General Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
Center for Applied Research on Aging, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
BMJ Open. 2023 Oct 18;13(10):e080101. doi: 10.1136/bmjopen-2023-080101.
Early identification of cognitive impairment (CI), including Alzheimer's disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an iPad-based, self-administered, validated cognitive assessment based on the National Institutes of Health (NIH) Toolbox Cognition Battery and coupled with clinician decision-support tools that is specifically tailored for CI/ADRD detection within diverse, primary care settings.
We will conduct a two-arm, primary care practice-randomised (N=24 practices; 45 257 active patients at the proposed practices), pragmatic trial among geographically diverse Oak Street Health sites to test the effectiveness of the MyCog paradigm to improve early detection CI/ADRD among low socioeconomic, black and Hispanic older adults compared with usual care. Participating practices randomised to the intervention arm will impart the MyCog paradigm as a new standard of care over a 3-year implementation period; as the cognitive component for Annual Wellness Visits and for any patient/informant-reported or healthcare provider-suspected cognitive concern. Rates of detected (cognitive test suggesting impairment) and/or diagnosed (relevant International Classification of Diseases-9/10 [ICD-9/10] code) cognitive deficits, impairments or dementias including ADRD will be our primary outcome of study compared between arms. Secondary outcomes will include ADRD severity (ie, mild or later stage), rates of cognitive-related referrals and rates of family member or caregiver involvement in ADRD care planning. We will use generalised linear mixed models to account for clustered study design. Secondary models will adjust for subject, clinic or visit-specific characteristics. We will use mixed-methods approaches to examine fidelity and cost-effectiveness of the MyCog paradigm.
The Institutional Review Board at Advarra has approved the study protocol (Pro00064339). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study.
NCT05607732.
早期识别认知障碍（CI），包括阿尔茨海默病和相关痴呆（ADRD），是公共卫生的首要重点。然而，在初级保健环境中，以及在健康状况存在差异的人群中，CI/ADRD 常常未被发现和诊断。MyCog 范式是一种基于 iPad 的、自我管理的、经过验证的认知评估，基于美国国立卫生研究院（NIH）工具箱认知电池，并结合临床医生决策支持工具，专门针对不同的初级保健环境中的 CI/ADRD 检测而设计。
我们将在地理上多样化的 Oak Street Health 站点进行一项两项、初级保健实践随机（N=24 个实践；拟议实践中的 45257 名活跃患者）、实用试验，以测试 MyCog 范式在提高低社会经济地位、黑人和西班牙裔老年人群中早期检测 CI/ADRD 方面的有效性，与常规护理相比。随机分配到干预组的参与实践将在 3 年的实施期间内将 MyCog 范式作为新的护理标准；作为年度健康访视的认知部分，以及任何患者/报告者报告或医疗保健提供者怀疑的认知问题。与手臂相比，我们将检测到的（认知测试提示受损）和/或诊断出的（相关国际疾病分类-9/10 [ICD-9/10] 代码）认知缺陷、障碍或痴呆，包括 ADRD 的比率作为研究的主要结果。次要结果将包括 ADRD 严重程度（即轻度或晚期）、认知相关转诊率以及家庭成员或照顾者参与 ADRD 护理计划的比率。我们将使用广义线性混合模型来解释聚类研究设计。二级模型将调整受试者、诊所或访问特定特征。我们将使用混合方法方法来检查 MyCog 范式的保真度和成本效益。
Advarra 的机构审查委员会已批准研究方案（Pro00064339）。结果将发表在同行评议的期刊上，并向研究的资助者提供摘要。
NCT05607732。
