SAVE Trial: SAfe Opioid Use Video Education
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Days to Opioid Cessation
研究概览
简要总结
The study will assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, the judicious use of opioids, and the proper disposal of opioids. This trial is a single-institution, randomized controlled trial comparing total post-discharge opioid use in breast reconstruction patients who view an educational video on proper opioid use to patients who do not receive intentional education (the current standard of care).
This will be the first project to inform opioid prescribing guidelines for breast reconstruction patients based on actual opioid use data and will describe a patient-centered intervention that is easily incorporated into current postoperative workflows. Broadly, the results of the study aim to set the foundation to incorporate cost-effective educational interventions across multiple surgical specialties that require postoperative opioid prescription.
详细描述
Opioids are widely overprescribed and overused after surgery, contributing to the current opioid misuse crisis which affects more than 10 million Americans annually. In the breast reconstruction after mastectomy population, studies report as many as 47% of patients go on to become prolonged users of opioids.
The primary goal is to assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, the judicious use of opioids, and the proper disposal of opioids. The proposed study is a single-institution, randomized controlled trial comparing total post-discharge opioid use in breast reconstruction patients who view an educational video on proper opioid use to patients who do not receive intentional education (the current standard of care). This project is directly relevant to the mission of the AHRQ to "improve health care patient safety and to provide a 360-degree view of the patient." Specifically, this will be the first project to inform opioid prescribing guidelines for breast reconstruction patients based on actual opioid use data and will describe a patient-centered intervention that is easily incorporated into current postoperative workflows. Broadly, the results of the study aim to set the foundation to incorporate cost-effective educational interventions across multiple surgical specialties that require postoperative opioid prescription.
Patients will be randomized to an opioid video vs. no opioid video cohort by a block randomization scheme based on a predefined computer-generated sequence (six blocks, six numbers per block) in a 1:1 intervention: no intervention ratio. Patients in the opioid video cohort will watch a 3-minute education video on proper opioid use preoperatively. The video includes information on (1) how to consume appropriate over-the-counter pain medication alongside opioids for optimal pain control, (2) how prescribed opioids should be used only to treat pain related to the surgery, and (3) the proper disposal of unused opioids. The video was created through the University of Utah Office of Patient Experience. Feedback regarding the educational content was provided by surgeons, pain management physicians, and pharmacists throughout the process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years of age or older
- •Patients undergoing abdominally based autologous free flap breast reconstruction after mastectomy for breast cancer or cancer prophylaxis
排除标准
- •Patients undergoing reoperations such as autologous breast reconstruction as a revision procedure following failed implant-based reconstruction
- •Patients undergoing multiple procedures such as mastectomy and immediate reconstruction
- •Patients with documented chronic opioid use prior to procedure, chronic pain condition
结局指标
主要结局
Days to Opioid Cessation
时间窗: up to 2 weeks postoperative
Total number of days until ceasing opioid use from breast reconstruction surgery to 2 weeks.
Total Opioid Consumption
时间窗: up to 2 weeks postoperative
Total opioid consumption post-discharge from breast reconstruction, measured in Morphine Milligram Equivalents (MMEs).
Total Opioid Consumption
时间窗: up to 2 weeks postoperative
Total opioid consumption post-discharge from breast reconstruction, measured in Morphine Milligram Equivalents (MMEs).
Days to Opioid Cessation
时间窗: up to 2 weeks postoperative
Total number of days until ceasing opioid use from breast reconstruction surgery to 2 weeks.
次要结局
- Opioids Prescribed Consumed(up to 2 weeks postoperative)
- Patient-reported Daily Pain Scores(up to 2 weeks postoperative)
- Days to Non-Opioid Analgesics Cessation(up to 2 weeks postoperative)
- Complication Types(up to 2 weeks postoperative)
- Non-Opioid Analgesics Consumed(up to 2 weeks postoperative)
- Opioids Prescribed Consumed(up to 2 weeks postoperative)
- Patient-reported Daily Pain Scores(up to 2 weeks postoperative)