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临床试验/NCT02050789
NCT02050789已完成不适用

Allowing Flexibility in Surgical Resident Duty Hours Trial

Northwestern University0 个研究点目标入组 152 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
主要终点
Death or Serious Morbidity

研究概览

简要总结

Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to debate how best to (re)structure postgraduate medical education.

There is concern that current restrictions may be detrimental to patient care and resident training. To investigate these issues, the investigators will be conducting a one-year, prospective randomized trial to examine how flexibility of duty hour requirements affects patient care when compared to current resident duty hour requirements. Further information about the study is available on the FIRST Trial website http://www.thefirsttrial.org/.

详细描述

Residency programs will be randomized to either (1) an intervention arm that eliminates several Accreditation Council for Graduate Medical Education (ACGME) duty hour requirements or (2) to a usual care arm where programs will continue adhering to current ACGME requirements. Programs in the intervention arm will be granted a waiver from current duty hour requirements by the ACGME and allowed to eliminate all resident duty hour rules with the following exceptions: Duty hours limited to 80 hours/week averaged over 4 weeks, minimum of one free day (no duty)/week averaged over 4 weeks, may not take in-house call more frequently than every 3rd night, averaged over 4 weeks, allowed to increase duty requirement flexibility for chief residents. The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care. Subsequently, the investigators will compare multiple postoperative outcomes between the two study arms using data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). The results of this study will provide high-quality empirical evidence upon which to base resident duty hour requirements in the future.

Updated April 1, 2014

Detailed statistical analysis plan available on the FIRST Trial website. http://www.thefirsttrial.org/Approval/Approval

A listing of the 152 ACS-NSQIP hospitals that have elected to participate in the FIRST Trial is available on the FIRST Trial website. http://www.thefirsttrial.org/Hospitals/Hospitals

Updated July 14, 2014

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

入选标准

  • General Surgery Residency Programs participating in ACS NSQIP

排除标准

  • Childrens' and VA Hospitals

结局指标

主要结局

Death or Serious Morbidity

时间窗: 30 days

The primary outcome for the trial is a composite measure of Death or Serious Morbidity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karl Bilimoria

Assistant Professor of Surgery

Northwestern University

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