Clinical trial NCT03456921: Using an End-of-life Conversation Game to Engage Underserved Communities in Advance Care Planning
Official title: Using an End-of-life Conversation Game to Engage Underserved Communities in Advance Care Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Vulnerable Populations
Advance Directives
Terminal Illness
Keywords: health games
community engagement
serious games
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: John and Wauna Harman Foundation
name: Hospice Foundation of America
First posted: 2018-03-07
Enrollment: 1122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This project uses an evidence-based and effective intervention--an end-of-life conversation game called "Hello"--to engage and activate participants to perform advance care planning. Quantitative data will be collected before and after immediately playing the game. Focus groups also will be held immediately after the game. Three months to nine months after playing the game, participants will complete surveys and also engage in semi-structured interviews about the game and about their ACP activities.
Primary purpose: OTHER

Brief summary: This national project will provide an effective, evidence-based intervention for advance care planning (ACP) to 50 underserved US communities, those with poor access to healthcare systems due to economic, cultural or other barriers. The project will also examine 15 of the 50 communities to learn about the unique needs of African American communities in regards to ACP and to assess the intervention with this population. The team includes the Hospice Foundation of America and a university-based research team from Penn State Milton S. Hershey Medical Center.

Detailed description: The project goal explores how best to meet the needs of underserved communities to improve engagement in the advance care planning (ACP) process, which is defined as a complex and ongoing process that involves discussions with loved ones and/or clinicians, and/or may involve completion of an advance directive document. This national project involves two components: 1) a community outreach program, Community Game Days; and 2) a research project. The community outreach component seeks to provide an effective, evidence based ACP intervention to 50 underserved communities (defined as those with poor access to healthcare systems due to economic, cultural or linguistic barriers). Of these, 15 African American communities across the United States will be selected for participation in the research aspect of the project which seeks to assess the program's impact on and to learn about the unique needs of African American populations with regard to ACP. A highly integrated, collaborative approach will be used, bringing together a national organization concerned about end-of-life care (the Hospice Foundation of America (HFA) and a university-based academic research team (led by Dr. Lauren Van Scoy at Penn State Milton S. Hershey Medical Center through her research program, Project Talk).

The project teams will organize and support a 14-month long community outreach project that will bring an end-of-life conversation game, "Hello," to 50 communities across the United States. The game has been found to stimulate substantive, enjoyable and meaningful end-of-life discussions among participants. Further, over 70% of participants who played the game went on to perform additional ACP behaviors.2-4 That body of research is limited, however, by a primarily Caucasian or South Asian Indian demographic. It is well established that African Americans have historically low rates of ACP completion when compared to Caucasians and that they often receive overly aggressive and unwanted care at the end-of-life.5,6 Thus, learning how best to engage the African American population in ACP activities is critical. Thus, this research project aims to determine whether and to what extent this priming activity yields similar results in African American communities. The research team will conduct mixed methods research on the impact of the game on the performance of subsequent ACP behavior as well as explore the broad needs of African American communities with regards to ACP.

Fifteen of the 50 qualified locations who can demonstrate through a screening process the ability to attract a majority African American audience will be selected to participate in the research aspect of the project which will involve: 1) pre-game questionnaires to assess population characteristics and readiness to engage in ACP, 2) post- game questionnaires to assess satisfaction, realism about the conversation game and readiness to engage in ACP, 3) post-game focus groups to further explore opinions about the game, the value of priming activities, and the broad needs of the community for encouraging ACP, and 4) 3 month follow-up phone interviews to assess ACP behaviors that have been performed and perceived impact of the priming activity. Participants from the additional 35 sites can opt-in to participate in a 3 months follow-up phone call. As the trial progressed, the time-frame for follow-up phone interviews was extended to 3 - 9 months.

Upon completion of this project, this collaboration is expected to have reached up to 1000 African American individuals and 1,500 other underserved individuals and provided them with an enjoyable and rich experience that facilitates communication about end-of-life issues. The research data is expected to provide a significant contribution to the field by yielding information about the needs of 15 African American communities as well as to yield data related to the impact of the priming activity (the game) on ACP behaviors in this traditionally underserved group.

Eligibility criteria: Inclusion Criteria:

1. Are over the age of 18
2. Attend a community Game Day event hosted as part of the Hospice Foundation of America community outreach "Hello Project"

Exclusion Criteria:

1. Do not speak English
2. Have significant difficulties with hearing or speaking difficulties by self-report
3. Do not provide informed consent

Primary outcomes:
measure: Rate of ACP Behaviors
timeFrame: 9 months post intervention
Secondary outcomes:
measure: Change in ACP Engagement Survey scores
timeFrame: Baseline (Day 0); immediately post-intervention (Day 0); 3-9 months post intervention
measure: Conversation satisfaction questionnaire
timeFrame: Immediately post-intervention (Day 0)
measure: ACP Values/Beliefs Questionnaire
timeFrame: immediately post-intervention (Day 0)
measure: Conversation Realism Questionnaire
timeFrame: immediately post-intervention (Day 0)
measure: Net Promoter Score
timeFrame: immediately post-intervention (0)
measure: Hello Game Assessment - Qualitative focus group interview
timeFrame: immediately post-intervention (Day 0)
measure: ACP Needs Assessment - Qualitative focus group interview
timeFrame: immediately post-intervention (Day 0)
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Lauren J Van Scoy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Scoy LJ, Green MJ, Witt PD, Bramble C, Richardson C, Putzig I, Toyobo O, Wasserman E, Chinchilli VM, Tucci A, Levi BH. Low Skepticism and Positive Attitudes About Advance Care Planning Among African Americans: a National, Mixed Methods Cohort Study. J Gen Intern Med. 2021 Mar;36(3):705-712. doi: 10.1007/s11606-020-06224-z. Epub 2020 Sep 18.