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

Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the Electronic Health Record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Algorithm in a Pragmatic, Patient-centered Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05905796
Acronym
eRADAR
Enrollment
1271
Registered
2023-06-15
Start date
2022-12-07
Completion date
2026-01-26
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Alzheimer Disease

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

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. The investigators 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. The investigators will also explore the impact of eRADAR implementation on healthcare utilization and patient experience.

Interventions

Research interventionists, who will be trained and licensed health practitioners (e.g., social workers), will ask participants about changes in memory or thinking and daily function, screen for depression, and administer a standard cognitive screening test. Research interventionalists will use a standardized note template to document results in the participant's EHR. Research interventionists will notify participants and PCPs if follow-up is recommended.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
Kaiser Permanente
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
New dementia diagnosis12 months after index dateRate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes

Secondary

MeasureTime frameDescription
Number of primary care visits6 months after index dateDefined from EHR data
Number of dementia-related laboratory tests performed6 months after index dateDefined from EHR data
Number of dementia-related neuroimaging tests performed6 months after index dateDefined from EHR data
Number of specialty visits or referrals for dementia assessment6 months after index dateDefined from EHR data
Percent of participants who receive new medications for dementia6 months after index dateDefined from medication orders or dispensings in the electronic health record
Number of urgent care and emergency department visits1 year after index dateDefined from EHR data
Number of inpatient days1 year after index dateDefined from EHR data
Number of scheduled visits missed1 year after index dateClinic "no shows"
Proportion of days covered for current prescriptions1 year after index dateStandard measure of medication adherence
New dementia diagnosis (secondary definitions)6 months after index dateRate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes
New diagnosis of mild cognitive impairment12 months after index dateRate of new diagnosis of mild cognitive impairment following the intervention, defined from EHR data
Proportion of people offered a brain health visit who accept and attend the visit3 months after invitation mailedRate of accepting brain health visit
Positive predictive value of eRADAR algorithm12 months after index dateProportion of people with a high risk eRADAR Score who attend a brain health visit who are diagnosed with dementia

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDeborah Barnes, PhD

University of California, San Francisco

PRINCIPAL_INVESTIGATORSascha Dublin, MD, PhD

KP Washington Health Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026