Clinical trial NCT04994782: GAMification to Encourage End-Of-Life Discussions Between ICD Patients and Caregivers
Official title: GAMification to Encourage End-Of-Life Discussions Between Implantable Cardioverter Defibrillator Recipients and Family Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Defibrillator User
Terminal Illness
Keywords: End-of-life
Healthcare Communication
Advance Directives
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Kentucky CCTS
First posted: 2021-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of GAME-EOL
timeFrame: At study completion, up to 3 months post intervention
measure: Completion of Advance Directives
timeFrame: 8 weeks post intervention
measure: Change in concordance of end of life (EOL) Attitudes
timeFrame: Baseline, post intervention
measure: Change in experience of end of life issues
timeFrame: Baseline, post intervention
measure: Change in attitudes about discussions and actions related to end of life
timeFrame: Baseline, post intervention
measure: Knowledge about the ICD in relation to end of life (EOL).
timeFrame: Baseline, post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Debra Moser, PhD
role: PRINCIPAL_INVESTIGATOR
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