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The Brain Health Study: Et pragmatisk, patientcentreret forsøg (eRADAR)

11. september 2026 opdateret af: University of California, San Francisco

Billig påvisning af demens ved hjælp af elektroniske patientjournaldata: Validering og test af den elektroniske patientjournal risiko for Alzheimers og demensvurderingsregel (eRADAR) Algoritme i et pragmatisk, patientcentreret forsøg.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1261

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94107
        • UCSF Primary Care at China Basin
      • San Francisco, California, Forenede Stater, 94115
        • Division of General Internal Medicine
      • San Francisco, California, Forenede Stater, 94143
        • Women's Health Primary Care

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Brain Health Assessment

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.
Ingen indgriben: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
New Diagnoses of Dementia (12 Months)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
New Diagnoses of Dementia or Mild Cognitive Impairment (12 Months)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

National Institute on Aging (NIA)
Kaiser Permanente

Efterforskere

  • Ledende efterforsker: Sascha Dublin, MD, PhD, KP Washington Health Research Institute
  • Ledende efterforsker: Deborah Barnes, PhD, University of California, San Francisco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. december 2022

Primær færdiggørelse (Faktiske)

6. oktober 2025

Studieafslutning (Faktiske)

26. januar 2026

Datoer for studieregistrering

Først indsendt

6. juni 2023

Først indsendt, der opfyldte QC-kriterier

6. juni 2023

Først opslået (Faktiske)

15. juni 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1R01AG069734 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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).

IPD-delingstidsramme

Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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