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Advance Care PlanningNCT04612738

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

A study testing Hello (serious game), The Conversation Project (CP) Starter Kit and Table Topics (general conversation game) in people with Advance Care Planning and Advance Directives, run by Milton S. Hershey Medical Center at 79 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Hello (serious game), The Conversation Project (CP) Starter Kit and Table Topics (general conversation game)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,800 participants
Where
79 sitesUnited States
Study dates
19 Mar 2022to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

United States79 sites

  • Cleveland Clinic

    Akron, Ohio, 44307

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 61763

  • DeSoto Memorial Hospital

    Arcadia, Florida, 34266

  • Pincham-Lincoln Community Center

    Athens, Alabama, 35611

  • Helene S. Mills

    Atlanta, Georgia, 30328

  • Seniors First of GA

    Atlanta, Georgia, 30345

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Northeast Mississippi Coalition Against COVID-19

    Belden, Mississippi, 38868

  • St. Mark Missionary Baptist Church

    Bennettsville, South Carolina, 29512

  • Grove Hall Senior Center

    Boston, Massachusetts, 02121

  • All Saints Episcopal Church

    Cameron, Texas, 76520

  • Stuart Community Center

    Carlisle, Pennsylvania, 17013

  • Turner Alumni Association

    Carthage, Texas, 75633

  • Welcome Home of Chattanooga

    Chattanooga, Tennessee, 37406

  • Trinity Lutheran Church

    Cherokee, Iowa, 51012

  • University of Chicago Medical Ctr

    Chicago, Illinois, 60616

  • High Point Neighborhood Family Center

    Clearwater, Florida, 33760

  • Hospice of the Western Reserve

    Cleveland, Ohio, 44110

  • McGregor Gardens

    Cleveland, Ohio, 44112

  • Hope Behavioral Health

    Cleveland, Ohio, 44120

  • Columbia Senior Activity Center

    Columbia, Missouri, 65201

  • Eastside Fellowship Ministries

    Columbus, Ohio, 43203

  • Dorothea Street Community Center

    Crane, Texas, 79731

  • St. Thomas the Apostle Catholic Church

    Crystal Lake, Illinois, 60014

  • Villa Schiano

    Elizabethville, Pennsylvania, 17023

  • Gilmer County Senior Center

    Ellijay, Georgia, 30540

  • Como Community Center

    Fort Worth, Texas, 76107

  • Reformed Church of Freehold

    Freehold, New Jersey, 07728

  • Washoe Tribe Health Center

    Gardnerville, Nevada, 89410

  • Georgetown Public Library

    Georgetown, Texas, 78626

  • Grayland Hall

    Grayland, Washington, 98547

  • Latino Hispanic American Community Center

    Harrisburg, Pennsylvania, 17104

  • People's Community Baptist Church

    Harrisburg, Pennsylvania, 17104

  • Ohio County Senior Centers

    Hartford, Kentucky, 42347

  • Greater Vision United Methodist Church

    Huntersville, North Carolina, 28078

  • Hospice & Home Care of Reno

    Hutchinson, Kansas, 67501

  • Ocean Beach Hospital

    Ilwaco, Washington, 98640

  • Lightways Hospice & Serious Illness Care

    Joilet, Illinois, 60435

  • Kingman Regional Medical Center

    Kingman, Arizona, 86409

  • Acadian Advocacy Network

    Lafayette, Louisiana, 70506

  • Hospice and Community Care

    Lancaster, Pennsylvania, 17602

  • Hospice and Community Care

    Lancaster, Pennsylvania, 17603

  • Booker T. Washington CES

    Las Cruces, New Mexico, 88001

  • Center for Practical Bioethics

    Lawrence, Kansas, 66101

  • St. Mary's Health System

    Lewiston, Maine, 04240

  • Bluegrass Care Navigators

    Lexington, Kentucky, 40504

  • Sunshine Terrace Foundation

    Logan, Utah, 84321

  • United Crescent Hill Ministries

    Louisville, Kentucky, 40206

  • Luray Fire Department

    Luray, Virginia, 22835

  • Hospice Care of Middletown

    Middletown, Ohio, 45044

  • HopeWest Montrose

    Montrose, Colorado, 81401

  • Union County Senior Services

    Morganfield, Kentucky, 42437

  • Colquitt Regional Medical Center

    Moultrie, Georgia, 31768

  • Christ Temple Church

    Muskegon Heights, Michigan, 49444

  • Community Economic Development Center

    New Bedford, Massachusetts, 02746

  • Corsi Senior Center

    New York, New York, 10029

  • Elder Law Project of North Mississippi Rural Legal Services

    Oxford, Mississippi, 38655

  • East End Community Center

    Portland, Maine, 04101

  • Hospice of St. Lawrence Valley

    Potsdam, New York, 13676

  • First Baptist Church

    Quincy, Illinois, 62301

  • University of Rochester Medical Center

    Rochester, New York, 14622

