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针对虚弱老年人的个性化护理计划(PROSPER):一项随机对照试验的方案。

PeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial.

机构信息

Academic Unit for Ageing and Stroke Research, University of Leeds, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, UK.

Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, LS2 9JT, UK.

出版信息

Trials. 2024 Jan 2;25(1):8. doi: 10.1186/s13063-023-07857-1.

Abstract

BACKGROUND

Frailty is common in older age and is characterised by loss of biological reserves across multiple organ systems. These changes associated with frailty mean older people can be vulnerable to sudden, dramatic changes in health because of relatively small problems. Older people with frailty are at increased risk of adverse outcomes including disability, hospitalisation, and care home admission, with associated reduction in quality of life and increased NHS and social care costs. Personalised Care Planning offers an anticipatory, preventative approach to supporting older adults to live independently for longer, but it has not been robustly evaluated in a population of older adults with frailty.

METHODS

Following an initial feasibility study, this multi-centre, individually randomised controlled trial aims to establish whether personalised care planning for older people improves health-related quality of life. It will recruit 1337 participants from general practices across Yorkshire and Humber and Mid-Mersey in the North of England. Eligible patients will be aged 65 and over with an electronic frailty index score of 0.21 or above, living in their own homes, without severe cognitive impairment and not in receipt of end-of-life care. Following confirmation of eligibility, informed consent and baseline data collection, participants will be individually randomised to the PeRsOnaliSed care Planning for oldER people with frailty (PROSPER) intervention or usual care in a 2.6:1 allocation ratio. Participants will not be blinded to allocation, but data collection and analysis will be blinded. The intervention will be delivered over 12 weeks by a Personal Independence Co-ordinator worker based within a voluntary sector organisation, Age UK. The primary outcomes are health-related quality of life, measured using both the physical and mental components of the Short-Form 12 Item Health Questionnaire at 12 months after randomisation. Secondary outcomes comprise activities of daily living, self-management capabilities and loneliness, admission to care homes, hospitalisations, and health and social care resource use at 12 months post randomisation. Parallel cost-effectiveness and process evaluations will be conducted alongside the trial.

DISCUSSION

The PROSPER study will evaluate the effectiveness and cost-effectiveness of a personalised care planning approach for older people with frailty and inform the process of its implementation.

TRIAL REGISTRATION

ISRCTN16123291 .  Registered on  28 August 2020.

摘要

背景

衰弱在老年人中很常见,其特征是多个器官系统的生物储备减少。与衰弱相关的这些变化意味着老年人可能会因为相对较小的问题而突然、显著地出现健康问题。衰弱的老年人发生不良后果的风险增加,包括残疾、住院和入住养老院,生活质量下降,国家医疗服务体系和社会护理成本增加。个性化护理计划为支持老年人更长久地独立生活提供了一种预期的、预防的方法,但在衰弱的老年人人群中,其效果尚未得到充分评估。

方法

在初始可行性研究之后,这项多中心、个体随机对照试验旨在确定针对老年人的个性化护理计划是否能改善与健康相关的生活质量。它将从英格兰北部约克郡和亨伯以及米德尔塞克斯的普通诊所招募 1337 名 65 岁及以上、电子衰弱指数评分在 0.21 或以上、居住在自己家中、无严重认知障碍且未接受临终关怀的参与者。在确认符合条件、获得知情同意并收集基线数据后,将对参与者进行个体随机分组,分别接受 PeRsOnaliSed care Planning for oldER people with frailty (PROSPER) 干预或常规护理,分配比例为 2.6:1。参与者不会对分组情况进行盲法,但数据收集和分析将进行盲法。该干预将由一名私人独立协调员工作人员在一个志愿组织“Age UK”中提供,为期 12 周。主要结果是使用 12 个月时的健康调查问卷的身体和心理成分来衡量与健康相关的生活质量。次要结果包括日常生活活动、自我管理能力和孤独感、入住养老院、住院和 12 个月后随机分组后的健康和社会保健资源使用情况。平行的成本效益和过程评估将与试验同时进行。

讨论

PROSPER 研究将评估针对衰弱老年人的个性化护理计划的有效性和成本效益,并为其实施过程提供信息。

试验注册

ISRCTN84000621。于 2020 年 8 月 28 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7134/10759371/d08777c6d433/13063_2023_7857_Fig1_HTML.jpg

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