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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Health Intervention | Experimental | Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician (PCP), who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable. |
|
| Usual care | No Intervention | Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Health Assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| New Dementia Diagnoses | Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes | 12 months after index date |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Received a New Diagnosis of Mild Cognitive Impairment or Dementia | Number of new diagnoses of mild cognitive impairment in the 12 months following study initiation, defined from EHR data | 12 months after index date |
| Number of Patients Who Received New Dementia Diagnoses in 18 Months of Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
- Currently receiving hospice care
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| Name | Affiliation | Role |
|---|---|---|
| Sascha Dublin, MD, PhD | KP Washington Health Research Institute | Principal Investigator |
| Deborah E. Barnes, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Burien Medical Center | Burien | Washington | 98166 | United States | ||
| Kaiser Permanente Kent Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28849435 | Background | 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. | |
| 31612463 | Background | 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. |
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This Individual Participant Data (IPD) plan applies to all quantitative study data, such as data collected specifically for the study and those derived from electronic health records (EHR), as well as the data collected via planned study surveys, which include only short qualitative free-text fields. We do not plan to share transcripts from in-depth qualitative interviews or recorded study assessment visits.
Data will be maintained on secure servers behind the firewalls at the two study sites: Kaiser Permanente Washington (KPWA) and the University of California, San Francisco (UCSF). De-identified or limited datasets containing individual-level data on which publications are based will be made available to qualified researchers for specified analyses. We will make the data available to users only under a data-use agreement (DUA).
Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.
Individuals interested in using KPWA data will be required to complete a standard form, sign a Data Use Agreement (DUA) and provide documentation of Institutional Review Board (IRB) approval. Data may then be accessed by qualified researchers via KPWA's Secure File Transfer (SFT) site. User registration will be required in order to access or download data files. As part of the registration process, users must agree to the conditions of use governing access to the data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | Brain Health Intervention | Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician, who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable. |
| FG001 | Usual Care | Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brain Health Intervention | Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician, who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | New Dementia Diagnoses | Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes | Posted | Count of Participants | Participants | 12 months after index date |
|
Adverse event data was collected over a period of 1 year and 6 months for each participant.
The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brain Health Intervention | Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician, who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Systematic Assessment | We only counted the first new diagnosis per patient. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sascha Dublin, MD, PhD | Kaiser Permanente Washington Health Research Institute | 206-287-2870 | Sascha.Dublin@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2023 | Apr 3, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2026 | Apr 3, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
Dementia diagnosis rate in 18 months defined from EHR data |
| 18 months after index date |
| Number of Patients Who Received a New Dementia Diagnosis in 6 Months of Follow-up | Number of patients with a new dementia diagnosis in 6 months of follow-up defined from the EHR. | 6 months |
| Number of Patients Who Received a New Dementia Medication | Receipt of new medications for dementia in 12 months, defined from medication orders or dispensings in the electronic health record | 12 months after index date |
| Number of Patients With Urgent Care/Emergency Department Visits | Number of participants who had at least 1 urgent care or emergency department visit in the 12 months following study initiation. | 1 year after index date |
| Average Number of Hospitalizations | Average number of hospitalizations (inpatient stays) per participant in the 1 year after study initiation. | 1 year after index date |
| Average Number of "no Shows" for Scheduled Clinic Visits | Average number of scheduled clinic visits missed per participant | 1 year after index date |
| Average Number of Visits in Primary Care - 6 Months | Average number of visits in primary care in the 6 months after study initiation | 6 months |
| Average Number of Visits in Primary Care - 12 Months | Average number of visits in primary care in the 12 months after study initiation | 12 months |
| Number of Patients Who Received a B12 Lab Test | Number of participants with at least 1 B12 lab test in the 12 months after study initiation. | 12 months |
| Number of Patients Who Received Neuroimaging | Number of patients with at least 1 Neuroimaging study (CT head, MRI brain) in 12 months following study initiation. | 12 months |
| Number of Patients Who Received Neurology Referrals | At least one referral to Neurology or Speech, Language, & Learning in 12 months following study initiation. | 12 months |
| Kent |
| Washington |
| 98030 |
| United States |
| Kaiser Permanente Renton Medical Center | Renton | Washington | 98056 | United States |
| Kaiser Permanente, Capitol Hill | Seattle | Washington | 98112 | United States |
| Kaiser Permanente Northgate Medical Center | Seattle | Washington | 98115 | United States |
| 34702167 | Background | 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. |
