Effect of an Opioid Disposal Pouch Versus Usual Care on Post Discharge Disposal of Unused Medication

September 11, 2020 updated by: Antoinette Zito, The Cleveland Clinic

Implementation of a Program for Safe Medication Disposal in a Perioperative Unit: A Response to the Opioid Crisis

The purpose of the study is to determine if opioid disposal bags/pouches are an effective method for disposing of unused opioid medications postoperatively

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Opioids are dispensed regularly to manage postoperative pain in patients undergoing surgery in hospitals and same day surgery centers. There has been a rise in the number of opioid misuse and overdoses nationally, with Ohio ranked first in the nation for drug overdose deaths in 2014 and Cuyahoga County leading the state with 666 overdose deaths in 2016(ref) As health care providers, it is our responsibility to respond to this epidemic. One measure to address this is to reduce the number of unused prescription opioids that remain in patients' possession when they no longer need them. (ref) Doing so will maximize safety by decreasing the availability of unused opioids. The purpose of this study is to determine if a product that deactivates opioids will be used as designed after oral opioid medication is no longer needed. The design of this study is a quality initiative project using a randomized control design. The setting is a surgery center in a suburban hospital in Cuyahoga County. The population is all adult surgery center patients that are prescribed opioids postoperatively who are discharged the same day. In addition to usual care, a medication disposal bag with instructions on how to use will be given to the patient prior to discharge. The patient will be called 30-45 days post discharge. The data will be collected on a case report form that will include information about disposal and information obtained from the patients medical record.

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Adults (>18 years)
  • Scheduled to go home on the day of surgery
  • Received a prescription for opioids
  • Willing to provide a telephone number and receive a phone call 30 days after surgery

Exclusion Criteria

  • Moderate to severe cognitive decline requiring caregiver support
  • Not able to speak or understand English (instructions only available in English)
  • Behavioral health diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Opioid Disposal Pouch
an opioid disposal pouch to inactivate and dispose of unused opioid medication within the first 30 days after surgery
Medication Disposal Pouch
Other Names:
  • Medsaway Pouch
NO_INTERVENTION: Usual Care
usual medication disposal includes multiple options as desired by patient; for example, flushing down toilet, giving to local pharmacist, giving to police department etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Disposal of Unused Opioid Medication
Time Frame: 30 days postoperatively
rate of patient reported unused oral opioid medication disposal between groups
30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds of disposal pouch use after adjusting for group assignment
Time Frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for group assignment (usual care versus disposal pouch group)
30 days postoperatively
Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain
Time Frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain
30 days postoperatively
Odds of disposal pouch use after adjusting for preoperative opioid use
Time Frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for preoperative opioid use
30 days postoperatively
Odds of disposal pouch use after adjusting for race
Time Frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for race
30 days postoperatively
Odds of disposal pouch use after adjusting for gender
Time Frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for gender
30 days postoperatively
Odds of disposal pouch use after adjusting for surgical procedure type
Time Frame: 30 days postoperatively
Odds of disposal pouch use after adjusting for surgical procedure type
30 days postoperatively
Odds of disposal pouch use after adjusting for insurance type
Time Frame: 30 days
Odds of disposal pouch use after adjusting for insurance type
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Zito Antoinette, MSN, Cleveland Clinic Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2017

Primary Completion (ACTUAL)

May 31, 2018

Study Completion (ACTUAL)

February 27, 2020

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (ACTUAL)

September 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 17-801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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