Patient Utilization of Opioid Destruction Bags in the Post op Period

Sponsor

University of Nebraska (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05875857

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized single-center prospective survey study to describe the patient utilization of opioid destruction bags in the post-operative period. Patients who underwent surgery for Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) will be eligible for inclusion if discharging to home with an opioid prescription. Patient data will be excluded if they are under 19 years of age, taking opioids prior to surgery or not prescribed an opioid at discharge. Patients will be excluded from the data if readmitted to hospital during follow-up time period, unable to be reached patients via phone/email after attempts on three separate days, did not have any leftover opioids after surgery, unwilling to answer survey questions or still taking opioids at time of survey. Eligible patients will be randomized between two groups: 1) Control group will receive current standard of care 2) Intervention group will receive a specialized handout and patient education on the safe storage of opioid medications, importance of opioid destruction, opioid destruction options and medication destruction (Deterra) bag before discharge. Participants will be phoned/emailed six to eight weeks post-surgery to complete a survey. Attempts will be made on three separate days to reach the patient via phone. If email is preferred by subject, three reminders will be sent to complete the survey. If patient is unreachable, then patient will be considered lost to follow up. Survey questions will be comprised of various question styles, including: yes/no, multiple choice, and free text answers.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Opioid Use, Unspecified Patient Empowerment Total Knee Arthoplasty Total Hip Arthroplasty	Behavioral: Opioid destruction education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Patient Utilization of Opioid Destruction Bags in the Post op Period

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Control group will receive current standard of care education and surveys at 6-8 weeks post discharge.
Experimental: Intervention Intervention group will receive a specialized handout and patient education on the safe storage of opioid medications, importance of opioid destruction, opioid destruction options and medication destruction (Deterra) bag before discharge. Surveys will be sent to group at 6-8 weeks post discharge.	Behavioral: Opioid destruction education Intervention group will receive a specialized handout and patient education on the safe storage of opioid medications, importance of opioid destruction, opioid destruction options and medication destruction (Deterra) bag before discharge.

Arm

Intervention/Treatment

No Intervention: Control

Control group will receive current standard of care education and surveys at 6-8 weeks post discharge.

Experimental: Intervention

Intervention group will receive a specialized handout and patient education on the safe storage of opioid medications, importance of opioid destruction, opioid destruction options and medication destruction (Deterra) bag before discharge. Surveys will be sent to group at 6-8 weeks post discharge.

Behavioral: Opioid destruction education

Outcome Measures

Primary Outcome Measures

Opioid destruction [Six to Eight weeks post discharge]
Opioid destruction rates-total number of subjects reporting they destroyed their un-used opioids

Secondary Outcome Measures

Alternative opioid destruction methods [Six to Eight weeks post discharge]
Utilization rate of alternate opioid destruction methods (take-back to pharmacy, mail back envelopes, flushing, etc.)-total number of subjects utilizing alternative opioid destruction methods.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients discharging to home and prescribed opioids at discharge post total knee arthroplasty or total hip arthroplasty .

Exclusion Criteria:

Under 19 years of age.
Opioid medication use prior to surgery
Patients not prescribed an opioid to take after discharge.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristin.Daniel, Pharmacist Program Coordinator, University of Nebraska

ClinicalTrials.gov Identifier:

NCT05875857

Other Study ID Numbers:

277-22-EP

First Posted:

May 25, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Analgesics, Opioid

Study Results

No Results Posted as of May 25, 2023