| BG001 | Usual Care | Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | After adding the numbers, they appear to agree with the overall n=3414 | Count of Participants | Participants |
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| Prior MCI diagnosis | Count of Participants | Participants |
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| Prior other memory diagnosis | Count of Participants | Participants |
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| Elixhauser comorbidity score mean | The Elixhauser comorbidity score is a comorbidity index (score) used to describe and adjust for disease (comorbidity) burden in patients. We used a modified version from van Walraven et al. The range of possible values is from -19 to +89, with higher values indicating worse comorbidity (corresponding to higher mortality risk). The reference for this version of the score is: Van Walraven C et al. A modification of the Elixhauser comorbidity measures into a point system for hospital death using administrative data. Med Care. 2009;47(6):626-33. doi: 10.1097/MLR.0b013e31819432e5. | Mean | Standard Deviation | Score on a scale |
|
| eRADAR score mean | The electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) is a risk score that uses existing electronic health record (EHR) data to estimate an individual's risk of having undiagnosed dementia. The range of possible values is from 0 to 1, with higher values indicating worse outcomes (higher risk of having undiagnosed dementia). The reference for this score is: Barnes DE et al. Development and validation of eRADAR: a tool using EHR data to detect unrecognized dementia. J Am Geriatr Soc. 2020; 68(1):103-111. doi: 10.1111/jgs.16182. | Mean | Standard Deviation | Score on a scale |
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|
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| Secondary | Number of Patients Who Received a New Diagnosis of Mild Cognitive Impairment or Dementia | Number of new diagnoses of mild cognitive impairment in the 12 months following study initiation, defined from EHR data | The analysis population excludes 1 person in the control arm and 2 people in the intervention arm who were randomized to the study but were later found to have died before the study initiation date. | Posted | Count of Participants | Participants | 12 months after index date |
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| Secondary | Number of Patients Who Received New Dementia Diagnoses in 18 Months of Follow-up | Dementia diagnosis rate in 18 months defined from EHR data | Posted | Count of Participants | Participants | 18 months after index date |
|
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|
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| Secondary | Number of Patients Who Received a New Dementia Diagnosis in 6 Months of Follow-up | Number of patients with a new dementia diagnosis in 6 months of follow-up defined from the EHR. | Posted | Count of Participants | Participants | 6 months |
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|
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| Secondary | Number of Patients Who Received a New Dementia Medication | Receipt of new medications for dementia in 12 months, defined from medication orders or dispensings in the electronic health record | The analysis population excludes 1 person in the control arm and 2 people in the intervention arm who were randomized to the study but were later found to have died before the study initiation date. | Posted | Count of Participants | Participants | 12 months after index date |
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| Secondary | Number of Patients With Urgent Care/Emergency Department Visits | Number of participants who had at least 1 urgent care or emergency department visit in the 12 months following study initiation. | Posted | Count of Participants | Participants | 1 year after index date |
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| Secondary | Average Number of Hospitalizations | Average number of hospitalizations (inpatient stays) per participant in the 1 year after study initiation. | Defined as the number of inpatient admissions in 1 year following study initiation. | Posted | Mean | Standard Deviation | inpatient stays | 1 year after index date |
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| Secondary | Average Number of "no Shows" for Scheduled Clinic Visits | Average number of scheduled clinic visits missed per participant | Posted | Mean | Standard Deviation | number of visits | 1 year after index date |
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| Secondary | Average Number of Visits in Primary Care - 6 Months | Average number of visits in primary care in the 6 months after study initiation | Posted | Mean | Standard Deviation | visits | 6 months |
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| Secondary | Average Number of Visits in Primary Care - 12 Months | Average number of visits in primary care in the 12 months after study initiation | Posted | Mean | Standard Deviation | visits | 12 months |
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| Secondary | Number of Patients Who Received a B12 Lab Test | Number of participants with at least 1 B12 lab test in the 12 months after study initiation. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Patients Who Received Neuroimaging | Number of patients with at least 1 Neuroimaging study (CT head, MRI brain) in 12 months following study initiation. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Patients Who Received Neurology Referrals | At least one referral to Neurology or Speech, Language, & Learning in 12 months following study initiation. | Posted | Count of Participants | Participants | 12 months |
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| 152 |
| 1,713 |
| 291 |
| 1,713 |
| 169 |
| 1,713 |
| EG001 | Usual Care | Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force). | 161 | 1,701 | 331 | 1,701 | 206 | 1,701 |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment | Diagnosis of suicidal ideation. We only counted the first diagnosis per person. |
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| Suicide attempt | Psychiatric disorders | Systematic Assessment | Injury or poisoning with a self-harm diagnosis. We only counted the first diagnosis per patient. |
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| New start of antidepressant | Psychiatric disorders | Systematic Assessment | We only counted the first event per patient. |
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |