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| Name | Class |
|---|---|
| Hospice Foundation of America | UNKNOWN |
| University of Kentucky | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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" |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hello (serious game) | Behavioral | 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. |
| 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 |
| 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 |
| 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. |
Inclusion Criteria Community Hosts
Research Participants
Exclusion Criteria Community Hosts
Research Participants
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| Name | Affiliation | Role |
|---|---|---|
| Lauren J. Van Scoy, MD | Penn State Milton S. Hershey Medical Center; Penn State University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pincham-Lincoln Community Center | Athens | Alabama | 35611 | United States | ||
| Kingman Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39700514 | Derived | 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. | |
| 36180899 | Derived |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Project Talk Trial-ICF-Hello-10122020 | Oct 12, 2020 |
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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.
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The principal investigator and statistical teams will be blinded to the allocation of study participants to the study arms.
|
| The Conversation Project (CP) Starter Kit | Behavioral | 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?'). |
|
This short-version survey measures readiness to perform ACP
| Baseline (Day 0); 6 months post-intervention |
| 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 |
| Kingman |
| Arizona |
| 86409 |
| United States |
| Accord Health Group | Show Low | Arizona | 85901 | United States |
| El Rio Neighborhood Center | Tucson | Arizona | 85745 | United States |
| Promotores y Promotoras | Santa Paula | California | 93060 | United States |
| Our Lady of Solitude | Soledad | California | 93960 | United States |
| Vitas | Walnut Creek | California | 94590 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| HopeWest Montrose | Montrose | Colorado | 81401 | United States |
| Stamford Senior Center | Stamford | Connecticut | 06901 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20020 | United States |
| DeSoto Memorial Hospital | Arcadia | Florida | 34266 | United States |
| High Point Neighborhood Family Center | Clearwater | Florida | 33760 | United States |
| St. Phillip AME Church | Tallahassee | Florida | 32308 | United States |
| City of Temple Terrace, Omar K. Lightfoot Center | Temple Terrace | Florida | 33617 | United States |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 61763 | United States |
| Helene S. Mills | Atlanta | Georgia | 30328 | United States |
| Seniors First of GA | Atlanta | Georgia | 30345 | United States |
| Gilmer County Senior Center | Ellijay | Georgia | 30540 | United States |
| Colquitt Regional Medical Center | Moultrie | Georgia | 31768 | United States |
| University of Chicago Medical Ctr | Chicago | Illinois | 60616 | United States |
| St. Thomas the Apostle Catholic Church | Crystal Lake | Illinois | 60014 | United States |
| Lightways Hospice & Serious Illness Care | Joilet | Illinois | 60435 | United States |
| First Baptist Church | Quincy | Illinois | 62301 | United States |
| Trinity Lutheran Church | Cherokee | Iowa | 51012 | United States |
| Hospice & Home Care of Reno | Hutchinson | Kansas | 67501 | United States |
| Center for Practical Bioethics | Lawrence | Kansas | 66101 | United States |
| Ohio County Senior Centers | Hartford | Kentucky | 42347 | United States |
| Bluegrass Care Navigators | Lexington | Kentucky | 40504 | United States |
| United Crescent Hill Ministries | Louisville | Kentucky | 40206 | United States |
| Union County Senior Services | Morganfield | Kentucky | 42437 | United States |
| Hospice of Lake Cumberland | Somerset | Kentucky | 42503 | United States |
| Acadian Advocacy Network | Lafayette | Louisiana | 70506 | United States |
| St. Mary's Health System | Lewiston | Maine | 04240 | United States |
| East End Community Center | Portland | Maine | 04101 | United States |
| Good Hope Union UMC | Silver Spring | Maryland | 20905 | United States |
| Holy Cross Health | Silver Spring | Maryland | 20910 | United States |
| Grove Hall Senior Center | Boston | Massachusetts | 02121 | United States |
| Community Economic Development Center | New Bedford | Massachusetts | 02746 | United States |
| Christ Temple Church | Muskegon Heights | Michigan | 49444 | United States |
| Northeast Mississippi Coalition Against COVID-19 | Belden | Mississippi | 38868 | United States |
| Elder Law Project of North Mississippi Rural Legal Services | Oxford | Mississippi | 38655 | United States |
| Columbia Senior Activity Center | Columbia | Missouri | 65201 | United States |
| Patch Center | St Louis | Missouri | 63111 | United States |
| Washoe Tribe Health Center | Gardnerville | Nevada | 89410 | United States |
| Reformed Church of Freehold | Freehold | New Jersey | 07728 | United States |
| Booker T. Washington CES | Las Cruces | New Mexico | 88001 | United States |
| Corsi Senior Center | New York | New York | 10029 | United States |
| Hospice of St. Lawrence Valley | Potsdam | New York | 13676 | United States |
| University of Rochester Medical Center | Rochester | New York | 14622 | United States |
| Greater Vision United Methodist Church | Huntersville | North Carolina | 28078 | United States |
| Plaza on Princess | Wilmington | North Carolina | 28401 | United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27045 | United States |
| Cleveland Clinic | Akron | Ohio | 44307 | United States |
| Hospice of the Western Reserve | Cleveland | Ohio | 44110 | United States |
| McGregor Gardens | Cleveland | Ohio | 44112 | United States |
| Hope Behavioral Health | Cleveland | Ohio | 44120 | United States |
| Eastside Fellowship Ministries | Columbus | Ohio | 43203 | United States |
| Hospice Care of Middletown | Middletown | Ohio | 45044 | United States |
| Hospital Council of Northwest Ohio | Toledo | Ohio | 43607 | United States |
| Stuart Community Center | Carlisle | Pennsylvania | 17013 | United States |
| Villa Schiano | Elizabethville | Pennsylvania | 17023 | United States |
| Latino Hispanic American Community Center | Harrisburg | Pennsylvania | 17104 | United States |
| People's Community Baptist Church | Harrisburg | Pennsylvania | 17104 | United States |
| Hospice and Community Care | Lancaster | Pennsylvania | 17602 | United States |
| Hospice and Community Care | Lancaster | Pennsylvania | 17603 | United States |
| St. Mark Missionary Baptist Church | Bennettsville | South Carolina | 29512 | United States |
| Welcome Home of Chattanooga | Chattanooga | Tennessee | 37406 | United States |
| All Saints Episcopal Church | Cameron | Texas | 76520 | United States |
| Turner Alumni Association | Carthage | Texas | 75633 | United States |
| Dorothea Street Community Center | Crane | Texas | 79731 | United States |
| Como Community Center | Fort Worth | Texas | 76107 | United States |
| Georgetown Public Library | Georgetown | Texas | 78626 | United States |
| Choice Hospice | Sulphur Springs | Texas | 75482 | United States |
| Sunshine Terrace Foundation | Logan | Utah | 84321 | United States |
| Luray Fire Department | Luray | Virginia | 22835 | United States |
| Carmel Baptist Church | Winchester | Virginia | 22601 | United States |
| Grayland Hall | Grayland | Washington | 98547 | United States |
| Ocean Beach Hospital | Ilwaco | Washington | 98640 | United States |
| 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. |
| Oct 24, 2020 |
| ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Project Talk Trial-ICF-Hosts-10122020 | Oct 12, 2020 | Oct 24, 2020 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Project Talk Trial-ICF-CPKit-10102020 | Oct 10, 2020 | Oct 24, 2020 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Project Talk Trial-ICF-Control-10122020 | Oct 12, 2020 | Oct 24, 2020 | ICF_000.pdf |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D003142 | Communication |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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