GAMification to Encourage End-Of-Life Discussions Between ICD Patients and Caregivers

Implantable Defibrillator User Clinical Trial

— GAME-EOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994782
• Other study ID #: 61699
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: March 27, 2023

Study information

• Verified date: August 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 27, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Death
• Implantable Defibrillator User
• Terminal Illness

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Debra Moser	University of Kentucky CCTS

Country where clinical trial is conducted

United States, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of GAME-EOL	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
Primary	Completion of Advance Directives	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
Primary	Change in concordance of end of life (EOL) Attitudes	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
Primary	Change in experience of end of life issues	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
Primary	Change in attitudes about discussions and actions related to end of life	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
Primary	Knowledge about the ICD in relation to end of life (EOL).	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