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Completed

NCT Number: NCT04553588

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Health System

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disposal pouch

Other

Medication Disposal Pouch

Other names: Medsaway Pouch

Primary outcomes

  1. Rate of Disposal of Unused Opioid Medication

    Time frame: 30 days postoperatively

    rate of patient reported unused oral opioid medication disposal between groups

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Odds of disposal pouch use after adjusting for race

    Time frame: 30 days postoperatively

    Odds of disposal pouch use after adjusting for race

  5. Odds of disposal pouch use after adjusting for gender

    Time frame: 30 days postoperatively

    Odds of disposal pouch use after adjusting for gender

  6. 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

  7. Odds of disposal pouch use after adjusting for insurance type

    Time frame: 30 days

    Odds of disposal pouch use after adjusting for insurance type

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Sep 17, 2020
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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