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

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.

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

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Other: Brain Health Assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 1271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • UCSF Primary Care at China Basin
    • San Francisco, California, United States, 94115
      • Division of General Internal Medicine
    • San Francisco, California, United States, 94143
      • Women's Health Primary Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain Health Intervention; Calculate eRADAR scores using EHR data to identify eligible individuals Invite eligible individuals for brain health assessment visit Enter results of brain health assessment visit into EHR Provide summary of results and recommended next steps to the Primary Care Physician and participant	Other: Brain Health Assessment; 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.
No Intervention: Usual Care; Usual care Individuals who meet eligibility criteria will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New dementia diagnosis	Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes	12 months after index date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value of eRADAR algorithm	Proportion of people with a high risk eRADAR Score who attend a brain health visit who are diagnosed with dementia	12 months after index date
Number of primary care visits	Defined from EHR data	6 months after index date
Number of dementia-related laboratory tests performed	Defined from EHR data	6 months after index date
Number of dementia-related neuroimaging tests performed	Defined from EHR data	6 months after index date
Number of specialty visits or referrals for dementia assessment	Defined from EHR data	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	6 months after index date
Number of urgent care and emergency department visits	Defined from EHR data	1 year after index date
Number of inpatient days	Defined from EHR data	1 year after index date
Number of scheduled visits missed	Clinic "no shows"	1 year after index date
Proportion of days covered for current prescriptions	Standard measure of medication adherence	1 year after index date
New dementia diagnosis (secondary definitions)	Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes	6 months after index date
New dementia diagnosis (secondary definitions)	Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes	18 months after index date
New diagnosis of mild cognitive impairment	Rate of new diagnosis of mild cognitive impairment following the intervention, defined from EHR data	12 months after index date
Proportion of people offered a brain health visit who accept and attend the visit	Rate of accepting brain health visit	3 months after invitation mailed

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA); Kaiser Permanente
• Investigators: Principal Investigator: Sascha Dublin, MD, PhD, KP Washington Health Research Institute; Principal Investigator: Deborah Barnes, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• Barnes DE, Zhou J, Walker RL, Larson EB, Lee SJ, Boscardin WJ, Marcum ZA, Dublin S. Development and Validation of eRADAR: A Tool Using EHR Data to Detect Unrecognized Dementia. J Am Geriatr Soc. 2020 Jan;68(1):103-111. doi: 10.1111/jgs.16182. Epub 2019 Oct 14.
• Lee SJ, Larson EB, Dublin S, Walker R, Marcum Z, Barnes D. A Cohort Study of Healthcare Utilization in Older Adults with Undiagnosed Dementia. J Gen Intern Med. 2018 Jan;33(1):13-15. doi: 10.1007/s11606-017-4162-3. No abstract available.
• Coley RY, Smith JJ, Karliner L, Idu AE, Lee SJ, Fuller S, Lam R, Barnes DE, Dublin S. External Validation of the eRADAR Risk Score for Detecting Undiagnosed Dementia in Two Real-World Healthcare Systems. J Gen Intern Med. 2023 Feb;38(2):351-360. doi: 10.1007/s11606-022-07736-6. Epub 2022 Jul 29.
• Dublin S, Greenwood-Hickman MA, Karliner L, Hsu C, Coley RY, Colemon L, Carrasco A, King D, Grace A, Lee SJ, Walsh JME, Barrett T, Broussard J, Singh U, Idu A, Yaffe K, Boustani M, Barnes DE. The electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Brain Health Trial: Protocol for an embedded, pragmatic clinical trial of a low-cost dementia detection algorithm. Contemp Clin Trials. 2023 Dec;135:107356. doi: 10.1016/j.cct.2023.107356. Epub 2023 Oct 17.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): October 6, 2025
• Study Completion (Actual): January 26, 2026

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 1R01AG069734 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Plan description: This Individual Participant Data (IPD) plan applies to all quantitative study data, such as data collected specifically for the study and those derived from electronic health records (EHR), as well as the data collected via planned study surveys, which include only short qualitative free-text fields. The investigators do not plan to share transcripts from in-depth qualitative interviews or recorded study assessment visits.

Data will be maintained on secure servers behind the firewalls at the two study sites: Kaiser Permanente Washington (KPWA) and the University of California, San Francisco (UCSF). De-identified or limited datasets containing individual-level data on which publications are based will be made available to qualified researchers for specified analyses. The investigators will make the data available to users only under a data-use agreement (DUA).

• IPD Sharing Time Frame: Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.

IPD Sharing Access Criteria

Individuals interested in using KPWA data will be required to complete a standard form, sign a Data Use Agreement (DUA) and provide documentation of IRB approval. Data may then be accessed by qualified researchers via KPWA's Secure File Transfer (SFT) site. User registration will be required in order to access or download data files. As part of the registration process, users must agree to the conditions of use governing access to the data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgment of the data resource.

Individuals interested in using UCSF data will be required to complete the same data request form. The UCSF Industry Contracts Division (ICD), which oversees incoming and outgoing transfer of all UCSF data, will review the form for compliance with UCSF policies.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No