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热点人群项目:一项阶梯楔形整群随机对照试验的研究方案,该试验旨在探究针对多个生活领域存在问题且急性护理使用率高的患者,提供为期12个月的主动、综合和个性化护理的成本效益。

Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use.

作者信息

Tiemes Vera, Leming Kimberley A, Borgdorff Hanneke, Bruijnzeels Marc Abraham, van Gestel Laurens C, Adriaanse Marieke A, van der Wel Mark, van den Akker-van Marle Elske M, Numans Mattijs E, Vos Rimke C

机构信息

Department of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The Netherlands

Department of Public Health and Primary Care/Health Campus the Hague, Leiden University Medical Center (LUMC), Leiden, The Netherlands.

出版信息

BMJ Open. 2025 Aug 10;15(8):e087940. doi: 10.1136/bmjopen-2024-087940.

DOI:10.1136/bmjopen-2024-087940
PMID:40784776
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12336530/
Abstract

INTRODUCTION

'Hotspotters' are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. As reliable data on effective interventions for this population are scarce, the goal of this study is to assess the cost-effectiveness of proactive, personalised, integrated care for this group.

METHODS AND ANALYSIS

The Hotspotters Project is planned as a stepped wedge cluster randomised controlled trial in 20 primary care practices in the Netherlands. All practices and participants will begin with standard care during the control period (2-8 months), followed by an intervention (12 months) consisting of a positive health intake with goal setting, multidisciplinary meetings, a personalised care plan and proactive care management. The study will conclude with a follow-up (2-8 months), resulting in a total study duration of 22 months. We plan to include 200 patients with (a) problems on two or more life domains and (b) at least two acute care encounters in the previous year. Possible Hotspotters are identified using an Adjusted Clinical Groups-based algorithm or via a local primary healthcare team.

OUTCOMES

Questionnaires and routine care data will be used to gather data on cost-effectiveness, which will then be assessed using multilevel analysis, with levels for the individual, cluster and duration of control period. Secondary outcomes will include psychological outcomes on self-regulation (proactive coping, patient activation, self-efficacy and intention), experience of care (satisfaction, perceived autonomy support and qualitative data from focus groups) and quality of life, qualitative analysis of the Positive Health approach, implementation outcomes and process evaluation including integration of care.

ETHICS AND DISSEMINATION

The Ethics Committee of Leiden University Medical Centre granted approval (METC-LDD, P21.123). Results will be shared through peer-reviewed publication and (inter)national conference presentations.

TRIAL REGISTRATION NUMBER

NCT05878054.

摘要

引言

“热点人群”是指有复杂护理需求的患者,其定义为在多个生活领域存在问题且急性护理使用率高。这些患者常常接受不匹配的护理,导致护理过度和医疗成本增加。由于针对这一人群的有效干预措施的可靠数据稀缺,本研究的目的是评估针对该群体的主动、个性化、综合护理的成本效益。

方法与分析

“热点人群项目”计划在荷兰的20家初级保健机构中进行一项阶梯楔形整群随机对照试验。在对照期(2至8个月),所有机构和参与者将从标准护理开始,随后进行为期12个月的干预,包括积极的健康评估与目标设定、多学科会议、个性化护理计划和主动护理管理。研究将以随访(2至8个月)结束,总研究时长为22个月。我们计划纳入200名患者,这些患者需满足以下条件:(a)在两个或更多生活领域存在问题;(b)前一年至少有两次急性护理就诊经历。可能的“热点人群”通过基于调整临床分组的算法或当地初级医疗团队来识别。

结果

将使用问卷和常规护理数据收集成本效益数据,然后使用多层次分析进行评估,分析层面包括个体、群组以及对照期时长。次要结果将包括自我调节方面的心理结果(积极应对、患者激活、自我效能和意愿)、护理体验(满意度、感知到的自主支持以及焦点小组的定性数据)和生活质量、对积极健康方法的定性分析、实施结果以及包括护理整合在内的过程评估。

伦理与传播

莱顿大学医学中心伦理委员会已批准(METC-LDD,P21.123)。研究结果将通过同行评审发表以及在(国际)会议上进行展示来分享。

试验注册号

NCT05878054

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c657/12336530/4c3fb856f0c2/bmjopen-15-8-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c657/12336530/ff1f187c44fb/bmjopen-15-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c657/12336530/4c3fb856f0c2/bmjopen-15-8-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c657/12336530/ff1f187c44fb/bmjopen-15-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c657/12336530/4c3fb856f0c2/bmjopen-15-8-g002.jpg

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