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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: Conversation Game

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 Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17011
      • Penn State Hershey College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Only; 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	Behavioral: Conversation Game; 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
Experimental: Caregiver Only; 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	Behavioral: Conversation Game; 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
Experimental: Surrogate Decision Maker with Patient; 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	Behavioral: Conversation Game; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-efficacy and readiness to perform advance care planning behaviors	55-item survey, likert scale ratings	Baseline (before study session) and 12 weeks post-study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experiences and perceptions of intervention	Focus-group, open-ended qualitative questions	10 minutes after intervention ends

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Lauren Van Scoy, MD, Penn State Hershey College of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Family caregivers; advance care planning; Advance directives; end-of-life care; health games
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 00003004