Clinical trial NCT05356702: 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 eRADAR Algorithm in a Pragmatic, Patient-centered Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2022-05-02
Enrollment: 3417
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: 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.

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 diagnoses
timeFrame: 12 months after index date
Secondary outcomes:
measure: Healthcare utilization
timeFrame: 6 months after index date
measure: Dementia medications
timeFrame: 6 months after index date
measure: Urgent care/emergency department visits
timeFrame: 1 year after index date
measure: Hospitalizations
timeFrame: 1 year after index date
measure: Clinic "no shows"
timeFrame: 1 year after index date
measure: Medication adherence
timeFrame: 1 year after index date
measure: New dementia diagnoses (secondary definitions)
timeFrame: 6 months after index date; 18 months after index date
measure: New diagnoses of mild cognitive impairment
timeFrame: 12 months after index date
measure: Rate of accepting brain health visit
timeFrame: 3 months after invitation mailed
measure: Positive predictive value of eRADAR algorithm
timeFrame: 12 months after index date
Other outcomes:
Locations:
city: Burien
country: United States
facility: Kaiser Permanente Burien Medical Center
state: Washington
city: Kent
country: United States
facility: Kaiser Permanente Kent Medical Center
state: Washington
city: Renton
country: United States
facility: Kaiser Permanente Renton Medical Center
state: Washington
city: Seattle
country: United States
facility: Kaiser Permanente, Capitol Hill
state: Washington
city: Seattle
country: United States
facility: Kaiser Permanente Northgate Medical Center
state: Washington
Study officials:
affiliation: KP Washington Health Research Institute
name: Sascha Dublin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Deborah E. Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.