Effect of an Opioid Disposal Pouch Versus Usual Care on P... | NCT04553588

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

NCT04553588

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Sep 17, 2020Actual

Enrollment

313Actual

Phase

Not Applicable

Conditions

Drug Prescriptions

Interventions

Disposal pouch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2017Actual

Primary Completion Date

May 31, 2018Actual

Completion Date

Feb 27, 2020Actual

First Submitted Date

Sep 7, 2020

First Submission Date that Met QC Criteria

Sep 11, 2020

First Posted Date

Sep 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2020

Last Update Posted Date

Sep 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antoinette Zito, Perioperative Educator, Office of Nursing Education and Professional Development, Principal Investigator, The Cleveland ClinicPrincipal Investigator

Lead Sponsor

The Cleveland ClinicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

313Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Disposal pouch	Other	Medication Disposal Pouch	Opioid Disposal Pouch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Disposal of Unused Opioid Medication	rate of patient reported unused oral opioid medication disposal between groups	30 days postoperatively

Secondary Outcomes

Measure	Description	Time Frame
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
Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zito Antoinette, MSN	Cleveland Clinic Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Health System		Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

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

Masking Info

Masking

Single

Masking Description

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.

Who Masked

Care Provider