Protocol for a Cluster Randomized Trial Comparing Team-Based to Clinician-Focused Implementation of Advance Care Planning in Primary Care

Abstract

Introduction: For many patients, primary care is an appropriate setting for advance care planning (ACP). ACP focuses on what matters most to patients and ensuring health care supports patient-defined goals. ACP may involve interactions between a clinician and a patient, but for seriously ill patients ACP could be managed by a team. Methods: We are conducting a cluster randomized trial comparing team-based to clinician-focused ACP using the Serious Illness Care Program (SICP) in 42 practices recruited from 7 practice-based research networks (PBRNs). Practices were randomized to one of the two models. Patients are referred to the study after engaging in ACP in primary care. Our target enrollment is 1260 subjects. Patient data are collected at enrollment, six months and one year. Primary outcomes are patient-reported goal-concordant care and days at home. Secondary outcomes include additional patient measures, clinician/team experience, and practice-level measures of SICP implementation. Study Implementation: This trial was designed and is conducted by the Meta-network Learning and Research Center (Meta-LARC), a consortium of PBRNs focused on integrating engagement with patients, families, and other stakeholders into primary care research and practice. The trial pairs a comparative effectiveness study with implementation of a new program and is designed to balance fidelity to the assigned model with flexibility to allow each practice to adapt implementation to their environment and priorities. Our dissemination will report the results of comparing the two models and the implementation experience of the practices to create guidance for the spread of ACP in primary care.

Deconstructing the Complexities of Advance Care Planning Outcomes: What Do We Know and Where Do We Go? A Scoping Review

“…Furthermore, decisions about which ACP stakeholder/pillar to focus on, which populations to include, which intervention to use, and which outcomes to assess will require a tailored approach based on the needs of the local environment. That said, given the current heterogeneity of ACP outcomes, future research should consider using some standardized outcomes so that trial findings can be compared, as some studies are attempting 154,155 . Finally, pragmatic trials measuring implementation strategies in real‐world settings are needed, and several are underway 152,154‐156 .…”

Prognostic Indices for Advance Care Planning in Primary Care: A Scoping Review

“…53,54 The Meta-network Learning And Research Center (Meta-LARC) ACP trial is 1 of these studies. 55 Meta-LARC is a consortium of 7 practice-based research networks in the United States and Canada including over 900 primary care practices and approximately 4000 clinicians who care for over 3 million patients. Meta-LARC is dedicated to increasing the quality, effectiveness, and safety of primary care through accelerated research and collaborative learning (https://www.ohsu.edu/ oregon-rural-practice-based-research-network/ meta-larc).…”

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial

“…The STADPLAN study takes place given the fact that most of the recent international publications on ACP interventions were conducted or are actually running in the primary care setting [54][55][56] or in the hospital setting [57][58][59] after a time of investigating ACP mainly in the nursing home setting [60]. However, more evidence on the effectiveness of ACP-interventions in different settings is needed, also taking into account the structures of respective healthcare systems.…”