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

Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the 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

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 Type: Interventional
• Enrollment (Actual): 3417
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Burien, Washington, United States, 98166
      • Kaiser Permanente Burien Medical Center
    • Kent, Washington, United States, 98030
      • Kaiser Permanente Kent Medical Center
    • Renton, Washington, United States, 98056
      • Kaiser Permanente Renton Medical Center
    • Seattle, Washington, United States, 98112
      • Kaiser Permanente, Capitol Hill
    • Seattle, Washington, United States, 98115
      • Kaiser Permanente Northgate Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (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; 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. They 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. Kaiser Permanente Washington 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 Dementia Diagnoses	Rate of new dementia diagnoses 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
Number of Patients Who Received a New Diagnosis of Mild Cognitive Impairment or Dementia	Number of new diagnoses of mild cognitive impairment in the 12 months following study initiation, defined from EHR data	12 months after index date
Number of Patients Who Received New Dementia Diagnoses in 18 Months of Follow-up	Dementia diagnosis rate in 18 months defined from EHR data	18 months after index date
Number of Patients Who Received a New Dementia Diagnosis in 6 Months of Follow-up	Number of patients with a new dementia diagnosis in 6 months of follow-up defined from the EHR.	6 months
Number of Patients Who Received a New Dementia Medication	Receipt of new medications for dementia in 12 months, defined from medication orders or dispensings in the electronic health record	12 months after index date
Number of Patients With Urgent Care/Emergency Department Visits	Number of participants who had at least 1 urgent care or emergency department visit in the 12 months following study initiation.	1 year after index date
Average Number of Hospitalizations	Average number of hospitalizations (inpatient stays) per participant in the 1 year after study initiation.	1 year after index date
Average Number of "no Shows" for Scheduled Clinic Visits	Average number of scheduled clinic visits missed per participant	1 year after index date
Average Number of Visits in Primary Care - 6 Months	Average number of visits in primary care in the 6 months after study initiation	6 months
Average Number of Visits in Primary Care - 12 Months	Average number of visits in primary care in the 12 months after study initiation	12 months
Number of Patients Who Received a B12 Lab Test	Number of participants with at least 1 B12 lab test in the 12 months after study initiation.	12 months
Number of Patients Who Received Neuroimaging	Number of patients with at least 1 Neuroimaging study (CT head, MRI brain) in 12 months following study initiation.	12 months
Number of Patients Who Received Neurology Referrals	At least one referral to Neurology or Speech, Language, & Learning in 12 months following study initiation.	12 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Sascha Dublin, MD, PhD, KP Washington Health Research Institute; Principal Investigator: Deborah E. 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.
• Palazzo L, Hsu C, Barnes DE, Gray MF, Greenwood-Hickman MA, Larson EB, Dublin S. Patient and caregiver perspectives on a tool to increase recognition of undiagnosed dementia: a qualitative study. BMC Geriatr. 2021 Oct 26;21(1):604. doi: 10.1186/s12877-021-02523-0.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): March 3, 2025
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 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: 1R01AG067427 (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. We 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. We 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 Institutional Review Board (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 acknowledgement of the data resource.
• 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