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: 10665566
• 负责人: Deborah E. Barnes
• 金额: $ 74.5万
• 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 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665566
• 关键词: Address; Advocate; Alzheimer' s Disease; Alzheimer' s disease patient; Alzheimer' s disease related dementia; Alzheimer' s disease risk; Anxiety; Articulation; Automobile Driving; Caregivers; Caring; Client satisfaction; Clinic; Clinical; Clinical Trials; Cognitive; Collaborations; Communities; Control Groups; 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; Primary Care; Primary Care Physician; 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; United States Preventative Services Task Force; Washington; Work; arm; care coordination; comparative effectiveness; dementia risk; efficacy testing; evidence base; experience; follow-up; health care service utilization; health data; high risk; implementation science; improved; innovation; intervention refinement; medication compliance; novel; novel strategies; older patient; outreach; patient oriented; pilot test; primary care clinic; primary care team; randomized trial; risk prediction model; screening; social stigma; success; tool; treatment as usual

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：近一半的阿尔茨海默病和相关痴呆症患者没有接受过治疗 确诊。诊断这些患者有很多潜在的好处，例如将他们和他们的病情联系起来 家庭获得适当的支持和服务。还有一些潜在的风险，例如耻辱、抑郁和 失去独立性。我们提议进行一项试点临床试验，以完善和测试一种检测患者的新方法 通过有针对性的外展活动，帮助患有未确诊的阿尔茨海默病或痴呆症的患者。我们的目标是最大化 早期发现的好处，同时最大限度地减少危害。创新：我们开发了电子健康 记录阿尔茨海默氏症和痴呆症评估规则 (eRADAR)，该规则使用 电子健康记录（EHR）可识别未确诊痴呆症风险较高的患者。此外， 我们采访了患者、护理人员、临床医生和医疗保健系统领导者，以告知计划 执行。我们当前的提案在很大程度上受到了这项初步工作的影响。我们估计，如果患者 以 eRADAR 分数位于前 15% 的患者为评估目标，我们将检测到近一半的患者 未确诊的痴呆症。调查人员：PI拥有痴呆症流行病学、风险预测方面的专业知识 建模和初级保健。他们成功合作开发了 eRADAR。联合调查人员带来 定性方法、实施科学和卫生系统变革方面的专业知识。方法：我们建议 一项试点临床试验，由 Kaiser Permanente 内两家诊所的约 50 名初级保健医生参与 华盛顿州 (KPWA) 将被随机分配，使其患者 (N=~12,000) 成为基于外展的目标 他们的 eRADAR 分数或常规护理（对照组）。我们驻扎在诊所的研究人员将开展工作 与初级保健团队一起接触 eRADAR 评分高的患者，进行初步的痴呆症筛查 评估、提出后续建议并在诊断后为患者提供支持。在目标 1 中，我们将开发 并根据患者、护理人员和初级人员的意见以迭代方式完善干预流程 护理团队。在目标 2 中，我们将评估 eRADAR 的性能，重点关注阳性预测值和 干预组与常规护理组的痴呆诊断率。在目标 3 中，我们将使用混合方法 评估 eRADAR 实施对医疗保健利用率以及患者和家庭成员的影响 经验。环境：KPWA 是一个学习型医疗保健系统，研究塑造实践和 实践塑造研究。 KPWA 在利用 Epic EMR 进行创新方面也拥有良好的记录， 在美国广泛使用，增加了传播潜力。摘要：拟议的研究将完善 并试点测试一种独特的方法，对未确诊的高风险患者进行有针对性的痴呆症筛查 失智。它将使用基于电子病历的新型工具和以患者为中心的外展流程。这项工作将奠定 全面临床试验的基础，我们将确定是否实施 eRADAR 改善老年人的护理和结果。