Chronic DiseaseCERCNCT02575417
Development of a Community Engagement Activity for Advance Care Planning
A study testing Conversation Game in people with Chronic Disease, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study will determine the feasibility of using an end-of-life conversation game (called "My Gift of Grace") as a community engagement activity series to help caregivers, patients with chronic illness, and/or their families perform advance care planning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Conversation Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Nov 2016
- 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
- Participants are eligible to participate if they fall into at least one of the following three groups:
- CAREGIVER criteria include:
- are 18 years or older
- speak and read English
- have been an unpaid caregiver for an adult over the age of 18 in the last 12 months. Being an unpaid caregiver may include helping with personal needs or household chores, managing a person's finances, arranging for outside services, or visiting regularly to see how they are doing. This person need not live with participants in order for them to identify as caregivers;
- are able to sit for about 2.5-3 hours
Show all 25Show fewer
- are able to focus on the game for about 1.5-2 hours
- can complete required survey
- care recipient is capable of discussing medical issues
- care recipient has not completed an AD in past 18 months
- PATIENT criteria include:
- are 18 years or older
- speak and read English
- have at least one chronic illness (cancer, chronic pulmonary disease, coronary artery disease, congestive heart failure, peripheral vascular disease, severe chronic liver disease, diabetes with end organ damage, renal failure-defined using Iezonnis' ICD-9 criteria67)
- have not completed an advance directive within the past 18 months
- are able to sit for about 2.5-3 hours
- are able to focus on the game for about 1.5-2 hours
- can complete required surveys
- SURROGATE DECISION MAKERS FOR PATIENTS WITH CHRONIC ILLNESS criteria include:
- considers themselves a surrogate decision maker for an adult with a chronic illness (defined above)
- are 18 years or older
- speak and read English
- are able to sit for about 2.5-3 hours
- are able to focus on the game for about 1.5-2 hours
- can complete required surveys
Who cannot join
- Do not fall into any of the three categories above
- Have a diagnosis of dementia (by self-report or chart review)
- Fall into the Surrogate Decision Maker category but the patient cannot also participate in the same study session
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 study will determine the feasibility of using an end-of-life conversation game (called "My Gift of Grace") as a community engagement activity series to help caregivers, patients with chronic illness, and/or their families perform advance care planning.
Read the detailed description
While many patients and caregivers of individuals with chronic illness recognize the importance of advance care planning, many feel uncomfortable initiating end-of-life conversations with loved ones. Few tools exist that effectively engage caregivers and address their particular concerns and needs. The investigators have preliminary data showing that an easily implementable intervention (a conversation game) effectively engages healthy participants in realistic and satisfying ACP conversations. However, the investigators have not yet tested the acceptability or feasibility of using the game in a population of caregivers and/or patients with chronic illness. This pilot project will enable us to engage community-based patients and caregivers to determine if they find the game a satisfying, acceptable, relevant, and effective tool for advance care planning.
- Conditions
- Chronic Disease
- Being tested
- Conversation Game
- Keywords
- advance care planning, end-of-life care, health games, Family caregivers, Advance directives
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversation GameBehavioural
The game consists of 47 question cards that prompt players to identify and articulate their values and beliefs related to dying and end-of-life issues; 20 questions have been selected for this study
| Study group | Role | What they receive |
|---|---|---|
| Patient Only | Experimental | Individuals who meet the following criteria will play "My Gift of Grace," a conversation game.
Eligibility Criteria for Patient Only Groups:
1. are 18 years or older
2. speak and read English
3. have at least one chronic illness (cancer, chronic pulmonary disease, coronary artery disease, congestive heart failure, peripheral vascular disease, severe chronic liver disease, diabetes with end organ damage, renal failure)
4. have not completed an advance directive within the past 18 months
5. are able to sit for about 2.5-3 hours
6. are able to focus on the game for about 1.5-2 hours
7. can complete required surveys Receives: Behavioral: Conversation Game |
| Caregiver Only | Experimental | Individuals who meet the following criteria will play "My Gift of Grace," a conversation game.
Eligibility Criteria for Caregiver Only Groups:
1. are 18 years or older
2. speak and read English
3. have been an unpaid caregiver for an adult over the age of 18 in the last 12 months. Being an unpaid caregiver may include helping with personal needs or household chores, managing a person's finances, arranging for outside services, or visiting regularly to see how they are doing. This person need not live with participants in order for them to identify as caregivers;
4. are able to sit for about 2.5-3 hours
5. are able to focus on the game for about 1.5-2 hours
6. can complete required survey
7. care recipient is capable of discussing medical issues
8. care recipient has not completed an AD in past 18 months Receives: Behavioral: Conversation Game |
| Surrogate Decision Maker with Patient | Experimental | Individuals who meet the following criteria will play "My Gift of Grace," a conversation game.
