- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04553588
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
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:
|
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.
Sponsor
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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