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Development of a Community Engagement Activity for Advance Care Planning (CERC)

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conversation Game
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Disease focused on measuring advance care planning, end-of-life care, health games, Family caregivers, Advance directives

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participants are eligible to participate if they fall into at least one of the following three groups:

  1. CAREGIVER criteria include:

    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

  2. PATIENT criteria include:

    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-defined using Iezonnis' ICD-9 criteria67)
    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

  3. SURROGATE DECISION MAKERS FOR PATIENTS WITH CHRONIC ILLNESS criteria include:

    1. considers themselves a surrogate decision maker for an adult with a chronic illness (defined above)
    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

Exclusion Criteria:

  1. Do not fall into any of the three categories above
  2. Have a diagnosis of dementia (by self-report or chart review)
  3. Fall into the Surrogate Decision Maker category but the patient cannot also participate in the same study session

Sites / Locations

  • Penn State Hershey College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patient Only

Caregiver Only

Surrogate Decision Maker with Patient

Arm Description

Individuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Patient Only Groups: 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) 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

Individuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Caregiver Only Groups: 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 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

Individuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Surrogate Decision Maker and Patient Group: considers themselves a surrogate decision maker for an adult with a chronic illness (defined in "Patient Only" Group) 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 both patient and surrogate decision maker are able to attend study session together patient must meet eligibility criteria defined in "Patient Only" group

Outcomes

Primary Outcome Measures

Change in self-efficacy and readiness to perform advance care planning behaviors
55-item survey, likert scale ratings

Secondary Outcome Measures

Experiences and perceptions of intervention
Focus-group, open-ended qualitative questions

Full Information

First Posted
October 12, 2015
Last Updated
October 12, 2020
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02575417
Brief Title
Development of a Community Engagement Activity for Advance Care Planning
Acronym
CERC
Official Title
Development of a Community Engagement Activity for Advance Care Planning
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
advance care planning, end-of-life care, health games, Family caregivers, Advance directives

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Only
Arm Type
Experimental
Arm Description
Individuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Patient Only Groups: 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) 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
Arm Title
Caregiver Only
Arm Type
Experimental
Arm Description
Individuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Caregiver Only Groups: 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 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
Arm Title
Surrogate Decision Maker with Patient
Arm Type
Experimental
Arm Description
Individuals who meet the following criteria will play "My Gift of Grace," a conversation game. Eligibility Criteria for Surrogate Decision Maker and Patient Group: considers themselves a surrogate decision maker for an adult with a chronic illness (defined in "Patient Only" Group) 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 both patient and surrogate decision maker are able to attend study session together patient must meet eligibility criteria defined in "Patient Only" group
Intervention Type
Behavioral
Intervention Name(s)
Conversation Game
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in self-efficacy and readiness to perform advance care planning behaviors
Description
55-item survey, likert scale ratings
Time Frame
Baseline (before study session) and 12 weeks post-study
Secondary Outcome Measure Information:
Title
Experiences and perceptions of intervention
Description
Focus-group, open-ended qualitative questions
Time Frame
10 minutes after intervention ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Van Scoy, MD
Organizational Affiliation
Penn State Hershey College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28743662
Citation
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.
Results Reference
result

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Development of a Community Engagement Activity for Advance Care Planning

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