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

Not Applicable
Active, not recruiting
Conditions
Alzheimer Disease
Dementia
Interventions
Other: Brain Health Assessment
Registration Number
NCT05356702
Lead Sponsor
Kaiser Permanente
Brief Summary

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

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
3417
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Brain Health InterventionBrain Health Assessment* 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
Primary Outcome Measures
NameTimeMethod
New dementia diagnoses12 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 Outcome Measures
NameTimeMethod
Urgent care/emergency department visits1 year after index date

Number of urgent care and emergency department visits

New dementia diagnoses (secondary definitions)6 months after index date; 18 months after index date

Dementia diagnosis rate in different time periods than for primary outcome, defined from EHR data

Clinic "no shows"1 year after index date

Number of scheduled visits missed

Medication adherence1 year after index date

Proportion of days covered

Dementia medications6 months after index date

Percent of participants who receive new medications for dementia, defined from medication orders or dispensings in the electronic health record

Rate of accepting brain health visit3 months after invitation mailed

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

Healthcare utilization6 months after index date

Number of primary care visits, laboratory tests performed, neuroimaging tests, and specialty visits or referrals, defined from EHR data

New diagnoses of mild cognitive impairment12 months after index date

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

Hospitalizations1 year after index date

Number of inpatient stays

Positive predictive value of eRADAR algorithm12 months after index date

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

Trial Locations

Locations (5)

Kaiser Permanente Northgate Medical Center

🇺🇸

Seattle, Washington, United States

Kaiser Permanente, Capitol Hill

🇺🇸

Seattle, Washington, United States

Kaiser Permanente Kent Medical Center

🇺🇸

Kent, Washington, United States

Kaiser Permanente Renton Medical Center

🇺🇸

Renton, Washington, United States

Kaiser Permanente Burien Medical Center

🇺🇸

Burien, Washington, United States

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