The Brain Health Study: un ensayo pragmático centrado en el paciente (eRADAR)
Detección de demencia a bajo costo utilizando datos de registros de salud electrónicos: validación y prueba del algoritmo de la regla de evaluación de riesgo de Alzheimer y demencia (eRADAR) del registro de salud electrónico en un ensayo pragmático centrado en el paciente.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94107
- UCSF Primary Care at China Basin
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San Francisco, California, Estados Unidos, 94115
- Division of General Internal Medicine
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San Francisco, California, Estados Unidos, 94143
- Women's Health Primary Care
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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 (PCP), who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable. |
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. |
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Sin intervención: Usual Care
Individuals in this arm did not receive any intervention but rather usual care. University of California, San Francisco (UCSF) does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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New Diagnoses of Dementia (12 Months)
Periodo de tiempo: 12 months after index date
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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 |
12 months after index date
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
New Diagnoses of Dementia or Mild Cognitive Impairment (12 Months)
Periodo de tiempo: 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 |
12 months after index date
|
|
New Diagnoses of Dementia (18 Months)
Periodo de tiempo: 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 |
18 months after index date
|
|
New Diagnoses of Dementia (6 Months)
Periodo de tiempo: 6 months after index date
|
Number of patients receiving new dementia diagnoses within 6 months of index date, defined using EHR data |
6 months after index date
|
|
New Dementia Medications (12 Months)
Periodo de tiempo: 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 |
12 months after index date
|
|
Urgent Care or Emergency Department Visits (12 Months)
Periodo de tiempo: 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 |
12 months after index date
|
|
Hospitalizations and Inpatient Admissions (12 Months)
Periodo de tiempo: 12 months after index date
|
Average number of hospitalizations and inpatient stays per participant within 12 months of index date |
12 months after index date
|
|
Scheduled Visits Missed (12 Months)
Periodo de tiempo: 12 months after index date
|
Average number of scheduled clinic visits missed ("no shows") per participant |
12 months after index date
|
|
Primary Care Visits (6 Months)
Periodo de tiempo: 6 months after index date
|
Average number of visits per participant in primary care within 6 months after the index date |
6 months after index date
|
|
Primary Care Visits (12 Months)
Periodo de tiempo: 12 months after index date
|
Average number of primary care visits per participant in the 12 months after their index date |
12 months after index date
|
|
B-12 Lab Tests (12 Months)
Periodo de tiempo: 12 months after index date
|
Number of patients with at least one B12 lab test in the 12 months after their index date |
12 months after index date
|
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Neuroimaging Tests (12 Months)
Periodo de tiempo: 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 |
12 months after index date
|
|
Neurology Referrals (12 Months)
Periodo de tiempo: 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 |
12 months after index date
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sascha Dublin, MD, PhD, KP Washington Health Research Institute
- Investigador principal: Deborah Barnes, PhD, University of California, San Francisco
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R01AG069734 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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. The investigators 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 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. The investigators will make the data available to users only under a data-use agreement (DUA).
Marco de tiempo para compartir IPD
Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.
Criterios de acceso compartido de IPD
Individuals interested in using data will be required to complete a standard form, sign a Data Use Agreement (DUA) and provide documentation of IRB approval. 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 acknowledgment of the data resource. The UCSF Industry Contracts Division (ICD), which oversees incoming and outgoing transfer of all UCSF data, will review registration materials for compliance with UCSF policies.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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