Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1:Advance care planning conversation game, 'Hello' 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)
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.
|
| Active Comparator: Group 2: The Conversation Project (CP) Starter Kit 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
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.
|
| Placebo Comparator: Group 3: Control Arm (Placebo control game, 'Table Topics') 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)
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?').
|
Outcome Measures
Primary Outcome Measures
- Rates of Completion of a Visually Verified Advance Directive [6 months post-intervention]
Study team confirms completion of a signed advance directive
Secondary Outcome Measures
- Rates of Other Advance Care Planning (ACP) behaviors [6 months post-intervention]
Performance of other ACP behaviors such as self-reported ACP completion, discussions with loved ones, financial preparations
- Advance Care Planning Engagement Survey [Baseline (Day 0); 6 months post-intervention]
This short-version survey measures readiness to perform ACP
Other Outcome Measures
- Previous Exposure to ACP Interventions and Advance Directives [Baseline (Day 0)]
This baseline assessment of ACP completion and exposure
- Attitudes, Values and Beliefs about Advance Care Planning Questionnaire [Baseline (Day 0)]
This 7-item measure accesses participants' values and beliefs about advance care planning. Scores are calculated by summative responses and the total score ranges from 7 - 49, with 7 being the least amount of skepticism (better outcome).
- Healthcare System Distrust Scale [Baseline (Day 0)]
An assessment of two primary domains of distrust (values and competence) in the healthcare system. This is a 9-item measure, scored 9 - 45 with 9 being the least amount of distrust.
- Experience and Comfort with Games Questionnaire [Baseline (Day 0 )]
This is a 4-item questionnaire to control for whether participants with familiarity with games respond differently to the intervention.
- Multidimensional Scale of Perceived Social Support [Baseline (Day 0)]
Measures participants' perceived adequacy of support from varied social supports. There are 12-items in this measure made on a 7-point Likert scale (1) being very strongly disagree to (7) being very strongly agree. This is a control for whether participants with varied social supports respond differently to the intervention.
- Acceptability of Intervention Measure [Immediately post-intervention (Day 0)]
This 3-item measure to access a participants' perceived acceptability of the intervention
- Conversation Satisfaction Questionnaire [Immediately post-intervention (Day 0)]
This is a 8-item questionnaire that assesses a participant's satisfaction with conversation, with each item scored on a 1 - 7 scale, with 1 being lowest conversation satisfaction. The items are averaged for the final score ranging 1 - 7 with 7 indicating the highest conversation satisfaction.
- Communication Quality Analysis (CQA) Measure [post-intervention]
This is a validated coding method which measures communication quality using outside observer ratings of audio recordings of an intervention.
- Qualitative Community Host Interview [2 weeks post-intervention]
A follow-up qualitative telephone interview will explore implementation and process outcomes.
- Participant Follow-up Qualitative Telephone Interview [2 weeks post-intervention]
A qualitative follow-up interview with a subset of intervention participants to explore experiences and perceptions of the intervention, adverse events and cultural norms related to healthcare and advance care planning.
- Six-Month Participant Follow-up Telephone Interview [6 months post-intervention]
This follow-up phone interview includes questionnaires that access whether participants went on to perform various behaviors related to advance care planning, as well as explore qualitatively how sociocultural environment impacts the advance care planning experience.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pincham-Lincoln Community Center | Athens | Alabama | United States | 35611 |
| 2 | High Point Neighborhood Family Center | Clearwater | Florida | United States | 33760 |
| 3 | Patch Center | Saint Louis | Missouri | United States | 63111 |
| 4 | Plaza on Princess | Wilmington | North Carolina | United States | 28401 |
| 5 | Latino Hispanic American Community Center | Harrisburg | Pennsylvania | United States | 17104 |
| 6 | People's Community Baptist Church | Harrisburg | Pennsylvania | United States | 17104 |
| 7 | Como Community Center | Fort Worth | Texas | United States | 76107 |
Sponsors and Collaborators
- Milton S. Hershey Medical Center
- Hospice Foundation of America
- University of Kentucky
Investigators
- Principal Investigator: Lauren J. Van Scoy, MD, Penn State Milton S. Hershey Medical Center; Penn State University College of Medicine
Study Documents (Full-Text)
- Informed Consent Form: Project Talk Trial-ICF-Control-10122020 - Oct 12, 2020
- Informed Consent Form: Project Talk Trial-ICF-Hello-10122020 - Oct 12, 2020
- Informed Consent Form: Project Talk Trial-ICF-CPKit-10102020 - Oct 10, 2020
- Informed Consent Form: Project Talk Trial-ICF-Hosts-10122020 - Oct 12, 2020
More Information
Publications
None provided.- STUDY00014689