Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA; Kaiser Permanente Bernard Tyson School of Medicine, Pasadena, CA, USA.
Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Contemp Clin Trials. 2023 Dec;135:107356. doi: 10.1016/j.cct.2023.107356. Epub 2023 Oct 17.
About half of people living with dementia have not received a diagnosis, delaying access to treatment, education, and support. We previously developed a tool, eRADAR, which uses information in the electronic health record (EHR) to identify patients who may have undiagnosed dementia. This paper provides the protocol for an embedded, pragmatic clinical trial (ePCT) implementing eRADAR in two healthcare systems to determine whether an intervention using eRADAR increases dementia diagnosis rates and to examine the benefits and harms experienced by patients and other stakeholders.
We will conduct an ePCT within an integrated healthcare system and replicate it in an urban academic medical center. At primary care clinics serving about 27,000 patients age 65 and above, we will randomize primary care providers (PCPs) to have their patients with high eRADAR scores receive targeted outreach (intervention) or usual care. Intervention patients will be offered a "brain health" assessment visit with a clinical research interventionist mirroring existing roles within the healthcare systems. The interventionist will make follow-up recommendations to PCPs and offer support to newly-diagnosed patients. Patients with high eRADAR scores in both study arms will be followed to identify new diagnoses of dementia in the EHR (primary outcome). Secondary outcomes include healthcare utilization from the EHR and patient, family member and clinician satisfaction assessed through surveys and interviews.
If this pragmatic trial is successful, the eRADAR tool and intervention could be adopted by other healthcare systems, potentially improving dementia detection, patient care and quality of life.
大约一半的痴呆症患者尚未得到诊断，这导致他们无法及时获得治疗、教育和支持。我们之前开发了一种工具，即 eRADAR，它使用电子健康记录（EHR）中的信息来识别可能患有未确诊痴呆症的患者。本文提供了一项嵌入式实用临床试验（ePCT）的方案，该试验将在两个医疗保健系统中实施 eRADAR，以确定使用 eRADAR 的干预措施是否能提高痴呆症的诊断率，并研究患者和其他利益相关者所经历的获益和危害。
我们将在一个综合医疗保健系统内开展一项 ePCT，并在一个城市学术医疗中心对其进行复制。在为 27000 名以上年龄在 65 岁及以上的患者提供服务的初级保健诊所，我们将随机分配初级保健提供者（PCP），使他们的高 eRADAR 评分患者接受有针对性的外展（干预）或常规护理。干预患者将获得与医疗保健系统内现有角色相匹配的临床研究干预者的“大脑健康”评估就诊。干预者将向 PCP 提出随访建议，并为新诊断的患者提供支持。在两个研究臂中具有高 eRADAR 评分的患者将接受随访，以在 EHR 中确定新诊断的痴呆症（主要结局）。次要结局包括从 EHR 中获得的医疗保健利用情况，以及通过调查和访谈评估患者、家属和临床医生的满意度。
如果这项实用试验取得成功，eRADAR 工具和干预措施可能会被其他医疗保健系统采用，从而有可能改善痴呆症的检测、患者护理和生活质量。
