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Enrolling by invitation NCT06506877

A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

No phase Interventional Cognitive Risk Assessment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH).
Who it may be relevant to
Registry conditions: Cognitive Risk Assessment. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • 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, a

Primary outcome measures

  • Adoption of RC and BACH: Frequency of Cognitive Screening [Time frame: Monthly assessment over the study duration (up to 1 year)]
  • Adoption of RC and BACH: Frequency of BACH Orders [Time frame: Monthly assessment over the study duration (up to 1 year)]
  • 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)]
  • 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)]
  • Effectiveness of RC and BACH: Prescription Rates for Related Medications [Time frame: Monthly assessment over the study duration (up to 1 year)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT06506877 · 20-1022 · R33AG069729

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