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: Active, not recruiting
• Conditions: Communication; Terminal Illness; Chronic Illness; Advance Care Planning; Advance Directives
• Intervention / Treatment: Behavioral: Hello (serious game); Behavioral: The Conversation Project (CP) Starter Kit; Other: Table Topics (general conversation game)

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: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • Pincham-Lincoln Community Center
  • Arizona
    • Kingman, Arizona, United States, 86409
      • Kingman Regional Medical Center
    • Show Low, Arizona, United States, 85901
      • Accord Health Group
    • Tucson, Arizona, United States, 85745
      • El Rio Neighborhood Center
  • California
    • Santa Paula, California, United States, 93060
      • Promotores y Promotoras
    • Soledad, California, United States, 93960
      • Our Lady of Solitude
    • Walnut Creek, California, United States, 94590
      • Vitas
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Montrose, Colorado, United States, 81401
      • HopeWest Montrose
  • Connecticut
    • Stamford, Connecticut, United States, 06901
      • Stamford Senior Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20020
      • MedStar Washington Hospital Center
  • Florida
    • Arcadia, Florida, United States, 34266
      • DeSoto Memorial Hospital
    • Clearwater, Florida, United States, 33760
      • High Point Neighborhood Family Center
    • Tallahassee, Florida, United States, 32308
      • St. Phillip AME Church
    • Temple Terrace, Florida, United States, 33617
      • City of Temple Terrace, Omar K. Lightfoot Center
  • Georgia
    • Albany, Georgia, United States, 61763
      • Phoebe Putney Memorial Hospital
    • Atlanta, Georgia, United States, 30328
      • Helene S. Mills
    • Atlanta, Georgia, United States, 30345
      • Seniors First of GA
    • Ellijay, Georgia, United States, 30540
      • Gilmer County Senior Center
    • Moultrie, Georgia, United States, 31768
      • Colquitt Regional Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60616
      • University of Chicago Medical Ctr
    • Crystal Lake, Illinois, United States, 60014
      • St. Thomas the Apostle Catholic Church
    • Joilet, Illinois, United States, 60435
      • Lightways Hospice & Serious Illness Care
    • Quincy, Illinois, United States, 62301
      • First Baptist Church
  • Iowa
    • Cherokee, Iowa, United States, 51012
      • Trinity Lutheran Church
  • Kansas
    • Hutchinson, Kansas, United States, 67501
      • Hospice & Home Care of Reno
    • Lawrence, Kansas, United States, 66101
      • Center for Practical Bioethics
  • Kentucky
    • Hartford, Kentucky, United States, 42347
      • Ohio County Senior Centers
    • Lexington, Kentucky, United States, 40504
      • Bluegrass Care Navigators
    • Louisville, Kentucky, United States, 40206
      • United Crescent Hill Ministries
    • Morganfield, Kentucky, United States, 42437
      • Union County Senior Services
    • Somerset, Kentucky, United States, 42503
      • Hospice of Lake Cumberland
  • Louisiana
    • Lafayette, Louisiana, United States, 70506
      • Acadian Advocacy Network
  • Maine
    • Lewiston, Maine, United States, 04240
      • St. Mary's Health System
    • Portland, Maine, United States, 04101
      • East End Community Center
  • Maryland
    • Silver Spring, Maryland, United States, 20905
      • Good Hope Union UMC
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02121
      • Grove Hall Senior Center
    • New Bedford, Massachusetts, United States, 02746
      • Community Economic Development Center
  • Michigan
    • Muskegon Heights, Michigan, United States, 49444
      • Christ Temple Church
  • Mississippi
    • Belden, Mississippi, United States, 38868
      • Northeast Mississippi Coalition Against COVID-19
    • Oxford, Mississippi, United States, 38655
      • Elder Law Project of North Mississippi Rural Legal Services
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Senior Activity Center
    • St Louis, Missouri, United States, 63111
      • Patch Center
  • Nevada
    • Gardnerville, Nevada, United States, 89410
      • Washoe Tribe Health Center
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Reformed Church of Freehold
  • New Mexico
    • Las Cruces, New Mexico, United States, 88001
      • Booker T. Washington CES
  • New York
    • New York, New York, United States, 10029
      • Corsi Senior Center
    • Potsdam, New York, United States, 13676
      • Hospice of St. Lawrence Valley
    • Rochester, New York, United States, 14622
      • University of Rochester Medical Center
