Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,500
- 主要终点
- 30-day mortality
研究概览
简要总结
The investigators are conducting a cluster randomized trial in a sample of 63 internal medicine (IM) training programs that are randomly assigned to either the current duty hour standards or less restricted flexible duty hour standards.
The trial includes a main protocol in which all randomized IM programs participate and two substudies. "Time and Motion" and "Sleep and Alertness", each conducted at a subset of IM programs and focusing on more detailed data collection at the intern level.
The main protocol will examine patient safety and costs as well as quality of education. The "Time and Motion" substudy examines additional educational outcomes. The "Sleep and Alertness" substudy examines intern sleep time and alertness.
详细描述
Title: Sleep duration (hours of sleep) as measured with an actigraph Time frame: Measured daily for 14 days
Title: Behavioral alertness as measured with Psychomotor vigilance test Time frame: Measured daily for 14 days
Title: Self perceived sleepiness as measured by the Karolinska Sleepiness Score Time frame: Measured daily for 14 days
Title: Time (hours per day) spent in direct patient care Description: Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern Time frame: measured daily over 2-4 wks
Title: Trainee satisfaction with education Description: Self-reported satisfaction with education as assessed thru survey questions Time frame: measured at baseline and at end of intervention year
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to:
- •Randomization to one of the two study arms.
- •Develop, and share with the study team, institutional duty hour schedules and regulatory policies/procedures that will ensure adherence to, and enforcement of, the duty hour regulations that apply to their study arm
- •Allow access and analysis of de-identified resident duty hour adherence data/logs, call schedules, and rotation schedules to the Study Team.
- •Participate, and encourage trainee participation at your institution, in beginning and end of year iCOMPARE surveys.
排除标准
- •The investigators excluded 119 programs that comprise the bottom 50% in resident-to-bed ratio and the bottom 25% in patient volume related to the diagnoses by which the patient population will be selected for evaluation of safety outcomes.
- •Within the 260 programs that remain, the investigators excluded the 65 in the lowest quartile of program size to ensure we can feasibly obtain sufficient trainee measurements.
- •The 195 remaining programs are eligible for inclusion.
- •The investigators have also excluded children and VA hospitals.
结局指标
主要结局
30-day mortality
时间窗: 12 months
The difference between 30-day mortality rate in the trial year minus the 30-day mortality rate in the pretrial year
次要结局
- Rate of prolonged length of stay(12 months)
- Time (hours per day) spent in direct patient care(measured daily over 2-4 wks)
- Program director satisfaction with trainee education(measured at baseline and end of intervention year)
- Total costs of patient care(12 months)
- Sleep duration (hours of sleep)(Measured daily for 14 days)
- Self perceived sleepiness(Measured daily for 14 days)
- Behavioral alertness(Measured daily for 14 days)
- Trainee satisfaction with education(measured at baseline and at end of intervention year)