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

IF 2.3 3区 医学 Q1 EMERGENCY MEDICINE
Helen A Snooks, Jenna K Jones, Fiona B Bell, Jonathon R Benger, Sarah L Black, Simon Dixon, Adrian Edwards, Helena Emery, Bridie A Evans, Gordon W Fuller, Steve Goodacre, Rebecca Hoskins, Jane Hughes, Ann John, Sasha Johnston, Matthew B Jones, Chris R Moore, Rakshita Parab, Richard Pilbery, Fiona C Sampson, Alan Watkins
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引用次数: 0

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).

紧急情况下带回家使用的纳洛酮:在分组随机试验中实施干预的可行性。
背景:死于阿片类药物的人数比其他任何一类药物都多。纳洛酮是一种阿片类药物拮抗剂,可以成套分发,供同伴使用。我们评估了在急诊环境中实施 "带回家纳洛酮"(THN)干预措施的可行性,作为设计明确的随机对照试验(RCT)的一部分:我们在英国急诊科(ED)和救护车服务的配对地点进行了分组随机对照试验。在干预地点,我们招募急诊医疗从业人员为阿片类药物过量或相关疾病患者提供 THN,招募时间为 2019-2021 年。我们根据四项预先确定的进展标准评估了干预措施实施的可行性,这些标准涵盖了现场注册和人员培训、符合条件的患者识别、THN 套件发放和严重不良事件:在随机抽取的 4 个干预地点中,有 299/687 (43.5%) 名临床工作人员接受了培训(ED1 = 107,AS1 = 121,ED2 = 25,AS2 = 46)。向符合条件的患者(21.7%)提供了 60 套 THN 套件(n:ED1 = 36,AS1 = 4,ED2 = 16,AS2 = 4)。在各医疗点中,还有 164 次未向符合条件的患者发放试剂盒,报告的原因包括:工作人员忘记(n = 136)、工作人员太忙(n = 15)、怀疑故意用药过量(n = 3)、没有试剂盒(n = 2)、药物护士已经发放(n = 4)、其他(n = 4)。根据工作人员的记录,另有 626 名患者不符合条件,但考虑纳入,原因如下:患者入院(n = 194)、患者潜逃(n = 161)、已招募(n = 64)、不合作或辱骂(n = 55)、工作人员未受过培训(n = 43)、意识水平下降(n = 41)、缺乏行为能力(n = 35)、患者在押(n = 21)、其他(n = 12)。无不良事件报告:员工和患者招募率较低,且不同地点的招募率差异很大。这项可行性研究不符合进展标准;未计划进行全面的 RCT 研究:ISRCTN13232859(注册日期:2018年2月16日)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Emergency Medicine
BMC Emergency Medicine Medicine-Emergency Medicine
CiteScore
3.50
自引率
8.00%
发文量
178
审稿时长
29 weeks
期刊介绍: BMC Emergency Medicine is an open access, peer-reviewed journal that considers articles on all urgent and emergency aspects of medicine, in both practice and basic research. In addition, the journal covers aspects of disaster medicine and medicine in special locations, such as conflict areas and military medicine, together with articles concerning healthcare services in the emergency departments.
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