A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

NCT ID: NCT06506877

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Cognitive Risk Assessment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Active

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Darlene Floden

Staff Neuropsychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R33AG069729

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-1022

Identifier Type: -

Identifier Source: org_study_id

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