Surgical Patient Knowledge and Safe Use of Opioids

Improving Surgical Patient Knowledge and Safe Use of Opioids - a Randomized Controlled Trial

Opioids are commonly prescribed for surgical patients to treat moderate to severe pain after surgery. However, opioids can be associated with serious complications such as respiratory depression and death. Currently, it is not routine practice to provide standardized written materials to surgical patients about the risks of opioids and how to safely use opioids after surgery. Investigator has developed an educational pamphlet specifically for surgical patients to educate them about the safe use of opioids.

The objective of this study is to determine whether the pamphlet increases surgical patients' knowledge about the safe use, proper storage and disposal of opioids.

Study Overview

• Status: Completed
• Conditions: Opioid Use
• Intervention / Treatment: Other: Educational

Detailed Description

Participants presenting to the preoperative clinic will be recruited for this trial. After informed consent is obtained, patients will be randomized to one of 2 groups: 1) educational pamphlet and standard care, or 2) control group - standard care (no pamphlet) All patients will complete the opioid knowledge questionnaire to test baseline knowledge on opioids. If patient is randomized to the educational pamphlet and standard care, patient will receive the educational pamphlet and standard care. After the patient reviews the pamphlet, the patient will complete the questionnaire again. If the patient is randomized to the control group, the patient will receive the usual standard of care.

All patients will be contacted by telephone 15 days and 30 days after surgery to conduct the follow-up.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital, University Health Network

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:

• All English speaking
• Adult (≥18 yrs) surgical patients presenting to the Preoperative Clinic

Exclusion Criteria:

• Patients who are on opioids for chronic pain
• Patients have taken opioids in the past 30 days
• Patients who are unable to read and understand English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational pamphlet and standard care; patients randomized to the educational pamphlet arm will receive the educational pamphlet	Other: Educational; Educational pamphlet will be given to intervention group.
No Intervention: control group - standard care; Patients randomized to control arm, will receive the standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge	Change in knowledge on safe opioid use questionnaire immediately post-education.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge retention	Knowledge retention of safe opioid use questionnaire 15 days/30 days post-education. Proper disposal of unused opioids.	15 and 30 days

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Ontario Ministry of Health and Long Term Care
• Investigators: Principal Investigator: Jean Wong, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: May 11, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Version 15-April-2019

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