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

Not Applicable

Withdrawn

• Conditions: Opioid Use; Opioid-Related Disorders; Opioid Overdose; Education; Opioid Withdrawal; Resusitation
• Interventions: Other: SOONER Video & Kit; Other: Standard of Care

• Registration Number: NCT04740099
• Lead Sponsor: Unity Health Toronto

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-05
• Study Start: 2021-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-10-03
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. adults ≥16 years of age, and

2. 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:

   1. has a history of taking opioids at recognized 'high doses' (whether by prescription or otherwise, defined as >100mg morphine equivalent per day);
   2. has required emergency care for opioid overdose previously;
   3. 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;
   4. uses non-medical opioids, injects opioids, or acquires opioids from sources other than a pharmacy or healthcare setting;
   5. has a history of non-medical opioid use who are being released from prison;
   6. 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.
   7. 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

1. plan to move away from Toronto during the study period
2. have no mode of contact or follow-up,
3. have a community do not resuscitate order,
4. have a terminal illness, end-of-life care, or illness likely to result in death within the study period,
5. are an active or previously practicing healthcare professional or professional first responder (e.g.: firefighter, police officer, lifeguard, industrial first responder), or
6. have insufficient English language skills to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOONER Training (Intervention)	SOONER Video & Kit	Arm receives video training and kit designed by SOONER team.
Standard of care training (control)	Standard of Care	Participant referred to standard of care (community based Naloxone training)

Primary Outcome Measures

Name	Time	Method
Satisfactory basic life support performance	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 Outcome Measures

Name	Time	Method
Performance on basic resuscitation skill: chest compressions	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.
Performance on basic resuscitation skill: order of operations	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.
Performance on basic resuscitation skill: Position the Victim	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.
Performance on basic resuscitation skill: Recognize the Emergency	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.
Performance on basic resuscitation skill: Activate emergency medical services	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.
Performance on basic resuscitation skill: Hand placement	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.
Performance on basic resuscitation skill: continue compressions until end of simulation	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.
Performance on basic resuscitation skill: Administer Naloxone	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.

Trial Locations

Locations (1)

St. Michael's Hospital, Unity Health Toronto; 🇨🇦 Toronto, Ontario, Canada