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

NCT04994782 | Completed

• 1 other identifier: 61699
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Implantable Defibrillator User; Terminal Illness

Keywords

End-of-life; Healthcare Communication; Advance Directives

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Usual care recipients

NO INTERVENTION

Participant dyads in this group will receive usual care (standard clinical education materials)

Usual care plus GAME-EOL intervention

EXPERIMENTAL

Participant dyads in this group will receive usual care (standard clinical education materials) plus the GAME-EOL intervention.

Behavioral: GAME-EOL

Interventions

GAME-EOL BEHAVIORAL

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.

Usual care plus GAME-EOL intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Debra Moser: lead
• University of Kentucky CCTS: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Debra Moser, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 6, 2021
• Study Start: January 20, 2021
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)