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研究方案:整群随机对照试验,以评估住院精神卫生康复单元中一项员工培训干预措施在提高服务使用者参与活动方面的临床效果和成本效益。

Study protocol: cluster randomised controlled trial to assess the clinical and cost effectiveness of a staff training intervention in inpatient mental health rehabilitation units in increasing service users' engagement in activities.

作者信息

Killaspy Helen, Cook Sarah, Mundy Tim, Craig Thomas, Holloway Frank, Leavey Gerard, Marston Louise, McCrone Paul, Koeser Leonardo, Arbuthnott Maurice, Omar Rumana Z, King Michael

出版信息

BMC Psychiatry. 2013 Aug 28;13:216. doi: 10.1186/1471-244X-13-216.

Abstract

BACKGROUND

This study focuses on people with complex and severe mental health problems who require inpatient rehabilitation. The majority have a diagnosis of schizophrenia whose recovery has been delayed due to non-response to first-line treatments, cognitive impairment, negative symptoms and co-existing problems such as substance misuse. These problems contribute to major impairments in social and everyday functioning necessitating lengthy admissions and high support needs on discharge to the community. Engagement in structured activities reduces negative symptoms of psychosis and may lead to improvement in function, but no trials have been conducted to test the efficacy of interventions that aim to achieve this.

METHODS/DESIGN: This study aims to investigate the clinical and cost-effectiveness of a staff training intervention to increase service users' engagement in activities. This is a single-blind, two-arm cluster randomised controlled trial involving 40 inpatient mental health rehabilitation units across England. Units are randomised on an equal basis to receive either standard care or a "hands-on", manualised staff training programme comprising three distinct phases (predisposing, enabling and reinforcing) delivered by a small team of psychiatrists, occupational therapists, service users and activity workers. The primary outcome is service user engagement in activities 12 months after randomisation, assessed using a standardised measure. Secondary outcomes include social functioning and costs and cost-effectiveness of care.

DISCUSSION

The study will provide much needed evidence for a practical staff training intervention that has potential to improve service user functioning, reducing the need for hospital treatment and supporting successful community discharge. The trial is registered with Current Controlled Trials (Ref ISRCTN25898179).

摘要

背景

本研究聚焦于需要住院康复的复杂且严重心理健康问题患者。大多数患者被诊断为精神分裂症,由于对一线治疗无反应、认知障碍、阴性症状以及诸如药物滥用等并存问题,其康复进程被延迟。这些问题导致社交和日常功能严重受损,需要长期住院,出院后对社区支持的需求也很高。参与结构化活动可减轻精神病性的阴性症状,并可能改善功能,但尚未进行试验来检验旨在实现这一目标的干预措施的疗效。

方法/设计:本研究旨在调查一项员工培训干预措施在提高服务使用者活动参与度方面的临床效果和成本效益。这是一项单盲、双臂整群随机对照试验,涉及英格兰的40个住院心理健康康复单元。各单元被平等随机分组,分别接受标准护理或一项“实践型”、按手册实施的员工培训项目,该项目由一小队精神科医生、职业治疗师、服务使用者和活动工作人员分三个不同阶段(诱导、促成和强化)实施。主要结局是随机分组12个月后服务使用者对活动的参与度,采用标准化测量方法进行评估。次要结局包括社会功能、护理成本及成本效益。

讨论

该研究将为一项实用的员工培训干预措施提供急需的证据,该干预措施有可能改善服务使用者的功能,减少住院治疗需求,并支持成功回归社区。该试验已在“当前对照试验”注册(注册号ISRCTN25898179)。

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