Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations

Study Overview
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Brief Summary
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Compared to the general population, individuals from underserved communities are more likely to receive low quality end-of-life care and unwanted, costly and burdensome treatments due in part to a lack of advance care planning (ACP; the process of discussing wishes for end-of-life care with loved ones/clinicians and documenting them in advance directives). This study will use existing, trusted, and respected social networks to evaluate two conversation-based tools intended to engage underserved individuals in discussions about end-of-life issue and motivate them to carry out ACP behaviors. Through this study, investigators will learn how best to engage underserved populations in ACP so as to: 1) increase the likelihood that patients from underserved communities will receive high-quality end-of-life care; 2) address health disparities related to end-of-life treatments; and 3) reduce unnecessary suffering for patients and their families.

Detailed Description
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The overall project goal of this 3-armed cluster, randomized control trial in underserved, diverse communities is to determine whether playing a serious conversation game called Hello is more effective than other advance care planning (ACP) approaches, or usual care (i.e., simply distributing an advance directive [AD]). The investigators will randomize 75 underserved communities across the US. The primary outcome is completion of a visually verified AD; secondary outcomes include performance of other ACP behaviors. Many Black/African Americans and Latina/Latino patients are more likely to receive low quality end-of- life medical care than White individuals- in fact, they are 3 times more likely than white Americans to die after a lengthy intensive care unit stay. Advance care planning (ACP)- the process of discussing one's wishes with loved ones and clinicians, and then documenting them in an advance directive (AD)- can help reduce these health inequities by preventing costly/burdensome treatments that are unlikely to reduce suffering or improve quality of life. Though  60% of Americans engage in ACP, <25% of underserved populations have done so- in large part due to distrust of the healthcare system/clinicians, and reluctance to discuss death and dying. This study leverages underserved communities' existing, trusted social networks to deploy two community-based ACP interventions and study their mechanisms of action. By identifying which interventions increase engagement in ACP in underserved communities (and why), this project will help improve quality of end-of-life care, reduce unnecessary suffering, and end-of-life healthcare costs which conserves public health resources.

Official Title
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Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations: a Cluster, Randomized Controlled Trial

Conditions
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Advance Care Planning, Advance Directives, Terminal Illness, Chronic Illness, Communication

Intervention / Treatment
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* Behavioral: Hello (serious game)
* Behavioral: The Conversation Project (CP) Starter Kit
* Other: Table Topics (general conversation game)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Community Hosts Ability to recruit 20 individuals from underserved populations to attend a community event Experience hosting a community event Experience working with underserved populations Participation in a series of mandatory live study-related web-based trainings Completes a research site agreement Research Participants Adults over the age of 18 years old in underserved populations Able to speak and read English and/or Spanish Have not completed an AD within the previous 5 years All participants regardless of health status Individuals from the same household can enroll Exclusion Criteria Community Hosts Inability to recruit 20 individuals from underserved populations Inexperience for hosting a community event Inexperience working with underserved populations Unable to attend a series of mandatory live study-related web-based trainings Do not provide informed consent Do not complete a research site agreement Previously hosted a Hello project event Research Participants Anyone <18 years of age Anyone not able to speak and read English and/or Spanish Have significant difficulties with hearing or speaking difficulties by self-report Completed an AD in the past 5 years Do not provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 3-armed, cluster randomized controlled trial that will compare the efficacy of two evidenced based interventions, with a nationally-promoted structured workbook, Conversation Project (CP) Starter Kit; and use of a Placebo/Attention control, non-ACP game called Table Topics. The primary outcome is completion of an advance directive 6 months post-intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1:Advance care planning conversation game, 'Hello'<br>The 'Hello' game is a commercially available serious game that consists of 32 questions prompting players to share their values, goals, and beliefs about end-of-life issues. The game is played with 4 - 5 players, with each receiving a game booklet and chips. A play reads the first question in the book. Then each player writes down their answers individually and takes turns sharing their answers with the group. Players control what they share, how long they share and when to move to the next questions. During the conversation, plays can acknowledge others for a thoughtful, poignant or even funny comments by giving them a chip. A pre-game coin flip determines whether the player with the most chips wins the game (heads) or player with the least chips win (tails) the game. Other names; previously name My Gift of Grace | Behavioral: Hello (serious game)<br>* Commercially available, 'Hello' 32 is a serious game that consists of 32 questions prompting players to share their values, goals, and beliefs about end-of-life issues. The creators developed the questions following interviews with palliative care clinicians, hospice nurses, and funeral directors, and then revised them through a series focus groups with >100 patients/caregivers from diverse backgrounds.<br>|
| Active Comparator: Group 2: The Conversation Project (CP) Starter Kit<br>The 'CP Starter Kit' (available for free online) is an 11-page workbook with open- ended prompts to consider one's values and preferences for end-of-life care, who to talk with about one's wishes, and suggestions on how to do so. | Behavioral: The Conversation Project (CP) Starter Kit<br>* The CP Starter Kit is one of the most widely promoted and disseminated ACP tools nationwide, is available for free online, and does not require a healthcare professional for use. Like 'Hello', it is intended to help individuals have end-of-life conversations with loved ones. The 11-page workbook has open- ended prompts to consider one's values and preferences for end-of-life care, who to talk with about one's wishes, and suggestions on how to do so. It also prompts participants to rank priorities on a 5-point scale (e.g., What are your concerns about treatment? 1= I'm worried I won't get enough care, 5= I'm worried I'll get overly aggressive care). The CP website provides resources for running a community event using the 'CP Starter Kit', including a 23-page manual, Coaching the Conversation- A Guide to Facilitating Conversation Groups, with details on hosting a community-based program.<br>|
| Placebo Comparator: Group 3: Control Arm (Placebo control game, 'Table Topics')<br>A placebo/attention control l conversation game called 'Table Topics' will be used. Table Topics is a general conversation starter game that is unrelated to advance care planning. It involves answering open-ended questions in a group setting about a variety of topics. | Other: Table Topics (general conversation game)<br>* Table topics is a popular, commercially available conversation starter game that consists of question cards to prompt conversations (e.g., 'What do you love about your hometown?').<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Completion of a Visually Verified Advance Directive | Study team confirms completion of a signed advance directive | 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Other Advance Care Planning (ACP) behaviors | Performance of other ACP behaviors such as self-reported ACP completion, discussions with loved ones, financial preparations | 6 months post-intervention | 
| Advance Care Planning Engagement Survey | This short-version survey measures readiness to perform ACP | Baseline (Day 0); 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serious games