A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

Not Applicable

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

• Registration Number: NCT06506877
• Lead Sponsor: The Cleveland Clinic

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Effectiveness of RC and BACH: Frequency of MCI/ADRD, Sleep Disorders, and Depression Diagnoses	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).
Adoption of RC and BACH: Frequency of Cognitive Screening	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).
Effectiveness of RC and BACH: Frequency of Referrals to Neuropsychology, Geriatrics/Neurology, Psychiatry/Psychology, and Sleep Medicine	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	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).
Adoption of RC and BACH: Frequency of BACH Orders	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).

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States