Clinical Trials Directory

Trials / Completed

CompletedNCT04994782

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Debra Moser · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGAME-EOLThe 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.

Timeline

Start date
2021-01-20
Primary completion
2023-03-27
Completion
2023-03-27
First posted
2021-08-06
Last updated
2023-08-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04994782. Inclusion in this directory is not an endorsement.