Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)

Study Overview
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Brief Summary
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Among people at risk of opioid overdose and receiving care in an academic emergency department, family practice, opioid substitution clinic or general inpatient units, does brief opioid overdose resuscitation training and naloxone distribution reduce resuscitation failures in a simulated overdose even, in comparison with standard-of-care referral to a local OEND program, within 14 days post-intervention? Can an integrated participant recruitment and retention strategy recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition rates in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings?

Official Title
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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.

Conditions
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Opioid Use, Opioid-Related Disorders, Opioid Withdrawal, Opioid Overdose, Education, Resusitation

Intervention / Treatment
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* Other: SOONER Video & Kit
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, multi-site, 2-armed, parallel-group, best available care controlled, analyst- and outcome assessor-blinded, superiority trial with embedded qualitative study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOONER Training (Intervention)<br>Arm receives video training and kit designed by SOONER team. | Other: SOONER Video & Kit<br>* A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic.<br>* Other names: SOONER Naloxone kit;|
| Other: Standard of care training (control)<br>Participant referred to standard of care (community based Naloxone training) | Other: Standard of Care<br>* A handout including a map and list of locations offering this service.<br>* Other names: Community Based Naloxone training referral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfactory basic life support performance | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |