Clinical trial NCT06090578: TabCAT Brain Health Assessment in Primary Care
Official title: A Pragmatic Trial of the TabCAT Brain Health Assessment for the Detection of Cognitive Impairment in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia
Keywords: Primary care
Cognitive assessment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-10-19
Enrollment: 180000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: During the 12-month steady state period
Secondary outcomes:
measure: 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.
timeFrame: During the 12-month steady state period
measure: The rate of patients who have a referral to Geriatrics, Neurology or Psychiatry.
timeFrame: During the 12-month steady state period
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California Department of Research & Evaluation
state: California
Study officials:
affiliation: University of California, San Francisco
name: Katherine Possin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.