Cluster Randomized Trial of a Mailed At-home Kit on Disposal of Unused Opioids Following Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 657
- 试验地点
- 2
- 主要终点
- Self-Reported Opioid Disposal
研究概览
简要总结
Many prescription opioids following surgery are left unused and are at risk of being misused or diverted. Encouraging proper disposal is important, yet motivating this behavior remains challenging as patients must understand the risks of opioids, the benefits of disposal, and identify opportunities and places to dispose of them safely. Alternative disposal techniques can improve disposal rates but may be lost or forgotten. Applying behavioral economics techniques may lower the barriers and promote disposal. The objective is to test the effect of a specifically timed, mailed, at-home kit on disposal rates following surgery.
详细描述
A pragmatic, cluster-randomized quality improvement study embedded in an existing automated, post-operative text messaging program to capture patient-reported outcomes (e.g., pain score, opioid use, ability to manage pain) and disposal as part of usual care. It was approved by the University of Pennsylvania Institutional Review Board with a waiver of informed consent.
All patients, 18 years or older, undergoing an orthopedic or urologic procedure and prescribed an opioid were approached and consented via text messaging. Patients without access to a text message capable device or non-English speaking were excluded. Participants were block randomized to usual care or a mailed at-home disposal packet. Usual care consisted of a text message hyperlink to nearby disposal locations. Intervention participants were mailed an at-home disposal packet timed to arrive between post-operative days four and seven based on prior data collection on reported use. The disposal packet (DisposeRx Inc.) contains a powder that sequesters unused opioids in a polymer gel. Patients self-reported disposal via the automated system.
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 (Participant)
盲法说明
Participant will be blinded to their random assignment into the control or treatment (medication disposal packet) group
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 or older
- •Undergoing an orthopedic or urologic procedure
- •Prescribed an opioid
- •SMS capable mobile device
- •English speaking
排除标准
- •Does not own a text message capable mobile phone
- •non-English speaking
结局指标
主要结局
Self-Reported Opioid Disposal
时间窗: The duration of the study; two months
The opioid disposal kits provided patients with a timely, easy, and safe disposal technique which was sent to them between post-operative day 4-7 which corresponds with historical trends in declining opioid use. This primary outcome is self-reported opioid disposal which is obtained via an automated text message sent to patients on post operative day 7.
次要结局
未报告次要终点
研究者
Anish Agarwal, MD, MPH, MS
Assistant Professor & Chief Wellness Officer | Department of Emergency Medicine
University of Pennsylvania
