Implantable Defibrillator UserGAME-EOLNCT04994782
GAMification to Encourage End-Of-Life Discussions Between ICD Patients and Caregivers
A study testing GAME-EOL in people with Implantable Defibrillator User and Terminal Illness, run by Debra Moser at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Implantable Defibrillator User, Terminal Illness
- What is being tested?
- GAME-EOL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 27 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Implantable Defibrillator User, Terminal Illness
- Being tested
- GAME-EOL
- Keywords
- End-of-life, Healthcare Communication, Advance Directives
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAME-EOLBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: GAME-EOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start20 Jan 2021
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Implantable Defibrillator UserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debra Moser
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky CCTS
- Responsible party
- Sponsor-investigator, Debra Moser, University of Kentucky
- Investigators
- Debra Moser, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994782
- Sponsor's protocol ID
- 61699
- Acronym
- GAME-EOL
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
PubMed 30700139Kramer DB, Kennedy KF, Noseworthy PA, Buxton AE, Josephson ME, Normand SL, Spertus JA, Zimetbaum PJ, Reynolds MR, Mitchell SL. Characteristics and outcomes of patients receiving new and replacement implantable cardioverter-defibrillators: results from the NCDR. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):488-97. doi: 10.1161/CIRCOUTCOMES.111.000054. Epub 2013 Jun 11.
PubMed 23759471Sherazi S, McNitt S, Aktas MK, Polonsky B, Shah AH, Moss AJ, Daubert JP, Zareba W. End-of-life care in patients with implantable cardioverter defibrillators: a MADIT-II substudy. Pacing Clin Electrophysiol. 2013 Oct;36(10):1273-9. doi: 10.1111/pace.12188. Epub 2013 Jun 3.
PubMed 23731284Tajouri TH, Ottenberg AL, Hayes DL, Mueller PS. The use of advance directives among patients with implantable cardioverter defibrillators. Pacing Clin Electrophysiol. 2012 May;35(5):567-73. doi: 10.1111/j.1540-8159.2012.03359.x. Epub 2012 Mar 20.
PubMed 22432897Merchant FM, Binney Z, Patel A, Li J, Peddareddy LP, El-Chami MF, Leon AR, Quest T. Prevalence, predictors, and outcomes of advance directives in implantable cardioverter-defibrillator recipients. Heart Rhythm. 2017 Jun;14(6):830-836. doi: 10.1016/j.hrthm.2017.02.022. Epub 2017 Feb 20.
PubMed 28232262Kinch Westerdahl A, Sjoblom J, Mattiasson AC, Rosenqvist M, Frykman V. Implantable cardioverter-defibrillator therapy before death: high risk for painful shocks at end of life. Circulation. 2014 Jan 28;129(4):422-9. doi: 10.1161/CIRCULATIONAHA.113.002648. Epub 2013 Nov 15.
PubMed 24243857Westerdahl AK, Sutton R, Frykman V. Defibrillator patients should not be denied a peaceful death. Int J Cardiol. 2015 Mar 1;182:440-6. doi: 10.1016/j.ijcard.2015.01.012. Epub 2015 Jan 6.
PubMed 25597981Miller JL. Social Determinants of Health and Disparities in Outcomes Related to Cardiovascular Health inVulnerable Populations. Nursing. 2017;PhD:204.
Scott AM, Caughlin JP. Communication nonaccommodation in family conversations about end-of-life health decisions. Health Commun. 2015;30(2):144-53. doi: 10.1080/10410236.2014.974128.
PubMed 25470439Weiner JS, Roth J. Avoiding iatrogenic harm to patient and family while discussing goals of care near the end of life. J Palliat Med. 2006 Apr;9(2):451-63. doi: 10.1089/jpm.2006.9.451.
PubMed 16629574Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.
PubMed 17267907Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.
PubMed 20332506Ahrens T, Yancey V, Kollef M. Improving family communications at the end of life: implications for length of stay in the intensive care unit and resource use. Am J Crit Care. 2003 Jul;12(4):317-23; discussion 324.
PubMed 12882061Parks SM, Winter L, Santana AJ, Parker B, Diamond JJ, Rose M, Myers RE. Family factors in end-of-life decision-making: family conflict and proxy relationship. J Palliat Med. 2011 Feb;14(2):179-84. doi: 10.1089/jpm.2010.0353. Epub 2011 Jan 21.
PubMed 21254816Siminoff LA, Rose JH, Zhang A, Zyzanski SJ. Measuring discord in treatment decision-making; progress toward development of a cancer communication and decision-making assessment tool. Psychooncology. 2006 Jun;15(6):528-40. doi: 10.1002/pon.989.
