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    Time: take-home naloxone in multicentre emergency settings: protocol for a feasibility study

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    Author
    Jones, Matthew
    Snooks, Helen
    Bulger, Jenna
    Watkins, Alan
    Moore, Chris
    Edwards, Adrian
    Evans, Birdie A.
    Fuller, Gordon
    John, Ann
    Benger, Jonathan cc
    Buykx, Penny
    Hoskins, Rebecca
    Dixon, Simon
    Goodacre, Steve
    Black, Sarah cc
    Parry, Emma
    Lawrence, Barbara
    Bell, Fiona
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    Keyword
    Emergency Medical Services
    Naloxone
    Randomized Controlled Trials as Topic
    Drug Overdose
    Journal title
    Emergency Medicine Journal
    
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    Show full item record
    URI
    http://hdl.handle.net/20.500.12417/1090
    DOI
    10.1136/emermed-2019-999.24
    Abstract
    Background Opioids such as heroin kill more people worldwide than any other drug. Death rates associated with opioid poisoning in the UK are at record levels. Naloxone is an opioid agonist which can be distributed in take home ‘kits’. This intervention is known as Take Home Naloxone (THN). Methods We propose to carry out a randomised controlled feasibility trial (RCT) of THN distributed in emergency settings clustered by Emergency Department (ED) catchment area, and local ambulance service; with anonymised linked data outcomes. This will include distribution of THN by paramedics and ED staff to patients at risk of opioid overdose. Existing linked data will be used to develop a discriminant function to retrospectively identify people at high risk of overdose death based on observable predictors of overdose to include in outcome follow up. Results We will gather outcomes up to one year including; deaths (and drug related); emergency admissions; intensive care admissions; ED attendances (and overdose related); 999 attendances (and for overdose); THN kits issued; and NHS resource usage. We will agree progression criteria following consultation with research team members related to sign up of sites; 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. https://emj.bmj.com/content/36/1/e10.1. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ DOI http://dx.doi.org/10.1136/emermed-2019-999.24
    ae974a485f413a2113503eed53cd6c53
    10.1136/emermed-2019-999.24
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    Publications - Yorkshire Ambulance Service
    Publications - South Western Ambulance Service

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