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The Brain Health Study: A Pragmatic, Patient-Centered Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05356702
Recruitment Status : Not yet recruiting
First Posted : May 2, 2022
Last Update Posted : May 2, 2022
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Other: Brain Health Assessment Not Applicable

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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the eRADAR Algorithm in a Pragmatic, Patient-centered Trial.
Estimated Study Start Date : May 15, 2022
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Brain Health Intervention
  • Calculate eRADAR scores using EHR data to identify eligible individuals
  • Invite eligible individuals for brain health assessment visit
  • Enter results of brain health assessment visit into EHR
  • Provide summary of results and recommended next steps to the Primary Care Physician and participant
Other: 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. 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.

No Intervention: Usual care
Individuals who meet eligibility criteria will receive usual care.



Primary Outcome Measures :
  1. New dementia diagnoses [ Time Frame: 12 months after index date ]
    Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes


Secondary Outcome Measures :
  1. Healthcare utilization [ Time Frame: 6 months after index date ]
    Number of primary care visits, laboratory tests performed, neuroimaging tests, and specialty visits or referrals, defined from EHR data

  2. Dementia medications [ Time Frame: 6 months after index date ]
    Percent of participants who receive new medications for dementia, defined from medication orders or dispensings in the electronic health record

  3. Urgent care/emergency department visits [ Time Frame: 1 year after index date ]
    Number of urgent care and emergency department visits

  4. Hospitalizations [ Time Frame: 1 year after index date ]
    Number of inpatient stays

  5. Clinic "no shows" [ Time Frame: 1 year after index date ]
    Number of scheduled visits missed

  6. Medication adherence [ Time Frame: 1 year after index date ]
    Proportion of days covered

  7. New dementia diagnoses (secondary definitions) [ Time Frame: 6 months after index date; 18 months after index date ]
    Dementia diagnosis rate in different time periods than for primary outcome, defined from EHR data

  8. New diagnoses of mild cognitive impairment [ Time Frame: 12 months after index date ]
    Rate of new diagnoses of mild cognitive impairment following the intervention, defined from EHR data

  9. Rate of accepting brain health visit [ Time Frame: 3 months after invitation mailed ]
    Proportion of people offered a brain health visit who accept and attend the visit

  10. Positive predictive value of eRADAR algorithm [ Time Frame: 12 months after index date ]
    Proportion of people with a high risk eRADAR Score who attend a brain health visit who are diagnosed with dementia



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05356702


Contacts
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Contact: Leonardo Colemon, MA 206-287-2877 Leonardo.X.Colemon@kp.org
Contact: Anna Carrasco, MPH 209-914-2415 anna.carrasco2@ucsf.edu

Sponsors and Collaborators
Kaiser Permanente
University of California, San Francisco
Investigators
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Principal Investigator: Sascha Dublin, MD, PhD KP Washington Health Research Institute
Principal Investigator: Deborah Barnes, PhD University of California, San Francisco
Publications:
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT05356702    
Other Study ID Numbers: 1R01AG067427, 1R01AG069734
1R01AG067427 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2022    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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).

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.
Access Criteria:

Individuals interested in using KPWA data will be required to complete a standard form, sign a Data Use Agreement (DUA) and provide documentation of 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.

Individuals interested in using UCSF data will be required to complete the same data request form. The UCSF Industry Contracts Division (ICD), which oversees incoming and outgoing transfer of all UCSF data, will review the form for compliance with UCSF policies.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders