Prospective Randomized Study Of Transitional Pain Service (TPS) With Mini-Cognitive Behavioral Therapy (CBT) Versus TPS Alone For Evaluating Hospital Readmission, Opioid Outcomes, And Chronic Post-Surgical Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
This study aims to evaluate the impact of a Transitional Pain Service (TPS) on hospital readmission rates, opioid consumption, and chronic post-surgical pain(CPSP), Despite increasing recognition of the benefits of integrated transitional pain care, there are limited prospective data evaluating its impact on 30-day readmissions, longitudinal opioid use, and CPSP. This protocol will systematically collect prospective patient data to assess these outcomes.
详细描述
Primary Objective:
To compare the 30-day hospital readmission rate in patients seen by to the Transitional Pain Service.
Secondary Objectives:
- To evaluate reduction in opioid use (MME) at 30, 60, 90, 180, and 365 days.
- To evaluate patient reported outcomes using BPI, CAGE-AID, SOAPP-14, ESAS, PROMIS-29 at 30, 60, 90, 180, and 365 days to assess patient-reported quality of life and pain outcomes longitudinally.
- To evaluate the incidence of CPSP
- To assess demographic and clinical predictors of readmission and opioid reduction.
- Compare outcomes between TPS patients who receive a brief, skills-based mini-CBT group intervention vs. TPS patients who do not receive mini-CBT, including:
- Time trends across 30, 60, 90 days, and 6 and 12 months.
- Opioid use (daily MME), and proportion achieving ≥30% MME reduction from baseline;
- Pain intensity (NRS/10), BPI severity & interference, PROMIS-29 domains;
- beyond 30-day hospital readmission rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Chronic pain syndrome Patients with a h/o or current substance use Patients on a daily opioid dose (morphine equivalency) of ≥90 Consulted for transitional pain service
排除标准
- •Not seen by transitional pain service
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点