Conducting Comparative Effectiveness, Multisite Palliative Care and Advance Care Planning Trials: Lessons Learned and Future Directions From PCORI-Funded Studies.

The Patient-Centered Outcomes Research Institute (PCORI) funded multiple large-scale comparative effectiveness clinical trials evaluating palliative care (PC) and advance care planning (ACP) healthcare delivery models. This article provides an overview of the most common barriers our investigative teams encountered while implementing these trials and the strategies we utilized to overcome these challenges, with particular attention to identifying research partners for multisite trials; addressing contracting and regulatory issues; creating a team governance structure; training and engaging study staff across sites; recruiting, consenting, and enrolling study participants; collecting PC and ACP data and study outcomes; and managing multisite collaborations. The goal of this article is to provide guidance on how to best plan for and conduct rigorous trials evaluating PC and ACP healthcare delivery interventions moving forward.

Duke Scholars

Author Maren Karine Olsen Biostatistics & Bioinformatics, Division of Biostatistics