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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 : July 8, 2019
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Jean Wong, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE May 11, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE May 23, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Change in knowledge [ Time Frame: day 1 ]
Change in knowledge on safe opioid use questionnaire immediately post-education.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical Patient Knowledge and Safe Use of Opioids
Official Title  ICMJE Improving Surgical Patient Knowledge and Safe Use of Opioids - a Randomized Controlled Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid Use
Intervention  ICMJE Other: Educational
Educational pamphlet will be given to intervention group.
Study Arms  ICMJE
  • Experimental: Educational pamphlet and standard care
    patients randomized to the educational pamphlet arm will receive the educational pamphlet
    Intervention: Other: Educational
  • No Intervention: control group - standard care
    Patients randomized to control arm, will receive the standard care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean Wong, MD 416-603-5118 jean.wong@uhn.ca
Contact: Nishanthi Liyanage, MD 4160603-5800 ext 3959 nishanthi.liyanage@uhnresearch.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959787
Other Study ID Numbers  ICMJE Version 15-April-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jean Wong, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Ontario Ministry of Health and Long Term Care
Investigators  ICMJE
Principal Investigator: Jean Wong, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP