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Advance Care PlanningNCT03456921

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

A study testing End-of-life conversation game called "Hello" in people with Advance Care Planning and Vulnerable Populations, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
End-of-life conversation game called "Hello"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,122 participants
Where
1 siteUnited States
Study dates
28 Feb 2018to 15 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Do not speak English
  • Have significant difficulties with hearing or speaking difficulties by self-report
  • Do not provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Penn State Hershey College of Medicine

    Hershey, Pennsylvania, 17011

Other trials in United States

About this study

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.

Read the 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.

Being tested
End-of-life conversation game called "Hello"
Keywords
health games, community engagement, serious games

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • End-of-life conversation game called "Hello"Other

    Also called Previously named "My Gift of Grace"

    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').

Study groups in NCT03456921
Study groupRoleWhat they receive
Game participantsExperimentalAll participants will engage in playing the end-of-life conversation game called "Hello", which involves answering open-ended questions about medical decision making and end-of-life issues.
Receives: Other: End-of-life conversation game called "Hello"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of ACP Behaviors

    This phone questionnaire assesses whether participants went on to perform various behaviors related to advance care planning.

    Measured: 9 months post intervention

Secondary outcomes (7)
  1. 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.

    Measured: Baseline (Day 0); immediately post-intervention (Day 0); 3-9 months post intervention

  2. 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.

    Measured: Immediately post-intervention (Day 0)

  3. 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).

    Measured: immediately post-intervention (Day 0)

  4. 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.

    Measured: immediately post-intervention (Day 0)

  5. 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).

    Measured: immediately post-intervention (0)

  6. Hello Game Assessment - Qualitative focus group interview

    Group discussions held to collect feedback and opinions about playing the conversation game. Data collected is qualitative.

    Measured: immediately post-intervention (Day 0)

  7. 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

    Measured: immediately post-intervention (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study start28 Feb 2018
  3. Primary completion15 Sep 2019
  4. Study completion15 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
1,122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03456921
Sponsor's protocol ID
Study00009009
Status last verified
Oct 2019
First submitted
23 Feb 2018
Last updated
4 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Aggregate data may be provided upon request

Publications

  • 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.

    PubMed 32948953

Questions about this trial

What is this clinical trial studying?

A study testing End-of-life conversation game called "Hello" in people with Advance Care Planning and Vulnerable Populations, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of ACP Behaviors (time frame: 9 months post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03456921, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.

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