O estudo da saúde do cérebro: um ensaio pragmático centrado no paciente (eRADAR)
Detecção de Demência de Baixo Custo Usando Dados de Registros Eletrônicos de Saúde: Validação e Teste do Algoritmo da Regra de Avaliação de Risco de Alzheimer e Demência do Registro Eletrônico de Saúde (eRADAR) em um ensaio pragmático centrado no 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
California
-
San Francisco, California, Estados Unidos, 94107
- UCSF Primary Care at China Basin
-
San Francisco, California, Estados Unidos, 94115
- Division of General Internal Medicine
-
San Francisco, California, Estados Unidos, 94143
- Women's Health Primary Care
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
|
Sem intervenção: 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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
New Diagnoses of Dementia (12 Months)
Prazo: 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 |
12 months after index date
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
New Diagnoses of Dementia or Mild Cognitive Impairment (12 Months)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
|
|
Neuroimaging Tests (12 Months)
Prazo: 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)
Prazo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R01AG069734 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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).
Prazo de Compartilhamento de IPD
Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .