Take home naloxone in multicentre emergency settings Protocol for a feasibility study

Title : Take home naloxone in multicentre emergency settings Protocol for a feasibility study

Abstract:

Background

Opioids such as heroin kill more people worldwide than any other drug. In the UK, death from opioid poisoning is at record levels. Naloxone is an opioid agonist which can be distributed in take home ‘kits’, known as Take Home Naloxone (THN).

Methods

We are in the early stages of carrying out a randomised controlled feasibility trial (RCT) of THN distributed in emergency settings clustered by Emergency Department (ED) catchment area, and local ambulance service. The trial will include distribution of THN by paramedics and ED staff to patients at risk of opioid overdose. A discriminant function will be developed retrospectively identify people at high risk of overdose death using routine anonymised linked data.

Results

We will gather anonymised linked data outcomes at one year including; deaths; emergency admissions; intensive care admissions; ED attendances; 999 attendances; THN kits issued; and NHS resource usage. We will agree progression criteria related to successful identification and provision of THN to eligible participants; successful follow up of eligible participants and opioid decedents; adverse event rate; successful data matching and data linkage; and retrieval of outcomes within three months of projected timeline.

Conclusions

THN programmes are currently run by some drug services in the UK. However, saturation is low. There has been a lack of experimental research in to THN, and so questions remain: Does THN reduce deaths? Are there unforeseen harms associated with THN? Is THN cost effective? This feasibility study will establish whether a fully powered cluster RCT can be used to answer these questions.

Biography:

Helen Snooks currently works as a Professor of Health Services Research in the Medical School at Swansea University. She led the Patient and Population Health Informatics research theme within the School. She received seconded for one and a half days a week to the National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre (NETSCC) at University of Southampton, as Health Technology Assessment Journal Editor and Senior Scientific Advisor to the Health Services and Delivery Research programme. Also led the Trials Unit in Swansea to full registration with the UKCRC, retain a strong interest in experimental evaluation methods and have a strong record of grant capture, totalling 30 million. The main research interests and expertise lie in the fields of Emergency Pre-hospital and Unscheduled Care, Primary Care, and research support. In these areas, the focus of work is to plan, design and carry out evaluations of health technologies and new models of service delivery which often involve changing roles and working across boundaries between service providers. The research is applied, pragmatic and leads to change and impact in the real world of policy and practice. Helen actively encourage and support public and patient involvement in my research to enhance relevance, accountability and quality. Snooks work is strongly patient-focused and collaborative, and uses mixed methods to achieve study aims.