Clinical trial NCT05905796: The Brain Health Study: A Pragmatic, Patient-Centered Trial
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: National Institute on Aging (NIA)
First posted: 2023-06-15
Enrollment: 1350
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: New dementia diagnosis
timeFrame: 12 months after index date
Secondary outcomes:
measure: Number of primary care visits
timeFrame: 6 months after index date
measure: Number of dementia-related laboratory tests performed
timeFrame: 6 months after index date
measure: Number of dementia-related neuroimaging tests performed
timeFrame: 6 months after index date
measure: Number of specialty visits or referrals for dementia assessment
timeFrame: 6 months after index date
measure: Percent of participants who receive new medications for dementia
timeFrame: 6 months after index date
measure: Number of urgent care and emergency department visits
timeFrame: 1 year after index date
measure: Number of inpatient days
timeFrame: 1 year after index date
measure: Number of scheduled visits missed
timeFrame: 1 year after index date
measure: Proportion of days covered for current prescriptions
timeFrame: 1 year after index date
measure: New dementia diagnosis (secondary definitions)
timeFrame: 6 months after index date
measure: New dementia diagnosis (secondary definitions)
timeFrame: 18 months after index date
measure: New diagnosis of mild cognitive impairment
timeFrame: 12 months after index date
measure: Proportion of people offered a brain health visit who accept and attend the visit
timeFrame: 3 months after invitation mailed
measure: Positive predictive value of eRADAR algorithm
timeFrame: 12 months after index date
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Primary Care at China Basin
state: California
city: San Francisco
country: United States
facility: Division of General Internal Medicine
state: California
city: San Francisco
country: United States
facility: Women's Health Primary Care
state: California
Study officials:
affiliation: University of California, San Francisco
name: Deborah Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KP Washington Health Research Institute
name: Sascha Dublin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dublin S, Greenwood-Hickman MA, Karliner L, Hsu C, Coley RY, Colemon L, Carrasco A, King D, Grace A, Lee SJ, Walsh JME, Barrett T, Broussard J, Singh U, Idu A, Yaffe K, Boustani M, Barnes DE. The electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Brain Health Trial: Protocol for an embedded, pragmatic clinical trial of a low-cost dementia detection algorithm. Contemp Clin Trials. 2023 Dec;135:107356. doi: 10.1016/j.cct.2023.107356. Epub 2023 Oct 17.
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.
citation: 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.
citation: Coley RY, Smith JJ, Karliner L, Idu AE, Lee SJ, Fuller S, Lam R, Barnes DE, Dublin S. External Validation of the eRADAR Risk Score for Detecting Undiagnosed Dementia in Two Real-World Healthcare Systems. J Gen Intern Med. 2023 Feb;38(2):351-360. doi: 10.1007/s11606-022-07736-6. Epub 2022 Jul 29.