Patient Utilization of Opioid Destruction Bags in the Post op Period

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Opioid Use; Total Knee Arthoplasty; Total Hip Arthroplasty; Patient Empowerment; Opioid Use, Unspecified
• Intervention / Treatment: Behavioral: Opioid destruction education

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin R Daniel, PharmD; Phone Number: 402-559-2434; Email: kdaniel@nebraskamed.com
• Study Contact Backup: Name: Stacie J Ethington, MSN RN; Phone Number: 402-559-3567; Email: sethington@nebraskamed.com

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid destruction	Opioid destruction rates-total number of subjects reporting they destroyed their un-used opioids	Six to Eight weeks post discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Kristin R Daniel, PharmD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 0277-22-EP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No