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。 诊断。诊断这些患者有许多潜在的好处，例如将他们和他们的家人联系起来。 家庭提供适当的支持和服务。也有潜在的风险，如耻辱，抑郁， 失去独立性。我们提出了一个试点临床试验，以完善和测试一种新的方法来检测患者 未确诊的阿尔茨海默病或痴呆症患者。我们的目标是最大化 早期发现的好处，同时尽量减少伤害。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）的风险，该规则使用 电子健康记录（EHR），以识别患有未确诊痴呆症风险升高的患者。此外，本发明还提供了一种方法， 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， 实施.我们目前的建议在很大程度上受到了这一初步工作的影响。我们估计，如果患者 eRADAR评分前15%的患者作为评估的目标，我们将检测到近一半的 未确诊的痴呆症研究人员：PI具有痴呆流行病学，风险预测 建模和初级保健。他们成功地合作开发了eRADAR。合作研究者带来 在定性方法，实施科学和卫生系统变革的专业知识。方法：我们建议 在Kaiser Permanente的两个诊所中， 华盛顿（KPWA）将随机分配其患者（N=~ 12，000），根据 他们的eRADAR评分或常规护理（对照组）。我们在诊所的研究人员将工作 与初级保健团队一起接触eRADAR评分高的患者，进行初步痴呆症检查 评估，提出后续建议，并在诊断后支持患者。在目标1中，我们将开发 并以迭代的方式完善干预过程，其中包括患者，护理人员和主要 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， 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， 实践塑造研究。KPWA在利用Epic EMR进行创新方面也有着良好的记录， 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 并对一种独特的方法进行了试点测试，该方法用于在未确诊的高风险患者中进行有针对性的痴呆症筛查。 痴呆它将使用一种新的基于EHR的工具和以患者为中心的外展流程。这项工作将奠定 为全面的临床试验奠定基础，在该试验中，我们将确定eRADAR的实施是否 改善老年人的护理和成果。