NCT03959787

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

2 active sites

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

May 11, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
5 months 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

11 months

First QC Date

May 11, 2019

Last Update Submit

October 27, 2021

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

  • Change in knowledge

    Change in knowledge on safe opioid use questionnaire immediately post-education.

    day 1

Secondary Outcomes (1)

  • Knowledge retention

    15 and 30 days

Study Arms (2)

Educational pamphlet and standard care

EXPERIMENTAL

patients randomized to the educational pamphlet arm will receive the educational pamphlet

Other: Educational

control group - standard care

NO INTERVENTION

Patients randomized to control arm, will receive the standard care.

Interventions

EducationalOTHER

Educational pamphlet will be given to intervention group.

Educational pamphlet and standard care

Eligibility Criteria

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

You may qualify if:

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

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 (2)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

  • Jean Wong, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2019

First Posted

May 22, 2019

Study Start

May 23, 2019

Primary Completion

April 30, 2020

Study Completion

September 30, 2020

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)