年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
352
试验地点
1
主要终点
Hours Slept on Overnight Extended Duty Call Shifts

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Refusal to consent to participate

研究组 & 干预措施

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.

干预措施: Mandatory Naps (Behavioral)

结局指标

主要结局

Hours Slept on Overnight Extended Duty Call Shifts

时间窗: 12 months

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

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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