- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04612738
Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations
Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations: a Cluster, Randomized Controlled Trial
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lauren J. Van Scoy, MD
- Phone Number: 717-531-6704
- Email: lvanscoy@pennstatehealth.psu.edu
Study Contact Backup
- Name: Heather J Costigan
- Phone Number: 717-531-6499
- Email: hcostigan@pennstatehealth.psu.edu
Study Locations
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Alabama
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Athens, Alabama, United States, 35611
- Completed
- Pincham-Lincoln Community Center
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Arizona
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Tucson, Arizona, United States, 85745
- Completed
- El Rio Neighborhood Center
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California
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Soledad, California, United States, 93960
- Recruiting
- Our Lady of Solitude
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Contact:
- Erandi Garcia
- Phone Number: 831-333-9023
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Hospital
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Contact:
- Hareklia Brackett
- Phone Number: 303-995-8001
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Florida
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Clearwater, Florida, United States, 33760
- Completed
- High Point Neighborhood Family Center
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Tallahassee, Florida, United States, 32308
- Completed
- St. Phillip AME Church
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Kentucky
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Hartford, Kentucky, United States, 42347
- Completed
- Ohio County Senior Centers
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Lexington, Kentucky, United States, 40504
- Completed
- Bluegrass Care Navigators
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Morganfield, Kentucky, United States, 42437
- Completed
- Union County Senior Services
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Maine
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Lewiston, Maine, United States, 04240
- Recruiting
- St. Mary's Health System
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Contact:
- Elizabeth Keene
- Phone Number: 207-777-8806
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Michigan
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Muskegon Heights, Michigan, United States, 49444
- Completed
- Christ Temple Church
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Missouri
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Saint Louis, Missouri, United States, 63111
- Completed
- Patch Center
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New York
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New York, New York, United States, 10029
- Completed
- Corsi Senior Center
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North Carolina
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Wilmington, North Carolina, United States, 28401
- Completed
- Plaza on Princess
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Winston-Salem, North Carolina, United States, 27045
- Recruiting
- Atrium Health Wake Forest Baptist
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Contact:
- Keith Stirewalt
- Phone Number: 336-716-5811
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Ohio
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Cleveland, Ohio, United States, 44110
- Completed
- Hospice of the Western Reserve
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17104
- Completed
- Latino Hispanic American Community Center
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Harrisburg, Pennsylvania, United States, 17104
- Completed
- People's Community Baptist Church
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Lancaster, Pennsylvania, United States, 17603
- Recruiting
- Hospice and Community Care
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Contact:
- Karen Stauffer
- Phone Number: 717-490-4074
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South Carolina
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Bennettsville, South Carolina, United States, 29512
- Completed
- St. Mark Missionary Baptist Church
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Texas
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Carthage, Texas, United States, 75633
- Completed
- Turner Alumni Association
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Fort Worth, Texas, United States, 76107
- Completed
- Como Community Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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" |
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.
|
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.
|
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?').
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of Completion of a Visually Verified Advance Directive
Time Frame: 6 months post-intervention
|
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
Time Frame: 6 months post-intervention
|
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
Time Frame: Baseline (Day 0); 6 months post-intervention
|
This short-version survey measures readiness to perform ACP
|
Baseline (Day 0); 6 months post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Previous Exposure to ACP Interventions and Advance Directives
Time Frame: Baseline (Day 0)
|
This baseline assessment of ACP completion and exposure
|
Baseline (Day 0)
|
Healthcare System Distrust Scale
Time Frame: 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.
|
Baseline (Day 0)
|
Experience and Comfort with Games Questionnaire
Time Frame: Baseline (Day 0 )
|
This is a 4-item questionnaire to control for whether participants with familiarity with games respond differently to the intervention.
|
Baseline (Day 0 )
|
Acceptability of Intervention Measure
Time Frame: Immediately post-intervention (Day 0)
|
This 3-item measure to access a participants' perceived acceptability of the intervention
|
Immediately post-intervention (Day 0)
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Conversation Satisfaction Questionnaire
Time Frame: 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.
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Immediately post-intervention (Day 0)
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Communication Quality Analysis (CQA) Measure
Time Frame: post-intervention
|
This is a validated coding method which measures communication quality using outside observer ratings of audio recordings of an intervention.
|
post-intervention
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Qualitative Community Host Interview
Time Frame: 2 weeks post-intervention
|
A follow-up qualitative telephone interview will explore implementation and process outcomes.
|
2 weeks post-intervention
|
Participant Follow-up Qualitative Telephone Interview
Time Frame: 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.
|
2 weeks post-intervention
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Six-Month Participant Follow-up Telephone Interview
Time Frame: 6 months post-intervention
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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.
|
6 months post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lauren J. Van Scoy, MD, Penn State Milton S. Hershey Medical Center; Penn State University College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00014689
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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