Eligibility Criteria for Surrogate Decision Maker and Patient Group:
1. considers themselves a surrogate decision maker for an adult with a chronic illness (defined in "Patient Only" Group)
2. are 18 years or older
3. speak and read English
4. are able to sit for about 2.5-3 hours
5. are able to focus on the game for about 1.5-2 hours
6. can complete required surveys
7. both patient and surrogate decision maker are able to attend study session together
8. patient must meet eligibility criteria defined in "Patient Only" group Receives: Behavioral: Conversation Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-efficacy and readiness to perform advance care planning behaviors
55-item survey, likert scale ratings
Measured: Baseline (before study session) and 12 weeks post-study
Secondary outcomes (1)
Experiences and perceptions of intervention
Focus-group, open-ended qualitative questions
Measured: 10 minutes after intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionNov 2016
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 Chronic DiseaseStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Van Scoy, Milton S. Hershey Medical Center
- Investigators
- Lauren Van Scoy, MD, Principal investigator, Penn State Hershey College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575417
- Sponsor's protocol ID
- 00003004
- Acronym
- CERC
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2015
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Scoy LJ, Reading JM, Hopkins M, Smith B, Dillon J, Green MJ, Levi BH. Community Game Day: Using an End-of-Life Conversation Game to Encourage Advance Care Planning. J Pain Symptom Manage. 2017 Nov;54(5):680-691. doi: 10.1016/j.jpainsymman.2017.07.034. Epub 2017 Jul 23.
PubMed 28743662
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Community Engagement Activity for Advance Care Planning
- ClinicalTrials.gov ID
- NCT02575417
- Acronym / sponsor ID
- CERC / 00003004
- Conditions
- Chronic Disease
- Keywords
- advance care planning, end-of-life care, health games, Family caregivers, Advance directives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Oct 2015 (estimated)
- 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 study will determine the feasibility of using an end-of-life conversation game (called "My Gift of Grace") as a community engagement activity series to help caregivers, patients with chronic illness, and/or their families perform advance care planning.
Detailed description
While many patients and caregivers of individuals with chronic illness recognize the importance of advance care planning, many feel uncomfortable initiating end-of-life conversations with loved ones. Few tools exist that effectively engage caregivers and address their particular concerns and needs. The investigators have preliminary data showing that an easily implementable intervention (a conversation game) effectively engages healthy participants in realistic and satisfying ACP conversations. However, the investigators have not yet tested the acceptability or feasibility of using the game in a population of caregivers and/or patients with chronic illness. This pilot project will enable us to engage community-based patients and caregivers to determine if they find the game a satisfying, acceptable, relevant, and effective tool for advance care planning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Only | Experimental | Behavioral: Conversation GameIndividuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Patient Only Groups: 1. are 18 years or older 2. speak and read English 3. have at least one chronic illness (cancer, chronic pulmonary disease, coronary artery disease, congestive heart failure, peripheral vascular disease, severe chronic liver disease, diabetes with end organ damage, renal failure) 4. have not completed an advance directive within the past 18 months 5. are able to sit for about 2.5-3 hours 6. are able to focus on the game for about 1.5-2 hours 7. can complete required surveys |
| Caregiver Only | Experimental | Behavioral: Conversation GameIndividuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Caregiver Only Groups: 1. are 18 years or older 2. speak and read English 3. have been an unpaid caregiver for an adult over the age of 18 in the last 12 months. Being an unpaid caregiver may include helping with personal needs or household chores, managing a person's finances, arranging for outside services, or visiting regularly to see how they are doing. This person need not live with participants in order for them to identify as caregivers; 4. are able to sit for about 2.5-3 hours 5. are able to focus on the game for about 1.5-2 hours 6. can complete required survey 7. care recipient is capable of discussing medical issues 8. care recipient has not completed an AD in past 18 months |
| Surrogate Decision Maker with Patient | Experimental | Behavioral: Conversation GameIndividuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Surrogate Decision Maker and Patient Group: 1. considers themselves a surrogate decision maker for an adult with a chronic illness (defined in "Patient Only" Group) 2. are 18 years or older 3. speak and read English 4. are able to sit for about 2.5-3 hours 5. are able to focus on the game for about 1.5-2 hours 6. can complete required surveys 7. both patient and surrogate decision maker are able to attend study session together 8. patient must meet eligibility criteria defined in "Patient Only" group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants are eligible to participate if they fall into at least one of the following three groups:
- CAREGIVER criteria include:
- PATIENT criteria include:
- SURROGATE DECISION MAKERS FOR PATIENTS WITH CHRONIC ILLNESS criteria include:
Key exclusion criteria (3 listed)
- Do not fall into any of the three categories above
- Have a diagnosis of dementia (by self-report or chart review)
- Fall into the Surrogate Decision Maker category but the patient cannot also participate in the same study session
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 |
|---|---|---|
| Conversation GameThe game consists of 47 question cards that prompt players to identify and articulate their values and beliefs related to dying and end-of-life issues; 20 questions have been selected for this study | Behavioural | Caregiver Only, Patient Only, Surrogate Decision Maker with Patient |
Primary outcome
Change in self-efficacy and readiness to perform advance care planning behaviors
Time frame: Baseline (before study session) and 12 weeks post-study
55-item survey, likert scale ratings
1 secondary outcome
Experiences and perceptions of intervention
Time frame: 10 minutes after intervention ends
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 14 Oct 2020.
- Results publication: PubMed 28743662Van Scoy LJ, Reading JM, Hopkins M, Smith B, Dillon J, Green MJ, Levi BH. Community Game Day: Using an End-of-Life Conversation Game to Encourage Advance Care Planning. J Pain Symptom Manage. 2017 Nov;54(5):680-691. doi: 10.1016/j.jpainsymman.2017.07.034. Epub 2017 Jul 23.
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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 Van Scoy, MD principal investigator
Penn State Hershey 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 Conversation Game in people with Chronic Disease, 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 25 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 14 Oct 2020. 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?
Change in self-efficacy and readiness to perform advance care planning behaviors (time frame: Baseline (before study session) and 12 weeks post-study). 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 NCT02575417, 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 14 Oct 2020.