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Protocol for Take-home naloxone In Multicentre Emergency (TIME) settings: feasibility study
Matthew Jones1, Fiona Bell2, Jonathan Benger3
1Swansea University, Wales, UK.
Pilot and Feasibility Studies
|July 17, 2020
Summary
This study assesses the feasibility of distributing take-home naloxone (THN) kits in emergency settings to combat rising opioid overdose deaths. Findings will inform a larger trial on THN
Area of Science:
- Public Health
- Emergency Medicine
- Pharmacology
Background:
- Opioid overdose deaths, particularly from heroin, are a global crisis with record levels in the UK.
- Take-home naloxone (THN) kits are distributed to witnesses for overdose emergencies, saving lives individually.
- Limited evidence exists on THN's aggregate effectiveness in specialist drug or emergency services.
Purpose of the Study:
- To determine the feasibility of a large-scale cluster randomised controlled trial (RCT) for THN distribution in emergency settings.
- To investigate whether THN kits reduce opioid overdose deaths in at-risk populations.
- To assess potential unforeseen harms and cost-effectiveness of THN distribution.
Main Methods:
- A feasibility study for an RCT of THN distribution in emergency settings across four sites (Emergency Department and ambulance service clusters).
- Intervention sites: paramedics and ED staff distribute THN to at-risk patients; control sites maintain usual practice.
- Data collection includes deaths, admissions, kit issuance, NHS resource use, and participant identification for up to 1 year post-recruitment.
Main Results:
- The study aims to establish feasibility based on pre-defined progression criteria for site recruitment, staff training, participant identification, THN provision, and outcome retrieval.
- Specific criteria include: 4 sites signed up, ≥50% staff trained, ≥50% eligible participants identified and receiving THN, ≥75% high-risk individuals identified for follow-up, ≥75% outcomes retrieved, and <10% adverse event rate difference.
Conclusions:
- This is the first randomised, robust investigation of THN distribution in emergency settings.
- The study addresses a critical evidence gap regarding THN's effectiveness in emergency care.
- Novel methods for participant identification and data capture are employed due to the infeasibility of informed consent in emergency settings.
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