Hybrid efficacy-effectiveness trial to promote goals-of-care discussions for patients with Alzheimer's disease and related dementias and their family caregivers - PROJECT SUMMARY/ABSTRACT Patients with Alzheimer’s disease and related dementias (ADRD) often experience high-intensity, potentially burdensome care near the end-of-life that may not align with their values and goals. Patients with ADRD and their families often face complex decisions about the most appropriate intensity of care. Goals-of- care discussions with clinicians are associated with improved patient and family outcomes and reduced intensity of care at the end of life. Although goals-of-care discussions can facilitate delivery of goal-concordant care, they currently occur infrequently or too late in the illness. Electronic health records (EHR) provide a key opportunity to identify patients who would benefit from these discussions and to promote these discussions, yet few prior interventions have used the EHR for this purpose. To address this gap, we propose an NIH Stage III hybrid efficacy-effectiveness trial of a communication-priming intervention, called Jumpstart, to increase the occurrence and quality of goals-of-care discussions with patients with ADRD and their family caregivers in the outpatient setting. We will use EHR data to identify patients and facilitate implementation of the intervention. In Aim 1, we will conduct a NIH Stage III hybrid efficacy-effectiveness trial of the adapted Jumpstart intervention compared to usual care to assess effectiveness for promoting occurrence and improving quality of goals-of care discussions and improving patient- and family-reported outcomes. The primary outcome is EHR documentation of a goals-of-care discussion by 3 months after enrollment. We will enroll 1200 patients with ADRD and their family caregivers. Aim 2 examines the mechanisms of action of the intervention on important patient- and family-centered outcomes including patients’ palliative care needs and the intervention’s effect on healthcare utilization, and monitors for unintended consequences of the intervention in terms of psychological distress and one-year all-cause mortality. In Aim 3, we will conduct a mixed-methods evaluation to explore further intervention improvements and identify barriers and facilitators to intervention implementation. Our team is well-positioned to accomplish these aims. We have experience conducting large, randomized trials with patient- and family-centered outcomes, biostatistics, qualitative and mixed methods analyses, ADRD research and policy, and implementation science methods. We have used informatics integrated with the EHR to identify patients with ADRD and measure quality of care similar to the methods proposed here, including measurement of the primary outcome. This study will provide important data for patients with ADRD, their family caregivers, clinicians, and healthcare systems on the efficacy of the Jumpstart intervention to improve communication and facilitate goal-concordant care and will provide insights for implementation of similar EHR-based interventions designed to improve communication and patient outcomes.
