Pain and Medication Use Following Surgery

Not Applicable

Completed

• Conditions: Opioid Use
• Interventions: Behavioral: Information Sheet; Behavioral: Deterra Drug Deactivation System

• Registration Number: NCT03179566
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-05
• Study Start: 2017-06-06
• Study First Posted: 2017-06-07
• Status Verified: 2017-09
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deterra Drug Deactivation System	Information Sheet	At discharge, patients will receive a Deterra Drug Deactivation System.
Deterra Drug Deactivation System	Deterra Drug Deactivation System	At discharge, patients will receive a Deterra Drug Deactivation System.
Information Sheet	Information Sheet	At discharge, patients will receive an informational sheet detailing options for safe drug disposal

Primary Outcome Measures

Name	Time	Method
Drug disposal	4 weeks post-surgery	Patient-reported disposal of left-over opioid medications in any manner

Secondary Outcome Measures

Name	Time	Method
Opioid disposal technique	4 weeks post-surgery	Patient-reported technique for disposal of left-over opioid medications specifically assessing for safe disposal using recommended disposal methods

Trial Locations

Locations (1)

East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States