Supporting Primary Care Patients and Clinicians in Decisions about Alzheimer's Disease Biomarkers
Funded Grant
Overview
Affiliation
View All
Overview
description
PROJECT SUMMARY/ABSTRACT Even though most patients with Mild Cognitive Impairment or dementia are diagnosed in primary care settings compared to subspecialty care settings, both underdiagnosis and misdiagnosis of Alzheimer’s disease (AD) are high in primary care. In addition, primary care clinicians report less comfort with diagnosing etiologies of cognitive impairment and endorse less confidence in evolving AD diagnostic methods. Although AD blood biomarkers (AD BBM) have been primarily used in research or subspecialty settings, the advent of AD-targeting therapies in 2023 and FDA-approved AD BBM in 2025 have increased demands upon primary care clinicians to establish accurate etiological diagnoses. Thus, it is critical to develop primary care-focused clinical decision support tools and aligned implementation supports that: a) enhance clinicians’ comfort in diagnosing AD and appropriately incorporating AD BBM into diagnostic workups for cognitive impairment, b) align with recommendations for AD BBM use, and c) align with patient/family values, preferences and needs. Although biomarker-informed practice has been shown to improve diagnostic accuracy and patient care, there are no AD BBM decision support tools designed with and for primary care patients and clinicians to support use of AD diagnostics in real-world settings. This R21 project will address this need to support patient-centered clinical decision-making related to AD etiologic evaluations. First, in Aim 1, we will conduct an AD BBM decision needs and support assessment and co-design an AD BBM tool and implementation guide for primary care. In a user-centered approach with the Ottawa Decision Support Framework, our team will interview patients, family, and clinicians (n~40 total) and follow a rigorous, multi-step co-design process to develop and refine an AD BBM decision support tool with an implementation package for AD BBM use for diagnosing etiologies of cognitive impairment. Second, in Aim 2, we will determine the acceptability, feasibility and preliminary efficacy of an AD BBM tool. Among 32 primary care patients undergoing etiologic evaluation of cognitive impairment, we will provide the AD BBM tool and measure: a) acceptability and feasibility of AD BBM use (R21 outcomes), b) patient preferences related to AD BBM use, clinician ordering of AD BBM (potential future primary outcomes), and c) patient decision conflict, patient self- efficacy, and patient-clinician communication (future secondary outcomes), as well as feasibility trial operating characteristics (i.e., recruitment, enrollment, retention, outcome completeness). Findings of this innovative study will inform a Stage 3 study to test an AD BBM decision support tool that is designed for use in primary care, aligns with AD BBM use recommendations, and leads to patient-centered decision making about AD diagnostic workups.
