Improving Surgical Patient Knowledge and Safe Use of Opioids

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT03629314

Collaborator

(none)

Enrollment

Location

Arm

25.5

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 educate surgical patients about the risks of opioids and how to safely use opioids after surgery. The investigators have developed an educational pamphlet specifically for surgical patients to educate them about the safe use of opioids. The objective of this pilot study is to determine the usability and readability of an educational pamphlet about the safe use, proper storage and disposal of opioids. The educational pamphlet will be modified based on the feedback from the pilot study and subsequently used for a randomized controlled trial.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use	Other: Educational pamphlet arm	N/A

Detailed Description

Twenty participants presenting to the preoperative clinic will be recruited for the pilot study. After informed consent is obtained, patients will be given an opioid knowledge questionnaire to complete before the education. They will then be given an educational pamphlet to review. After they have reviewed the educational pamphlet, they will complete the same opioid knowledge questionnaire. They will also complete a questionnaire evaluating the patient educational pamphlet. The pamphlet will be modified based on the feedback from the patients in the pilot study.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Educational-Interventional Pilot studyEducational-Interventional Pilot study

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Improving Surgical Patient Knowledge and Safe Use of Opioids

Actual Study Start Date :

Aug 15, 2018

Actual Primary Completion Date :

Jun 25, 2019

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Educational Pamphlet arm Educational Pamphlet will be provided to all participants to review, questionnaire will be provided to complete before and after review of the pamphlets	Other: Educational pamphlet arm Educational pamphlets will be provided to review and questionnaire will be provided to complete before and after review of the pamphlet

Arm

Intervention/Treatment

Experimental: Educational Pamphlet arm

Educational Pamphlet will be provided to all participants to review, questionnaire will be provided to complete before and after review of the pamphlets

Other: Educational pamphlet arm

Educational pamphlets will be provided to review and questionnaire will be provided to complete before and after review of the pamphlet

Outcome Measures

Primary Outcome Measures

Opioid Education Questionnaire [10 - 15 minutes]
Total score 0-15 with higher scores representing more knowledge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥18 years adults
Proficient in English
scheduled for elective surgery

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Jean Wong, MD, University Health Network/Toronto Western Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jean Wong, Principal Investigator, University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03629314

Other Study ID Numbers:

18-5723

First Posted:

Aug 14, 2018

Last Update Posted:

Oct 28, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Keywords provided by Jean Wong, Principal Investigator, University Health Network, Toronto

Opioid

Study Results

No Results Posted as of Oct 28, 2021