Allowing Flexibility in Surgical Resident Duty Hours Trial
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
- 否
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
Karl Bilimoria
Assistant Professor of Surgery
Northwestern University
