Moore Chris, Lloyd Gregory, Oretti Rossana, Russell Ian, Snooks Helen
Medical and Clinical Services Directorate, Welsh Ambulance Services NHS Trust, Blackweir Ambulance Station, Cardiff, UK.
BMJ Open. 2014 Mar 20;4(3):e004712. doi: 10.1136/bmjopen-2013-004712.
'Take Home' Naloxone (THN) kits for use by peers in the event of an opioid overdose may reduce further overdose and deaths, but distribution through Drugs Services may not reach those at highest risk. Attendance by paramedics at emergency calls for patients who have suffered an overdose presents an opportunity to distribute THN kits. In this feasibility study we will assess the acceptability of this intervention, and gather data to inform definitive trial planning.
Cluster randomised trial with staggered allocation of paramedics (clusters) to groups. We will invite paramedics in an urban area of south Wales, UK to take part. We will randomly allocate those that accept to training sessions during the first 4 months of the trial. Patients attended by paramedics who have been trained and issued THN kits will fall into the intervention group. Patients attended by paramedics following usual practice (until they receive their training and THN kits) will fall into the control group. We will gather data about processes and outcomes of care: numbers of patients eligible for intervention, offered and accepted THN, attended emergency department, suffered further overdose, died within 3 months and about follow-up rates: numbers of patients consented, completed (postal or telephone) questionnaire. We will gather qualitative data about acceptability to patients and paramedics through interviews and focus groups.
Ethical approval for this study was granted on 7 December 2011, by South East Wales Research Ethics Committee, Panel C. Results of this study will be reported through peer-reviewed scientific journals, conference presentations and internal organisational report. We will also seek to report our findings through local and national substance misuse networks and publications.
ISRCTN98216498.
“带回家”纳洛酮（THN）试剂盒供同伴在阿片类药物过量使用时使用，可能会减少进一步的过量使用和死亡，但通过药物服务机构分发可能无法覆盖到风险最高的人群。护理人员在接到过量用药患者的急救电话时出诊，为分发THN试剂盒提供了一个机会。在这项可行性研究中，我们将评估这种干预措施的可接受性，并收集数据为确定性试验规划提供信息。
采用整群随机试验，将护理人员（整群）交错分配到不同组。我们将邀请英国南威尔士一个市区的护理人员参与。我们将随机分配那些同意参与的人员在试验的前4个月参加培训课程。接受过培训并收到THN试剂盒的护理人员出诊的患者将归入干预组。按照常规做法出诊的护理人员（直到他们接受培训并收到THN试剂盒）所护理的患者将归入对照组。我们将收集有关护理过程和结果的数据：符合干预条件的患者数量、提供并接受THN的患者数量、到急诊科就诊的患者数量、再次过量用药的患者数量、3个月内死亡的患者数量，以及随访率：同意参与的患者数量、完成（邮寄或电话）问卷的患者数量。我们将通过访谈和焦点小组收集有关患者和护理人员可接受性的定性数据。
本研究于2011年12月7日获得东南威尔士研究伦理委员会C组的伦理批准。本研究结果将通过同行评审的科学期刊、会议报告和内部组织报告进行汇报。我们还将寻求通过地方和国家药物滥用网络及出版物汇报我们的研究结果。
ISRCTN98216498。
