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临床试验/NCT03179566
NCT03179566已完成不适用

Safe Opioid Disposal After Surgery Trial

University of Michigan2 个研究点 分布在 1 个国家目标入组 391 人开始时间: 2017年6月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
391
试验地点
2
主要终点
Drug disposal

研究概览

简要总结

Patients will be randomized to one of two interventions intended to facilitate safe disposal of opioids after cessation following surgery. For pragmatic reasons, participants will be randomized by day to either the information sheet or the disposal bag using a block randomization schedule. To ensuring adequate sample size, patients will be enrolled for a ~4-week period following the 2-week usual care run in period. In the event that the sample size estimate has not been reached after the 4-week intervention period, additional patients will be enrolled accordingly.

详细描述

The lack of evidence-based guidelines for postoperative opioid prescribing has contributed to a surplus of opioid pills within our patients' homes and communities, increasing the potential for diversion and nonmedical use. A recent study suggests that for outpatient general surgery procedures, roughly 72% of prescribed opioids go unused. Current opioid disposal options are limited to DEA-authorized opioid collectors, including select law enforcement agencies, pharmacies, or organized pill drop events, and many patients remain unaware of these avenues. Several studies have found that few patients have knowledge about opioid disposal options and even fewer dispose of their unconsumed opioids.

Unconsumed opioids pose a diversion risk. In the 2011 National Survey on Drug Use and Health, 70.8% of those who used a prescription medication non-medically obtained the medication from a friend or relative, with or without their knowledge. Additionally, nonmedical prescription opioid use is a common pathway to heroin use. Importantly, over 80% of young intravenous drug users report initiation of prescription opioid misuse prior to heroin.

Considering that 40% of the prescriptions written by surgeons are for opioids and patients frequently have excess opioids and limited options for and/or knowledge of opioid disposal, the present study will provide patients with information and novel options for opioid disposal as part of the surgical care pathway.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Scheduled for surgery at Michigan Medicine's East Ann Arbor Ambulatory Surgery & Medical Procedures Center

排除标准

  • Unable to speak English
  • Inability to understand or complete the surveys
  • Other conditions that preclude meaningful participation in the study

研究组 & 干预措施

Usual Care

No Intervention

For the first two weeks, there will be no intervention or changes to the usual discharge instructions

Information Sheet

Active Comparator

At discharge, patients will receive an informational sheet detailing options for safe drug disposal

干预措施: Information Sheet (Behavioral)

Deterra Drug Deactivation System

Active Comparator

At discharge, patients will receive a Deterra Drug Deactivation System.

干预措施: Information Sheet (Behavioral)

Deterra Drug Deactivation System

Active Comparator

At discharge, patients will receive a Deterra Drug Deactivation System.

干预措施: Deterra Drug Deactivation System (Behavioral)

结局指标

主要结局

Drug disposal

时间窗: 4 weeks post-surgery

Patient-reported disposal of left-over opioid medications in any manner

次要结局

  • Opioid disposal technique(4 weeks post-surgery)

研究者

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

Chad Brummett

Associate Professor of Anesthesiology

University of Michigan

研究点 (2)

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