NCT03629314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

August 7, 2018

Last Update Submit

October 27, 2021

Conditions

Keywords

Opioid

Outcome Measures

Primary Outcomes (1)

  • Opioid Education Questionnaire

    Total score 0-15 with higher scores representing more knowledge

    10 - 15 minutes

Study Arms (1)

Educational Pamphlet arm

EXPERIMENTAL

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

Interventions

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

Educational Pamphlet arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years adults
  • Proficient in English
  • scheduled for elective surgery

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

  • Jean Wong, MD

    University Health Network/Toronto Western Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Educational-Interventional Pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 14, 2018

Study Start

August 15, 2018

Primary Completion

June 25, 2019

Study Completion

September 30, 2020

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations