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

Study Overview
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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.

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

Conditions
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Dementia, Alzheimer Disease

Intervention / Treatment
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* Other: Brain Health Assessment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain Health Intervention<br>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 | Other: Brain Health Assessment<br>* 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.<br>|
| No Intervention: Usual care<br>Individuals who meet eligibility criteria will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare utilization | Number of primary care visits, laboratory tests performed, neuroimaging tests, and specialty visits or referrals, defined from EHR data | 6 months after index date | 
| Dementia medications | Percent of participants who receive new medications for dementia, defined from medication orders or dispensings in the electronic health record | 6 months after index date | 
| Urgent care/emergency department visits | Number of urgent care and emergency department visits | 1 year after index date | 
| Hospitalizations | Number of inpatient stays | 1 year after index date | 
| Clinic no shows | Number of scheduled visits missed | 1 year after index date | 
| Medication adherence | Proportion of days covered | 1 year after index date | 
| New dementia diagnoses (secondary definitions) | Dementia diagnosis rate in different time periods than for primary outcome, defined from EHR data | 6 months after index date; 18 months after index date | 
| New diagnoses of mild cognitive impairment | Rate of new diagnoses of mild cognitive impairment following the intervention, defined from EHR data | 12 months after index date | 
| Rate of accepting brain health visit | Proportion of people offered a brain health visit who accept and attend the visit | 3 months after invitation mailed | 
| Positive predictive value of eRADAR algorithm | Proportion of people with a high risk eRADAR Score who attend a brain health visit who are diagnosed with dementia | 12 months after index date |