To examine randomised controlled trial (RCT) progression criteria including emergency department (ED) attendance and non-fatal overdose, from a holistic, integrated health and social care outreach intervention (PHOENIx), for people experiencing homelessness with recent non-fatal street drug overdose.Pilot RCT. 1:1 randomisation to PHOENIx plus usual care (UC) or UC.Glasgow, Scotland.128 adults experiencing homelessness with at least one non-fatal street drug overdose in the preceding 6 months.Pharmacists from the National Health Service and third sector homelessness workers offered weekly outreach. PHOENIx teams develop therapeutic relationships to address health (physical health, mental health and problem drug use) and social care (housing, welfare benefits and social prescribing) in addition to UC. UC comprised building-based primary and secondary health, social and third sector services.Primary: progression criteria: recruitment (≥100 participants in 4 months); ≥80% of participants with data collected at baseline, 6 and 9 months; ≥60% of participants retained in the trial at each follow-up period (6 and 9 months); ≥60% of participants receiving the intervention weekly; any reduction in the rate of presentation to ED and overdoses, at 6- or 9-month follow-up. Secondary: participants with, and time to: hospitalisations; health-related quality of life (QoL); treatment uptake for physical and mental health conditions, and problematic drug use.Progression criteria were exceeded. In PHOENIx compared with UC, there appeared to be a delay in the median time to ED visit, overdose and hospitalisation but no improvement in number of participants with ED visits, overdoses or hospitalisations. QoL and treatment uptake appeared to be higher in PHOENIx versus UC at 6 and 9 months.A definitive RCT is merited, to assess the impact of PHOENIx on people with multiple, severe disadvantages.ISRCTN10585019.
检验随机对照试验(RCT)进展标准,包括急诊(ED)就诊和非致命性过量用药情况,这些标准来自一项针对近期有非致命性街头药物过量的无家可归者的整体、综合的健康和社会关怀外展干预措施(PHOENIx)。试点随机对照试验。按1:1比例随机分配到PHOENIx加常规护理(UC)组或常规护理组。地点在苏格兰格拉斯哥。128名无家可归的成年人,在过去6个月内至少有一次非致命性街头药物过量。来自国民医疗服务体系的药剂师和第三部门的无家可归者工作者每周提供外展服务。PHOENIx团队除常规护理外,还建立治疗关系以解决健康(身体健康、心理健康和药物滥用问题)和社会关怀(住房、福利和社会处方)问题。常规护理包括基于机构的初级和二级健康、社会和第三部门服务。
主要标准:进展标准:招募(4个月内≥100名参与者);≥80%的参与者在基线、6个月和9个月时收集数据;≥60%的参与者在每个随访期(6个月和9个月)仍留在试验中;≥60%的参与者每周接受干预;在6个月或9个月随访时,急诊就诊率和过量用药率有所降低。
次要标准:参与者出现以下情况及达到相关情况的时间:住院;与健康相关的生活质量(QoL);身心健康状况以及药物滥用问题的治疗接受情况。
进展标准已超额完成。与常规护理组相比,PHOENIx组在急诊就诊、过量用药和住院的中位时间似乎有所延迟,但急诊就诊、过量用药或住院的参与者人数没有改善。在6个月和9个月时,PHOENIx组的生活质量和治疗接受情况似乎高于常规护理组。有必要进行一项确定性的随机对照试验,以评估PHOENIx对具有多种严重不利条件的人群的影响。ISRCTN10585019