A Technology-Driven Intervention to Improve Early Detection and Management of Cognitive Impairment

NCT05723523 | Completed DMC

• 2 other identifiers: A22-245R33AG069770
• Study Type: interventional
• Target: 3,230
• Locations: 1 country
• Sites: 2

Brief Summary

Most experts advocate for early detection of cognitive impairment (CI) so that patients and caregivers can be prepared for making difficult decisions and to improve quality of life, but studies show that screening alone isn't sufficient to change clinician actions related to early detection. Using predictive modelling developed with machine learning methods and sophisticated clinical decision support (CDS) tools, it is possible to identify patients at elevated risk for CI and make it much easier for primary care to engage and support patients and caregivers in meaningful care planning. The goal of this study is to implement and evaluate a low-cost, highly scalable CI-CDS system integrated within the electronic health record that has high potential to improve early CI detection and care and translate massive public and private sector investments in health informatics into tangible health benefits for large numbers of people.

Conditions

Dementia; Cognitive Impairment

Keywords

Clinical Decision Support; Cognitive Impairment; Dementia; Prediction Model

Outcome Measures

Primary Outcomes (1)

• CI Diagnosis

  CI detection as indicated by EHR documentation of CI diagnosis up to 24 months after index visit.

  up to 24 months post index visit

Secondary Outcomes (2)

• Clinician Confidence

  Pre-implementation and up to 12 months post-implementation

• Healthcare Utilization Costs

  up to 24 months post index visit

Study Arms (2)

CI-CDS

EXPERIMENTAL

In clinics randomized to the CI-CDS, the providers will be given the option to use the CI-CDS tool during eligible patient encounters.

Other: CI-CDS

Usual Care (UC)

NO INTERVENTION

In clinics randomized to UC, patients will receive usual care at their primary care visits over the accrual period (no intervention will be given).

Interventions

CI-CDS OTHER

The CI-CDS system is a clinical decision support tool that assists clinicians in the diagnosis and management of cognitive impairment.

CI-CDS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Primary care office visit at a randomized clinic during the accrual period, AND
• Patient is age 65 or over, AND
• Patient has no CI diagnosis documented in the EHR prior to the visit, AND
• Patient has:
• Any abnormal score on a comprehensive cognitive assessment (MoCA, MMSE or SLUMS) in the prior 18 months, OR
• a MiniCog score of \<3 in the prior 18 months and there is no evidence of subsequent comprehensive cognitive assessment (MoCA, MMSE, SLUMS), OR
• No cognitive testing in the last 18 months and a risk of a dementia diagnosis in the next 3 years \>=15% as calculated by the MC-PLUS algorithm developed in the R61 phase
• AND

You may not qualify if:

• Patient has received active parenteral chemotherapy within the last year
• Patient has stage 4 or equivalent cancer diagnosis
• Patient is enrolled in hospice care or palliative care program

Sponsors & Collaborators

• HealthPartners Institute: lead
• OCHIN, Inc.: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

HealthPartners

Bloomington, Minnesota, 55425, United States

Location

OCHIN, Inc.

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 10, 2023
• Study Start: August 23, 2023
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

US (2)