Comparing two advance care planning conversation activities to motivate advance directive completion in underserved communities across the USA: The Project Talk Trial study protocol for a cluster, randomized controlled trial

Lauren J. Van Scoy, Benjamin H. Levi, Cindy Bramble, William Calo, Vernon M. Chinchilli, Lindsey Currin, Denise Grant, Christopher Hollenbeak, Maria Katsaros, Sara Marlin, Allison M. Scott, Amy Tucci, Erika VanDyke, Emily Wasserman, Pamela Witt, Michael J. Green

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Advance care planning (ACP) is a process involving conversations between patients, loved ones, and healthcare providers that consider patient preferences for the types of medical therapies received at the end of life. Underserved populations, including Black, Hispanic, rural, and low-income communities are less likely to engage in ACP than other communities, a health inequity that results in lower-quality care and reduced hospice utilization. The purpose of this trial is to compare efficacy of two interventions intended to motivate ACP (particularly advance directive completion) for those living in underserved communities. Methods: This 3-armed cluster, randomized controlled mixed methods design is being conducted in 75 community venues in underserved communities across the USA. The goal of the trial is to compare the efficacy of two interventions at motivating ACP. Arm 1 uses an end-of-life conversation game (Hello); Arm 2 uses a nationally utilized workshop format for ACP conversations (The Conversation Project); and Arm 3 uses an attention control game (TableTopics). Events are held in partnership with 75 local community-based host organizations and will involve 1500 participants (n=20 per event). The primary outcome is completion of a visually verified advance directive at 6 months post-event. Primary analyses compare efficacy of each intervention to each other and the control arm. Secondary mixed methods outcomes include (a) other ACP behaviors and engagement; (b) communication quality; (c) impact of sociocultural environment on ACP (via qualitative interviews); and (d) implementation and sustainability. Subgroup analyses examine outcomes for Black, Hispanic, and rural groups in particular. Discussion: This trial will add to the evidence base behind various conversational ACP interventions, examine potential mechanisms of action for such interventions, and provide qualitative data to better understand the sociocultural environment of how community-based ACP interventions are experienced by underserved populations. Results will also provide important data for future researchers to learn whether visual verification of advance directives is necessary or whether reliance on self-reported outcomes is of comparable value. Data from this study will inform ways to effectively motivate underserved communities to participate in advance care planning. Trial registration: ClinicalTrials.gov NCT04612738. Registered on October 12, 2020. All information from the WHO Trial Registration Data Set can be found within the protocol.

Original languageEnglish
Article number829
JournalTrials
Volume23
Issue number1
DOIs
StatePublished - Dec 2022

Bibliographical note

Funding Information:
The trial project team, led by the principal investigator, consists of an interdisciplinary team of experts in advance care planning, end-of-life care, critical care, ethics, medical humanities, community engagement, health economics, statistics, hospice, implementation science, and public health. This full interdisciplinary trial team is supported by a team of two project managers, several research assistants, graduate students, and a marketing specialist. The project is also supported by a national grief expert.

Funding Information:
The study authors thank the following individuals for their contributions to making this project and protocol come to fruition: Angela Novas, MSN, RN, CRNP, ACHPN, Margaret Hopkins, MA, MEd, Nick Jehlen at Common Practice, LLC, the team at Kate DeBartolo and Patty Webster, MPH at The Conversation Project (an initiative of the Institute for Healthcare Improvement), the team at TableTopics , Kenneth Doka, PhD, MDiv, and our safety monitoring committee members Jennifer McCormick, PhD, MPP and David Mauger, PhD. We also thank the John and Wauna Foundation for their support of the pilot work that led to this trial and protocol.

Publisher Copyright:
© 2022, The Author(s).

Keywords

  • Advance care planning
  • Advance directives
  • Health behavior
  • Health communication
  • Health games
  • Mixed methods
  • Randomized controlled trial
  • Terminal illness
  • Underserved communities

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Fingerprint

Dive into the research topics of 'Comparing two advance care planning conversation activities to motivate advance directive completion in underserved communities across the USA: The Project Talk Trial study protocol for a cluster, randomized controlled trial'. Together they form a unique fingerprint.

Cite this