Swansea University, Swansea, UK.
Yorkshire Ambulance Service, Wakefield, UK.
BMC Emerg Med. 2024 Aug 29;24(1):155. doi: 10.1186/s12873-024-01061-3.
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).
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.
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.
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.
ISRCTN13232859 (Registered 16/02/2018).
阿片类药物的致死人数超过任何其他类别的药物。纳洛酮是一种阿片类拮抗剂，可以分发给同伴进行管理。我们评估了在紧急情况下实施带药回家纳洛酮（THN）干预的可行性，这是设计一项确定性随机对照试验（RCT）的一部分。
我们在英国急诊部（ED）和救护服务配对的地点进行了一项聚类 RCT。在干预地点，我们招募急诊医疗保健从业人员向阿片类药物过量或相关病症的患者提供 THN，招募工作于 2019 年至 2021 年进行。我们根据四个预定的进展标准评估干预实施的可行性，这些标准涵盖了站点注册和员工培训；确定合格患者；发放 THN 试剂盒和严重不良事件。
在从 4 个地点中随机选择的两个干预地点，对 299/687 名（43.5%）临床工作人员进行了培训（ED1=107，AS1=121，ED2=25，AS2=46）。向 60 名符合条件的患者提供了 THN 试剂盒（21.7%）（n：ED1=36，AS1=4，ED2=16，AS2=4）。在所有地点，另有 164 名符合条件的患者未获得试剂盒，原因包括：工作人员忘记（n=136）、工作人员太忙（n=15）、疑似故意过量（n=3）、无试剂盒可用（n=2）、已由药物护士发放（n=4）、其他（n=4）。工作人员记录了 626 名其他不符合条件但被认为有资格纳入的患者，列出的原因包括：患者住院（n=194）、患者逃跑（n=161）、已招募（n=64）、不合作或辱骂（n=55）、工作人员未培训（n=43）、意识水平降低（n=41）、无能力（n=35）、患者被拘留（n=21）、其他（n=12）。没有报告不良事件。
工作人员和患者的招募人数很少，且各地点差异很大。这项可行性研究未达到进展标准；不计划进行完全有效的 RCT。
ISRCTN8226503（2018 年 2 月 16 日注册）。
