跳至主要内容
临床试验/NCT05169281
NCT05169281已完成不适用

Cluster Randomized Trial of a Mailed At-home Kit on Disposal of Unused Opioids Following Surgery

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 657 人开始时间: 2021年3月24日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anish Agarwal, MD, MPH, MS

Assistant Professor & Chief Wellness Officer | Department of Emergency Medicine

University of Pennsylvania

研究点 (2)

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