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Greater Vision United Methodist Church
    • Wilmington, North Carolina, United States, 28401
      • Plaza on Princess
    • Winston-Salem, North Carolina, United States, 27045
      • Atrium Health Wake Forest Baptist
  • Ohio
    • Akron, Ohio, United States, 44307
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44110
      • Hospice of the Western Reserve
    • Cleveland, Ohio, United States, 44112
      • McGregor Gardens
    • Cleveland, Ohio, United States, 44120
      • Hope Behavioral Health
    • Columbus, Ohio, United States, 43203
      • Eastside Fellowship Ministries
    • Middletown, Ohio, United States, 45044
      • Hospice Care of Middletown
    • Toledo, Ohio, United States, 43607
      • Hospital Council of Northwest Ohio
  • Pennsylvania
    • Carlisle, Pennsylvania, United States, 17013
      • Stuart Community Center
    • Elizabethville, Pennsylvania, United States, 17023
      • Villa Schiano
    • Harrisburg, Pennsylvania, United States, 17104
      • Latino Hispanic American Community Center
    • Harrisburg, Pennsylvania, United States, 17104
      • People's Community Baptist Church
    • Lancaster, Pennsylvania, United States, 17602
      • Hospice and Community Care
    • Lancaster, Pennsylvania, United States, 17603
      • Hospice and Community Care
  • South Carolina
    • Bennettsville, South Carolina, United States, 29512
      • St. Mark Missionary Baptist Church
  • Tennessee
    • Chattanooga, Tennessee, United States, 37406
      • Welcome Home of Chattanooga
  • Texas
    • Cameron, Texas, United States, 76520
      • All Saints Episcopal Church
    • Carthage, Texas, United States, 75633
      • Turner Alumni Association
    • Crane, Texas, United States, 79731
      • Dorothea Street Community Center
    • Fort Worth, Texas, United States, 76107
      • Como Community Center
    • Georgetown, Texas, United States, 78626
      • Georgetown Public Library
    • Sulphur Springs, Texas, United States, 75482
      • Choice Hospice
  • Utah
    • Logan, Utah, United States, 84321
      • Sunshine Terrace Foundation
  • Virginia
    • Luray, Virginia, United States, 22835
      • Luray Fire Department
    • Winchester, Virginia, United States, 22601
      • Carmel Baptist Church
  • Washington
    • Grayland, Washington, United States, 98547
      • Grayland Hall
    • Ilwaco, Washington, United States, 98640
      • Ocean Beach Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

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"	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?').

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Previous Exposure to ACP Interventions and Advance Directives	This baseline assessment of ACP completion and exposure	Baseline (Day 0)
Healthcare System Distrust Scale	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	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	This 3-item measure to access a participants' perceived acceptability of the intervention	Immediately post-intervention (Day 0)
Conversation Satisfaction Questionnaire	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.	Immediately post-intervention (Day 0)
Communication Quality Analysis (CQA) Measure	This is a validated coding method which measures communication quality using outside observer ratings of audio recordings of an intervention.	post-intervention
Qualitative Community Host Interview	A follow-up qualitative telephone interview will explore implementation and process outcomes.	2 weeks post-intervention
Participant Follow-up Qualitative Telephone Interview	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
Six-Month Participant Follow-up Telephone Interview	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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: University of Kentucky; Hospice Foundation of America
• 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

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: serious games
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Chronic Disease; Communication
• Other Study ID Numbers: STUDY00014689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Our study team is highly motivated to share data with outside investigators as a means to ensure reproducibility of findings, further the scientific inquiry, and to avoid unintentional duplication of research. However, only de-identified data would be shared from this database under the auspices of the PI, and only after securing a Data Transfer Agreement. Whether the individual participant data or aggregated data will be determined based on each individual request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No