  • Promotores y Promotoras

    Santa Paula, California, 93060

  • Accord Health Group

    Show Low, Arizona, 85901

  • Good Hope Union UMC

    Silver Spring, Maryland, 20905

  • Holy Cross Health

    Silver Spring, Maryland, 20910

  • Our Lady of Solitude

    Soledad, California, 93960

  • Hospice of Lake Cumberland

    Somerset, Kentucky, 42503

  • Patch Center

    St Louis, Missouri, 63111

  • Stamford Senior Center

    Stamford, Connecticut, 06901

  • Choice Hospice

    Sulphur Springs, Texas, 75482

  • St. Phillip AME Church

    Tallahassee, Florida, 32308

  • City of Temple Terrace, Omar K. Lightfoot Center

    Temple Terrace, Florida, 33617

  • Hospital Council of Northwest Ohio

    Toledo, Ohio, 43607

  • El Rio Neighborhood Center

    Tucson, Arizona, 85745

  • Vitas

    Walnut Creek, California, 94590

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20020

  • Plaza on Princess

    Wilmington, North Carolina, 28401

  • Carmel Baptist Church

    Winchester, Virginia, 22601

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27045

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Hello (serious game), The Conversation Project (CP) Starter Kit, Table Topics (general conversation game)
Keywords
serious games
Medical subject headings
Chronic Disease, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hello (serious game)Behavioural

    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 KitBehavioural

    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)Other

    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?').

Study groups in NCT04612738
Study groupRoleWhat they receive
Group 1:Advance care planning conversation game, 'Hello'Active comparatorThe '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"
Receives: Behavioral: Hello (serious game)
Group 2: The Conversation Project (CP) Starter KitActive comparatorThe '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.
Receives: Behavioral: The Conversation Project (CP) Starter Kit
Group 3: Control Arm (Placebo control game, 'Table Topics')Placebo comparatorA 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.
Receives: Other: Table Topics (general conversation game)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion of a Self-reported or Visually Verified Advance Directive

    Study team confirms completion of a signed advance directive collected via self-report or visual verification

    Measured: 6 months post-intervention

Secondary outcomes (2)

  1. Completion of at least one Other Advance Care Planning (ACP) behavior

    Performance of at least one other ACP behaviors, since the event, such as self-reported ACP completion, discussions with loved ones, conversations with care providers, financial preparations (long-term health insurance, life insurance, disability insurance, etc.), nursing home/long-term care planning, hospice or palliative care planning, funeral arrangements, etc.

    Measured: 6 months post-intervention

  2. Change in Advance Care Planning(ACP) Engagement Readiness 4-Item Survey

    This short-version survey measures stages of readiness to perform ACP.

    Measured: Baseline (Day of event participation); 6 months post-event participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2020
  2. Study start19 Mar 2022
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a 3-armed, cluster randomized controlled trial that will compare the efficacy of two evidenced based interventions, with a nationally-promoted structured workbook, Conversation Project (CP) Starter Kit; and use of a Placebo/Attention control, non-ACP game called Table Topics. The primary outcome is completion of an advance directive 6 months post-intervention.
Masking
Single blind
Who is masked
Investigator
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04612738
Sponsor's protocol ID
STUDY00014689
Status last verified
Sep 2026
First submitted
12 Oct 2020
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 39700514

  • 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.

    PubMed 36180899

Questions about this trial

What is this clinical trial studying?

A study testing Hello (serious game), The Conversation Project (CP) Starter Kit and Table Topics (general conversation game) in people with Advance Care Planning and Advance Directives, run by Milton S. Hershey Medical Center at 79 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of a Self-reported or Visually Verified Advance Directive (time frame: 6 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04612738, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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