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Surgical Patient Knowledge and Safe Use of Opioids

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ClinicalTrials.gov Identifier: NCT03959787
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Jean Wong, University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Opioid Use Other: Educational Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Surgical Patient Knowledge and Safe Use of Opioids - a Randomized Controlled Trial
Estimated Study Start Date : May 13, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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.



Primary Outcome Measures :
  1. Change in knowledge [ Time Frame: day 1 ]
    Change in knowledge on safe opioid use questionnaire immediately post-education.


Secondary Outcome Measures :
  1. Knowledge retention [ Time Frame: 15 and 30 days ]
    Knowledge retention of safe opioid use questionnaire 15 days/30 days post-education. Proper disposal of unused opioids.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959787


Contacts
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Contact: Jean Wong, MD 416-603-5118 jean.wong@uhn.ca
Contact: Asmita Bhoite, CRA 416-669-3059 asmita.bhoite@wchospital.ca

Locations
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Canada, Ontario
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Jean Wong, MD    416-603-5800 ext 3635    jean.wong@uhn.ca   
Contact: Asmita Bhoite, BAMS,CRA    416-669-3059    asmita.bhoite@wchospital.ca   
Principal Investigator: Jean Wong, MD         
Toronto Western Hospital, University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Jean Wong, MD    416-603-5800 ext 3635    jean.wong@uhn.ca   
Contact: Nishanthi Liyanage, MD    416 603 5800 ext 3959    nishanthi.liyanage@uhnresearch.ca   
Principal Investigator: Jean Wong, MD         
Sponsors and Collaborators
University Health Network, Toronto
Ontario Ministry of Health and Long Term Care
Investigators
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Principal Investigator: Jean Wong, MD University Health Network, Toronto

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Responsible Party: Jean Wong, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03959787     History of Changes
Other Study ID Numbers: Version 15-April-2019
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No