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.

Unity Health Toronto1 site in 1 countryDecember 2021

ConditionsOpioid Use Opioid-Related Disorders Opioid Withdrawal Opioid Overdose Education Resusitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Opioid Use
Sponsor: Unity Health Toronto
Locations: 1
Primary Endpoint: Satisfactory basic life support performance
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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?

Registry

clinicaltrials.gov

Start Date

December 2021

End Date

March 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Unity Health Toronto

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Performance on basic resuscitation skill: chest compressions(4-14 days after enrolment)
Performance on basic resuscitation skill: order of operations(4-14 days after enrolment)
Performance on basic resuscitation skill: Position the Victim(4-14 days after enrolment)
Performance on basic resuscitation skill: Recognize the Emergency(4-14 days after enrolment)
Performance on basic resuscitation skill: Activate emergency medical services(4-14 days after enrolment)
Performance on basic resuscitation skill: Hand placement(4-14 days after enrolment)
Performance on basic resuscitation skill: continue compressions until end of simulation(4-14 days after enrolment)
Performance on basic resuscitation skill: Administer Naloxone(4-14 days after enrolment)