- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04740099
Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER) (SOONER)
Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER): Randomized Trial and Embedded Qualitative Study to Compare the Effectiveness of point-of Care Overdose Education and Naloxone Distribution Versus Referral to an Existing Community Program in the Management of Simulated Opioid-associated Resuscitative Emergencies.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M6G3L8
- St. Michael's Hospital, Unity Health Toronto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adults ≥16 years of age, and
Eligible for overdose education according to criteria adapted from the 2015 American Heart Association Guidelines by meeting any one or more of the following criteria:
- has a history of taking opioids at recognized 'high doses' (whether by prescription or otherwise, defined as >100mg morphine equivalent per day);
- has required emergency care for opioid overdose previously;
- is enrolled in opioid agonist treatment programs, including methadone or buprenorphine maintenance programs, or stopped an opioid agonist treatment program in the last 6 months;
- uses non-medical opioids, injects opioids, or acquires opioids from sources other than a pharmacy or healthcare setting;
- has a history of non-medical opioid use who are being released from prison;
- is receiving prescription opioid therapy with risk factors for adverse effects, including i. relevant comorbidities, ii. co-prescriptions of benzodiazepines or other sedatives, iii. concomitant ongoing alcohol use, iv. use of prescription opioids not as prescribed.
- is likely to witness an opioid overdose, defined as anyone who lives with or is in frequent contact with others who use opioids, or who has previously witnessed an opioid overdose.
Exclusion Criteria:
- plan to move away from Toronto during the study period
- have no mode of contact or follow-up,
- have a community do not resuscitate order,
- have a terminal illness, end-of-life care, or illness likely to result in death within the study period,
- are an active or previously practicing healthcare professional or professional first responder (e.g.: firefighter, police officer, lifeguard, industrial first responder), or
- have insufficient English language skills to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SOONER Training (Intervention)
Arm receives video training and kit designed by SOONER team.
|
A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic.
Other Names:
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Other: Standard of care training (control)
Participant referred to standard of care (community based Naloxone training)
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A handout including a map and list of locations offering this service.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfactory basic life support performance
Time Frame: 4-14 days after enrolment
|
Satisfactory basic life support performance on a standardized high fidelity overdose simulation, as assessed by the consensus of two trained clinicians.
|
4-14 days after enrolment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance on basic resuscitation skill: Recognize the Emergency
Time Frame: 4-14 days after enrolment
|
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians.
Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
|
4-14 days after enrolment
|
Performance on basic resuscitation skill: Position the Victim
Time Frame: 4-14 days after enrolment
|
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians.
Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
|
4-14 days after enrolment
|
Performance on basic resuscitation skill: Activate emergency medical services
Time Frame: 4-14 days after enrolment
|
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians.
Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
|
4-14 days after enrolment
|
Performance on basic resuscitation skill: Administer Naloxone
Time Frame: 4-14 days after enrolment
|
Skill performance on device preparation and correct administration will be rated as either satisfactory or unsatisfactory by two trained clinicians.
Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
|
4-14 days after enrolment
|
Performance on basic resuscitation skill: Hand placement
Time Frame: 4-14 days after enrolment
|
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians.
Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
|
4-14 days after enrolment
|
Performance on basic resuscitation skill: chest compressions
Time Frame: 4-14 days after enrolment
|
Skill performance (rate and depth of chest compressions) will be rated as either satisfactory or unsatisfactory by two trained clinicians.
Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
|
4-14 days after enrolment
|
Performance on basic resuscitation skill: continue compressions until end of simulation
Time Frame: 4-14 days after enrolment
|
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians.
Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
|
4-14 days after enrolment
|
Performance on basic resuscitation skill: order of operations
Time Frame: 4-14 days after enrolment
|
Skill performance will be rated as either satisfactory or unsatisfactory by two trained clinicians.
Inter-rater reliability of the assessors for each of the eight secondary outcome skills will be calculated.
|
4-14 days after enrolment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized assessor-implemented survey and interview responses to measure overdose-related knowledge and behaviours
Time Frame: 4-14 days after enrolment
|
The questionnaires were developed for the Toronto Public Health OEND program evaluation using data points from other overdose education and naloxone distribution programs and from the validated Opioid Overdose Knowledge and Attitudes Scales (OOKS and OOAS). We also included relevant questions from a national survey of injection drug users (ITRACK, Health Canada) and the CAMH Monitor conducted by the Centre for Addiction and Mental Health (CAMH). The questionnaire items include:
|
4-14 days after enrolment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carol Strike, PhD, University of Toronto
- Study Chair: Aaron Orkin, MD, University of Toronto
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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