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.

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?

Study Overview

• Status: Withdrawn
• Conditions: Opioid-Related Disorders; Opioid Use; Education; Opioid Withdrawal; Opioid Overdose; Resusitation
• Intervention / Treatment: Other: SOONER Video & Kit; Other: Standard of Care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6G3L8
      • St. Michael's Hospital, Unity Health Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized assessor-implemented survey and interview responses to measure overdose-related knowledge and behaviours	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: Demographics: age, gender, ethnicity, housing status, and neighbourhood; Prescription medications; Opioid and non-opioid drug use in past 4 weeks: drug, amount, route, frequency; Drug use setting: where and with whom opioids were used; Periods of abstinence; Use of prevention strategies, and speaking to others about overdose or overdose response; Knowledge of overdose and naloxone use; Status of naloxone kit; Willingness and confidence to respond to overdose	4-14 days after enrolment

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: University of Toronto; Toronto Public Health; Ontario College of Art and Design (OCAD)
• 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): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Drug Overdose; Opiate Overdose; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: 19-169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All publications will indicate that original de-identified study data and statistical coding is available upon request from the Steering Committee. This information and will be shared freely with corresponding scholars and the public, on request.
• IPD Sharing Time Frame: Available on an ongoing basis upon request
• IPD Sharing Access Criteria: At the discretion of the research team
• 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: No
• Studies a U.S. FDA-regulated device product: No