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

Penn State Health

Status: Enrolling

Conditions: Chronic Illness; Terminal Illness; Advance Care Planning; Communication; Advance Directives

Treatments: Behavioral: The Conversation Project (CP) Starter Kit; Other: Table Topics (general conversation game); Behavioral: Hello (serious game)

Study type: Interventional

Funder types: Other

Identifiers

NCT04612738

STUDY00014689

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Community Hosts

1. Ability to recruit 20 individuals from underserved populations to attend a community event
2. Experience hosting a community event
3. Experience working with underserved populations
4. Participation in a series of mandatory live study-related web-based trainings
5. Completes a research site agreement

Research Participants

1. Adults over the age of 18 years old in underserved populations
2. Able to speak and read English and/or Spanish
3. Have not completed an AD within the previous 5 years
4. All participants regardless of health status
5. Individuals from the same household can enroll

Exclusion Criteria Community Hosts

1. Inability to recruit 20 individuals from underserved populations
2. Inexperience for hosting a community event
3. Inexperience working with underserved populations
4. Unable to attend a series of mandatory live study-related web-based trainings
5. Do not provide informed consent
6. Do not complete a research site agreement
7. Previously hosted a Hello project event

Research Participants

1. Anyone <18 years of age
2. Anyone not able to speak and read English and/or Spanish
3. Have significant difficulties with hearing or speaking difficulties by self-report
4. Completed an AD in the past 5 years
5. Do not provide informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 3 patient groups, including a placebo group

Group 1:Advance care planning conversation game, 'Hello'

Active Comparator group

Description:

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"

Treatment:

Behavioral: Hello (serious game)

Group 2: The Conversation Project (CP) Starter Kit

Active Comparator group

Description:

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.

Treatment:

Behavioral: The Conversation Project (CP) Starter Kit

Group 3: Control Arm (Placebo control game, 'Table Topics')

Placebo Comparator group

Description:

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.

Treatment:

Other: Table Topics (general conversation game)