Background “Take Home” Naloxone (THN) kits for use by peers in the event of an opioid overdose may reduce further overdose and deaths, but distribution through Drugs Services may not reach those at highest risk. Attendance by paramedics at emergency calls for patients who have suffered an overdose presents an opportunity to distribute THN kits. In this feasibility study we will assess the acceptability of this intervention, and gather data to inform definitive trial planning.
Design and methods Cluster randomised trial with staggered allocation of paramedics (clusters) to groups. We will invite paramedics in an urban area of south Wales, UK to participate. Paramedics will be randomly allocated to training sessions during the first four-months of the trial. Patients attended by paramedics who have been trained and issued THN kits will fall into the intervention group. Patients attended by paramedics following usual practice (until they receive their training and THN kits) will fall into the control group. We will gather data about processes and outcomes of care: numbers of patients eligible for intervention, offered and accepted THN, attended Emergency Department, suffered further overdose, died during study period and about follow up rates: numbers of patients consented, completed (postal or telephone) questionnaire. We will gather qualitative data about acceptability to patients and paramedics through interviews and focus groups.
Discussion Naloxone is considered a very safe drug with few known side effects. However, drug taking or help seeking behaviours may be altered by the provision of the kits and evidence is required to underpin widespread implementation of this new route for THN. This feasibility study will determine the acceptability of the intervention to patients and practitioners, casemix, volume and demographics; recruitment and follow up rates; and preliminary outcome data to inform definitive trial planning.
- data management
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