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

Abstract

IntroductionThe 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 analysisStrategies 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 disseminationThe 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 numberClinicalTrials.gov registry (NCT03821649).

Expert Perspectives on Pilot and Feasibility Studies: A Delphi Study and Consolidation of Considerations for Behavioral Interventions

“…Retention strategies, such as flexible scheduling, reminders, compensation, consistency in study staff (continuity of relationships), gathering multiple contacts, thank you and birthday cards, follow-up phone calls within a given period, can reduce the rate of participant drop-out. 139 , 147 – 149 Where dropouts occur, reasons for withdrawal from the study can be collected. 128 , 150 Factors influencing retention, both positively and negatively, including participant motivation/aspirations, expectations, perceived need for an intervention, accessibility of intervention (location delivered), can be collected from both participants and intervention deliverers.…”

Consolidated guidance for behavioral intervention pilot and feasibility studies

“…Retention strategies, such as flexible scheduling, reminders, compensation, consistency in study staff (continuity of relationships), gathering multiple contacts, thank you and birthday cards, and follow-up phone calls within a given period, can reduce the rate of participant drop-out [139,[147][148][149]. Where dropouts occur, reasons for withdrawal from the study can be collected [128,150].…”

Assessment of knowledge and behaviors of an opioid overdose education and naloxone distribution program during the Coronavirus disease 2019 pandemic.

“…Prevention of opioid induced mortality is directly related to the administration of naloxone in a timely manner. 10,11 Having higher distribution of naloxone can avert 21% opioid overdoses in communities. 12 Syringe service programs (SSPs) are ideal environments to supply individuals who are at high risk of opioid overdose or witnessing an opioid overdose additional access to opioid overdose education and naloxone distribution (OEND).…”