Not provided
Not provided
Not provided
Not provided
The study never started due to COVID-19.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Toronto Public Health | OTHER_GOV |
| Ontario College of Art and Design (OCAD) | UNKNOWN |
| University of Toronto | OTHER |
Not provided
Not provided
Not provided
Not provided
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?
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOONER Training (Intervention) | Experimental | Arm receives video training and kit designed by SOONER team. |
|
| Standard of care training (control) | Other | Participant referred to standard of care (community based Naloxone training) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOONER Video & Kit | Other | A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic. |
|
| 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 |
| 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 |
| 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:
|
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carol Strike, PhD | University of Toronto | Principal Investigator |
| Aaron Orkin, MD | University of Toronto | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital, Unity Health Toronto | Toronto | Ontario | M6G3L8 | Canada |
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.
Available on an ongoing basis upon request
At the discretion of the research team
Not provided
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000083682 | Opiate Overdose |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D020794 | Receptor Protein-Tyrosine Kinases |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
Not provided
Not provided
Pragmatic, multi-site, 2-armed, parallel-group, best available care controlled, analyst- and outcome assessor-blinded, superiority trial with embedded qualitative study.
Not provided
Not provided
Not provided
|
| Standard of Care | Other | A handout including a map and list of locations offering this service. |
|
|
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 |
| 4-14 days after enrolment |
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |