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.
1 other identifier
interventional
1,271
1 country
3
Brief Summary
The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2022
CompletedFirst Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2026
CompletedMarch 20, 2026
March 1, 2026
2.8 years
June 6, 2023
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Number of primary care visits
6 months after index date
Number of dementia-related laboratory tests performed
6 months after index date
Number of dementia-related neuroimaging tests performed
6 months after index date
Number of specialty visits or referrals for dementia assessment
6 months after index date
Percent of participants who receive new medications for dementia
6 months after index date
- +9 more secondary outcomes
Study Arms (2)
Brain Health Intervention
EXPERIMENTALCalculate 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
Usual Care
NO INTERVENTIONUsual care Individuals who meet eligibility criteria will receive usual care.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Currently receiving hospice care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Kaiser Permanentecollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (3)
UCSF Primary Care at China Basin
San Francisco, California, 94107, United States
Division of General Internal Medicine
San Francisco, California, 94115, United States
Women's Health Primary Care
San Francisco, California, 94143, United States
Related Publications (4)
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.
PMID: 37858616BACKGROUNDLee 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.
PMID: 28849435BACKGROUNDBarnes 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.
PMID: 31612463BACKGROUNDColey 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.
PMID: 35906516BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Barnes, PhD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Sascha Dublin, MD, PhD
KP Washington Health Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 15, 2023
Study Start
December 7, 2022
Primary Completion
October 6, 2025
Study Completion
January 26, 2026
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.
- 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.
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).