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临床试验/NCT02814305
NCT02814305已完成不适用

Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

University of Pennsylvania0 个研究点目标入组 79 人开始时间: 2015年3月1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
79
主要终点
Unused opioids

研究概览

简要总结

Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills.

Aims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery.

Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

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

  • •Non-institutionalized

排除标准

  • •pregnancy
  • •a history of opioid analgesic misuse/abuse
  • •ongoing participation in other clinical research
  • •or daily use of opioid analgesics in the week prior to surgery

研究组 & 干预措施

Control

No Intervention

Patient receives neither educational nor financial interventions

Financial intervention only

Experimental

Patient receives financial (pharmacy offer) intervention only

干预措施: Financial (Behavioral)

Educational intervention only

Experimental

Patient receives educational (narrative) intervention only

干预措施: Educational (Behavioral)

Both interventions

Experimental

Patient receives both educational and financial interventions

干预措施: Financial (Behavioral)

Both interventions

Experimental

Patient receives both educational and financial interventions

干预措施: Educational (Behavioral)

结局指标

主要结局

Unused opioids

时间窗: 21 days after surgery

Number of opioids reported unused by the patient after postoperative day 21

次要结局

  • Intent to dispose of opioids(Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21)

研究者

申办方类型
Other
责任方
Sponsor

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