A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

NeuroTherapia, Inc.

Status: Invitation-only

Conditions: Cognitive Risk Assessment

Treatments: Behavioral: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06506877

20-1022

R33AG069729 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Provider Inclusion Criteria:

• Must see adults aged 60 years or older in their practice.
• Must be a prescribing provider.

Exclusion Criteria:

• Provider sees patients at more than one participating study site.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Active

Experimental group

Description:

Active Phase: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

Treatment:

Behavioral: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

Control

No Intervention group

Description:

Control Phase: Prior to implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)