Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial

Aaron M Orkin, Mercy Charles, Kristine Norris, Rekha Thomas, Leigh Chapman, Amy Wright, Douglas M Campbell, Curtis Handford, Michelle Klaiman, Shaun Hopkins, Rita Shahin, Kevin Thorpe, Peter Jüni, Janet Parsons, Kate Sellen, Nick Goso, Richard Hunt, Pamela Leece, Laurie J Morrison, Vicky Stergiopoulos, Suzanne Turner, Carol Strike, Aaron M Orkin, Mercy Charles, Kristine Norris, Rekha Thomas, Leigh Chapman, Amy Wright, Douglas M Campbell, Curtis Handford, Michelle Klaiman, Shaun Hopkins, Rita Shahin, Kevin Thorpe, Peter Jüni, Janet Parsons, Kate Sellen, Nick Goso, Richard Hunt, Pamela Leece, Laurie J Morrison, Vicky Stergiopoulos, Suzanne Turner, Carol Strike

Abstract

Aim: We plan to conduct a randomised clinical trial among people likely to witness opioid overdose to compare the educational effectiveness of point-of-care naloxone distribution with best-available care, by observing participants' resuscitation skills in a simulated overdose. This mixed methods feasibility study aims to assess the effectiveness of recruitment and retention strategies and acceptability of study procedures.

Methods: We implemented candidate-driven recruitment strategies with verbal consent and destigmatizing study materials in a family practice, emergency department, and addictions service. People ≥16 years of age who are likely to witness overdose were randomized to point-of-care naloxone distribution or referral to an existing program. We evaluated participant skills as a responder to a simulated overdose 3-14 days post-recruitment. Retention strategies included flexible scheduling, reminders, cash compensation and refreshments. The primary outcome was recruitment and retention feasibility, defined as the ability to recruit 28 eligible participants in 28 days, with <50% attrition at the outcome simulation. Acceptability of study procedures and motivations for participation were assessed in a semi-structured interview.

Results: We enrolled 30 participants over 24 days, and retained 21 participants (70%, 95%CI 56.7-100). The most common motivation for participation was a desire to serve the community or loved ones in distress. Participants reported that study procedures were acceptable and that the outcome simulation provided a supportive and affirming environment.

Conclusion: The planned trial is ready for implementation. Recruitment and retention is feasible and study processes are acceptable for people who are likely to witness overdose. (Registration: NCT03821649).

Keywords: Addiction medicine; Bystanders; Emergency medicine; Feasibility trial; Harm reduction; Opioid overdose; Overdose education and naloxone distribution; Pilot trial; Prehospital care; Public health; Randomized control trial; Resuscitation; Simulation; Study recruitment; Study retention; Substance use.

© 2021 The Authors.

Figures

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Fig. 1
CONSORT feasibility diagram.

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Source: PubMed

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