NCT04612738

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

81 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 19, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

November 14, 2025

Status Verified

May 1, 2025

Enrollment Period

3.9 years

First QC Date

October 12, 2020

Last Update Submit

November 12, 2025

Conditions

Keywords

serious games

Outcome Measures

Primary Outcomes (1)

  • Rates of Completion of a Visually Verified Advance Directive

    Study team confirms completion of a signed advance directive

    6 months post-intervention

Secondary Outcomes (2)

  • Rates of Other Advance Care Planning (ACP) behaviors

    6 months post-intervention

  • Advance Care Planning Engagement Survey

    Baseline (Day 0); 6 months post-intervention

Other Outcomes (9)

  • Previous Exposure to ACP Interventions and Advance Directives

    Baseline (Day 0)

  • Healthcare System Distrust Scale

    Baseline (Day 0)

  • Experience and Comfort with Games Questionnaire

    Baseline (Day 0 )

  • +6 more other outcomes

Study Arms (3)

Group 1:Advance care planning conversation game, 'Hello'

ACTIVE COMPARATOR

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)

Group 2: The Conversation Project (CP) Starter Kit

ACTIVE COMPARATOR

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

Group 3: Control Arm (Placebo control game, 'Table Topics')

PLACEBO COMPARATOR

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)

Interventions

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 1:Advance care planning conversation game, 'Hello'

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 2: The Conversation Project (CP) Starter Kit

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?').

Group 3: Control Arm (Placebo control game, 'Table Topics')

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (81)

