The Brain Health Study: A Pragmatic, Patient-Centered Trial

Not Applicable

Active, not recruiting

• Conditions: Alzheimer Disease; Dementia

• Registration Number: NCT05356702
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-02
• Study Start: 2022-06-29
• Primary Completion: 2024-10-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3417

Inclusion Criteria

• 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

Exclusion Criteria

• Currently receiving hospice care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
New dementia diagnoses	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

Secondary Outcome Measures

Name	Time	Method
Clinic "no shows"	1 year after index date	Number of scheduled visits missed
Urgent care/emergency department visits	1 year after index date	Number of urgent care and emergency department visits
Dementia medications	6 months after index date	Percent of participants who receive new medications for dementia, defined from medication orders or dispensings in the electronic health record
Rate of accepting brain health visit	3 months after invitation mailed	Proportion of people offered a brain health visit who accept and attend the visit
Healthcare utilization	6 months after index date	Number of primary care visits, laboratory tests performed, neuroimaging tests, and specialty visits or referrals, defined from EHR data
New diagnoses of mild cognitive impairment	12 months after index date	Rate of new diagnoses of mild cognitive impairment following the intervention, defined from EHR data
Hospitalizations	1 year after index date	Number of inpatient stays
Positive predictive value of eRADAR algorithm	12 months after index date	Proportion of people with a high risk eRADAR Score who attend a brain health visit who are diagnosed with dementia
New dementia diagnoses (secondary definitions)	6 months after index date; 18 months after index date	Dementia diagnosis rate in different time periods than for primary outcome, defined from EHR data
Medication adherence	1 year after index date	Proportion of days covered

Trial Locations

Locations (5)

Kaiser Permanente Burien Medical Center; 🇺🇸 Burien, Washington, United States

Kaiser Permanente Kent Medical Center; 🇺🇸 Kent, Washington, United States

Kaiser Permanente Renton Medical Center; 🇺🇸 Renton, Washington, United States

Kaiser Permanente, Capitol Hill; 🇺🇸 Seattle, Washington, United States

Kaiser Permanente Northgate Medical Center; 🇺🇸 Seattle, Washington, United States