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Published in: Trials 1/2022

Open Access 01-12-2022 | Care | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2022

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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.
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Metadata
Title
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
Authors
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
Publication date
01-12-2022
Publisher
BioMed Central
Keywords
Care
Living Will
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06746-3

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