Over five million Americans currently live with Alzheimer's disease (AD) or an AD-related dementia (AD/ADRD). Distressing symptoms and frequent transitions between care settings increase over the illness trajectory. Family caregivers also experience adverse outcomes. Pragmatic clinical trials embedded (ePCTs) in healthcare systems (HCS) are needed to accelerate the translation of evidence-based interventions for persons with dementia (PWD) and their caregivers. To accomplish this larger goal, dementia-specific methods in patient and caregiver reported outcome (PCRO) measurement are required to measure outcomes such as function, symptom distress, quality of life, and caregiver experience. However, conceptual and methodologic gaps remain in development of AD/ADRD PCROs, and methodologic barriers constrain data collection for use in ePCTs. The overarching objective of this U54 application is to establish the National Institute on Aging (NIA) AD/ADRD HCS Collaboratory. Within the AD/ADRD Collaboratory, the overarching objective of the Patient & Caregiver Reported Outcomes (PCRO) Core is to develop and support use of PCROs relevant to PWD and caregivers, working in collaboration with Administration and other AD/ADRD Collaboratory Cores and Teams. The PCRO Core will be led by Dr. Laura Hanson, who combines experience in clinical trials for PWD and their caregivers with extensive expertise in measuring quality and outcomes in serious illness. PCRO Core members have expertise in clinical geriatrics and dementia care processes, dementia PCROs, measurement science, health disparities for PWD and their caregivers, large datasets, and data capture for pragmatic trials and demonstration projects. They will meet the following Specific Aims:
Aim 1. To synthesize evidence and create a searchable library of AD/ADRD Clinical Outcome Assessments (COAs), including patient-reported outcomes (PROs), caregiver-reported outcomes (CROs), observer-reported outcomes (ObsROs), performance outcomes (PerfOs), and clinician-reported outcomes (ClinROs) relevant to ePCTs and demonstration projects to improve care and health outcomes for PWD and their caregivers;
Aim 2. To define and disseminate best practices for efficient, high-quality data collection systems for AD/ADRD COAs that can be captured in electronic health records (EHRs), registries, and administrative databases for use in the Technical/Data Core;
Aim 3. To provide expert guidance and consultation on the measurement and research application of AD/ADRD COAs to AD/ADRD Collaboratory pilot project leaders and junior career development awardees, as well as NIA-funded investigators leading ePCTs focused on PWD and their caregivers. IMPACT: The NIA AD/ADRD HCS Collaboratory is responsive to an urgent need for ePCTs to improve care and outcomes. The PCRO Core will fill current critical gaps in measurement and data collection systems to capture the outcomes most significant to PWD, their caregivers, and the clinicians who provide their healthcare.
