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.