PubMed 16206332
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAMification to Encourage End-Of-Life Discussions Between Implantable Cardioverter Defibrillator Recipients and Family Members
- ClinicalTrials.gov ID
- NCT04994782
- Acronym / sponsor ID
- GAME-EOL / 61699
- Conditions
- Implantable Defibrillator User, Terminal Illness
- Keywords
- End-of-life, Healthcare Communication, Advance Directives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Debra MoserUniversity, hospital or other
- Collaborators
- University of Kentucky CCTS
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: GAME-EOLParticipant dyads in this group will receive usual care (standard clinical education materials) plus the GAME-EOL intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAME-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. | Behavioural | Usual care plus GAME-EOL intervention |
Primary outcome
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
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 30700139Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
- Background: PubMed 23759471Kramer DB, Kennedy KF, Noseworthy PA, Buxton AE, Josephson ME, Normand SL, Spertus JA, Zimetbaum PJ, Reynolds MR, Mitchell SL. Characteristics and outcomes of patients receiving new and replacement implantable cardioverter-defibrillators: results from the NCDR. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):488-97. doi: 10.1161/CIRCOUTCOMES.111.000054. Epub 2013 Jun 11.
- Background: PubMed 23731284Sherazi S, McNitt S, Aktas MK, Polonsky B, Shah AH, Moss AJ, Daubert JP, Zareba W. End-of-life care in patients with implantable cardioverter defibrillators: a MADIT-II substudy. Pacing Clin Electrophysiol. 2013 Oct;36(10):1273-9. doi: 10.1111/pace.12188. Epub 2013 Jun 3.
- Background: PubMed 22432897Tajouri TH, Ottenberg AL, Hayes DL, Mueller PS. The use of advance directives among patients with implantable cardioverter defibrillators. Pacing Clin Electrophysiol. 2012 May;35(5):567-73. doi: 10.1111/j.1540-8159.2012.03359.x. Epub 2012 Mar 20.
- Background: PubMed 28232262Merchant FM, Binney Z, Patel A, Li J, Peddareddy LP, El-Chami MF, Leon AR, Quest T. Prevalence, predictors, and outcomes of advance directives in implantable cardioverter-defibrillator recipients. Heart Rhythm. 2017 Jun;14(6):830-836. doi: 10.1016/j.hrthm.2017.02.022. Epub 2017 Feb 20.
- Background: PubMed 24243857Kinch Westerdahl A, Sjoblom J, Mattiasson AC, Rosenqvist M, Frykman V. Implantable cardioverter-defibrillator therapy before death: high risk for painful shocks at end of life. Circulation. 2014 Jan 28;129(4):422-9. doi: 10.1161/CIRCULATIONAHA.113.002648. Epub 2013 Nov 15.
- Background: PubMed 25597981Westerdahl AK, Sutton R, Frykman V. Defibrillator patients should not be denied a peaceful death. Int J Cardiol. 2015 Mar 1;182:440-6. doi: 10.1016/j.ijcard.2015.01.012. Epub 2015 Jan 6.
- BackgroundMiller JL. Social Determinants of Health and Disparities in Outcomes Related to Cardiovascular Health inVulnerable Populations. Nursing. 2017;PhD:204.
- Background: PubMed 25470439Scott AM, Caughlin JP. Communication nonaccommodation in family conversations about end-of-life health decisions. Health Commun. 2015;30(2):144-53. doi: 10.1080/10410236.2014.974128.
- Background: PubMed 16629574Weiner JS, Roth J. Avoiding iatrogenic harm to patient and family while discussing goals of care near the end of life. J Palliat Med. 2006 Apr;9(2):451-63. doi: 10.1089/jpm.2006.9.451.
- Background: PubMed 17267907Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.
- Background: PubMed 20332506Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.
- Individual participant dataSharing planned: No
Related trials for Implantable Defibrillator User
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruitingObservational study
TRAjectories and CLinical ExpeRiences of ICD Therapy Study
Implantable Defibrillator User
Recruiting
Effectiveness of Exercise After an ICD
Heart Arrest, Implantable Defibrillator User
Recruiting
Self-Management Interventions After an ICD Shock
Implantable Defibrillator User, Stress Reaction
Active, not recruitingPhase 4
Targeted Potassium Levels for Prevention of ICD Therapy
Ventricular Arrhythmias and Cardiac Arrest, Implantable Defibrillator User
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Moser, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAME-EOL in people with Implantable Defibrillator User and Terminal Illness, run by Debra Moser at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of GAME-EOL (time frame: At study completion, up to 3 months post intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994782, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.