Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty: Phase 2 Intervention Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are:
- Is the intervention feasible and acceptable to patients?
- Does the intervention result in a decrease in opioid dose during the preoperative period?
Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •decided to pursue primary, unilateral total knee or hip arthroplasty with planned surgery date in 4-8 weeks
- •currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months
- •have a reliable telephone number for contact
- •speaks English
排除标准
- •Taking opioid medications that include:
- •Buprenorphine
- •Methadone
- •Long-acting formulations of opioid pain medications (e.g., extended-release oxycodone and extended-release morphine)
- •Transdermal formations of opioid pain medications (e.g., fentanyl patches)
研究组 & 干预措施
Pharmacist-led opioid taper intervention
The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period. Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.
干预措施: opioid taper (Behavioral)
结局指标
主要结局
Acceptability
时间窗: From enrollment until approximately 2 weeks after surgery
Mixed-methods assessment of the intervention by participants. Participants will provide qualitative feedback at multiple points during and after the intervention, and will quantitatively rate satisfaction at the end of the study. These results will be analyzed jointly to determine acceptability.
次要结局
- Study Retention Rate(From enrollment until approximately 2 weeks after surgery)
- Perioperative Pain(From enrollment until approximately 2 weeks after surgery)
- Taper Efficacy(From enrollment until the time of surgery)
- Study Recruitment Rate(From enrollment until approximately 2 weeks after surgery)
研究者
Kevin Riggs
Assistant Professor
University of Alabama at Birmingham