Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized
研究概览
简要总结
The investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Undergoing a scheduled surgery
- •English speaking
- •Ability and willingness to complete questionnaires and assessments.
排除标准
- •Any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator.
- •Known Pregnancy
- •Elevated Suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression Inventory assessing suicidal thoughts.
- •Coexisting Chronic Pain Disorder of moderate severity in area other than surgical target
结局指标
主要结局
Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized
时间窗: Duration of the study - up to 2 years per participant
Factors that contribute to non-completion of the study, measured at baseline for each patient, will be analyzed.
次要结局
- Efficacy - time to opioid cessation(Duration of the trial - Up to 2 years per participant)
研究者
Jennifer Hah
Assistant Professor
Stanford University