Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations
NCT ID: NCT04612738
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2022-03-19
2026-01-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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"
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.
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 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.
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 (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?').
Interventions
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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.
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.
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?').
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Hospice Foundation of America
UNKNOWN
University of Kentucky
OTHER
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Lauren Van Scoy
Associate Professor of Medicine, Humanities, and Public Health Sciences; Co-director of Penn State Mixed Methods Core
Principal Investigators
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Lauren J. Van Scoy, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State Milton S. Hershey Medical Center; Penn State University College of Medicine
Locations
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Pincham-Lincoln Community Center
Athens, Alabama, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Accord Health Group
Show Low, Arizona, United States
El Rio Neighborhood Center
Tucson, Arizona, United States
Promotores y Promotoras
Santa Paula, California, United States
Our Lady of Solitude
Soledad, California, United States
Vitas
Walnut Creek, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
HopeWest Montrose
Montrose, Colorado, United States
Stamford Senior Center
Stamford, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
DeSoto Memorial Hospital
Arcadia, Florida, United States
High Point Neighborhood Family Center
Clearwater, Florida, United States
St. Phillip AME Church
Tallahassee, Florida, United States
City of Temple Terrace, Omar K. Lightfoot Center
Temple Terrace, Florida, United States
47Million Reasons Healthcare Movement
West Palm Beach, Florida, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Helene S. Mills
Atlanta, Georgia, United States
Seniors First of GA
Atlanta, Georgia, United States
Gilmer County Senior Center
Ellijay, Georgia, United States
Colquitt Regional Medical Center
Moultrie, Georgia, United States
University of Chicago Medical Ctr
Chicago, Illinois, United States
St. Thomas the Apostle Catholic Church
Crystal Lake, Illinois, United States
Lightways Hospice & Serious Illness Care
Joilet, Illinois, United States
First Baptist Church
Quincy, Illinois, United States
Trinity Lutheran Church
Cherokee, Iowa, United States
Hospice & Home Care of Reno
Hutchinson, Kansas, United States
Center for Practical Bioethics
Lawrence, Kansas, United States
Ohio County Senior Centers
Hartford, Kentucky, United States
Bluegrass Care Navigators
Lexington, Kentucky, United States
United Crescent Hill Ministries
Louisville, Kentucky, United States
Union County Senior Services
Morganfield, Kentucky, United States
Hospice of Lake Cumberland
Somerset, Kentucky, United States
Acadian Advocacy Network
Lafayette, Louisiana, United States
St. Mary's Health System
Lewiston, Maine, United States
East End Community Center
Portland, Maine, United States
Good Hope Union UMC
Silver Spring, Maryland, United States
Holy Cross Health
Silver Spring, Maryland, United States
Grove Hall Senior Center
Boston, Massachusetts, United States
Community Economic Development Center
New Bedford, Massachusetts, United States
Christ Temple Church
Muskegon Heights, Michigan, United States
Northeast Mississippi Coalition Against COVID-19
Belden, Mississippi, United States
Elder Law Project of North Mississippi Rural Legal Services
Oxford, Mississippi, United States
Columbia Senior Activity Center
Columbia, Missouri, United States
Patch Center
St Louis, Missouri, United States
Washoe Tribe Health Center
Gardnerville, Nevada, United States
Reformed Church of Freehold
Freehold, New Jersey, United States
Booker T. Washington CES
Las Cruces, New Mexico, United States
Corsi Senior Center
New York, New York, United States
Hospice of St. Lawrence Valley
Potsdam, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Greater Vision United Methodist Church
Huntersville, North Carolina, United States
Plaza on Princess
Wilmington, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Cleveland Clinic
Akron, Ohio, United States
Hospice of the Western Reserve
Cleveland, Ohio, United States
McGregor Gardens
Cleveland, Ohio, United States
Hope Behavioral Health
Cleveland, Ohio, United States
Eastside Fellowship Ministries
Columbus, Ohio, United States
Hospice Care of Middletown
Middletown, Ohio, United States
Hospital Council of Northwest Ohio
Toledo, Ohio, United States
Harney County Home Health & Hospice
Burns, Oregon, United States
Stuart Community Center
Carlisle, Pennsylvania, United States
Villa Schiano
Elizabethville, Pennsylvania, United States
Latino Hispanic American Community Center
Harrisburg, Pennsylvania, United States
People's Community Baptist Church
Harrisburg, Pennsylvania, United States
Hospice and Community Care
Lancaster, Pennsylvania, United States
Hospice and Community Care
Lancaster, Pennsylvania, United States
St. Mark Missionary Baptist Church
Bennettsville, South Carolina, United States
Welcome Home of Chattanooga
Chattanooga, Tennessee, United States
All Saints Episcopal Church
Cameron, Texas, United States
Turner Alumni Association
Carthage, Texas, United States
Dorothea Street Community Center
Crane, Texas, United States
Como Community Center
Fort Worth, Texas, United States
Georgetown Public Library
Georgetown, Texas, United States
Choice Hospice
Sulphur Springs, Texas, United States
Sunshine Terrace Foundation
Logan, Utah, United States
Luray Fire Department
Luray, Virginia, United States
Carmel Baptist Church
Winchester, Virginia, United States
Grayland Hall
Grayland, Washington, United States
Ocean Beach Hospital
Ilwaco, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Crystal Rapp
Role: primary
Susan Turner
Role: primary
Susan Stout
Role: primary
Michelle Munzner
Role: primary
Ronda Buffington
Role: primary
Gloria Esoimeme
Role: primary
Lisa Oliver
Role: primary
Media Bragg
Role: primary
Shari Robesky
Role: primary
Dianne Feltham
Role: primary
Cherise Detweiler
Role: primary
Monica Korba
Role: primary
Tiffany Moore
Role: primary
Cynthia Tyson
Role: primary
Beth Montgomery
Role: primary
Josie Zamora
Role: primary
Justine Waddell
Role: primary
Susan Abernethy
Role: primary
References
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Costigan HJ, VanDyke E, Calo WA, Tucci A, Van Scoy LJ; Project Talk Trial Collaborative Working Group Members. Adapting Advance Care Planning Interventions for Hispanic Communities Across the U.S. Am J Hosp Palliat Care. 2025 Dec;42(12):1290-1297. doi: 10.1177/10499091241306427. Epub 2024 Dec 19.
Van Scoy LJ, Levi BH, Bramble C, Calo W, Chinchilli VM, Currin L, Grant D, Hollenbeak C, Katsaros M, Marlin S, Scott AM, Tucci A, VanDyke E, Wasserman E, Witt P, Green MJ. 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. Trials. 2022 Sep 30;23(1):829. doi: 10.1186/s13063-022-06746-3.
Provided Documents
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Document Type: Informed Consent Form: Project Talk Trial-ICF-Hello-10122020
Document Type: Informed Consent Form: Project Talk Trial-ICF-Hosts-10122020
Document Type: Informed Consent Form: Project Talk Trial-ICF-CPKit-10102020
Document Type: Informed Consent Form: Project Talk Trial-ICF-Control-10122020
Other Identifiers
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STUDY00014689
Identifier Type: -
Identifier Source: org_study_id