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.
1 other identifier
interventional
3,417
1 country
5
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 Jun 2022
Typical duration for not_applicable
5 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
First Submitted
Initial submission to the registry
April 27, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2025
CompletedApril 6, 2025
April 1, 2025
2.3 years
April 27, 2022
April 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Healthcare utilization
6 months after index date
Dementia medications
6 months after index date
Urgent care/emergency department visits
1 year after index date
Hospitalizations
1 year after index date
Clinic "no shows"
1 year after index date
- +5 more secondary outcomes
Study Arms (2)
Brain Health Intervention
EXPERIMENTAL* 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
Usual care
NO INTERVENTIONIndividuals 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. 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.
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
- Kaiser Permanentelead
- University of California, San Franciscocollaborator
Study Sites (5)
Kaiser Permanente Burien Medical Center
Burien, Washington, 98166, United States
Kaiser Permanente Kent Medical Center
Kent, Washington, 98030, United States
Kaiser Permanente Renton Medical Center
Renton, Washington, 98056, United States
Kaiser Permanente, Capitol Hill
Seattle, Washington, 98112, United States
Kaiser Permanente Northgate Medical Center
Seattle, Washington, 98115, United States
Related Publications (3)
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.
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: 31612463BACKGROUNDPalazzo 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.
PMID: 34702167BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sascha Dublin, MD, PhD
KP Washington Health Research Institute
- PRINCIPAL INVESTIGATOR
Deborah E. Barnes, PhD
University of California, San Francisco
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
April 27, 2022
First Posted
May 2, 2022
Study Start
June 29, 2022
Primary Completion
October 15, 2024
Study Completion
April 15, 2025
Last Updated
April 6, 2025
Record last verified: 2025-04
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 acknowledgement of the data resource.
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).