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

Communication Clinical Trial

Official title:

Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations: a Cluster, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612738
• Other study ID #: STUDY00014689
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Heather J Costigan
• Phone: 717-531-6499
• Email: hcostigan[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning
• Advance Directives
• Chronic Disease
• Chronic Illness
• Communication
• Death
• Terminal Illness

Intervention

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.
• 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.

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?').

Locations

Country	Name	City	State
United States	Cleveland Clinic	Akron	Ohio
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	Pincham-Lincoln Community Center	Athens	Alabama
United States	University of Colorado Hospital	Aurora	Colorado
United States	Northeast Mississippi Coalition Against COVID-19	Belden	Mississippi
United States	St. Mark Missionary Baptist Church	Bennettsville	South Carolina
United States	Harney County Home Health & Hospice	Burns	Oregon
United States	Turner Alumni Association	Carthage	Texas
United States	Welcome Home of Chattanooga	Chattanooga	Tennessee
United States	Trinity Lutheran Church	Cherokee	Iowa
United States	University of Chicago Medical Ctr	Chicago	Illinois
United States	High Point Neighborhood Family Center	Clearwater	Florida
United States	Hope Behavioral Health	Cleveland	Ohio
United States	Hospice of the Western Reserve	Cleveland	Ohio
United States	Como Community Center	Fort Worth	Texas
United States	Washoe Tribe Health Center	Gardnerville	Nevada
United States	Latino Hispanic American Community Center	Harrisburg	Pennsylvania
United States	People's Community Baptist Church	Harrisburg	Pennsylvania
United States	Ohio County Senior Centers	Hartford	Kentucky
United States	Greater Vision United Methodist Church	Huntersville	North Carolina
United States	Hospice & Home Care of Reno	Hutchinson	Kansas
United States	Ocean Beach Hospital	Ilwaco	Washington
United States	Lightways Hospice & Serious Illness Care	Joliet	Illinois
United States	Acadian Advocacy Network	Lafayette	Louisiana
United States	Hospice and Community Care	Lancaster	Pennsylvania
United States	Hospice and Community Care	Lancaster	Pennsylvania
United States	Center for Practical Bioethics	Lawrence	Kansas
United States	St. Mary's Health System	Lewiston	Maine
United States	Bluegrass Care Navigators	Lexington	Kentucky
United States	Sunshine Terrace Foundation	Logan	Utah
United States	Hospice Care of Middletown	Middletown	Ohio
United States	HopeWest Montrose	Montrose	Colorado
United States	Union County Senior Services	Morganfield	Kentucky
United States	Christ Temple Church	Muskegon Heights	Michigan
United States	Corsi Senior Center	New York	New York
United States	Elder Law Project of North Mississippi Rural Legal Services	Oxford	Mississippi
United States	Hospice of St. Lawrence Valley	Potsdam	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Patch Center	Saint Louis	Missouri
United States	Promotores y Promotoras	Santa Paula	California
United States	Holy Cross Health	Silver Spring	Maryland
United States	Our Lady of Solitude	Soledad	California
United States	Hospice of Lake Cumberland	Somerset	Kentucky
United States	Choice Hospice	Sulphur Springs	Texas
United States	St. Phillip AME Church	Tallahassee	Florida
United States	Hospital Council of Northwest Ohio	Toledo	Ohio
United States	El Rio Neighborhood Center	Tucson	Arizona
United States	Vitas	Walnut Creek	California
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	47Million Reasons Healthcare Movement	West Palm Beach	Florida
United States	Plaza on Princess	Wilmington	North Carolina
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Hospice Foundation of America, University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Previous Exposure to ACP Interventions and Advance Directives	This baseline assessment of ACP completion and exposure	Baseline (Day 0)
Other	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)
Other	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 )
Other	Acceptability of Intervention Measure	This 3-item measure to access a participants' perceived acceptability of the intervention	Immediately post-intervention (Day 0)
Other	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)
Other	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
Other	Qualitative Community Host Interview	A follow-up qualitative telephone interview will explore implementation and process outcomes.	2 weeks post-intervention
Other	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
Other	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
Primary	Rates of Completion of a Visually Verified Advance Directive	Study team confirms completion of a signed advance directive	6 months post-intervention
Secondary	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
Secondary	Advance Care Planning Engagement Survey	This short-version survey measures readiness to perform ACP	Baseline (Day 0); 6 months post-intervention