Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.

Introduction: The surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants' performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial.
Methods and Analysis: Strategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2 weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered.
Ethics and Dissemination: The study has been reviewed by ethics boards at St. Michael's Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations.
Trial Registration Number: ClinicalTrials.gov registry (NCT03821649).
Competing Interests: Competing interests: AO: evidence reviewer for ILCOR 2015, and writer for AHA/HSFC Guidelines on CPR and Resuscitation in 2015. Receives salary support from the Canadian Institutes of Health Research, the Schwartz/Reisman Emergency Medicine Institute, and the University of Toronto Department of Family and Community Medicine. AO is an evidence reviewer for the International Liaison Committee on Resuscitation and a coauthor for the 2015 American Heart Association Guidelines for CPR and ECC concerning opioid overdose and 2019 American Heart Association Guidelines updates on First Aid. CH: Contract with Toronto Central Local Health Integration Network as primary care clinical lead for the mid-east Toronto sub-region. MK: speaker honoraria from the Ontario Pharmacists Association continuing education programs on the topic of opioid use disorder. I do not address take home naloxone beyond mentioning that the programme exists (Major >$5000). Advisory Committee Member, Health Quality Ontario, Quality Standard on Opioid Use Disorder, but recused from voting on standards that involved take-home naloxone. PL: Advisory Committee Member, Health Quality Ontario, Quality Standard: Opioid Use Disorder; Quality Statement 6 pertains to access to naloxone and overdose education. LM: contributor to the 2015 guidelines and ILCOR consensus on science where opioid management was reviewed and updated.
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