NCT03456921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,122

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

February 23, 2018

Last Update Submit

October 31, 2019

Conditions

Keywords

health gamescommunity engagementserious games

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in ACP Engagement Survey scores

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

  • Conversation satisfaction questionnaire

    Immediately post-intervention (Day 0)

  • ACP Values/Beliefs Questionnaire

    immediately post-intervention (Day 0)

  • Conversation Realism Questionnaire

    immediately post-intervention (Day 0)

  • Net Promoter Score

    immediately post-intervention (0)

  • +2 more secondary outcomes

Study Arms (1)

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.

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

Interventions

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').

Also known as: Previously named "My Gift of Grace"
Game participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey College of Medicine

Hershey, Pennsylvania, 17011, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Lauren J Van Scoy

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Humanities and Public Health Sciences

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 7, 2018

Study Start

February 28, 2018

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

November 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Aggregate data may be provided upon request

Locations