Alzheimer Disease, Dementia
Conditions
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.
Interventions
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.
Sponsors
Kaiser Permanente
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Dementia Diagnoses | 12 months after index date | Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Received a New Diagnosis of Mild Cognitive Impairment or Dementia | 12 months after index date | Number of new diagnoses of mild cognitive impairment in the 12 months following study initiation, defined from EHR data |
| Number of Patients Who Received New Dementia Diagnoses in 18 Months of Follow-up | 18 months after index date | Dementia diagnosis rate in 18 months defined from EHR data |
| Number of Patients Who Received a New Dementia Diagnosis in 6 Months of Follow-up | 6 months | Number of patients with a new dementia diagnosis in 6 months of follow-up defined from the EHR. |
| Number of Patients Who Received a New Dementia Medication | 12 months after index date | Receipt of new medications for dementia in 12 months, defined from medication orders or dispensings in the electronic health record |
| Number of Patients With Urgent Care/Emergency Department Visits | 1 year after index date | Number of participants who had at least 1 urgent care or emergency department visit in the 12 months following study initiation. |
| Average Number of Hospitalizations | 1 year after index date | Average number of hospitalizations (inpatient stays) per participant in the 1 year after study initiation. |
| Average Number of "no Shows" for Scheduled Clinic Visits | 1 year after index date | Average number of scheduled clinic visits missed per participant |
| Average Number of Visits in Primary Care - 6 Months | 6 months | Average number of visits in primary care in the 6 months after study initiation |
| Average Number of Visits in Primary Care - 12 Months | 12 months | Average number of visits in primary care in the 12 months after study initiation |
| Number of Patients Who Received a B12 Lab Test | 12 months | Number of participants with at least 1 B12 lab test in the 12 months after study initiation. |
| Number of Patients Who Received Neuroimaging | 12 months | Number of patients with at least 1 Neuroimaging study (CT head, MRI brain) in 12 months following study initiation. |
| Number of Patients Who Received Neurology Referrals | 12 months | At least one referral to Neurology or Speech, Language, \& Learning in 12 months following study initiation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSascha Dublin, MD, PhD
KP Washington Health Research Institute
PRINCIPAL_INVESTIGATORDeborah E. Barnes, PhD
University of California, San Francisco
Participant flow
Recruitment details
This embedded pragmatic trial included eligible patients at 5 primary care clinics at Kaiser Permanente Washington. Patients were identified from the electronic health record, eligibility criteria were applied, and then patients were randomized in clusters. The cluster was the primary care provider (PCP) panel, to avoid contamination. PCPs were not enrolled or studied in this trial. Patients were initiated into the study between 6/29/2022 and 10/16/2023.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 84.44 Years STANDARD_DEVIATION 5.95 |
| Elixhauser comorbidity score mean | 7.06 Score on a scale STANDARD_DEVIATION 8.57 |
| eRADAR score mean | 0.06 Score on a scale STANDARD_DEVIATION 0.05 |
| Prior MCI diagnosis | 238 Participants |
| Prior other memory diagnosis | 527 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 118 Participants |
| Race/Ethnicity, Customized Missing/Declined | 94 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 281 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black/African American | 77 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 2679 Participants |
| Race/Ethnicity, Customized Other race | 49 Participants |
| Sex: Female, Male Female | 1008 Participants |
| Sex: Female, Male Male | 786 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 152 / 1,713 | 161 / 1,701 |
| other Total, other adverse events | 169 / 1,713 | 206 / 1,701 |
| serious Total, serious adverse events | 291 / 1,713 | 331 / 1,701 |
Outcome results
None listed