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Take-home naloxone administered in emergency settings: feasibility of intervention implementation in a cluster randomized trial

Abstract:

Background: Opioids kill more people than any other class of drug. Naloxone is an opioid antagonist which can be distributed in kits for peer administration. We assessed the feasibility of implementing a Take-home Naloxone (THN) intervention in emergency settings, as part of designing a definitive randomised controlled trial (RCT).

Methods: We undertook a clustered RCT on sites pairing UK Emergency Departments (ED) and ambulance services. At intervention sites, we recruited emergency healthcare practitioners to supply THN to patients presenting with opioid overdose or related condition, with recruitment across 2019–2021. We assessed feasibility of intervention implementation against four predetermined progression criteria covering site sign up and staff training; identification of eligible patients; issue of THN kits and Serious Adverse Events.

Results: At two intervention sites, randomly selected from 4, 299/687 (43.5%) clinical staff were trained (ED1 = 107, AS1 = 121, ED2 = 25, AS2 = 46). Sixty THN kits were supplied to eligible patients (21.7%) (n: ED1 = 36, AS1 = 4, ED2 = 16, AS2 = 4). Across sites, kits were not issued to eligible patients on a further 164 occasions, with reasons reported including: staff forgot (n = 136), staff too busy (n = 15), and suspected intentional overdose (n = 3), no kit available (n = 2), already given by drugs nurse (n = 4), other (n = 4). Staff recorded 626 other patients as ineligible but considered for inclusion, with reasons listed as: patient admitted to hospital (n = 194), patient absconded (n = 161) already recruited (n = 64), uncooperative or abusive (n = 55), staff not trained (n = 43), reduced consciousness level (n = 41), lack of capacity (n = 35), patient in custody (n = 21), other (n = 12). No adverse events were reported.

Conclusion: Staff and patient recruitment were low and varied widely by site. This feasibility study did not meet progression criteria; a fully powered RCT is not planned.

Trial Registration: ISRCTN13232859 (Registered 16/02/2018).

Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1186/s12873-024-01061-3

Authors


More by this author
Role:
Author
ORCID:
0000-0003-0173-8843
More by this author
Role:
Author
ORCID:
0000-0003-4503-1903


Publisher:
BioMed Central
Journal:
BMC Emergency Medicine More from this journal
Volume:
24
Issue:
1
Article number:
155
Publication date:
2024-08-29
Acceptance date:
2024-07-29
DOI:
EISSN:
1471-227X
Pmid:
39198758


Language:
English
Keywords:
Pubs id:
2041145
Local pid:
pubs:2041145
Deposit date:
2024-11-29

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