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Surgical Patient Knowledge and Safe Use of Opioids

NCT ID: NCT03959787

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Educational pamphlet and standard care

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

Group Type EXPERIMENTAL

Educational

Intervention Type OTHER

Educational pamphlet will be given to intervention group.

control group - standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational

Educational pamphlet will be given to intervention group.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Jean Wong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Wong, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Women's College Hospital

Toronto, Ontario, Canada

Site Status

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Version 15-April-2019

Identifier Type: -

Identifier Source: org_study_id