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

Drug Prescriptions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553588
• Other study ID #: 17-801
• Status: Completed
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: February 27, 2020

Study information

• Verified date: September 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: February 27, 2020
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Prescriptions

Intervention

Other:
• Disposal pouch
Medication Disposal Pouch

Locations

Country	Name	City	State
United States	Cleveland Clinic Health System	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Disposal of Unused Opioid Medication	rate of patient reported unused oral opioid medication disposal between groups	30 days postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	Odds of disposal pouch use after adjusting for race	Odds of disposal pouch use after adjusting for race	30 days postoperatively
Secondary	Odds of disposal pouch use after adjusting for gender	Odds of disposal pouch use after adjusting for gender	30 days postoperatively
Secondary	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
Secondary	Odds of disposal pouch use after adjusting for insurance type	Odds of disposal pouch use after adjusting for insurance type	30 days