Identifying and supporting patients with undiagnosed dementia using the EHR Risk of Alzheimer's and Dementia Assessment Rule (eRADAR): a pilot clinical trial

使用 EHR 阿尔茨海默氏症和痴呆症风险评估规则 (eRADAR) 识别和支持未确诊的痴呆症患者：一项试点临床试验

• 批准号: 10409614
• 负责人: Deborah E. Barnes
• 金额: $ 76.52万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10409614
• 关键词: Address; Advisory Committees; Advocate; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; Americas; Anxiety; Automobile Driving; Caregivers; Caring; Client satisfaction; Clinic; Clinical; Clinical Trials; Cognitive; Communities; Data; Dementia; Detection; Development; Diagnosis; Disease; Early Diagnosis; Education; Elderly; Electronic Health Record; Emergency department visit; Environment; Epidemiology; Family; Family member; Feedback; Focus Groups; Foundations; Funding; Future; Gerontology; Goals; Harm Reduction; Health; Health system; Healthcare; Healthcare Systems; Immunochemistry; Impaired cognition; Integrated Delivery of Health Care; Intervention; Interview; Investigation; Learning; Mammography; Mental Depression; Methods; Modeling; Multi-Institutional Clinical Trial; Outcome; Patients; Performance; Personal Satisfaction; Persons; Predictive Value; Preventive service; Primary Care Physician; Primary Health Care; Procedures; Process; Qualitative Methods; Quality of Care; Randomized; Recommendation; Reporting; Research; Research Personnel; Risk; Risk Assessment; Risk Behaviors; Services; Shapes; Site; Social isolation; Societies; Surveys; System; Testing; United States National Institutes of Health; Washington; Work; base; care coordination; care outcomes; comparative effectiveness; dementia risk; efficacy testing; evidence base; experience; follow-up; health care service utilization; high risk; implementation science; improved; innovation; medication compliance; novel; novel strategies; older patient; outreach; patient oriented; pilot test; randomized trial; risk prediction model; screening; social stigma; success; systems research; tool; treatment as usual; usual care arm

Significance: Nearly half of people living with Alzheimer's disease and related dementias have not been diagnosed. There are many potential benefits of diagnosing these patients, such as connecting them and their families with appropriate support and services. There are also potential risks such as stigma, depression, and loss of independence. We propose a pilot clinical trial to refine and test a novel approach for detecting patients with undiagnosed Alzheimer's disease or dementia through targeted outreach. Our goal is to maximize the benefits of early detection while minimizing harms. Innovation: We have developed the electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR), which uses information in the electronic health record (EHR) to identify patients with an elevated risk of undiagnosed dementia. In addition, we have interviewed patients, caregivers, clinicians and healthcare system leaders to inform plans for implementation. Our current proposal is heavily informed by this preliminary work. We estimate that, if patients with eRADAR scores in the top 15% were targeted for assessment, we would detect nearly half of patients with undiagnosed dementia. Investigators: The PIs have expertise in dementia epidemiology, risk prediction modeling and primary care. They collaborated successfully to develop eRADAR. Co-investigators bring expertise in qualitative methods, implementation science, and health system change. Approach: We propose a pilot clinical trial in which about 50 primary care physicians at two clinics within Kaiser Permanente Washington (KPWA) will be randomly assigned to have their patients (N=~12,000) targeted for outreach based on their eRADAR scores or to usual care (control group). Our research staff embedded in the clinics will work with the primary care team to reach out to patients with high eRADAR scores, conduct a preliminary dementia assessment, make follow-up recommendations, and support patients after diagnosis. In Aim 1, we will develop and refine intervention processes in an iterative fashion with input from patients, caregivers and primary care teams. In Aim 2, we will assess eRADAR's performance, focusing on positive predictive value and dementia diagnosis rates in the intervention vs. usual care groups. In Aim 3, we will use mixed methods to assess the impact of eRADAR implementation on healthcare utilization and patient and family member experiences. Environment: KPWA is a learning healthcare system, where research shapes practice and practice shapes research. KPWA also has a strong track record of innovation utilizing the Epic EMR, which is widely used in the US, increasing the potential for dissemination. Summary: The proposed study will refine and pilot test a unique approach for targeted dementia screening in patients at high risk of having undiagnosed dementia. It will use a novel EHR-based tool and patient-centered outreach processes. This work will lay the groundwork for a full-scale clinical trial in which we will determine whether implementation of eRADAR improves care and outcomes for older adults.

意义：近一半患有阿尔茨海默氏病和相关痴呆症的人没有 诊断。诊断这些患者有许多潜在的好处，例如将他们及其连接起来 有适当支持和服务的家庭。也有潜在的风险，例如污名，抑郁和 失去独立性。我们提出了一项试验临床试验，以完善和测试一种用于检测患者的新方法 通过未诊断的阿尔茨海默氏病或​​痴呆症通过有针对性的外展。我们的目标是最大化 早期检测的好处，同时最大程度地减少危害。创新：我们已经开发了电子健康 记录阿尔茨海默氏症和痴呆评估规则（Eradar）的风险，该规则使用了信息 电子健康记录（EHR）确定患有痴呆症的风险升高的患者。此外， 我们采访了患者，看护人，临床医生和医疗保健系统领导者，以告知计划 执行。这项初步工作为我们目前的提议提供了广泛的了解。我们估计，如果患者 在前15％的Eladar分数被以评估为目标的情况下，我们将发现近一半的患者 未诊断的痴呆症。调查人员：PI在痴呆流行病学，风险预测方面具有专业知识 建模和初级保健。他们成功地合作开发了Eradar。共同投资者带来 定性方法，实施科学和卫生系统的变化方面的专业知识。方法：我们建议 一项试验临床试验，在Kaiser Permanente的两个诊所中，大约50名初级保健医生 华盛顿（KPWA）将随机分配其患者（n = 〜12,000）针对基于外展的目标 在他们的Eradar分数或通常的护理（对照组）上。我们的研究人员嵌入了诊所中 与初级保健团队接触较高的埃达尔分数患者，进行初步痴呆症 评估，提出后续建议并在诊断后支持患者。在AIM 1中，我们将发展 并以患者，看护人和初级的意见进行迭代方式完善干预过程 护理团队。在AIM 2中，我们将评估Eradar的表现，专注于积极的预测价值和 干预与常规护理组中的痴呆症诊断率。在AIM 3中，我们将使用混合方法来 评估实施对医疗保健利用的影响以及患者和家人 经验。环境：KPWA是一种学习医疗系统，研究塑造实践和 练习形状研究。 KPWA还利用Epic EMR的创新记录很强， 在美国广泛使用，增加了传播的潜力。摘要：拟议的研究将完善 试点测试一种独特的方法，用于未诊断的高风险患者的靶向痴呆症筛查 失智。它将使用基于EHR的新型工具和以患者为中心的外展工艺。这项工作将放置 全尺度临床试验的基础工作，我们将确定是否实施ERADAR 改善老年人的护理和结果。