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Completed

NCT Number: NCT05905796

The Brain Health Study: 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.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of General Internal Medicine, San Francisco, California, United States

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About this study

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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Health Assessment

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. 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.

Primary outcomes

  1. New dementia diagnosis

    Time frame: 12 months after index date

    Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes

Secondary outcomes

  1. Number of primary care visits

    Time frame: 6 months after index date

    Defined from EHR data

  2. Number of dementia-related laboratory tests performed

    Time frame: 6 months after index date

    Defined from EHR data

  3. Number of dementia-related neuroimaging tests performed

    Time frame: 6 months after index date

    Defined from EHR data

  4. Number of specialty visits or referrals for dementia assessment

    Time frame: 6 months after index date

    Defined from EHR data

  5. Percent of participants who receive new medications for dementia

    Time frame: 6 months after index date

    Defined from medication orders or dispensings in the electronic health record

  6. Number of urgent care and emergency department visits

    Time frame: 1 year after index date

    Defined from EHR data

  7. Number of inpatient days

    Time frame: 1 year after index date

    Defined from EHR data

  8. Number of scheduled visits missed

    Time frame: 1 year after index date

    Clinic "no shows"

  9. Proportion of days covered for current prescriptions

    Time frame: 1 year after index date

    Standard measure of medication adherence

  10. New dementia diagnosis (secondary definitions)

    Time frame: 6 months after index date

    Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes

  11. New dementia diagnosis (secondary definitions)

    Time frame: 18 months after index date

    Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes

  12. New diagnosis of mild cognitive impairment

    Time frame: 12 months after index date

    Rate of new diagnosis of mild cognitive impairment following the intervention, defined from EHR data

  13. Proportion of people offered a brain health visit who accept and attend the visit

    Time frame: 3 months after invitation mailed

    Rate of accepting brain health visit

  14. Positive predictive value of eRADAR algorithm

    Time frame: 12 months after index date

    Proportion of people with a high risk eRADAR Score who attend a brain health visit who are diagnosed with dementia

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Kaiser Permanente
  • National Institute on Aging (NIA)

Registry information

Official study title

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.

Acronym: eRADAR

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 15, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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