Opioid UseNCT03959787
Surgical Patient Knowledge and Safe Use of Opioids
A study testing Educational in people with Opioid Use, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- What is being tested?
- Educational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 23 May 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All English speaking
- Adult (≥18 yrs) surgical patients presenting to the Preoperative Clinic
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Women's College Hospital
Toronto, Ontario, M5S 1B2
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
About this study
Official title: Improving Surgical Patient Knowledge and Safe Use of Opioids - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Opioid Use
- Being tested
- Educational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationalOther
Educational pamphlet will be given to intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Educational pamphlet and standard care | Experimental | patients randomized to the educational pamphlet arm will receive the educational pamphlet Receives: Other: Educational |
| control group - standard care | No intervention | Patients randomized to control arm, will receive the standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge
Change in knowledge on safe opioid use questionnaire immediately post-education.
Measured: day 1
Secondary outcomes (1)
Knowledge retention
Knowledge retention of safe opioid use questionnaire 15 days/30 days post-education. Proper disposal of unused opioids.
Measured: 15 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start23 May 2019
- Primary completion30 Apr 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Jean Wong, University Health Network, Toronto
- Investigators
- Jean Wong, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959787
- Sponsor's protocol ID
- Version 15-April-2019
- Status last verified
- Oct 2021
- First submitted
- 11 May 2019
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Surgical Patient Knowledge and Safe Use of Opioids - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03959787
- Acronym / sponsor ID
- Version 15-April-2019
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- 23 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational pamphlet and standard care | Experimental | Other: Educationalpatients randomized to the educational pamphlet arm will receive the educational pamphlet |
| control group - standard care | No intervention | –Patients randomized to control arm, will receive the standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All English speaking
- Adult (≥18 yrs) surgical patients presenting to the Preoperative Clinic
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationalEducational pamphlet will be given to intervention group. | Other | Educational pamphlet and standard care |
Primary outcome
Change in knowledge
Time frame: day 1
Change in knowledge on safe opioid use questionnaire immediately post-education.
1 secondary outcome
Knowledge retention
Time frame: 15 and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Wong, MD principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational in people with Opioid Use, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.