A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06506877
Status
Enrolling By Invitation

Conditions

  • Cognitive Risk Assessment

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH) — BEHAVIORAL
    Enrolled providers will have access to two cognitive screening tools during the active phase. The first tool is a Cognitive Risk-Calculator (RC), integrated into the Electronic Health Record, to help providers identify patients who are at high risk of exhibiting cognitive decline. The second tool is a computerized cognitive screening tool, the Brief Assessment of Cognitive Health (BACH), which patients complete independently. Results are automatically entered into the patient's medical record, along with patient-specific flags for concerns about depression and/or sleep disorder. The purpose of these tools is to facilitate cognitive screening and treatment for factors that may be contributing to cognitive decline.

Study Details

This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Administrative and EHR data will provide quantitative metrics of adoption (tool use) and effectiveness (change in provider behavior) while observations, interviews, and questionnaires will assess fidelity, acceptability, and feasibility for all stakeholders. Analyses will consider provider characteristics, clinic attributes, and regional variations in patient characteristics (e.g., SES, race/ethnicity).

Key Dates

Start date
Apr 3, 2024
Status verified
Aug 2025
Primary completion
Sep 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Active
    Active Phase: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)
  • No Intervention: Control
    Control Phase: Prior to implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

Primary Outcome Measure

Adoption of RC and BACH: Frequency of Cognitive Screening [ Time Frame: Monthly assessment over the study duration (up to 1 year) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195-

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