Dementia, Alzheimer Disease
Conditions
Brief summary
The eRADAR Brain Health Study is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual 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 patients at risk of undiagnosed dementia. 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.
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. 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.
Sponsors
University of California, San Francisco
Kaiser Permanente
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
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 Diagnoses of Dementia (12 Months) | 12 months after index date | Number of patients who received new dementia diagnoses within 12 months, identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New Diagnoses of Dementia or Mild Cognitive Impairment (12 Months) | 12 months after index date | Number of patients who received a new diagnosis of dementia or mild cognitive impairment within 12 months, defined from EHR data |
| New Diagnoses of Dementia (18 Months) | 18 months after index date | Number of patients who received a new diagnosis of dementia within 18 months of index date, defined from EHR data |
| New Diagnoses of Dementia (6 Months) | 6 months after index date | Number of patients receiving new dementia diagnoses within 6 months of index date, defined using EHR data |
| New Dementia Medications (12 Months) | 12 months after index date | Number of patients who received a new medication for dementia in 12 months, defined from medication orders or dispensings in the electronic health record |
| Urgent Care or Emergency Department Visits (12 Months) | 12 months after index date | Number of patients who had at least 1 urgent care or emergency department visit in the 12 months following their index date |
| Hospitalizations and Inpatient Admissions (12 Months) | 12 months after index date | Average number of hospitalizations and inpatient stays per participant within 12 months of index date |
| Scheduled Visits Missed (12 Months) | 12 months after index date | Average number of scheduled clinic visits missed ("no shows") per participant |
| Primary Care Visits (6 Months) | 6 months after index date | Average number of visits per participant in primary care within 6 months after the index date |
| Primary Care Visits (12 Months) | 12 months after index date | Average number of primary care visits per participant in the 12 months after their index date |
| B-12 Lab Tests (12 Months) | 12 months after index date | Number of patients with at least one B12 lab test in the 12 months after their index date |
| Neuroimaging Tests (12 Months) | 12 months after index date | Number of patients with at least one neuroimaging study (CT head, MRI brain) in the 12 months after their index date |
| Neurology Referrals (12 Months) | 12 months after index date | Number of patients with at least one referral to Neurology or the Memory and Aging Center in the 12 months after their index date |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeborah Barnes, PhD
University of California, San Francisco
PRINCIPAL_INVESTIGATORSascha Dublin, MD, PhD
KP Washington Health Research Institute
Participant flow
Recruitment details
A research study programmer extracted EHR data to identify patients who met eligibility criteria within each study clinic. Eligible patients were then randomized in blocks based on their primary care provider to intervention or usual care groups. The date of randomization was used as their initiation date into the study. All patients initiated were followed through the electronic health record for outcomes, except those who were later found to have died prior to the initiation date.
Pre-assignment details
Primary care providers (PCPs) served as the unit of randomization but were not enrolled in the trial. 42 PCPs were randomized to the intervention group, of whom 40 had at least one high-risk patient that was included in the study. 39 PCPs were randomized to usual care, of whom 36 had at least one high-risk patient that was included in the study. A subset of PCPs and care partners of patients in the intervention group participated in qualitative interviews that were not part of the trial.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 84.66 Years STANDARD_DEVIATION 5.77 |
| Elixhauser comorbidity score | 7.19 score on a scale STANDARD_DEVIATION 8.29 |
| eRADAR score | 0.06 Score on a scale STANDARD_DEVIATION 0.04 |
| Prior diagnosis of memory problem or concern | 62 Participants |
| Prior diagnosis of mild cognitive impairment | 26 Participants |
| Race/Ethnicity, Customized Another or More Than One Race | 58 Participants |
| Race/Ethnicity, Customized Asian | 405 Participants |
| Race/Ethnicity, Customized Black or African American | 120 Participants |
| Race/Ethnicity, Customized Hispanic or Latino (any race) | 56 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 10 Participants |
| Race/Ethnicity, Customized White | 250 Participants |
| Sex/Gender, Customized Female | 346 Participants |
| Sex/Gender, Customized Male | 319 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 53 / 681 | 33 / 575 |
| other Total, other adverse events | 78 / 681 | 52 / 575 |
| serious Total, serious adverse events | 239 / 681 | 162 / 575 |
Outcome results
None listed