5-Cog Paradigm to Improve Detection of Cognitive Impairment in Primary Care: Pragmatic Clinical Trial

在初级保健环境中，与痴呆症相关的认知障碍经常被低估。这一问题在健康差距人群中更为普遍。我们开发了5-Cog简要认知评估，它简单易用，标准化，只需5分钟，不需要告密者，并考虑到当前评估的主要技术、文化和后勤障碍。我们目前正在进行一项简单的随机临床试验，以检验5-Cog范式(5-Cog简短认知评估结合临床决策工具)在1200名有认知问题的老年人样本中改善痴呆症护理的临床效果，这些老年人在布朗克斯的一家初级保健诊所提出。中期分析显示，与主动控制组相比，5-Cog模式导致新的认知障碍诊断增加了8倍以上，初级保健医生改善的痴呆症护理行动增加了3倍以上。在这些非常有希望的结果的基础上，在这次更新中，我们提出了一种在现实世界环境中的混合型1型有效性实施设计，以适应和测试5-Cog范式的有效性，以增加对存在认知问题的老年人的认知障碍护理的检测。研究目标包括：1.使用实用的整群随机试验设计，评估在布朗克斯和印第安纳州的22个初级保健诊所的6600名老年患者中，5-Cog范例相对于加强的常规护理增加“事件认知障碍”检测(新的MCI和痴呆症诊断)的有效性。由于诊断而不采取行动并不能改善患者的护理，因此，“改善的痴呆症护理”将被视为次要结果。结果还将在NIH指定的健康差距人群中进行检查，包括少数民族、社会经济困难人群和农村服务不足人群。2.使用执行研究综合框架指导的混合方法，衡量在不同初级保健诊所实施5-COG模式的机制和主持人。3.从社会角度评估5-COG模式的成本效益。这项拟议的研究对RFA-NS-22-009高度响应，重点关注可扩展的方法，以解决早期发现事件认知障碍的未得到满足的需求，包括在经历健康差异的人群中。

Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. This problem is more prevalent in health disparities populations. We developed the 5-Cog brief cognitive assessment that is simple to use, standardized, takes <5 minutes, does not require informants, and accounts for major technical, cultural, and logistical barriers of current assessments. We are presently conducting a simple randomized clinical trial to examine the clinical efficacy of the 5-Cog paradigm (5-Cog brief cognitive assessment paired with a clinical decision-making tool) to improve dementia care in 1,200 predominantly minority sample of older adults with cognitive concerns presenting to a primary care clinic in the Bronx. Interim analysis revealed that the 5-Cog paradigm resulted in an over 8-fold increase in new cognitive impairment diagnoses and over 3-fold increase in improved dementia care actions by primary care physicians compared to an active control arm. Following up on these very promising results, in this renewal, we propose a hybrid Type 1 effectiveness-implementation design in real-world settings to adapt and test the effectiveness of the 5-Cog paradigm to increase detection of cognitive impairment care in older adults presenting with cognitive concerns. Study aims include: 1. To evaluate, using a pragmatic cluster-randomized trial design, the effectiveness of the 5-Cog paradigm to increase ‘incident cognitive impairment’ detection (new MCI and dementia diagnoses) relative to enhanced usual care in 6,600 older patients presenting with cognitive concerns in 22 primary care clinics in Bronx and Indiana. As diagnosis without action will not improve patient care, ‘improved dementia care’ will be examined as a secondary outcome. Results will also be examined in NIH designated health disparity populations including minority, socio-economically challenged, and rural underserved populations. 2. To measure, using mixed methods guided by the Consolidated Framework for Implementation Research, the mechanisms and the moderators of the implementation of the 5-Cog paradigm in the diverse primary care clinics. 3. To assess the cost effectiveness of the 5-Cog paradigm from a societal perspective. This proposed study, which is highly responsive to RFA-NS-22-009, focuses on scalable approaches to address the unmet need of early detection of incident cognitive impairment, including in populations that experience health disparities.