Enrolling by Invitation

NCT Number: NCT06506877

A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

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).

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Cognitive Risk Assessment

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Adoption of RC and BACH: Frequency of Cognitive Screening

Time frame: Monthly assessment over the study duration (up to 1 year)

Number of cognitive screening events per month, stratified by screening tool (BACH vs other) and Risk Calculator category (high vs low risk).
Adoption of RC and BACH: Frequency of BACH Orders

Time frame: Monthly assessment over the study duration (up to 1 year)

Number of BACH orders or pre-visit order sets executed per month, stratified by Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Frequency of MCI/ADRD, Sleep Disorders, and Depression Diagnoses

Time frame: Monthly assessment over the study duration (up to 1 year)

Incidence of new diagnoses for cognitive impairment (including MCI and ADRD), sleep disorders, and depression per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Frequency of Referrals to Neuropsychology, Geriatrics/Neurology, Psychiatry/Psychology, and Sleep Medicine

Time frame: Monthly assessment over the study duration (up to 1 year)

Number of orders and consults placed to specialty services per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Prescription Rates for Related Medications

Time frame: Monthly assessment over the study duration (up to 1 year)

Number of new medication orders relevant to cognition, sleep, and mood per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

National Institute on Aging (NIA)

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jul 18, 2024
Registry last updated: Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.