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以利益相关者为导向的实用主义临床试验方案:TabCAT-BHA 用于初级保健中认知障碍的检测。

Stakeholder-informed pragmatic trial protocol of the TabCAT-BHA for the detection of cognitive impairment in primary care.

机构信息

Department of Neurology, University of California, San Francisco, San Francisco, USA.

Global Brain Health Institute, University of California, San Francisco, San Francisco, USA.

出版信息

BMC Prim Care. 2024 Aug 6;25(1):286. doi: 10.1186/s12875-024-02544-9.

DOI:10.1186/s12875-024-02544-9
PMID:39107706
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11302096/
Abstract

BACKGROUND

Cognitive impairment and dementia are frequently under-recognized. Health system strategies anchored in primary care are essential to address gaps in timely, comprehensive diagnosis. The goal of this paper is to describe the adaptation of a tablet-based brain health assessment (TabCAT-BHA) intervention and the study protocol to test its effectiveness in improving the detection of cognitive impairment, including dementia.

METHODS

This mixed-methods, pragmatic, cluster randomized, hybrid effectiveness-implementation trial is being conducted in two 18-month waves with 26 Kaiser Permanente Southern California primary care clinics, with 13 serving as intervention clinics and 13 as usual care clinics. Patients 65 years and older with memory concerns (n ~ 180,000) receiving care at the 26 clinics will be included in the analyses. Primary care clinics are provided the following practice supports as part of the TabCAT-BHA intervention: brief education and training on neurocognitive disorders and study workflows; digital tools to assess cognitive function and support clinician decision making and documentation; and registered nurse support during the work-up and post-diagnosis periods for primary care providers, patients, and families. The intervention was adapted based on engagement with multiple levels of clinical and operational leaders in the healthcare system. Effectiveness outcomes include rates of cognitive impairment diagnosis in primary care and rates of completed standardized cognitive assessments and specialist referrals with incident diagnoses. Implementation outcomes include acceptability-appropriateness-feasibility, adoption, and fidelity.

RESULTS

We identified seven themes organized by system-, provider-, and patient-level domains that were used to adapt the TabCAT-BHA intervention. Accordingly, changes were made to the provider education, diagnostic work-up, and post-diagnostic support. Results will be reported in fall of 2027.

CONCLUSIONS

Our engagement with multiple primary and specialty care clinical and operational leaders to adapt the TabCAT-BHA intervention to these primary care clinics has informed the protocol to evaluate the intervention's effectiveness for improving the detection of cognitive impairment, including dementia, in an integrated healthcare system.

TRIAL REGISTATION

Clinicaltrials.gov: NCT06090578 (registered 10/24/23).

摘要

背景

认知障碍和痴呆症经常被低估。以初级保健为基础的卫生系统策略对于解决及时、全面诊断方面的差距至关重要。本文的目的是描述基于平板电脑的大脑健康评估(TabCAT-BHA)干预措施的改编,并介绍测试该干预措施在提高认知障碍(包括痴呆症)检测效果的研究方案。

方法

本混合方法、实用、集群随机、混合有效性-实施试验在两个 18 个月的波次中进行,涉及 26 家 Kaiser Permanente 南加州初级保健诊所,其中 13 家为干预诊所,13 家为常规护理诊所。在这 26 家诊所接受治疗的、有记忆问题的 65 岁及以上患者(n~180000 人)将被纳入分析。初级保健诊所将获得以下实践支持,作为 TabCAT-BHA 干预措施的一部分:神经认知障碍和研究工作流程的简要教育和培训;评估认知功能和支持临床医生决策和记录的数字工具;以及注册护士在初级保健提供者、患者和家庭的工作流程和诊断后期间的支持。干预措施是根据与医疗保健系统中多个临床和运营领导的参与进行改编的。有效性结果包括初级保健中认知障碍诊断率以及完成标准化认知评估和专家转诊率,包括新诊断病例。实施结果包括可接受性-适当性-可行性、采用和保真度。

结果

我们确定了七个主题,这些主题按系统、提供者和患者层面的领域组织,用于改编 TabCAT-BHA 干预措施。因此,对提供者教育、诊断工作流程和诊断后支持进行了更改。结果将于 2027 年秋季报告。

结论

我们与多个初级保健和专科临床和运营领导进行了接触,以改编 TabCAT-BHA 干预措施,使其适应这些初级保健诊所,这为评估该干预措施在改善综合医疗保健系统中认知障碍(包括痴呆症)检测效果的协议提供了信息。

试验注册

Clinicaltrials.gov:NCT06090578(2023 年 10 月 24 日注册)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/78d2/11302096/6c831f884442/12875_2024_2544_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/78d2/11302096/42fe1ee41b5c/12875_2024_2544_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/78d2/11302096/6c831f884442/12875_2024_2544_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/78d2/11302096/42fe1ee41b5c/12875_2024_2544_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/78d2/11302096/6c831f884442/12875_2024_2544_Fig2_HTML.jpg

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