Non-Pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management: The NOHARM Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 81,938
- 试验地点
- 4
- 主要终点
- PROMIS-CAT Pain
研究概览
简要总结
The purpose of this study is to test the impact of a bundled NOHARM Conversation Guide with clinical decision support intervention embedded within an Electronic Health Record (EHR) on pain and function 3 months following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •All patients 18 years of age and older.
- •Must be undergoing qualifying surgeries at participating sites.
- •Patients under 18 years of age.
排除标准
- •- Patients under 18 years of age.
研究组 & 干预措施
Control Arm
Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches. The control arm consists of all patients receiving surgery in implementation tranches in which the intervention has not been implemented yet (per the study schedule).
Intervention
Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches in which the intervention will be implemented per the study schedule.
干预措施: Conversation Guide + Clinical Support (Behavioral)
结局指标
主要结局
PROMIS-CAT Pain
时间窗: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome.
PROMIS-CAT Physical Function
时间窗: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome.
Use of Non-Pharmacological Pain Control Modalities
时间窗: 3 Months Post-Surgery
Number of participants using Non-Pharmacological Pain Control Modalities
PROMIS-CAT Pain
时间窗: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome.
PROMIS-CAT Physical Function
时间窗: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome.
PROMIS-CAT Anxiety
时间窗: Baseline (before hospital discharge), 3-Months Post-Surgery
Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome.
Use of Non-Pharmacological Pain Control Modalities
时间窗: 3 Months Post-Surgery
Number of participants using Non-Pharmacological Pain Control Modalities
Opioid Use
时间窗: 3-Months Post-Surgery
Binary variables indicating presence or absence of opioid administration and prescription during the hospital encounter associated with the index surgery and during the post-discharge follow-up period.
次要结局
未报告次要终点
研究者
Andrea Cheville
Principal Investigator
Mayo Clinic