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

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

Detailed Description
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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.

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

Conditions
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Drug Prescriptions

Intervention / Treatment
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* Other: Disposal pouch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group design; patients randomized to receive usual postoperative care after discharge or usual postoperative care plus a disposal pouch to safely eliminate opioid medication no longer needed
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid Disposal Pouch<br>an opioid disposal pouch to inactivate and dispose of unused opioid medication within the first 30 days after surgery | Other: Disposal pouch<br>* Medication Disposal Pouch<br>* Other names: Medsaway Pouch;|
| No Intervention: Usual Care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Disposal of Unused Opioid Medication | 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 | 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 | 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 | Odds of disposal pouch use after adjusting for preoperative opioid use | 30 days postoperatively | 
| Odds of disposal pouch use after adjusting for race | Odds of disposal pouch use after adjusting for race | 30 days postoperatively | 
| Odds of disposal pouch use after adjusting for gender | Odds of disposal pouch use after adjusting for gender | 30 days postoperatively | 
| Odds of disposal pouch use after adjusting for surgical procedure type | Odds of disposal pouch use after adjusting for surgical procedure type | 30 days postoperatively | 
| Odds of disposal pouch use after adjusting for insurance type | Odds of disposal pouch use after adjusting for insurance type | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid misuse, disposal, disposal pouch, postoperative surgery