Clinical trial NCT04612738: Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations
Official title: Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations: a Cluster, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advance Care Planning
Advance Directives
Terminal Illness
Chronic Illness
Communication
Keywords: serious games
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Hospice Foundation of America
name: University of Kentucky
First posted: 2020-11-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of Completion of a Visually Verified Advance Directive
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Rates of Other Advance Care Planning (ACP) behaviors
timeFrame: 6 months post-intervention
measure: Advance Care Planning Engagement Survey
timeFrame: Baseline (Day 0); 6 months post-intervention
Other outcomes:
measure: Previous Exposure to ACP Interventions and Advance Directives
timeFrame: Baseline (Day 0)
measure: Healthcare System Distrust Scale
timeFrame: Baseline (Day 0)
measure: Experience and Comfort with Games Questionnaire
timeFrame: Baseline (Day 0 )
measure: Acceptability of Intervention Measure
timeFrame: Immediately post-intervention (Day 0)
measure: Conversation Satisfaction Questionnaire
timeFrame: Immediately post-intervention (Day 0)
measure: Communication Quality Analysis (CQA) Measure
timeFrame: post-intervention
measure: Qualitative Community Host Interview
timeFrame: 2 weeks post-intervention
measure: Participant Follow-up Qualitative Telephone Interview
timeFrame: 2 weeks post-intervention
measure: Six-Month Participant Follow-up Telephone Interview
timeFrame: 6 months post-intervention
Locations:
city: Athens
country: United States
facility: Pincham-Lincoln Community Center
state: Alabama
city: Kingman
country: United States
facility: Kingman Regional Medical Center
state: Arizona
city: Show Low
country: United States
facility: Accord Health Group
state: Arizona
city: Tucson
country: United States
facility: El Rio Neighborhood Center
state: Arizona
city: Santa Paula
country: United States
facility: Promotores y Promotoras
state: California
city: Soledad
country: United States
facility: Our Lady of Solitude
state: California
city: Walnut Creek
country: United States
facility: Vitas
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Montrose
country: United States
facility: HopeWest Montrose
state: Colorado
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: High Point Neighborhood Family Center
state: Florida
city: Tallahassee
country: United States
facility: St. Phillip AME Church
state: Florida
city: Temple Terrace
country: United States
facility: City of Temple Terrace, Omar K. Lightfoot Center
state: Florida
city: West Palm Beach
country: United States
facility: 47Million Reasons Healthcare Movement
state: Florida
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Helene S. Mills
state: Georgia
city: Atlanta
country: United States
facility: Seniors First of GA
state: Georgia
city: Ellijay
country: United States
facility: Gilmer County Senior Center
state: Georgia
city: Moultrie
country: United States
facility: Colquitt Regional Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Ctr
state: Illinois
city: Crystal Lake
country: United States
facility: St. Thomas the Apostle Catholic Church
state: Illinois
city: Joliet
country: United States
facility: Lightways Hospice & Serious Illness Care
state: Illinois
city: Cherokee
country: United States
facility: Trinity Lutheran Church
state: Iowa
city: Hutchinson
country: United States
facility: Hospice & Home Care of Reno
state: Kansas
city: Lawrence
country: United States
facility: Center for Practical Bioethics
state: Kansas
city: Hartford
country: United States
facility: Ohio County Senior Centers
state: Kentucky
city: Lexington
country: United States
facility: Bluegrass Care Navigators
state: Kentucky
city: Louisville
country: United States
facility: United Crescent Hill Ministries
state: Kentucky
city: Morganfield
country: United States
facility: Union County Senior Services
state: Kentucky
city: Somerset
country: United States
facility: Hospice of Lake Cumberland
state: Kentucky
city: Lafayette
country: United States
facility: Acadian Advocacy Network
state: Louisiana
city: Lewiston
country: United States
facility: St. Mary's Health System
state: Maine
city: Silver Spring
country: United States
facility: Good Hope Union UMC
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Health
state: Maryland
city: Boston
country: United States
facility: Grove Hall Senior Center
state: Massachusetts
city: New Bedford
country: United States
facility: Community Economic Development Center
state: Massachusetts
city: Muskegon Heights
country: United States
facility: Christ Temple Church
state: Michigan
city: Belden
country: United States
facility: Northeast Mississippi Coalition Against COVID-19
state: Mississippi
city: Oxford
country: United States
facility: Elder Law Project of North Mississippi Rural Legal Services
state: Mississippi
city: Saint Louis
country: United States
facility: Patch Center
state: Missouri
city: Gardnerville
country: United States
facility: Washoe Tribe Health Center
state: Nevada
city: Freehold
country: United States
facility: Reformed Church of Freehold
state: New Jersey
city: Las Cruces
country: United States
facility: Booker T. Washington CES
state: New Mexico
city: New York
country: United States
facility: Corsi Senior Center
state: New York
city: Potsdam
country: United States
facility: Hospice of St. Lawrence Valley
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Huntersville
country: United States
facility: Greater Vision United Methodist Church
state: North Carolina
city: Wilmington
country: United States
facility: Plaza on Princess
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Akron
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: Hospice of the Western Reserve
state: Ohio
city: Cleveland
country: United States
facility: Hope Behavioral Health
state: Ohio
city: Columbus
country: United States
facility: Eastside Fellowship Ministries
state: Ohio
city: Middletown
country: United States
facility: Hospice Care of Middletown
state: Ohio
city: Toledo
country: United States
facility: Hospital Council of Northwest Ohio
state: Ohio
city: Burns
country: United States
facility: Harney County Home Health & Hospice
state: Oregon
city: Carlisle
country: United States
facility: Stuart Community Center
state: Pennsylvania
city: Elizabethville
country: United States
facility: Villa Schiano
state: Pennsylvania
city: Harrisburg
country: United States
facility: Latino Hispanic American Community Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: People's Community Baptist Church
state: Pennsylvania
city: Lancaster
country: United States
facility: Hospice and Community Care
state: Pennsylvania
city: Lancaster
country: United States
facility: Hospice and Community Care
state: Pennsylvania
city: Bennettsville
country: United States
facility: St. Mark Missionary Baptist Church
state: South Carolina
city: Chattanooga
country: United States
facility: Welcome Home of Chattanooga
state: Tennessee
city: Carthage
country: United States
facility: Turner Alumni Association
state: Texas
city: Crane
country: United States
facility: Dorothea Street Community Center
state: Texas
city: Fort Worth
country: United States
facility: Como Community Center
state: Texas
city: Sulphur Springs
country: United States
facility: Choice Hospice
state: Texas
city: Logan
country: United States
facility: Sunshine Terrace Foundation
state: Utah
city: Luray
country: United States
facility: Luray Fire Department
state: Virginia
city: Winchester
country: United States
facility: Carmel Baptist Church
state: Virginia
city: Ilwaco
country: United States
facility: Ocean Beach Hospital
state: Washington
Study officials:
affiliation: Penn State Milton S. Hershey Medical Center; Penn State University College of Medicine
name: Lauren J. Van Scoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.