Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Compliance Rate With Assigned Treatment
研究概览
简要总结
Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.
详细描述
EHR Embedded Comparative Effectiveness Studies-CPS will be held in the Center for Pain and Spine at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either activity restriction or no activity restriction following lumbar discectomy.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18) able to consent
- •Sufficient fluency in English
- •Indications for discectomy
- •Able to restrict activities or to resume activities as tolerated
排除标准
- •Pregnant women
- •Prisoners
- •Children (<18).
结局指标
主要结局
Compliance Rate With Assigned Treatment
时间窗: Upon completion of surgery approximately 24 days post-randomization
Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions.
Percentage Eligible Patients Participating in Study
时间窗: 1 day, during the recruitment period from October 23 2020 to August 7, 2021
Percentage of those identified as being eligible who were enrolled.
次要结局
未报告次要终点
研究者
Tor D. Tosteson
Professor
Dartmouth-Hitchcock Medical Center
