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Pain and Medication Use Following Surgery (SODAS)

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ClinicalTrials.gov Identifier: NCT03179566
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
Michigan Department of Health and Human Services
Information provided by (Responsible Party):
Chad Brummett, 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.

Condition or disease Intervention/treatment Phase
Opioid Use Behavioral: Information Sheet Behavioral: Deterra Drug Deactivation System Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A run-in period will precede the randomization sequence. Individuals will be randomized to one of two groups based on the day of their surgery.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safe Opioid Disposal After Surgery Trial
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Arm Intervention/treatment
No Intervention: Usual Care
For the first two weeks, there will be no intervention or changes to the usual discharge instructions
Active Comparator: Information Sheet
At discharge, patients will receive an informational sheet detailing options for safe drug disposal
Behavioral: Information Sheet
Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge. Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.
Active Comparator: Deterra Drug Deactivation System
At discharge, patients will receive a Deterra Drug Deactivation System.
Behavioral: Information Sheet
Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge. Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.
Behavioral: Deterra Drug Deactivation System
This system is a pouch that deactivates prescription drugs, rendering them ineffective for misuse and safe for regular garbage disposal. It uses a patented activated carbon technology to deactivate drugs, including pills, liquids, and patches, and has been found to be 99% percent effective in studies funded by the National Institute of Drug Abuse (NIDA). Additionally, the pouches are made from environmentally friendly materials and contain active ingredients that are considered non-toxic and pose minimal risk, according to their MSDS. Nurses will provide the Deterra bag and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.



Primary Outcome Measures :
  1. Drug disposal [ Time Frame: 4 weeks post-surgery ]
    Patient-reported disposal of left-over opioid medications in any manner


Secondary Outcome Measures :
  1. Opioid disposal technique [ Time Frame: 4 weeks post-surgery ]
    Patient-reported technique for disposal of left-over opioid medications specifically assessing for safe disposal using recommended disposal methods



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179566


Locations
United States, Michigan
East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Michigan Department of Health and Human Services
Investigators
Principal Investigator: Chad Brummett, MD Michigan Medicine, Department of Anesthesiology

Additional Information:
Publications:

Responsible Party: Chad Brummett, Associate Professor of Anesthesiology, University of Michigan
ClinicalTrials.gov Identifier: NCT03179566     History of Changes
Other Study ID Numbers: HUM00129418
MA-2017 ( Other Grant/Funding Number: Michigan Department of Health and Human Services )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chad Brummett, University of Michigan:
drug disposal