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

Primary Purpose

Opioid Use, Opioid-Related Disorders, Opioid Withdrawal

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SOONER Video & Kit
Standard of Care
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • St. Michael's Hospital, Unity Health Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SOONER Training (Intervention)

Standard of care training (control)

Arm Description

Arm receives video training and kit designed by SOONER team.

Participant referred to standard of care (community based Naloxone training)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 4, 2019
Last Updated
September 28, 2022
Sponsor
Unity Health Toronto
Collaborators
Toronto Public Health, Ontario College of Art and Design (OCAD), University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04740099
Brief Title
Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)
Acronym
SOONER
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study never started due to COVID-19.
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Toronto Public Health, Ontario College of Art and Design (OCAD), University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid-Related Disorders, Opioid Withdrawal, Opioid Overdose, Education, Resusitation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOONER Training (Intervention)
Arm Type
Experimental
Arm Description
Arm receives video training and kit designed by SOONER team.
Arm Title
Standard of care training (control)
Arm Type
Other
Arm Description
Participant referred to standard of care (community based Naloxone training)
Intervention Type
Other
Intervention Name(s)
SOONER Video & Kit
Other Intervention Name(s)
SOONER Naloxone kit
Intervention Description
A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Community Based Naloxone training referral
Intervention Description
A handout including a map and list of locations offering this service.
Primary Outcome Measure Information:
Title
Satisfactory basic life support performance
Description
Satisfactory basic life support performance on a standardized high fidelity overdose simulation, as assessed by the consensus of two trained clinicians.
Time Frame
4-14 days after enrolment
Secondary Outcome Measure Information:
Title
Performance on basic resuscitation skill: Recognize the Emergency
Description
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.
Time Frame
4-14 days after enrolment
Title
Performance on basic resuscitation skill: Position the Victim
Description
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.
Time Frame
4-14 days after enrolment
Title
Performance on basic resuscitation skill: Activate emergency medical services
Description
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.
Time Frame
4-14 days after enrolment
Title
Performance on basic resuscitation skill: Administer Naloxone
Description
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.
Time Frame
4-14 days after enrolment
Title
Performance on basic resuscitation skill: Hand placement
Description
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.
Time Frame
4-14 days after enrolment
Title
Performance on basic resuscitation skill: chest compressions
Description
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.
Time Frame
4-14 days after enrolment
Title
Performance on basic resuscitation skill: continue compressions until end of simulation
Description
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.
Time Frame
4-14 days after enrolment
Title
Performance on basic resuscitation skill: order of operations
Description
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.
Time Frame
4-14 days after enrolment
Other Pre-specified Outcome Measures:
Title
Standardized assessor-implemented survey and interview responses to measure overdose-related knowledge and behaviours
Description
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
Time Frame
4-14 days after enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Strike, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aaron Orkin, MD
Organizational Affiliation
University of Toronto
Official's Role
Study Chair
Facility Information:
Facility Name
St. Michael's Hospital, Unity Health Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6G3L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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