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一项由同伴提供的自我管理干预措施预防危机解决团队使用者复发的临床及成本效益随机对照试验:研究方案

Randomised controlled trial of the clinical and cost-effectiveness of a peer-delivered self-management intervention to prevent relapse in crisis resolution team users: study protocol.

作者信息

Johnson Sonia, Mason Oliver, Osborn David, Milton Alyssa, Henderson Claire, Marston Louise, Ambler Gareth, Hunter Rachael, Pilling Stephen, Morant Nicola, Gray Richard, Weaver Tim, Nolan Fiona, Lloyd-Evans Brynmor

机构信息

Division of Psychiatry, University College London, London, UK.

R & D Department, Camden and Islington NHS Foundation Trust, London, UK.

出版信息

BMJ Open. 2017 Oct 27;7(10):e015665. doi: 10.1136/bmjopen-2016-015665.

Abstract

INTRODUCTION

Crisis resolution teams (CRTs) provide assessment and intensive home treatment in a crisis, aiming to offer an alternative for people who would otherwise require a psychiatric inpatient admission. They are available in most areas in England. Despite some evidence for their clinical and cost-effectiveness, recurrent concerns are expressed regarding discontinuity with other services and lack of focus on preventing future relapse and readmission to acute care. Currently evidence on how to prevent readmissions to acute care is limited. Self-management interventions, involving supporting service users in recognising and managing signs of their own illness and in actively planning their recovery, have some supporting evidence, but have not been tested as a means of preventing readmission to acute care in people leaving community crisis care. We thus proposed the current study to test the effectiveness of such an intervention. We selected peer support workers as the preferred staff to deliver such an intervention, as they are well-placed to model and encourage active and autonomous recovery from mental health problems.

METHODS AND ANALYSIS

The CORE (CRT Optimisation and Relapse Prevention) self-management trial compares the effectiveness of a peer-provided self-management intervention for people leaving CRT care, with treatment as usual supplemented by a booklet on self-management. The planned sample is 440 participants, including 40 participants in an internal pilot. The primary outcome measure is whether participants are readmitted to acute care over 1 year of follow-up following entry to the trial. Secondary outcomes include self-rated recovery at 4 and at 18 months following trial entry, measured using the Questionnaire on the Process of Recovery. Analysis will follow an intention to treatment principle. Random effects logistic regression modelling with adjustment for clustering by peer support worker will be used to test the primary hypothesis.

ETHICS AND DISSEMINATION

The CORE self-management trial was approved by the London Camden and Islington Research Ethics Committee (REC ref: 12/LO/0988). A Trial Steering Committee and Data Monitoring Committee oversee the progress of the study. We will report on the results of the clinical trial, as well as on the characteristics of the participants and their associations with relapse.

TRIAL REGISTRATION NUMBER

ISRCTN 01027104;pre-results stage.

摘要

引言

危机解决团队(CRTs)在危机中提供评估和强化家庭治疗,旨在为那些原本需要住院接受精神科治疗的人提供另一种选择。在英格兰的大多数地区都设有危机解决团队。尽管有一些证据表明它们具有临床疗效和成本效益,但人们对其与其他服务的连续性以及缺乏对预防未来复发和再次入院接受急性护理的关注仍存在反复担忧。目前,关于如何预防再次入院接受急性护理的证据有限。自我管理干预措施,包括支持服务使用者识别和管理自身疾病的症状以及积极规划康复过程,有一些支持性证据,但尚未作为预防离开社区危机护理的人再次入院接受急性护理的手段进行测试。因此,我们开展了本研究以测试这种干预措施的有效性。我们选择同伴支持工作者作为提供此类干预的首选人员,因为他们非常适合为从心理健康问题中积极自主康复树立榜样并给予鼓励。

方法与分析

CORE(危机解决团队优化与复发预防)自我管理试验比较了同伴提供的自我管理干预措施对离开危机解决团队护理的人的有效性,以及常规治疗辅以一本自我管理手册的效果。计划样本为440名参与者,其中包括40名内部试点参与者。主要结局指标是参与者在进入试验后的1年随访期内是否再次入院接受急性护理。次要结局包括在进入试验后的4个月和18个月时使用康复过程问卷测量的自我评定康复情况。分析将遵循意向性治疗原则。将使用随机效应逻辑回归模型,并对同伴支持工作者的聚类进行调整,以检验主要假设。

伦理与传播

CORE自我管理试验已获得伦敦卡姆登和伊斯灵顿研究伦理委员会批准(伦理审查委员会编号:12/LO/0988)。一个试验指导委员会和数据监测委员会监督研究进展。我们将报告临床试验结果,以及参与者的特征及其与复发的关联。

试验注册号

ISRCTN 01027104;结果前阶段。

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