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通过创新护理预防和应对虚弱的社区居住患者危机(PRACTIC):一项有效性整群随机对照试验的方案。

PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC): protocol for an effectiveness cluster randomised controlled trial.

机构信息

The Research Centre for Age-Related Functional Decline and Disease, Innlandet Hospital Trust, Ottestad, Norway.

Department of Health, Care and Nursing, Faculty of Medicine NTNU, Norwegian University of Science and Technology, Gjøvik, Norway.

出版信息

Trials. 2024 May 6;25(1):304. doi: 10.1186/s13063-024-08117-6.

Abstract

BACKGROUND

Demographic changes, with an increasing number and proportion of older people with multimorbidity and frailty, will put more pressure on home care services in municipalities. Frail multimorbid people receiving home care services are at high risk of developing crises, defined as critical challenges and symptoms, which demand immediate and new actions. The crises often result in adverse events, coercive measures, and acute institutionalisation. There is a lack of evidence-based interventions to prevent and resolve crises in community settings.

METHODS

This is a participatory action research design (PAR) in a 6-month cluster randomised controlled trial (RCT). The trial will be conducted in 30 municipalities, including 150 frail community-dwelling participants receiving home care services judged by the services to be at risk of developing crisis. Each municipality (cluster) will be randomised to receive either the locally adapted TIME intervention (the intervention group) or care as usual (the control group). The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a manual-based, multicomponent programme that includes a rigorous assessment of the crisis, one or more interdisciplinary case conferences, and the testing and evaluation of customised treatment measures. PAR in combination with an RCT will enhance adaptations of the intervention to the local context and needs. The primary outcome is as follows: difference in change between the intervention and control groups in individual goal achievement to resolve or reduce the challenges of the crises between baseline and 3 months using the PRACTIC Goal Setting Interview (PGSI). Among the secondary outcomes are the difference in change in the PGSI scale at 6 months and in neuropsychiatric symptoms (NPSs), quality of life, distress perceived by professional carers and next of kin, and institutionalisation at 3 and 6 months.

DISCUSSION

Through customised interventions that involve patients, the next of kin, the social context, and health care services, crises may be prevented and resolved. The PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC) study will enhance innovation for health professionals, management, and users in the development of new knowledge and a new adapted approach towards crises.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT05651659. Registered 15.12.22.

摘要

背景

人口结构变化导致患有多种疾病和身体虚弱的老年人数量和比例不断增加,这将给市政府的家庭护理服务带来更大的压力。接受家庭护理服务的体弱多病的多重患者有发生危机的高风险,这些危机被定义为严重的挑战和症状,需要立即采取新的行动。这些危机往往导致不良事件、强制性措施和急性机构化。目前缺乏针对社区环境中预防和解决危机的循证干预措施。

方法

这是一项为期 6 个月的群组随机对照试验(RCT)中的参与式行动研究设计(PAR)。该试验将在 30 个市进行,包括 150 名被服务机构判断为有发生危机风险的体弱多病的社区居住参与者,他们正在接受家庭护理服务。每个市(群组)将随机接受本地改编的 TIME 干预(干预组)或常规护理(对照组)。目标跨学科神经精神症状评估和治疗模型(TIME)是一个基于手册的多组分方案,包括对危机的严格评估、一次或多次跨学科病例会议,以及定制治疗措施的测试和评估。PAR 与 RCT 相结合,将增强干预措施对当地情况和需求的适应性。主要结局如下:在基线和 3 个月时,使用实践目标设定访谈(PGSI),比较干预组和对照组在解决或减轻危机挑战方面的个体目标实现情况的变化差异。次要结局包括 6 个月时 PGSI 量表的变化差异以及神经精神症状(NPSs)、生活质量、专业护理人员和亲属感知的痛苦以及 3 个月和 6 个月时的机构化情况。

讨论

通过涉及患者、亲属、社会环境和医疗保健服务的定制干预措施,可能预防和解决危机。预防和解决体弱多病的社区居住患者危机的创新护理(PRACTIC)研究将增强卫生专业人员、管理层和用户在开发新知识和新的适应方法方面的创新能力,以应对危机。

试验注册

ClinicalTrials.gov 标识符:NCT05651659。注册于 2022 年 12 月 15 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4f7/11075302/ee120b824812/13063_2024_8117_Fig1_HTML.jpg

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