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.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Satisfactory basic life support performance
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Satisfactory basic life support performance
时间窗: 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.
次要结局
- Performance on basic resuscitation skill: chest compressions(4-14 days after enrolment)
- Performance on basic resuscitation skill: order of operations(4-14 days after enrolment)
- Performance on basic resuscitation skill: Position the Victim(4-14 days after enrolment)
- Performance on basic resuscitation skill: Recognize the Emergency(4-14 days after enrolment)
- Performance on basic resuscitation skill: Activate emergency medical services(4-14 days after enrolment)
- Performance on basic resuscitation skill: Hand placement(4-14 days after enrolment)
- Performance on basic resuscitation skill: continue compressions until end of simulation(4-14 days after enrolment)
- Performance on basic resuscitation skill: Administer Naloxone(4-14 days after enrolment)