跳至主要内容
临床试验/NCT05356702
NCT05356702已完成不适用

Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the eRADAR Algorithm in a Pragmatic, Patient-centered Trial.

Kaiser Permanente10 个研究点 分布在 1 个国家目标入组 3,417 人开始时间: 2022年6月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,417
试验地点
10
主要终点
New dementia diagnoses

研究概览

简要总结

The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.

详细描述

eRADAR stands for "electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule." It is a low-cost tool or algorithm that uses readily available EHR data elements to identify high-risk patients. We will conduct a pragmatic randomized controlled trial to assess the impact of implementing eRADAR as part of a supported outreach process on dementia detection rates. We will also explore the impact of eRADAR implementation on healthcare utilization and patient experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • No prior diagnosis of dementia (defined from EHR diagnosis codes) and not receiving medications for dementia
  • Active patient at participating clinic
  • Adequate data to calculate eRADAR score

排除标准

  • - Currently receiving hospice care

研究组 & 干预措施

Brain Health Intervention

Experimental

Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician (PCP), who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable.

干预措施: Brain Health Assessment (Other)

Usual care

No Intervention

Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).

结局指标

主要结局

New dementia diagnoses

时间窗: 12 months after index date

Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes

New Dementia Diagnoses

时间窗: 12 months after index date

Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes

次要结局

  • Clinic "no shows"(1 year after index date)
  • Medication adherence(1 year after index date)
  • Dementia medications(6 months after index date)
  • Rate of accepting brain health visit(3 months after invitation mailed)
  • Urgent care/emergency department visits(1 year after index date)
  • Healthcare utilization(6 months after index date)
  • New diagnoses of mild cognitive impairment(12 months after index date)
  • Hospitalizations(1 year after index date)
  • New dementia diagnoses (secondary definitions)(6 months after index date; 18 months after index date)
  • Positive predictive value of eRADAR algorithm(12 months after index date)
  • Number of Patients Who Received a New Diagnosis of Mild Cognitive Impairment or Dementia(12 months after index date)
  • Number of Patients Who Received New Dementia Diagnoses in 18 Months of Follow-up(18 months after index date)
  • Number of Patients Who Received a New Dementia Diagnosis in 6 Months of Follow-up(6 months)
  • Number of Patients Who Received a New Dementia Medication(12 months after index date)
  • Number of Patients With Urgent Care/Emergency Department Visits(1 year after index date)
  • Average Number of Hospitalizations(1 year after index date)
  • Average Number of "no Shows" for Scheduled Clinic Visits(1 year after index date)
  • Average Number of Visits in Primary Care - 6 Months(6 months)
  • Average Number of Visits in Primary Care - 12 Months(12 months)
  • Number of Patients Who Received a B12 Lab Test(12 months)
  • Number of Patients Who Received Neuroimaging(12 months)
  • Number of Patients Who Received Neurology Referrals(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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