Education, Opioid Overdose, Opioid-Related Disorders, Opioid Use, Opioid Withdrawal, Resusitation
Conditions
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?
Interventions
OTHERSOONER Video & Kit
A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic.
OTHERStandard of Care
A handout including a map and list of locations offering this service.
Sponsors
Toronto Public Health
Ontario College of Art and Design (OCAD)
University of Toronto
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: 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: 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. |
| 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: 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: 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: 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Standardized assessor-implemented survey and interview responses to measure overdose-related knowledge and behaviours | 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 |
Countries
Canada
Outcome results
None listed