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DementiaCI WizardNCT05723523

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

A study testing CI-CDS in people with Dementia and Cognitive Impairment, run by HealthPartners Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia, Cognitive Impairment
What is being tested?
CI-CDS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,230 participants
Where
2 sitesUnited States
Study dates
23 Aug 2023to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • HealthPartners

    Bloomington, Minnesota, 55425

  • OCHIN, Inc.

    Portland, Oregon, 97201

Other trials in United States

About this study

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.

Read the 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.

Being tested
CI-CDS
Keywords
Clinical Decision Support, Cognitive Impairment, Dementia, Prediction Model
Medical subject headings
Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CI-CDSOther

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

Study groups in NCT05723523
Study groupRoleWhat they receive
CI-CDSExperimentalIn clinics randomized to the CI-CDS, the providers will be given the option to use the CI-CDS tool during eligible patient encounters.
Receives: Other: CI-CDS
Usual Care (UC)No interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. CI Diagnosis

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

    Measured: up to 24 months post index visit

Secondary outcomes (2)
  1. Clinician Confidence

    Clinician confidence in detecting and diagnosing cognitive impairment as indicated by survey administered pre- and post- implementation of the CI-CDS system.

    Measured: Pre-implementation and up to 12 months post-implementation

  2. Healthcare Utilization Costs

    For a subset of insured patients, cost of utilization of healthcare including emergency room and inpatient visits as indicated by insurance claim information.

    Measured: up to 24 months post index visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start23 Aug 2023
  3. Primary completion31 Aug 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05723523
Sponsor's protocol ID
A22-245
Other IDs
R33AG069770
Acronym
CI Wizard
Status last verified
Nov 2025
First submitted
2 Feb 2023
Last updated
4 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • JaKa MM, Rossom RC, Crouse B, Crain AL, Gustafson SK, Ekstrom HL, Zibley LJ, Borson S, O'Connor PJ, Werner AM, Appana D, von Sternberg TL, Hanson LR. Exposure to clinical decision support and training increases primary care clinician confidence in managing cognitive impairment care but not confidence to diagnose. BMC Prim Care. 2025 Nov 12;26(1):360. doi: 10.1186/s12875-025-03053-z.

    PubMed 41225324
  • JaKa MM, Rossom RC, Borson S, O'Connor PJ, Zibley LJ, von Sternberg TL, Crain AL, Ekstrom HL, Crouse B, Werner AM, Hanson LR. Confidence in diagnosing and managing care for cognitive impairment in primary care: a survey comparing barriers by primary care clinician type. Fam Pract. 2024 Oct 8;41(5):761-769. doi: 10.1093/fampra/cmae043.

    PubMed 39221923

Questions about this trial

What is this clinical trial studying?

A study testing CI-CDS in people with Dementia and Cognitive Impairment, run by HealthPartners Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CI Diagnosis (time frame: up to 24 months post index visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05723523, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.

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