TabCAT Brain Health Assessment in Primary Care

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090578
• Other study ID #: U01NS128913
• Secondary ID: U01NS128913
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: September 14, 2026

Study information

• Verified date: October 2023
• Source: University of California, San Francisco
• Contact: Collette Goode, BS
• Phone: 415-514-0881
• Email: collette.goode[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180000
• Est. completion date: September 14, 2026
• Est. primary completion date: September 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California Department of Research & Evaluation	Pasadena	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Kaiser Permanente, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, Tso — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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