TabCAT Brain Health Assessment in Primary Care

A Pragmatic Trial of the TabCAT Brain Health Assessment for the Detection of Cognitive Impairment in Primary Care

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Other: TabCAT Brain Health Assessment

Detailed Description

Twenty-six Kaiser Permanente Southern California (KPSC) primary care clinics will be randomized in two waves to receive either the TabCAT-BHA paradigm or usual care. Clinics have been matched in pairs by number of providers, median panel size, the racial/ethnic makeup of the patient panel, baseline rates of cognitive impairment diagnosis, rates of telehealth encounters, and percentage of members who are 65+ in the practice. The trial will be conducted over two 18-month waves, with six intervention practices in the first wave and seven intervention practices starting in the second wave. All patients seen at least once across these 26 practices will be included in the trial and the primary analyses will use data extracted from the EMR. Patients in the intervention practices will receive care in accordance with the TabCAT-BHA paradigm whereas patients in the control practices will continue with usual care workflows. The intervention will include a 6-month startup period during which the research team will partner with the physician leads to adapt the paradigm workflows to each practice and onboard the PCPs, and then a 12-month steady state period when effectiveness on the primary and secondary outcomes will be measured. During the TabCAT-BHA paradigm intervention, pragmatically, primary care providers concerned that their patients are exhibiting signs of cognitive decline will refer them to clinical research associates located in the primary care clinics who will then perform the TabCAT-BHA tablet-based test either on the spot or as a scheduled procedure visit. The tablet-based test provides an automated scoring report that includes guidance for providers to identify reversible causes of cognitive impairment, involving a care partner, diagnostic disclosure, community and educational resources, and specialty referral including the option to refer the patient for a "Brain Health Consultation" telephone call with a study nurse or social worker.

• Study Type: Interventional
• Enrollment (Estimated): 180000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Collette Goode, BS; Phone Number: 415-514-0881; Email: collette.goode@ucsf.edu
• Study Contact Backup: Name: Katherine Possin, PhD; Phone Number: 415-476-1889; Email: katherine.possin@ucsf.edu

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91101
      • Recruiting
      • Kaiser Permanente Southern California Department of Research & Evaluation
      • Contact: Huong Q Nguyen, PhD; Phone Number: 626-773-0873; Email: huong.q2.nguyen@kp.org
      • Contact: Mayra Macias; Phone Number: 626-344-6667; Email: mayra.macias@kp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients under the age of 18.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TabCAT-Brain Health Assessment; 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; Primary care providers concerned that their patients are exhibiting signs of cognitive decline will refer them to clinical associates located in the clinics who will then perform the TabCAT-BHA tablet-based test either on the spot or as a scheduled procedure visit. 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. The paradigm also includes an optional "Brain Health Consultation," a telephone encounter with a dementia expert nurse or social worker to help address the gaps in care immediately following PCP diagnosis of MCI or dementia.
No Intervention: Usual Care; Patients in the control practices will continue with usual care workflows.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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+. The list of cognitive impairment diagnoses are published in the supplement of PMID: 35124639.	During the 12-month steady state period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Rate is out of all patients with an encounter at the clinic during the 12-month steady state period and an incident cognitive impairment diagnosis. The window for incident cognitive impairment diagnoses will be the steady state period + 4 months after. The standardized cognitive assessment must occur during the steady state period and +/- 4 months of the incident diagnosis. All standardized cognitive assessments will be counted. See diagnosis list in PMID: 35124639 by the categories dementia, mild cognitive impairment, and other cognitive impairment. Incident diagnoses are the first time that any of these diagnoses are documented in the medical record by any outpatient provider, using a 2 year look back window. In addition, incident diagnoses of mild cognitive impairment and dementia will be counted even if an "other cognitive impairment diagnosis" was previously made.	During the 12-month steady state period
The rate of patients who have a referral to Geriatrics, Neurology or Psychiatry.	Rate is out of all patients with an incident diagnosis, as defined in Outcome 2. The referral must occur within the 12-month steady state period + 4 months after, and within +/- 4 months of the incident diagnosis.	During the 12-month steady state period

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Kaiser Permanente
• Investigators: Principal Investigator: Katherine Possin, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): September 14, 2026

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Primary care; Cognitive assessment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: U01NS128913 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared outside of Kaiser Permanente Southern California.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No