NCT06506877

A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Cognitive Risk Assessment

Interventions

Type	Name	Description
BEHAVIORAL	Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)	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.

Timeline

• Start date: 2024-04-03
• Primary completion: 2026-09-01
• Completion: 2026-12-31
• First posted: 2024-07-18
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States