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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05356702
• Other study ID #: 1R01AG067427
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 3422
• Est. completion date: July 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• Brain Health Assessment
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Burien Medical Center	Burien	Washington
United States	Kaiser Permanente Kent Medical Center	Kent	Washington
United States	Kaiser Permanente Renton Medical Center	Renton	Washington
United States	Kaiser Permanente Northgate Medical Center	Seattle	Washington
United States	Kaiser Permanente, Capitol Hill	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barnes DE, Zhou J, Walker RL, Larson EB, Lee SJ, Boscardin WJ, Marcum ZA, Dublin S. Development and Validation of eRADAR: A Tool Using EHR Data to Detect Unrecognized Dementia. J Am Geriatr Soc. 2020 Jan;68(1):103-111. doi: 10.1111/jgs.16182. Epub 2019 Oct 14. — View Citation

Lee SJ, Larson EB, Dublin S, Walker R, Marcum Z, Barnes D. A Cohort Study of Healthcare Utilization in Older Adults with Undiagnosed Dementia. J Gen Intern Med. 2018 Jan;33(1):13-15. doi: 10.1007/s11606-017-4162-3. No abstract available. — View Citation

Palazzo L, Hsu C, Barnes DE, Gray MF, Greenwood-Hickman MA, Larson EB, Dublin S. Patient and caregiver perspectives on a tool to increase recognition of undiagnosed dementia: a qualitative study. BMC Geriatr. 2021 Oct 26;21(1):604. doi: 10.1186/s12877-021-02523-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Urgent care/emergency department visits	Number of urgent care and emergency department visits	1 year after index date
Secondary	Hospitalizations	Number of inpatient stays	1 year after index date
Secondary	Clinic "no shows"	Number of scheduled visits missed	1 year after index date
Secondary	Medication adherence	Proportion of days covered	1 year after index date
Secondary	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
Secondary	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
Secondary	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
Secondary	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