A Technology-Driven Intervention to Improve Early Detection and Management of Cognitive Impairment (CI Wizard)

January 5, 2024 updated by: HealthPartners Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevalence of Alzheimer's disease (AD) and AD-related dementias (ADRD) is expected to triple by 2050, contributing to decreased quality of life, increased medical care utilization, and additional burden on an already stressed primary care system. Many clinicians lack confidence to assess, diagnose and manage cognitive impairment (CI), and more than 50% of patients with CI are undiagnosed. Unfortunately, studies show that even in settings with high rates of standardized CI screening, very few patients who screen positive have documentation of any clinician follow-up action. To address these important problems, a machine learning model (called MC-PLUS) was developed and validated using electronic health record (EHR) data to identify patients at elevated risk of a future dementia diagnosis (AD/ADRD). A web-based and EHR-integrated CI clinical decision support (CI-CDS) system was also developed and validated to engage patients and clinicians in conversation about elevated dementia risk, and to give clinicians the confidence and tools they need to diagnose and manage CI. Both MC-PLUS and the CI-CDS system have been added into an existing web-based CDS platform that has high use rates and primary care clinician satisfaction, and is already seamlessly integrated within the EHR. This CDS platform improves outcomes for patients with chronic diseases such as diabetes and high cardiovascular risk as shown in published studies. After systematically validating the CI-CDS system with expert champions and conducting a pilot test at three primary care clinics, a pragmatic, clinic-randomized, controlled clinical trial is now being implemented in 38 primary care clinics randomized to receive CI-CDS or usual care (UC). All primary care visits that take place at the randomized clinics after the CI-CDS system is implemented will be screened for intervention eligibility. Patients will be accrued into the study on the date of their first visit during the accrual period that meets all intervention eligibility criteria and followed for the duration of the observation period. Primary care clinicians in the intervention clinics will be encouraged but not required to use the CI-CDS with eligible patients, so that the decision to use or not use CI-CDS at a given clinical encounter is up to the clinician. The CI-CDS user interface will provide updated clinical recommendations at primary care encounters for patients with elevated CI risk or with a CI diagnosis. The interface will enable the user to administer diagnostic screening exams (e.g., Montreal Cognitive Assessment (MoCA), Patient Health Questionnaire (PHQ-9)), place quick orders (e.g., referrals, procedures, lab assessments, medications), accurately diagnose CI, provide patient education materials (e.g., diagnoses, legal documents, community resources), and manage CI (e.g., visualize trends in screening exams, lab values, medications). If successful, the CI-CDS system will improve rates of new CI diagnosis and narrow existing sociodemographic disparities in adults with elevated dementia risk at index visit in CI-CDS compared to UC clinics. The impact of the intervention on care management and care plans will be evaluated using EHR data and chart audits. Change in clinician confidence in CI detection and care management will be evaluated in CI-CDS compared to UC clinics. Determinants of clinician actions in response to the CDS system will be assessed using behavior change theory and technology acceptance constructs, and phone surveys of patient and caregiver dyads will be conducted to evaluate intervention effects on feelings of preparedness for decision making and distress. The CI-CDS system is immediately scalable to large numbers of patients through the existing non-commercialized CDS platform already in use for millions of patients in care systems spanning 14 states. The CDS system implemented as described could maximize return on massive investments that have been made in EHR systems, and provide a prototype to rapidly and consistently translate evolving evidence-based CI guidelines into personalized CI care and guidance within primary care.

Study Type

Interventional

Enrollment (Estimated)

3001

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

-First visit during the accrual period at which all prior inclusion criteria are met

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CI-CDS
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
The CI-CDS system is a clinical decision support tool that assists clinicians in the diagnosis and management of cognitive impairment.
No Intervention: Usual Care (UC)
In clinics randomized to UC, patients will receive usual care at their primary care visits over the accrual period (no intervention will be given).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CI Diagnosis
Time Frame: up to 24 months post index visit
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Confidence
Time Frame: Pre-implementation and 12 months post-implementation
Clinician confidence in detecting and diagnosing cognitive impairment as indicated by survey administered pre- and post- implementation of the CI-CDS system.
Pre-implementation and 12 months post-implementation
Healthcare Utilization Costs
Time Frame: up to 24 months post index visit
For a subset of insured patients, cost of utilization of healthcare including emergency room and inpatient visits as indicated by insurance claim information.
up to 24 months post index visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

National Institute on Aging (NIA)
OCHIN, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 2, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A22-245
  • R33AG069770 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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