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Pain and Medication Use Following Surgery (SODAS)

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University of Michigan

Status

Completed

Conditions

Opioid Use

Treatments

Behavioral: Deterra Drug Deactivation System
Behavioral: Information Sheet

Study type

Interventional

Funder types

Other

Identifiers

NCT03179566
MA-2017 (Other Grant/Funding Number)
HUM00129418

Details and patient eligibility

About

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.

Full 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.

Enrollment

391 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

391 participants in 3 patient groups

Usual Care
No Intervention group
Description:
For the first two weeks, there will be no intervention or changes to the usual discharge instructions
Information Sheet
Active Comparator group
Description:
At discharge, patients will receive an informational sheet detailing options for safe drug disposal
Treatment:
Behavioral: Information Sheet
Deterra Drug Deactivation System
Active Comparator group
Description:
At discharge, patients will receive a Deterra Drug Deactivation System.
Treatment:
Behavioral: Deterra Drug Deactivation System
Behavioral: Information Sheet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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