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TabCAT Brain Health Assessment in Primary Care

Primary Purpose

Mild Cognitive Impairment, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TabCAT Brain Health Assessment
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mild Cognitive Impairment focused on measuring Primary care, Cognitive assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Permanente Southern California Department of Research & EvaluationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TabCAT-Brain Health Assessment

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 13, 2023
Last Updated
October 20, 2023
Sponsor
University of California, San Francisco
Collaborators
Kaiser Permanente, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT06090578
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
September 14, 2026 (Anticipated)
Study Completion Date
September 14, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Kaiser Permanente, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Dementia
Keywords
Primary care, Cognitive assessment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TabCAT-Brain Health Assessment
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in the control practices will continue with usual care workflows.
Intervention Type
Other
Intervention Name(s)
TabCAT Brain Health Assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
During the 12-month steady state period
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
During the 12-month steady state period
Title
The rate of patients who have a referral to Geriatrics, Neurology or Psychiatry.
Description
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.
Time Frame
During the 12-month steady state period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Collette Goode, BS
Phone
415-514-0881
Email
collette.goode@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Possin, PhD
Phone
415-476-1889
Email
katherine.possin@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Possin, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Southern California Department of Research & Evaluation
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huong Q Nguyen, PhD
Phone
626-773-0873
Email
huong.q2.nguyen@kp.org
First Name & Middle Initial & Last Name & Degree
Mayra Macias
Phone
626-344-6667
Email
mayra.macias@kp.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared outside of Kaiser Permanente Southern California.
Citations:
PubMed Identifier
35124639
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.
Results Reference
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TabCAT Brain Health Assessment in Primary Care

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