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

NCT ID: NCT05356702

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2025-04-15

Brief Summary

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The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.

Detailed Description

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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.

Conditions

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Dementia Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Brain Health Assessment

Intervention Type OTHER

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.

Usual care

Individuals who meet eligibility criteria will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sascha Dublin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KP Washington Health Research Institute

Deborah E. Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Kaiser Permanente Burien Medical Center

Burien, Washington, United States

Site Status

Kaiser Permanente Kent Medical Center

Kent, Washington, United States

Site Status

Kaiser Permanente Renton Medical Center

Renton, Washington, United States

Site Status

Kaiser Permanente, Capitol Hill

Seattle, Washington, United States

Site Status

Kaiser Permanente Northgate Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28849435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31612463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34702167 (View on PubMed)

Other Identifiers

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1R01AG067427

Identifier Type: NIH

Identifier Source: org_study_id

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