Conducting Comparative Effectiveness, Multisite Palliative Care and Advance Care Planning Trials

Author:

El-Jawahri Areej1,Waterman Brittany2,Enguidanos Susan3,Gibbs Lisa4,Navarro Victor5,Olsen Maren6,Temel Jennifer1,Totten Annette7,Grudzen Corita R.8

Affiliation:

1. Division of Hematology-Oncology, Massachusetts General Hospital, Boston, MA

2. Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH

3. Leonard Davis School of Gerontology, University of Southern California, Los Angeles, CA

4. Department of Medicine, University of California, Irvine, Orange, CA

5. Department of Medicine, Thomas Jefferson University, Philadelphia, PA

6. Department of Biostatistics and Bioinformatics, Duke University, Durham, NC

7. Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR

8. Division of Supportive and Acute Care Services, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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