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Completed

NCT Number: NCT05356702

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

Kaiser Permanente Burien Medical Center, Burien, Washington, United States

Loading trial locations.

About this study

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.

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. 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.

Primary outcomes

  1. New Dementia Diagnoses

    Time frame: 12 months after index date

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

Secondary outcomes

  1. Number of Patients Who Received a New Diagnosis of Mild Cognitive Impairment or Dementia

    Time frame: 12 months after index date

    Number of new diagnoses of mild cognitive impairment in the 12 months following study initiation, defined from EHR data

  2. Number of Patients Who Received New Dementia Diagnoses in 18 Months of Follow-up

    Time frame: 18 months after index date

    Dementia diagnosis rate in 18 months defined from EHR data

  3. Number of Patients Who Received a New Dementia Diagnosis in 6 Months of Follow-up

    Time frame: 6 months

    Number of patients with a new dementia diagnosis in 6 months of follow-up defined from the EHR.

  4. Number of Patients Who Received a New Dementia Medication

    Time frame: 12 months after index date

    Receipt of new medications for dementia in 12 months, defined from medication orders or dispensings in the electronic health record

  5. Number of Patients With Urgent Care/Emergency Department Visits

    Time frame: 1 year after index date

    Number of participants who had at least 1 urgent care or emergency department visit in the 12 months following study initiation.

  6. Average Number of Hospitalizations

    Time frame: 1 year after index date

    Average number of hospitalizations (inpatient stays) per participant in the 1 year after study initiation.

  7. Average Number of "no Shows" for Scheduled Clinic Visits

    Time frame: 1 year after index date

    Average number of scheduled clinic visits missed per participant

  8. Average Number of Visits in Primary Care - 6 Months

    Time frame: 6 months

    Average number of visits in primary care in the 6 months after study initiation

  9. Average Number of Visits in Primary Care - 12 Months

    Time frame: 12 months

    Average number of visits in primary care in the 12 months after study initiation

  10. Number of Patients Who Received a B12 Lab Test

    Time frame: 12 months

    Number of participants with at least 1 B12 lab test in the 12 months after study initiation.

  11. Number of Patients Who Received Neuroimaging

    Time frame: 12 months

    Number of patients with at least 1 Neuroimaging study (CT head, MRI brain) in 12 months following study initiation.

  12. Number of Patients Who Received Neurology Referrals

    Time frame: 12 months

    At least one referral to Neurology or Speech, Language, & Learning in 12 months following study initiation.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the eRADAR Algorithm in a Pragmatic, Patient-centered Trial.

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 2, 2022
Registry last updated
Jul 6, 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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