COMPAS Trial. Collecting Outcomes and Managing Pain After Surgery: Predicting Patients at High Risk for Chronic Opioid Use and Creating Algorithms to Responsibly Tailor Opioid Prescribing and Weaning After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Opioid Use of Participants
研究概览
简要总结
The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-90 years old who are undergoing elective orthopedic surgery at Duke Health.
- •Patients must have their own smartphone IOS or Android device.
- •Patients must be able to read English.
排除标准
- •Lacking capacity to provide consent.
- •Cannot read English
- •Under 18 years of age
- •Older than 90 years of age
结局指标
主要结局
Opioid Use of Participants
时间窗: 6 months
Total number of patients with self reported use of opioids.
Reported Pain of Participants measured via Pain Catastrophizing pain scale.
时间窗: 6 Months
Statements regarding pain are rated on a scale from 0 to 4 with 0 meaning "not at all" and 4 meaning "all the time"
Practicality of Mobile Application
时间窗: 6 Months
How long participants actively use the app to track their opined use and pain.
Reported Pain of Participants measured via PROMIS-29
时间窗: 6 Months
28 Questions regarding pain are ranked on a 5-point Likert Scale with 1 meaning "not at all" and 5 meaning "very much".
次要结局
未报告次要终点