Disposal Interventions for Safe Prescription Opioid Surplus Elimination: The DISPOSE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 499
- 试验地点
- 2
- 主要终点
- Number of participants using a safe drug disposal method for leftover prescription opioids
研究概览
简要总结
This study evaluates two interventions intended to increase the safe disposal of leftover prescription opioids, compared to no intervention. Participants will receive an informational sheet describing how to safely dispose of leftover prescription opioids, an informational sheet with a drug disposal kit, or no intervention. Participants will be randomized by day for pragmatic reasons.
详细描述
Many persons who receive a prescription for opioids report having leftover opioids once the prescription is finished. Leftover prescription opioids serve as a reservoir of products for misuse, given 90% of people who misuse prescription opioids report obtaining the opioids from a friend, family member, or a legitimate prescription. The best way to increase the rate of safe disposal of leftover opioids is unclear. The present study will generate evidence comparing how well a drug disposal system compares with providing an informational handout on properly disposing of leftover prescription opioids. Participants will be randomized by day to one of two disposal interventions or no disposal intervention. Disposal interventions include a drug disposal kit or an informational sheet describing how to safely dispose of leftover prescription opioids. Storage and disposal characteristics for leftover prescription opioids will be measured using standardized telephone calls with participants at 3 weeks after filling the opioid prescription. If therapy is not concluded at 3 weeks or participants are not available, then a second standardized telephone call with participants will take place at 6 weeks after filling the opioid prescription.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are unaware of treatment assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (age ≥ 18 years) who pick up a prescription for themselves or a family member at a Johns Hopkins pharmacy
- •English speaking
- •Residential address and phone number in the United States
- •Filling a new prescription consisting of an immediate release opioid medication (i.e., immediate release morphine, oxycodone, hydromorphone, hydrocodone, tramadol; alone or in combination with acetaminophen) with ≤ 7 days' supply
排除标准
- •Age < 18 years
- •Non-English speaking
- •Residential address and/or phone number outside the United States
- •Opioid medication listed in participant's active medication list prior to prescription fill
- •Filling any prescription consisting of any opioid with 8 or more days' supply
- •Filling any prescription consisting of any extended-release / long-acting opioid medication (i.e., extended-release morphine, oxymorphone, oxycodone, hydromorphone, fentanyl, methadone, buprenorphine)
- •Filling an opioid prescription indicated for cough or shortness of breath
研究组 & 干预措施
Informational Sheet
Persons picking up an opioid prescription will receive an informational sheet that describes how to properly dispose of leftover opioid medications
干预措施: Informational Sheet (Behavioral)
Drug Disposal Kit
Persons picking up an opioid prescription will receive a drug disposal kit (DisposeRx Drug Disposal kit) and instructions on how to use it
干预措施: Informational Sheet (Behavioral)
Drug Disposal Kit
Persons picking up an opioid prescription will receive a drug disposal kit (DisposeRx Drug Disposal kit) and instructions on how to use it
干预措施: DisposeRx Drug Disposal kit (Behavioral)
No intervention
Persons picking up an opioid prescription will receive no additional information or materials on disposal.
结局指标
主要结局
Number of participants using a safe drug disposal method for leftover prescription opioids
时间窗: Up to 6 weeks after prescription fill
Participants who report "yes" to disposing of leftover prescription opioid medication using a disposal intervention that aligns with recommendations from the Food and Drug Administration (i.e., using a take-back program, drug disposal kit, or flushing in the toilet)
次要结局
- Number of participants using any drug disposal method for leftover prescription opioids(Up to 6 weeks after prescription fill)
- Number of participants who completed prescription opioid therapy(Up to 6 weeks after prescription fill)
- Number of participants with safe storage of prescription opioids(Up to 6 weeks after prescription fill)