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 is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual care.

Study Overview

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

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 patients at risk of undiagnosed dementia. 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): 1261
• 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: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain Health Intervention; 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.	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; Individuals in this arm did not receive any intervention but rather usual care. University of California, San Francisco (UCSF) does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New Diagnoses of Dementia (12 Months)	Number of patients who received new dementia diagnoses within 12 months, identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes	12 months after index date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New Diagnoses of Dementia or Mild Cognitive Impairment (12 Months)	Number of patients who received a new diagnosis of dementia or mild cognitive impairment within 12 months, defined from EHR data	12 months after index date
New Diagnoses of Dementia (18 Months)	Number of patients who received a new diagnosis of dementia within 18 months of index date, defined from EHR data	18 months after index date
New Diagnoses of Dementia (6 Months)	Number of patients receiving new dementia diagnoses within 6 months of index date, defined using EHR data	6 months after index date
New Dementia Medications (12 Months)	Number of patients who received a new medication for dementia in 12 months, defined from medication orders or dispensings in the electronic health record	12 months after index date
Urgent Care or Emergency Department Visits (12 Months)	Number of patients who had at least 1 urgent care or emergency department visit in the 12 months following their index date	12 months after index date
Hospitalizations and Inpatient Admissions (12 Months)	Average number of hospitalizations and inpatient stays per participant within 12 months of index date	12 months after index date
Scheduled Visits Missed (12 Months)	Average number of scheduled clinic visits missed ("no shows") per participant	12 months after index date
Primary Care Visits (6 Months)	Average number of visits per participant in primary care within 6 months after the index date	6 months after index date
Primary Care Visits (12 Months)	Average number of primary care visits per participant in the 12 months after their index date	12 months after index date
B-12 Lab Tests (12 Months)	Number of patients with at least one B12 lab test in the 12 months after their index date	12 months after index date
Neuroimaging Tests (12 Months)	Number of patients with at least one neuroimaging study (CT head, MRI brain) in the 12 months after their index date	12 months after index date
Neurology Referrals (12 Months)	Number of patients with at least one referral to Neurology or the Memory and Aging Center in the 12 months after their index date	12 months after index date

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): October 6, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 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

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 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 data will be required to complete a standard form, sign a Data Use Agreement (DUA) and provide documentation of IRB approval. 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. The UCSF Industry Contracts Division (ICD), which oversees incoming and outgoing transfer of all UCSF data, will review registration materials 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