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

NCT ID: NCT04553588

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-15

Study Completion Date

2020-02-27

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.

Conditions

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Drug Prescriptions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers
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.

Study Groups

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Opioid Disposal Pouch

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

Group Type ACTIVE_COMPARATOR

Disposal pouch

Intervention Type OTHER

Medication Disposal Pouch

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Disposal pouch

Medication Disposal Pouch

Intervention Type OTHER

Other Intervention Names

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Medsaway Pouch

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Antoinette Zito

Perioperative Educator, Office of Nursing Education and Professional Development, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zito Antoinette, MSN

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Health System

Locations

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Cleveland Clinic Health System

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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17-801

Identifier Type: -

Identifier Source: org_study_id

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