SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Opioid disposal compliance
研究概览
简要总结
There is an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder that is substantiated with economic data. SafeMedWaste, Inc. (SMW) has developed the patented SafeMedWaste in-home drug disposal container, that completely destroys opioids within minutes and can be placed in the regular trash, without risk of ground or municipal water contamination.
A pilot randomized clinical trial will evaluate the use of SafeMedWaste in 300 adult patients in outpatient surgery clinics undergoing shoulder and knee surgery.
详细描述
The trial will evaluate opioid disposal rates and events related to opioid diversion and use disorder in 300 adult patients 18 years of age and older undergoing outpatient knee and shoulder surgery who are prescribed opioids to manage their acute post-surgical pain.
Patients will be randomized into two arms. During the standard of care post op visits (2-, 6- and 10- weeks), when the treating physician has determined that the patient will no longer need opioids to manage their post-surgical pain, all patients will receive general instructions by video on opioid disposal recorded by one of the orthopedic surgeons. Patients in the treatment arm will also be given the SafeMedWaste opioid disposal system and watch an instructional video on how to use the product.
All patients will complete a pre-surgery survey and a post-surgery survey 90 days after surgery. Patients will self-report their disposal or non-disposal of the drugs, documented with pictures uploaded to the patient's MyChart account. Data from the surveys will be statistically analyzed to identify significant factors that influenced patients' behavior vis-à-vis opioid disposal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Inclusion Criteria:
- •Subject is 18 + years of age
- •Subject is opioid naive (within the last 3 months), as evidenced by MyChart patient record or response to medical history questions
- •Subject is scheduled to undergo shoulder and/or knee surgery
排除标准
- •Subject has a history of opioid addiction, as evidenced by MyChart patient record or response to medical history questions
- •Subject is currently utilizing prescription narcotics for any reason, as evidenced by MyChart patient record or response to medical history questions
- •Subject does not have the mental capacity to make their own healthcare decisions
- •Subject is unable to provide written consent
结局指标
主要结局
Opioid disposal compliance
时间窗: Within 3 months following surgery
Opioid disposal compliance will be tracked up to 3 months post-surgery, as reported by patients in post-surgery survey and/or documented with pictures uploaded by patient to MyChart.
次要结局
未报告次要终点