Pincham-Lincoln Community Center

Athens, Alabama, 35611, United States

COMPLETED

Kingman Regional Medical Center

Kingman, Arizona, 86409, United States

RECRUITING

Accord Health Group

Show Low, Arizona, 85901, United States

RECRUITING

El Rio Neighborhood Center

Tucson, Arizona, 85745, United States

COMPLETED

Promotores y Promotoras

Santa Paula, California, 93060, United States

COMPLETED

Our Lady of Solitude

Soledad, California, 93960, United States

COMPLETED

Vitas

Walnut Creek, California, 94590, United States

COMPLETED

University of Colorado Hospital

Aurora, Colorado, 80045, United States

COMPLETED

HopeWest Montrose

Montrose, Colorado, 81401, United States

COMPLETED

Stamford Senior Center

Stamford, Connecticut, 06901, United States

RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20020, United States

COMPLETED

DeSoto Memorial Hospital

Arcadia, Florida, 34266, United States

RECRUITING

High Point Neighborhood Family Center

Clearwater, Florida, 33760, United States

COMPLETED

St. Phillip AME Church

Tallahassee, Florida, 32308, United States

COMPLETED

City of Temple Terrace, Omar K. Lightfoot Center

Temple Terrace, Florida, 33617, United States

RECRUITING

47Million Reasons Healthcare Movement

West Palm Beach, Florida, 33406, United States

WITHDRAWN

Phoebe Putney Memorial Hospital

Albany, Georgia, 61763, United States

RECRUITING

Helene S. Mills

Atlanta, Georgia, 30328, United States

RECRUITING

Seniors First of GA

Atlanta, Georgia, 30345, United States

COMPLETED

Gilmer County Senior Center

Ellijay, Georgia, 30540, United States

RECRUITING

Colquitt Regional Medical Center

Moultrie, Georgia, 31768, United States

COMPLETED

University of Chicago Medical Ctr

Chicago, Illinois, 60616, United States

COMPLETED

St. Thomas the Apostle Catholic Church

Crystal Lake, Illinois, 60014, United States

COMPLETED

Lightways Hospice & Serious Illness Care

Joilet, Illinois, 60435, United States

COMPLETED

First Baptist Church

Quincy, Illinois, 62301, United States

RECRUITING

Trinity Lutheran Church

Cherokee, Iowa, 51012, United States

COMPLETED

Hospice & Home Care of Reno

Hutchinson, Kansas, 67501, United States

COMPLETED

Center for Practical Bioethics

Lawrence, Kansas, 66101, United States

COMPLETED

Ohio County Senior Centers

Hartford, Kentucky, 42347, United States

COMPLETED

Bluegrass Care Navigators

Lexington, Kentucky, 40504, United States

COMPLETED

United Crescent Hill Ministries

Louisville, Kentucky, 40206, United States

RECRUITING

Union County Senior Services

Morganfield, Kentucky, 42437, United States

COMPLETED

Hospice of Lake Cumberland

Somerset, Kentucky, 42503, United States

COMPLETED

Acadian Advocacy Network

Lafayette, Louisiana, 70506, United States

COMPLETED

St. Mary's Health System

Lewiston, Maine, 04240, United States

COMPLETED

East End Community Center

Portland, Maine, 04101, United States

RECRUITING

Good Hope Union UMC

Silver Spring, Maryland, 20905, United States

COMPLETED

Holy Cross Health

Silver Spring, Maryland, 20910, United States

COMPLETED

Grove Hall Senior Center

Boston, Massachusetts, 02121, United States

RECRUITING

Community Economic Development Center

New Bedford, Massachusetts, 02746, United States

COMPLETED

Christ Temple Church

Muskegon Heights, Michigan, 49444, United States

COMPLETED

Northeast Mississippi Coalition Against COVID-19

Belden, Mississippi, 38868, United States

COMPLETED

Elder Law Project of North Mississippi Rural Legal Services

Oxford, Mississippi, 38655, United States

COMPLETED

Columbia Senior Activity Center

Columbia, Missouri, 65201, United States

RECRUITING

Patch Center

St Louis, Missouri, 63111, United States

COMPLETED

Washoe Tribe Health Center

Gardnerville, Nevada, 89410, United States

COMPLETED

Reformed Church of Freehold

Freehold, New Jersey, 07728, United States

COMPLETED

Booker T. Washington CES

Las Cruces, New Mexico, 88001, United States

COMPLETED

Corsi Senior Center

New York, New York, 10029, United States

COMPLETED

Hospice of St. Lawrence Valley

Potsdam, New York, 13676, United States

COMPLETED

University of Rochester Medical Center

Rochester, New York, 14622, United States

COMPLETED

Greater Vision United Methodist Church

Huntersville, North Carolina, 28078, United States

COMPLETED

Plaza on Princess

Wilmington, North Carolina, 28401, United States

COMPLETED

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27045, United States

COMPLETED

Cleveland Clinic

Akron, Ohio, 44307, United States

COMPLETED

Hospice of the Western Reserve

Cleveland, Ohio, 44110, United States

COMPLETED

McGregor Gardens

Cleveland, Ohio, 44112, United States

RECRUITING

Hope Behavioral Health

Cleveland, Ohio, 44120, United States

COMPLETED

Eastside Fellowship Ministries

Columbus, Ohio, 43203, United States

RECRUITING

Hospice Care of Middletown

Middletown, Ohio, 45044, United States

COMPLETED

Hospital Council of Northwest Ohio

Toledo, Ohio, 43607, United States

COMPLETED

Harney County Home Health & Hospice

Burns, Oregon, 97720, United States

WITHDRAWN

Stuart Community Center

Carlisle, Pennsylvania, 17013, United States

RECRUITING

Villa Schiano

Elizabethville, Pennsylvania, 17023, United States

COMPLETED

Latino Hispanic American Community Center

Harrisburg, Pennsylvania, 17104, United States

COMPLETED

People's Community Baptist Church

Harrisburg, Pennsylvania, 17104, United States

COMPLETED

Hospice and Community Care

Lancaster, Pennsylvania, 17602, United States

COMPLETED

Hospice and Community Care

Lancaster, Pennsylvania, 17603, United States

COMPLETED

St. Mark Missionary Baptist Church

Bennettsville, South Carolina, 29512, United States

COMPLETED

Welcome Home of Chattanooga

Chattanooga, Tennessee, 37406, United States

COMPLETED

All Saints Episcopal Church

Cameron, Texas, 76520, United States

COMPLETED

Turner Alumni Association

Carthage, Texas, 75633, United States

COMPLETED

Dorothea Street Community Center

Crane, Texas, 79731, United States

COMPLETED

Como Community Center

Fort Worth, Texas, 76107, United States

COMPLETED

Georgetown Public Library

Georgetown, Texas, 78626, United States

RECRUITING

Choice Hospice

Sulphur Springs, Texas, 75482, United States

COMPLETED

Sunshine Terrace Foundation

Logan, Utah, 84321, United States

COMPLETED

Luray Fire Department

Luray, Virginia, 22835, United States

COMPLETED

Carmel Baptist Church

Winchester, Virginia, 22601, United States

RECRUITING

Grayland Hall

Grayland, Washington, 98547, United States

RECRUITING

Ocean Beach Hospital

Ilwaco, Washington, 98640, United States

COMPLETED

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Chronic DiseaseCommunication

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Lauren J. Van Scoy, MD

    Penn State Milton S. Hershey Medical Center; Penn State University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The principal investigator and statistical teams will be blinded to the allocation of study participants to the study arms.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Humanities, and Public Health Sciences; Co-director of Penn State Mixed Methods Core

Study Record Dates

First Submitted

October 12, 2020

First Posted

November 3, 2020

Study Start

March 19, 2022

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

November 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

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.

Locations