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

• ClinicalTrials.gov Identifier: NCT04740099
• Recruitment Status: Suspended
• First Posted: February 5, 2021
• Last Update Posted: February 5, 2021
• Sponsor: Unity Health Toronto
• Collaborators: Toronto Public Health; Ontario College of Art and Design (OCAD); University of Toronto
• Information provided by (Responsible Party): Unity Health Toronto

Study Description

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?

Condition or disease	Intervention/treatment	Phase
Opioid Use; Opioid-Related Disorders; Opioid Withdrawal; Opioid Overdose; Education; Resusitation	Other: SOONER Video & Kit; Other: Standard of Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: 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.
• Estimated Study Start Date: March 2021
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: March 2023

Arms and Interventions

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 Name: SOONER Naloxone kit
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 Name: Community Based Naloxone training referral

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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.
3. 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. 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.
5. 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.
6. 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.
7. 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.
8. 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.

Other Outcome Measures:

1. 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:

   1. Demographics: age, gender, ethnicity, housing status, and neighbourhood
   2. Prescription medications
   3. Opioid and non-opioid drug use in past 4 weeks: drug, amount, route, frequency
   4. Drug use setting: where and with whom opioids were used
   5. Periods of abstinence
   6. Use of prevention strategies, and speaking to others about overdose or overdose response
   7. Knowledge of overdose and naloxone use
   8. Status of naloxone kit
   9. Willingness and confidence to respond to overdose

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Canada, Ontario

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada, M6G3L8

Sponsors and Collaborators

Unity Health Toronto

Toronto Public Health

Ontario College of Art and Design (OCAD)

University of Toronto

Investigators

• Principal Investigator: Carol Strike, PhD; University of Toronto
• Study Chair: Aaron Orkin, MD; University of Toronto

More Information

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT04740099
• Other Study ID Numbers: 19-169
• First Posted: February 5, 2021
• Last Update Posted: February 5, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code
• Time Frame: Available on an ongoing basis upon request
• Access Criteria: At the discretion of the research team

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Opioid-Related Disorders; Drug Overdose; Opiate Overdose; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Naloxone; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents