Population-Based Pragmatic Trial of Advance Care Planning in Primary Care in the University of California Health System.

Varying intensity of advance care planning (ACP) interventions at the population level has not been compared among seriously ill patients in primary care. This project will implement, test, and disseminate real-world scalable ACP interventions among primary care clinics across three University of California Health systems. The three ACP interventions are (1) distribution of an advance directive (AD) with targeted ACP messaging, (2) the AD, messaging, plus prompting patients to engage with the website (PREPARE), and (3) the AD, messaging, PREPARE, plus Care Coordinator engagement with patients and clinicians. We will identify a population cohort of seriously ill primary care patients and implement the ACP interventions using electronic health record (EHR) patient portals and postal mailings. Forty-five clinics across the three health systems will be cluster randomized to one of the three ACP interventions. The primary outcome for the population cohort is AD or Physician Orders for Life-Sustaining Treatment documentation in the EHR. A subset of the population cohort will be surveyed to assess patient-centered outcomes, including care consistent with goals at baseline, 12 months, and 24 months. Caregivers will be interviewed if patients are unable to be surveyed or die. ACP documentation, goal concordant care, and among decedents, health care utilization will be compared among intervention arms. The project is guided by a Study Advisory Group and Community Advisory Groups at each site to ensure rigorous patient-centered methods and consistency of implementation. Intervention fidelity will be evaluated using the Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM) framework. Challenges to implementation of this three-site health system trial and to intervention fidelity stem from site/clinic/system cultures, increasing attention to end-of-life care from payers and regulators, and growing pressures by health systems to implement ACP interventions. Stakeholder engagement is required to ensure consistent interventions across sites.