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

Not Applicable

Recruiting

• Conditions: Advance Care Planning; Advance Directives; Terminal Illness; Chronic Illness; Communication

• Registration Number: NCT04612738
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-03
• Study Start: 2022-03-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rates of Completion of a Visually Verified Advance Directive	6 months post-intervention	Study team confirms completion of a signed advance directive

Secondary Outcome Measures

Name	Time	Method
Advance Care Planning Engagement Survey	Baseline (Day 0); 6 months post-intervention	This short-version survey measures readiness to perform ACP
Rates of Other Advance Care Planning (ACP) behaviors	6 months post-intervention	Performance of other ACP behaviors such as self-reported ACP completion, discussions with loved ones, financial preparations

Trial Locations

Locations (71)

Pincham-Lincoln Community Center; 🇺🇸 Athens, Alabama, United States

Kingman Regional Medical Center; 🇺🇸 Kingman, Arizona, United States

Accord Health Group; 🇺🇸 Show Low, Arizona, United States

El Rio Neighborhood Center; 🇺🇸 Tucson, Arizona, United States

Promotores y Promotoras; 🇺🇸 Santa Paula, California, United States

Our Lady of Solitude; 🇺🇸 Soledad, California, United States

Vitas; 🇺🇸 Walnut Creek, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

HopeWest Montrose; 🇺🇸 Montrose, Colorado, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

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