Opioid Reduction Program for Total Knee Replacement Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Opioid pills (dose and type) prescribed by Campbell Clinic.
研究概览
简要总结
In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.
详细描述
The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups.
There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened "booster" session approximately 2-weeks post-op.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •18 years or older.
- •Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription.
- •Access to a telephone.
- •Able to consent in English.
排除标准
- •Under the age of
- •Contraindications to use of opioid medication.
- •No access to a telephone.
- •Unable to understand consent materials in English.
结局指标
主要结局
Opioid pills (dose and type) prescribed by Campbell Clinic.
时间窗: 12-weeks post-op.
transcribed from medical record at Campbell Clinic
Opioid pill count questionnaire.
时间窗: 12-weeks post-op.
self-report from participant of how many opioids are left in the bottle at the 12 week assessment
Opioid pills prescribed outside of Campbell Clinic.
时间窗: 12-weeks post-op.
assessed via scan of prescription drug monitoring database for Tennessee
次要结局
- KOOS Jr.(12-weeks post-op.)
研究者
Karen Derefinko, PhD
Associate Professor
University of Tennessee