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

Not Applicable
Active, not recruiting
Conditions
Dementia
Alzheimer Disease
Interventions
Other: Brain Health Assessment
Registration Number
NCT05905796
Lead Sponsor
University of California, San Francisco
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

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1350
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 AssessmentCalculate 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 diagnosis12 months after index date

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

Secondary Outcome Measures
NameTimeMethod
Number of dementia-related laboratory tests performed6 months after index date

Defined from EHR data

Number of specialty visits or referrals for dementia assessment6 months after index date

Defined from EHR data

Number of urgent care and emergency department visits1 year after index date

Defined from EHR data

Number of dementia-related neuroimaging tests performed6 months after index date

Defined from EHR data

New diagnosis of mild cognitive impairment12 months after index date

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

Number of inpatient days1 year after index date

Defined from EHR data

New dementia diagnosis (secondary definitions)18 months after index date

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

Number of primary care visits6 months after index date

Defined from EHR data

Proportion of days covered for current prescriptions1 year after index date

Standard measure of medication adherence

Percent of participants who receive new medications for dementia6 months after index date

Defined from medication orders or dispensings in the electronic health record

Number of scheduled visits missed1 year after index date

Clinic "no shows"

Proportion of people offered a brain health visit who accept and attend the visit3 months after invitation mailed

Rate of accepting brain health visit

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 (3)

Division of General Internal Medicine

🇺🇸

San Francisco, California, United States

Women's Health Primary Care

🇺🇸

San Francisco, California, United States

UCSF Primary Care at China Basin

🇺🇸

San Francisco, California, United States

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