GAMification to Encourage End-Of-Life Discussions Between ICD Patients and Caregivers (GAME-EOL)

August 17, 2023 updated by: Debra Moser

GAMification to Encourage End-Of-Life Discussions Between Implantable Cardioverter Defibrillator Recipients and Family Members

The purpose of this study is to determine the feasibility and efficacy of the GAMification to Encourage End-Of-Life (GAME-EOL) intervention, which uses the Hello Game program to encourage and facilitate quality end-of-life (EOL) discussions between implantable cardioverter defibrillators (ICD) recipients and family members of ICD recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Implantable cardioverter defibrillators (ICD)s are first-line treatment for the primary and secondary prevention of sudden cardiac arrest in populations with a history of, or at high risk for, lethal arrhythmias. Despite the relatively short survival expectancy following device implantation, many ICD recipients do not participate in advance care planning and either have no advance directives or advance directives that do not address end-of-life (EOL) decisions related to ICDs. The prevalence of ICD recipients with general advance directives ranges from 10-30%. Of these advance directives, only 2% have language related to the ICD specifically, leaving hundreds of thousands of ICD recipients at risk of unnecessary and painful shocks. Approximately 30% of ICD recipients will receive a shock in the active dying phase of a terminal illness, from which resuscitation was not intended.

Communication among family members is integral to EOL decision-making. Appropriate quality discussions can create concordance of perceptions and well thought out advance care plans for EOL that are congruent with the values and beliefs of the chronically ill and family members. The Hello Game (commonpractice.com) was created to encourage conversations among families about EOL choices. The gameplay presents a series of questions that include practical and philosophical question prompts. These questions range from 1) What kind of music would you like to be listening to on your last day alive? to 2) Who should your health care surrogate seek advice from if they need to make a decision about your care? Participation in the game has been found to improve advance care planning behaviors.

The purpose of this pilot study is to determine the feasibility and efficacy of the GAME-EOL intervention, which uses the Hello Game to encourage and facilitate quality EOL discussions between ICD recipients and family members.

Aim 1: To determine feasibility of the GAME-EOL intervention to facilitate EOL conversations between ICD recipients and family members.

Aim 2: To provide preliminary estimates of the efficacy of the GAME-EOL intervention on: (2.1) Completion of advance directives (2.2) Completion of device specific advance directives (2.3) Discussion of EOL choices between ICD recipients and family members

Aim 3: To examine efficacy of GAME-EOL on improving the concordance of EOL perceptions and advance care planning between ICD recipients and family members.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ICD recipients with a family member or friend who lives with them or provides a significant role in the healthcare decision making process
  • Internet access

Exclusion Criteria:

  • Age less than 18 years
  • No family member or friend willing to participate with the ICD recipient
  • Significant cognitive impairment
  • Institutionalization (e.g., nursing home, prison)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care recipients
Participant dyads in this group will receive usual care (standard clinical education materials)
Experimental: Usual care plus GAME-EOL intervention
Participant dyads in this group will receive usual care (standard clinical education materials) plus the GAME-EOL intervention.
Behavioral: GAME-EOL
The GAME-EOL involves Hello game booklets as well as meetings with an interventionist. Players (ICD recipient and their family member or friend dyad) take turns asking the questions in their booklet and providing their answers to the question. The gameplay continues until all questions are answered or the dyad wishes to stop. Following the completion of the game play, participants will be offered the opportunity to complete advance directives using the conversation guide and advance directive form included in the conversation guide that accompanies the questionnaire booklet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of GAME-EOL
Time Frame: At study completion, up to 3 months post intervention

The feasibility, likability, and acceptability of GAME-EOL will be assessed using a Likert style questionnaire and one open-ended question. Recruitment and retention statistics will be calculated to provide additional quantitative assessment of feasibility and acceptability.

This questionnaire consists of 18 Likert style questions and one open-response section allowing participants to place additional comments. These questions are broken down into six categories: 1) four questions relating to the content of the education and intervention sessions, 2) four questions related to the technology used to collect data (it's feasibility and user-friendliness), 3) three questions related to the intervention itself, 4) four questions related to the effectiveness of the instructional methodology, 5) three questions about the participants comfort level throughout the study, and 6) one section for additional comments
At study completion, up to 3 months post intervention
Completion of Advance Directives
Time Frame: 8 weeks post intervention
The prevalence of completed general and device specific advance directives will be compared to reports in the literature to determine effectiveness. Medical records will be reviewed eight weeks following completion of data collection to determine if the advance directives were communicated to the healthcare provider and placed in the participants' electronic medical record. Additionally, 8 weeks following study completion, the participants will be contacted for a self-report of conversations with healthcare providers and family.
8 weeks post intervention
Change in concordance of end of life (EOL) Attitudes
Time Frame: Baseline, post intervention
The Preferences for Care Near the End-of-Life instrument will be used to determine congruence of EOL attitudes between ICD recipient and family member. This 32-item questionnaire uses a 5-point Likert scale to identify attitudes toward EOL care with questions such as "I do not want CPR" and "I want my family to make all of my decisions". The instrument will be completed by the ICD recipient and an adapted version with the stem of the question changed from "I" to "my family member" will be completed by family members. Completed instruments will be compared to determine the convergence of attitudes and clarity of communication that occurred during the intervention. This instrument has been found to be valid and reliable in multiple populations. This instrument will be completed by both patients and family members.
Baseline, post intervention
Change in experience of end of life issues
Time Frame: Baseline, post intervention

This 10 item subscale of the ICD End-of-Life Questionnaire assesses the experiences of end of life issues using a 5-point Likert scale ranging from 'Not at all' to 'Very much so'. These questions center around a participant's or Caregiver's worries about the ICD device in every-day and EOL contexts. These questions will be asked at the initial Baseline assessment and then again after the education/intervention. The differences in experiences and worries will be assessed. A higher score (the 'Very much so' option) relates to higher levels of worry and anxiety about their device.

This instrument will be completed by both patients and family members.
Baseline, post intervention
Change in attitudes about discussions and actions related to end of life
Time Frame: Baseline, post intervention

This 18 item subscale of the ICD End-of-Life Questionnaire assesses the attitudes about discussions and actions related to end of life, which break down into two categories. For the first 10 questions, patients can select either 'Agree' or Disagree'. These assess the attitudes a participant has about discussing, with a healthcare professional, the issue of turning off the ICD in the event they are experiencing painful shocks. The remaining 8 questions are intended to assess their attitudes toward the ICD itself in the context of deteriorated health. Participants have the choice of selecting 'Yes', 'No', and 'Can't take a stand'. We will also qualitatively analyze the recorded interventions to detect any change of attitudes about EOL topics.

This instrument will be completed by both patients and family members.
Baseline, post intervention
Knowledge about the ICD in relation to end of life (EOL).
Time Frame: Baseline, post intervention

This 11 item subscale of the ICD End-of-Life Questionnaire assesses the knowledge about the ICD in relation to EOL. It contains 11 items divided into ethical aspects, function of the ICD, and practical consequences, and has been shown to be valid and reliable in the ICD recipient and caregiver populations. This will be administered before and after the intervention so that we may see the effects of the intervention and education on the patient's/caregiver's understanding of their device. For each question, participants can either select 'True', 'False', or 'Don't know'.

This instrument will be completed by both patients and family members.
Baseline, post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Debra Moser

Collaborators

University of Kentucky CCTS

Investigators

  • Principal Investigator: Debra Moser, PhD, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

March 27, 2023

Study Completion (Actual)

March 27, 2023

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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