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, 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

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.

Keywords: Advance care planning; Advance directives; Health behavior; Health communication; Health games; Mixed methods; Randomized controlled trial; Terminal illness; Underserved communities.

Conflict of interest statement

The Principal Investigator (LJV) is an unpaid scientific advisor for Common Practice, LLC, which is the company that designed the Hello game. The remaining authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Overview of mixed methods study design. The study design involves a three-armed, cluster randomized controlled trial of two ACP interventions and an attention control. Gray boxes represent mixed methods data elements. CP = Conversation Project; CQA= Communication Quality Analysis; ACP= advance care planning
Fig. 2
Fig. 2
Overview of the Communication Quality Analysis coding procedures. A domain score is calculated for each of the six communication quality domains. As participants meet the definitions of each domain, the scores are increased. A domain score is assigned every 5 min for each of the six domains. All domains are scored 1–7 with “7” being the highest-quality score
Fig. 3
Fig. 3
Calculation of the multiple goals score. The multiple goals score is a summative measure of all 6 quality domains that is reported in a single “breadth” score. To calculate the multiple goals score, each of the six domain scores are combined into three goals scores (task, relational, and identity goals). For each of these three goals, a normative score of “0” or “1” is assigned based on whether the score is above or below the sample mean. The MGS score is calculated for each time segment by taking the sum of each of the three normative goals scores (resulting a range from 0 to 3). Once the MGS score is calculated for each 5-min time interval, scores are then averaged across time intervals

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