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

NCT04553588 | Completed

• 1 other identifier: 17-801
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

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

Conditions

Drug Prescriptions

Keywords

opioid misuse; disposal; disposal pouch; postoperative surgery

Outcome Measures

Primary Outcomes (1)

• Rate of Disposal of Unused Opioid Medication

  rate of patient reported unused oral opioid medication disposal between groups

  30 days postoperatively

Secondary Outcomes (7)

• Odds of disposal pouch use after adjusting for group assignment

  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

  30 days postoperatively

• Odds of disposal pouch use after adjusting for race

  30 days postoperatively

• Odds of disposal pouch use after adjusting for gender

  30 days postoperatively

Study Arms (2)

Opioid Disposal Pouch

ACTIVE COMPARATOR

an opioid disposal pouch to inactivate and dispose of unused opioid medication within the first 30 days after surgery

Other: Disposal pouch

Usual Care

NO INTERVENTION

usual medication disposal includes multiple options as desired by patient; for example, flushing down toilet, giving to local pharmacist, giving to police department etc.

Interventions

Disposal pouch OTHER

Medication Disposal Pouch

Also known as: Medsaway Pouch

Opioid Disposal Pouch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Health System

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Zito Antoinette, MSN

  Cleveland Clinic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care provider did not receive communication regarding group assignment; patients allocated to the intervention group received a disposal pouch prior to discharge and after physician discharge orders were finalized.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Perioperative Educator, Office of Nursing Education and Professional Development, Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 17, 2020
• Study Start: July 15, 2017
• Primary Completion: May 31, 2018
• Study Completion: February 27, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)