Using an End-of-life Conversation Game to Engage Underserved Communities in Advance Care Planning

Advance Care Planning Clinical Trial

Official title:

Using an End-of-life Conversation Game to Engage Underserved Communities in Advance Care Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456921
• Other study ID #: Study00009009
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: October 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1122
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning
• Advance Directives
• Terminal Illness
• Vulnerable Populations

Intervention

Other:
• End-of-life conversation game called "Hello"
To play 'Hello', players are provided 32 open-ended questions in a prearranged order and an equal number of game chips. A player reads aloud the first question. Players then individually write down their answers, and take turns sharing answers with the group (players can opt to pass). Players control how long they share, what they share, and when they are ready to proceed to the next question. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').

Locations

Country	Name	City	State
United States	Penn State Hershey College of Medicine	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Hospice Foundation of America, John and Wauna Harman Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ACP Behaviors	This phone questionnaire assesses whether participants went on to perform various behaviors related to advance care planning.	9 months post intervention
Secondary	Change in ACP Engagement Survey scores	This validated questionnaire measure assesses engagement in various ACP behaviors and/or readiness to perform ACP behaviors. Items are scored on a 5 point Likert scale (1-5, with 5 indicating highest readiness to perform ACP). Items are averaged for a final score ranging 1-5.	Baseline (Day 0); immediately post-intervention (Day 0); 3-9 months post intervention
Secondary	Conversation satisfaction questionnaire	Measures participants' satisfaction with the conversation. There are 5 items in the measure, each item is 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)
Secondary	ACP Values/Beliefs Questionnaire	Measure participants' attitudes about ACP. This a 8-item questionnaire. Scores are calculated by summative responses and the total score ranges from 7-49 with 7 being the least amount of skepticism (a better outcome).	immediately post-intervention (Day 0)
Secondary	Conversation Realism Questionnaire	The Conversation Realism survey is an 8-item questionnaire that measures how realistic players felt the game conversation was. Each question is measured with a 7- point Likert scale, with "1" being the least realistic and "7" being the most realistic (better outcome) conversation.	immediately post-intervention (Day 0)
Secondary	Net Promoter Score	The Net Promoter Score is a widely single-question (How likely are you to recommend Hello to friends and family?) used to measure participants' game experience on a 10-point scale. It is measured in two ways: (1) raw score is measured on a 10-point scale with 0 being "not likely at all" to 10 (better outcome) being "extremely likely" (2) calculated score = 10-point scale is broken down as follows: detractor score (0-6); passive score (7-8); promoter score (9-10). Passive scores are ignored. The calculated score is: (total number of promoters) - (total number of detractors) / (total number of responses) = score ranging from - 100 to +100 with +100 being the best (better outcome).	immediately post-intervention (0)
Secondary	Hello Game Assessment - Qualitative focus group interview	Group discussions held to collect feedback and opinions about playing the conversation game. Data collected is qualitative.	immediately post-intervention (Day 0)
Secondary	ACP Needs Assessment - Qualitative focus group interview	Qualitative focus groups will explore the needs of diverse African American populations with regards to ACP and end-of-life planning	immediately post-intervention (Day 0)