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

Alzheimer Disease Clinical Trial

— eRADAR  

Official title:

Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the Electronic Health Record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Algorithm in a Pragmatic, Patient-centered Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905796
• Other study ID #: 1R01AG069734
• Secondary ID: 1R01AG069734
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Alana Elop, MS
• Phone: 415-361-3602
• Email: alana.elop[@]ucsf.edu
• 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:

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 information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: September 30, 2025
• Est. primary completion date: March 31, 2025
• 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. Research interventionalists 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	Division of General Internal Medicine	San Francisco	California
United States	UCSF Primary Care at China Basin	San Francisco	California
United States	Women's Health Primary Care	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Kaiser Permanente Washington, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New dementia diagnosis	Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes	12 months after index date
Secondary	Number of primary care visits	Defined from EHR data	6 months after index date
Secondary	Number of dementia-related laboratory tests performed	Defined from EHR data	6 months after index date
Secondary	Number of dementia-related neuroimaging tests performed	Defined from EHR data	6 months after index date
Secondary	Number of specialty visits or referrals for dementia assessment	Defined from EHR data	6 months after index date
Secondary	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	Number of urgent care and emergency department visits	Defined from EHR data	1 year after index date
Secondary	Number of inpatient days	Defined from EHR data	1 year after index date
Secondary	Number of scheduled visits missed	Clinic "no shows"	1 year after index date
Secondary	Proportion of days covered for current prescriptions	Standard measure of medication adherence	1 year after index date
Secondary	New dementia diagnosis (secondary definitions)	Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes	6 months after index date
Secondary	New dementia diagnosis (secondary definitions)	Rate of new dementia diagnosis identified from the electronic health record (EHR) using prespecified set of ICD-10 codes	18 months after index date
Secondary	New diagnosis of mild cognitive impairment	Rate of new diagnosis of mild cognitive impairment following the intervention, defined from EHR data	12 months after index date
Secondary	Proportion of people offered a brain health visit who accept and attend the visit	Rate of accepting brain health 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