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.
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
- Conditions the study is for
- Advance Care Planning, Vulnerable Populations, Advance Directives
- 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
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 group | Role | What they receive |
|---|---|---|
| Game participants | Experimental | All 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.
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)
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
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)
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)
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)
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)
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)
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.
- First posted7 Mar 2018
- Study start28 Feb 2018
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- John and Wauna Harman Foundation, Hospice Foundation of America
- Responsible party
- Principal investigator, Lauren Van Scoy, Milton S. Hershey Medical Center
- Investigators
- Lauren J Van Scoy, Principal investigator, Penn State College of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an End-of-life Conversation Game to Engage Underserved Communities in Advance Care Planning
- ClinicalTrials.gov ID
- NCT03456921
- Acronym / sponsor ID
- Study00009009
- Keywords
- health games, community engagement, serious games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,122 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- John and Wauna Harman Foundation, Hospice Foundation of America
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Game participants | Experimental | Other: End-of-life conversation game called "Hello"All 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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"
Key exclusion criteria (3 listed)
- Do not speak English
- Have significant difficulties with hearing or speaking difficulties by self-report
- Do not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| End-of-life conversation game called "Hello"Also: 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'). | Other | Game participants |
Primary outcome
Rate of ACP Behaviors
Time frame: 9 months post intervention
This phone questionnaire assesses whether participants went on to perform various behaviors related to advance care planning.
7 secondary outcomes
Change in ACP Engagement Survey scores
Time frame: Baseline (Day 0); immediately post-intervention (Day 0); 3-9 months post intervention
Conversation satisfaction questionnaire
Time frame: Immediately post-intervention (Day 0)
ACP Values/Beliefs Questionnaire
Time frame: immediately post-intervention (Day 0)
Conversation Realism Questionnaire
Time frame: immediately post-intervention (Day 0)
Net Promoter Score
Time frame: immediately post-intervention (0)
Hello Game Assessment - Qualitative focus group interview
Time frame: immediately post-intervention (Day 0)
ACP Needs Assessment - Qualitative focus group interview
Time frame: immediately post-intervention (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Derived from this study: PubMed 32948953Van 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.
- Individual participant dataSharing planned: No. Aggregate data may be provided upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren J Van Scoy principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
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.