Impacting the Disposal of Unused Opioid

Impacting the Disposal of Unused Opioid Analgesics Through Education in the Orthopaedic Population: A Randomized Control Trial

The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject.

Study Overview

• Status: Completed
• Conditions: Opioid Use and Disposal
• Intervention / Treatment: Other: Pamphlet education; Other: Pamphlet education + texts

Detailed Description

Opioids are used to treat acute pain after surgery, but can lead to misuse and abuse. Very few patients properly dispose of unused opioids and the majority of opioids are stored in the home in unlocked containers as opposed to being properly disposed of. Improper disposal of opioid medications is a concern due to the potential for nonmedical use and has the potential to cause injury or death for patients and their family members that can access the medications. The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject. There is evidence that an educational brochure significantly increases proper disposal rates, albeit only to about 25%. The goal of this study is to evaluate the impact of an educational pamphlet on proper opioid disposal in the total joint arthoplasty population, and to see if the addition of a text messaging system can increase further increase proper disposal rates.

• Study Type: Interventional
• Enrollment (Actual): 563
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient undergoing primary total hip or knee arthroplasty
• Age ≥18 years old

Exclusion Criteria:

• Patients allergic to oxycodone
• Patients consuming opioids during the 4 weeks prior to surgery
• Patients with a history of opioid dependence
• Patients undergoing revision total knee or hip arthroplasty
• Non-English speaking patients
• Age <18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Education; Patients in this arm receive no education regarding how to dispose of their opiate medication
Experimental: Pamphlet education; Patients receive an educational pamphlet only, to be given at the preoperative teaching class, prior to their standard 3-week postoperative clinic appointment, and prior to their standard 6-week postoperative clinic appointment.	Other: Pamphlet education; Patients receive an educational intervention explaining proper opioid disposal
Experimental: Pamphlet education + texts; Patients receive an educational pamphlet, to be given at the preoperative teaching class, prior to their standard 3-week postoperative clinic appointment, and prior to their standard 6-week postoperative clinic appointment. In addition, 3 automated text messages sent at those same time points.	Other: Pamphlet education + texts; Patients receive an educational intervention and text message explaining proper opioid disposal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disposal rates	The rate of an arm's disposal is calculated by comparing the number that properly disposed of their excess medication to the number that did not	6 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continued taking opiate rate	We will also look at whether the education affects the number of patients that continue taking opiates	6 weeks after surgery

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Craig Della Valle, MD, Rush

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): June 3, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 18092505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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