EMPOWER: Evaluating the Ability to Reduce Morphine Equivalent Dose for Chronic Pain Patients Receiving Opioid-therapy Through a Web-based E-Health Self-management Program: a Randomized Multi-site Clinical Trial in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 2
- 主要终点
- Decrease in Morphine Equivalent Dose (MED)
研究概览
简要总结
This is a 10-month internet-based randomized controlled trial to evaluate whether an online chronic pain management program ("E-Health") can assist with reduced opioid reliance in chronic pain patients. About half of the eligible participants will receive access to the E-Health program in addition to their standard chronic pain treatment; the other half will just continue receiving their standard chronic pain treatment.
详细描述
This study will determine whether an innovative, accessible E-health intervention can assist with reduced opioid reliance in chronic pain patients, which can, ultimately, reduce risks of unintended opioid overdose and death. Importantly, the study will contribute to a better understanding of the mechanisms contributing to opioid use reduction while managing pain. The findings may assist in developing treatment options for a population at risk for opioid adverse effects.
Potential participants will be identified through electronic health record (EHR) queries at participating sites. Participants will be assessed at baseline, at the end of the 4-month treatment period, and at 6 months following end-of-treatment through an electronic data capture system accessed by the participants. Other outcome data will be obtained from the participant's EHR data.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 25-80 years of age
- •Be able to understand the study, and having understood, provide informed consent in English
- •Have a daily average prescribed MED ≥ 20 mg over a recent three-month period
- •Have a chronic pain-related diagnosis
- •Self-report current use of opioid medication(s) to treat pain
- •Have a Brief Pain Inventory Pain Intensity score ≥3
- •Have internet access and a working email account
排除标准
- •Be anyone who, in the judgment of study staff, would be unlikely to complete the study (e.g., planning to change to a different primary care clinic, have a terminal illness, etc.)
- •Be unwilling/unable to complete the WebNeuro assessments
- •Be pregnant
- •Be a prisoner
研究组 & 干预措施
Treatment As Usual
Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
E-Health+
Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
干预措施: E-health program (Behavioral)
结局指标
主要结局
Decrease in Morphine Equivalent Dose (MED)
时间窗: Baseline and 10 months
Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.
次要结局
- Pain Intensity(Baseline and 10 months)
研究者
T. John Winhusen, PhD
Professor; Vice Chair and Division Director of Addiction Sciences
University of Cincinnati