Clinical trial NCT04553588: Effect of an Opioid Disposal Pouch Versus Usual Care on Post Discharge Disposal of Unused Medication
Official title: Implementation of a Program for Safe Medication Disposal in a Perioperative Unit: A Response to the Opioid Crisis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Prescriptions
Keywords: opioid misuse
disposal
disposal pouch
postoperative surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Disposal of Unused Opioid Medication
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Odds of disposal pouch use after adjusting for group assignment
timeFrame: 30 days postoperatively
measure: Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain
timeFrame: 30 days postoperatively
measure: Odds of disposal pouch use after adjusting for preoperative opioid use
timeFrame: 30 days postoperatively
measure: Odds of disposal pouch use after adjusting for race
timeFrame: 30 days postoperatively
measure: Odds of disposal pouch use after adjusting for gender
timeFrame: 30 days postoperatively
measure: Odds of disposal pouch use after adjusting for surgical procedure type
timeFrame: 30 days postoperatively
measure: Odds of disposal pouch use after adjusting for insurance type
timeFrame: 30 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Health System
state: Ohio
Study officials:
affiliation: Cleveland Clinic Health System
name: Zito Antoinette, MSN
role: PRINCIPAL_INVESTIGATOR
References: