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严重精神疾病健康改善概况(HIP):一项群组随机对照试验的研究方案。

The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial.

机构信息

Faculty of Health and Social Care, University of Hull, Hull, HU6 7RX, UK.

出版信息

Trials. 2011 Jul 4;12:167. doi: 10.1186/1745-6215-12-167.

DOI:10.1186/1745-6215-12-167
PMID:21726440
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3148991/
Abstract

BACKGROUND

The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability.

METHODS/DESIGN: A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts.

SUBJECTS

Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs.

PRIMARY OBJECTIVE

To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS) 36 Item Short Form Health Survey version 2 [SF-36v2].

SECONDARY OBJECTIVES

To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients) will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT) basis.

DISCUSSION

The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is hoped the HIP trial will provide a timely contribution to evidence on organisation and delivery of care for patients, clinicians and policy makers.

ISRCTN

ISRCTN41137900.

摘要

背景

严重精神疾病健康改善概况(HIP)是一种简洁实用的工具,它使精神科护士能够与患者合作,共同筛查身体健康状况,并在确定存在风险的变量时采取基于证据的行动。初步试验已证明其具有临床实用性和可接受性。

方法/设计:一项在两家国民保健署信托基金的成人社区精神卫生团队中工作的精神科护士(MHN)参与的、单盲平行分组集群随机对照试验,具有二级经济分析和过程观察。随机分组单位:MHN。

研究对象

在参与的 MHN 的患者中,年龄在 18 岁以上,诊断为精神分裂症、分裂情感障碍或双相情感障碍。

主要目标

通过医疗结局研究(MOS)36 项简明健康调查短表版本 2(SF-36v2)的生理成分评分,确定 HIP 方案对患者身体健康的影响。

次要目标

确定 HIP 方案对以下方面的影响:成本效益、心理健康、心血管风险、MHN 的身体健康护理态度和知识,以及 NHS 对 HIP 方案的可接受性。同意的护士(和患者)将被随机分配接受 HIP 方案或常规治疗。将在基线和 12 个月时进行测量,并在 12 个月后进行过程观察,包括评估患者和专业人员的体验以及观察对护理计划和初级-二级保健接口沟通的任何影响。将根据意向治疗(ITT)原则进行分析。

讨论

试验和过程观察的结果将提供有关 HIP 方案在支持 MHN 解决严重精神疾病中的身体共病的有效性的信息。鉴于目前严重精神疾病患者中身体共病和死亡率高得令人无法接受,希望 HIP 试验将为患者、临床医生和政策制定者提供有关护理组织和提供的及时证据。

ISRCTN

ISRCTN41137900。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecac/3148991/e9e0583996e3/1745-6215-12-167-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecac/3148991/e9e0583996e3/1745-6215-12-167-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecac/3148991/e9e0583996e3/1745-6215-12-167-1.jpg

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