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: Active, not recruiting
• 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; 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. 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 who meet eligibility criteria will receive usual care.

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
Healthcare utilization	Number of primary care visits, laboratory tests performed, neuroimaging tests, and specialty visits or referrals, defined from EHR data	6 months after index date
Dementia medications	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
Urgent care/emergency department visits	Number of urgent care and emergency department visits	1 year after index date
Hospitalizations	Number of inpatient stays	1 year after index date
Clinic "no shows"	Number of scheduled visits missed	1 year after index date
Medication adherence	Proportion of days covered	1 year after index date
New dementia diagnoses (secondary definitions)	Dementia diagnosis rate in different time periods than for primary outcome, defined from EHR data	6 months after index date; 18 months after index date
New diagnoses of mild cognitive impairment	Rate of new diagnoses of mild cognitive impairment following the intervention, defined from EHR data	12 months after index date
Rate of accepting brain health visit	Proportion of people offered a brain health visit who accept and attend the visit	3 months after invitation mailed
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

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): October 15, 2024
• Study Completion (Estimated): April 15, 2025

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): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

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 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