TabCAT Brain Health Assessment in Primary Care

NCT06090578 | Recruiting

• 1 other identifier: U01NS128913
• Study Type: interventional
• Target: 180,000
• Locations: 1 country
• Sites: 1

Brief Summary

Efficient and user-friendly paradigms to detect cognitive impairment, including dementia are needed in primary care. The TabCAT Brain Health Assessment accurately detects cognitive impairment via an appealing tablet interface with automated scoring and EMR integration. This study will evaluate the effectiveness of the paradigm on detection rates and other brain health outcomes via a pragmatic cluster randomized trial in 26 Kaiser Southern California primary care clinics.

Conditions

Mild Cognitive Impairment; Dementia

Keywords

Primary care; Cognitive assessment

Outcome Measures

Primary Outcomes (1)

• The rate of patients with at least one cognitive impairment diagnosis documented in the medical record by any primary care provider during the 12-month steady state period at the clinic.

  Rate is out of all patients with an encounter during the steady state period at the clinic. The primary analyses for all outcomes are limited to ages 65+.

  During the 12-month steady state period

Secondary Outcomes (2)

• The rate of patients who have a documented standardized cognitive assessment performed in the primary care clinic within 4 months of an incident cognitive impairment diagnosis.

  During the 12-month steady state period

• The rate of patients who have a referral to Geriatrics, Neurology or Psychiatry.

  During the 12-month steady state period

Study Arms (2)

TabCAT-Brain Health Assessment Clinical Pathway

EXPERIMENTAL

Primary care providers concerned that their patients are exhibiting signs of cognitive decline based on patient, informant (family), or provider concerns will refer them for a TabCAT-BHA assessment and follow-up care.

Other: TabCAT Brain Health Assessment Clinical Pathway

Usual Care Clinical Pathway

NO INTERVENTION

Patients in the control practices will continue with usual care workflows.

Interventions

TabCAT Brain Health Assessment Clinical Pathway OTHER

Primary care providers concerned that their patients are exhibiting signs of cognitive decline will refer them to clinical associates who will then perform the TabCAT-BHA tablet-based test. The TabCAT-BHA paradigm comprises 7-10 minutes of tablet-based testing and an optional 3-minute self-administered informant survey captures behavioral symptoms and change from baseline. The results are available to the PCP in the EMR along with turnkey guidance to evaluate for reversible causes, identify and involve a care partner, make and disclose diagnosis, provide community and educational resources, and make medical referrals as appropriate. Nursing support is available to support the PCP in making the diagnosis and to consult to the family via telephone post-diagnosis to address immediate care needs.

TabCAT-Brain Health Assessment Clinical Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with at least one encounter at an intervention clinic during the intervention period
• Age 18+ (limited to 65+ for primary analyses)

You may not qualify if:

• Patients under the age of 18.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kaiser Permanente: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Kaiser Permanente Southern California Department of Research & Evaluation

Pasadena, California, 91101, United States

RECRUITING

Related Publications (2)

• Bernstein Sideman A, Chalmer R, Ayers E, Gershon R, Verghese J, Wolf M, Ansari A, Arvanitis M, Bui N, Chen P, Chodos A, Corriveau R, Curtis L, Ehrlich AR, Tomaszewski Farias SE, Goode C, Hill-Sakurai L, Nowinski CJ, Premkumar M, Rankin KP, Ritchie CS, Tsoy E, Weiss E, Possin KL. Lessons from Detecting Cognitive Impairment Including Dementia (DetectCID) in Primary Care. J Alzheimers Dis. 2022;86(2):655-665. doi: 10.3233/JAD-215106.

  PMID: 35124639 RESULT

• Sideman AB, Nguyen HQ, Langer-Gould A, Lee EA, Borson S, Shen E, Tsoy E, Macias M, Goode C, Rankin K, Kramer J, Possin KL. Stakeholder-informed pragmatic trial protocol of the TabCAT-BHA for the detection of cognitive impairment in primary care. BMC Prim Care. 2024 Aug 6;25(1):286. doi: 10.1186/s12875-024-02544-9.

  PMID: 39107706 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Katherine Possin, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Collette Goode, BS

CONTACT

415-514-0881; collette.goode@ucsf.edu

Katherine Possin, PhD

CONTACT

415-476-1889; katherine.possin@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pragmatic cluster randomized trial. 26 primary care clinics will be randomized in two 18-month waves to receive either the TabCAT-BHA paradigm or usual care. The first wave will include six intervention practices and the second wave will include seven intervention practices.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: July 27, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)