Digital detection of dementia (D(3)): a study protocol for a pragmatic cluster-randomized trial examining the application of patient-reported outcomes and passive clinical decision support systems

BACKGROUND: Early detection of Alzheimer’s disease and related dementias (ADRD) in a primary care setting is challenging due to time constraints and stigma. The implementation of scalable, sustainable, and patient-driven processes may improve early detection of ADRD; however, there are competing approaches; information may be obtained either directly from a patient (e.g., through a questionnaire) or passively using electronic health record (EHR) data. In this study, we aim to identify the benefit of a combined approach using a pragmatic cluster-randomized clinical trial. METHODS: We have developed a Passive Digital Marker (PDM), based on machine learning algorithms applied to EHR data, and paired it with a patient-reported outcome (the Quick Dementia Rating Scale or QDRS) to rapidly share an identified risk of impairment to a patient’s physician. Clinics in both south Florida and Indiana will be randomly assigned to one of three study arms: 1200 patients in each of the two populations will be administered either the PDM, the PDM with the QDRS, or neither, for a total of 7200 patients across all clinics and populations. Both incidence of ADRD diagnosis and acceptance into ADRD diagnostic work-up regimens is hypothesized to increase when patients are administered both the PDM and QDRS. Physicians performing the work-up regimens will be blind to the study arm of the patient. DISCUSSION: This study aims to test the accuracy and effectiveness of the two scalable approaches (PDM and QDRS) for the early detection of ADRD among older adults attending primary care practices. The data obtained in this study may lead to national early detection and management program for ADRD as an efficient and beneficial method of reducing the current and future burden of ADRD, as well as improving the annual rate of newly documented ADRD in primary care practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05231954. Registered February 9, 2022.