NCT Number: NCT04612738
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Pincham-Lincoln Community Center, Athens, Alabama, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Community Hosts
Research Participants
Exclusion criteria
Community Hosts
Research Participants
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 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 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?').
Time frame: 6 months post-intervention
Study team confirms completion of a signed advance directive
Time frame: 6 months post-intervention
Performance of other ACP behaviors such as self-reported ACP completion, discussions with loved ones, financial preparations
Time frame: Baseline (Day 0); 6 months post-intervention
This short-version survey measures readiness to perform ACP
Time frame: Baseline (Day 0)
This baseline assessment of ACP completion and exposure
Time frame: Baseline (Day 0)
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.
Time frame: Baseline (Day 0 )
This is a 4-item questionnaire to control for whether participants with familiarity with games respond differently to the intervention.
Time frame: Immediately post-intervention (Day 0)
This 3-item measure to access a participants' perceived acceptability of the intervention
Time frame: Immediately post-intervention (Day 0)
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.
Time frame: post-intervention
This is a validated coding method which measures communication quality using outside observer ratings of audio recordings of an intervention.
Time frame: 2 weeks post-intervention
A follow-up qualitative telephone interview will explore implementation and process outcomes.
Time frame: 2 weeks post-intervention
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.
Time frame: 6 months post-intervention
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.
Milton S. Hershey Medical Center
Other
Project Talk Trial: Engaging Underserved Communities in End-of-life Conversations: a Cluster, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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