Patient Utilization of Opioid Destruction Bags in the Post op Period

Opioid Use Clinical Trial

Official title:

Patient Utilization of Opioid Destruction Bags in the Post op Period

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05875857
• Other study ID #: 0277-22-EP
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study on how patients use and store opioid pain medications at home after surgery and what happens to left over pills when patients are done taking them. Participants will be taught the proper storage and destruction of opioid pain medications, then contacted in 6-8 weeks about pain medication used, stored disposed of.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use
• Opioid Use, Unspecified
• Patient Empowerment
• Total Hip Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid destruction	Opioid destruction rates-total number of subjects reporting they destroyed their un-used opioids	Six to Eight weeks post discharge
Secondary	Alternative opioid destruction methods	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.	Six to Eight weeks post discharge