Protocol for a multi-site study of the effects of overdose prevention education with naloxone distribution program in Skåne County, Sweden

Abstract

Background Continuously high rates of overdose deaths in Sweden led to the decision by the Skåne County to initiate the first regional take-home naloxone program in Sweden. The project aims to study the effect of overdose prevention education and naloxone distribution on overdose mortality in Skåne County. Secondary outcome measures include non-fatal overdoses and overdose-related harm in the general population, as well as cohort-specific effects in study participants regarding overdoses, mortality and retention in naloxone program. Methods Implementation of a multi-site train-the-trainer cascade model was launched in June 2018. Twenty four facilities, including opioid substitution treatment units, needle exchange programs and in-patient addiction units were included for the first line of start-up, aspiring to reach a majority of individuals at-risk within the first 6 months. Serving as self-sufficient naloxone hubs, these units provide training, naloxone distribution and study recruitment. During 3 years, questionnaires are obtained from initial training, follow up, every sixth month, and upon refill. Estimated sample size is 2000 subjects. Naloxone distribution rates are reported, by each unit, every 6 months. Medical diagnoses, toxicological raw data and data on mortality and cause of death will be collected from national and regional registers, both for included naloxone recipients and for the general population. Data on vital status and treatment needs will be collected from registers of emergency and prehospital care. Discussion Despite a growing body of literature on naloxone distribution, studies on population effect on mortality are scarce. Most previous studies and reports have been uncontrolled, thus not being able to link naloxone distribution to survival, in relation to a comparison period. As Swedish registers present the opportunity to monitor individuals and entire populations over time, conditions for conducting systematic follow-ups in the Swedish population are good, serving the opportunity to study the impact of large scale overdose prevention education and naloxone distribution and thus fill the knowledge gap. Trial registration Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications, NCT 03570099, registered on 26 June 2018.

Characteristics of and Experience Among People Who Use Take-Home Naloxone in Skåne County, Sweden

“…This project had the advantages of being politically and financially supported and of having a regional infrastructure allowing for efficient implementation and access to patients at risk through a network of multiple local healthcare sites by utilization of train-the-trainer model ( 39 ). As Swedish regulations state that naloxone only can be prescribed to patients at risk of opioid overdose, the goal was to increase awareness and to motivate all patients to accept training and THN offered at targeted sites.…”

“…The OPEND training curriculum previously described in detail in Troberg et al ( 39 ) is based on a train-the-trainer model where the project leaders train staff at all sites, whom in turn train their patients. The train-the-trainer education sessions encourages trainers to include patients on a broader level.…”

“…Training and distribution continued during the Covid-19 pandemic, though patients' practical (hands on) practice on the CPR-manikin was paused, in accordance with government recommendations and restrictions. Train-the-trainer sessions ( 39 ) were held outdoors, or on-line, to accommodate new sites opening during the pandemic. Exceptions were only made if deemed necessary, and if requirements on safety precautions could be met.…”

“…An informed consent was obtained, and patients were asked to fill out the questionnaire. A full description of the questionnaires has previously been described in Troberg et al ( 39 ). The following description of collected data only concerns questions currently applied in this study.…”

Socioeconomic correlates of incident and fatal opioid overdose among Swedish people with opioid use disorder

“…This is important in order to identify subgroups of people with OUD who could benefit from prioritized opioid OD prevention and take-home naloxone distribution. The opioid antidote naloxone was introduced for take-home use in Sweden in 2018 in order to save people’s lives [ 27 ].…”