Heart Failure, Sudden Cardiac Death
Conditions
Keywords
Patient Education, ICD, Implantable Cardioverter Defibrillator, Video, Decision, Decision making
Brief summary
VIVID is a prospective, multicenter, randomized clinical trial in African American patients that will to evaluate: (1) the effect of an educational video on knowledge of sudden cardiac death (SCD) and implantable cardioverter defibrillators (ICDs); (2) the effect of an educational video on the decision for ICD implantation, decisional conflict, and receipt of an ICD within 90 days; and 3) the effect of racial concordance between study patients and video participants (health care providers/patients) on the decision for ICD implantation, decisional conflict and ICD receipt within 90 days.
Detailed description
VIVID is a prospective, multicenter, randomized clinical trial that will evaluate three specific research questions. In black patients eligible for a primary prevention implantable cardioverter defibrillator (ICD), 1) what is the effect of a patient-centered educational video compared with usual care (UC) on knowledge of SCD (Sudden Cardiac Death), associated risk factors, and ICDs; 2) what is the effect of a patient-centered educational video compared with UC on the decision for ICD implantation, decisional conflict, and receipt of an ICD within 90 days; 3) what is the effect of racial concordance between study patients and video participants (health care providers/patients) on the decision for ICD implantation, decisional conflict and ICD receipt within 90 days. In addition, in-depth qualitative interviews (IQI) with a sample of trial participants will be conducted to determine the salient influences on their decision and explore the reasons for their ultimate decision and subsequent implantation or non-implantation of an ICD. Approximately 480 patients eligible for a primary prevention ICD will be enrolled at approximately 12 hospitals in this study. Study sites selected for VIVID will be geographically diverse and provide care to a significant proportion of racial and ethnic minority patients. Patient's will be mailed a letter regarding the study, prior to their initial visit. At the initial visit, patients will be approached about participation in the trial. For those interested, informed consent will be obtained and patients will be randomized. The investigators will be utilizing electronic consents on an iPad. Black patients will be randomized to one of 3 arms: educational videos presented in the same format; one with black participants (patients and providers) or the other with white participants (patients and providers); The third arm will be usual care (control) and the provider can interact with the patient consistent with their typical/usual care. Notably, for both intervention and control arms, all patient management decisions are completely at the discretion of the care providers.
Interventions
OTHEREducational Video1
OTHEREducational Video 2
OTHERUsual Care 3
Sponsors
Patient-Centered Outcomes Research Institute
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Non-hospitalized patients with ejection fraction ≤35% 2. New York Heart Association class I-III heart failure, 3. Age \>21 4. Eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death 5. Self-identified race as black 6. Provision of informed consent to participate in the study.
Exclusion criteria
1. Life expectancy \<12 months 2. Listed for Orthotropic Heart Transplantation (OHT) 3. Transplant (OHT) or OHT imminent within 12 months, 4. History of ventricular fibrillation or sustained ventricular tachycardia without reversible causes 5. ICD already implanted 6. Myocardial infarction within the last 40 days, 7. Coronary revascularization within the last 3 months, 8. Patients who are unable to understand the study procedures due to cognitive or language barriers. 9. Inpatients will be excluded from the study because decision-making processes are thought to be appreciably different in inpatients as compared with outpatients. 10. Plan for subcutaneous ICD (Sub-Q ICD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Saying Yes to ICD | 7 days | Proportion of patients who have decided by 7 days to receive an ICD among patients randomized to the video intervention compared with health care provider counseling (usual care) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Patient Knowledge (Pre and Post Intervention) | Baseline preintervention and Baseline (approximately 20mins later) post intervention | Difference in Knowledge Questionnaire scores before and after receiving the intervention. Range of 0 to 13, with higher score indicating greater knowledge about ICDs. |
| Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video | 7 days | Proportion of patients who watched a racially concordant video and who decided by 7 days to receive an ICD |
| Changes in Decisional Conflict (Pre and Post) | Baseline pre intervention and 1 week post intervention | Difference in Decisional Conflict Scale score from baseline pre-intervention to 1 week post-intervention, range of 0-100 with higher value indicating greater conflict about the decision to receive an ICD. |
| ICD Receipt Within 90 Days of Enrollment. | 3 Months | Number of participants receiving ICD implant within 90 days of enrollment as assessed by medical record review. |
| Time Spent With Patients by Providers in Each Arm of the Study | Baseline | Number of minutes spent with patients during baseline visit as measured by baseline questionnaire timer |
| Patient Knowledge | 1 week | Assessment of knowledge retention at one week through re-administration of baseline Knowledge Questionnaire. Scale of 0-13, with higher score indicating more knowledge about ICDs. |
Other
| Measure | Time frame | Description |
|---|---|---|
| In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD | 3 Month | In-depth phone interview |
| In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD | 3 Month | In-depth phone interview |
| In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD Therapy | 1 week | In-depth phone interview |
| In-depth Qualitative Interviews Focused on Impact of the Video on the Decision | 3 Month | In-depth phone interview |
| In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision | 3 Month | In-depth phone interview |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Racially Concordant Video Participants watching a video in which actors are primarily of the same race (Black/African American) as the participant. | 108 |
| Racially Discordant Video Participants watching a video in which actors are primarily not of the same race (not Black/African American) as the participant | 111 |
| Usual Care (no Video) Standard Care/ No video | 111 |
| Total | 330 |
Baseline characteristics
| Characteristic | Racially Concordant Video | Racially Discordant Video | Usual Care (no Video) | Total |
|---|---|---|---|---|
| Age, Continuous | 59.0 years | 59.0 years | 60.1 years | 59.3 years |
| Race/Ethnicity, Customized Black/African American | 108 Participants | 111 Participants | 111 Participants | 330 Participants |
| Region of Enrollment United States | 108 participants | 111 participants | 111 participants | 330 participants |
| Sex/Gender, Customized Gender Female | 44 Participants | 42 Participants | 35 Participants | 121 Participants |
| Sex/Gender, Customized Gender Male | 63 Participants | 69 Participants | 76 Participants | 208 Participants |
| Sex/Gender, Customized Gender Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 4 / 111 | 0 / 111 |
| other Total, other adverse events | 0 / 108 | 0 / 111 | 0 / 111 |
| serious Total, serious adverse events | 0 / 108 | 0 / 111 | 0 / 111 |
Outcome results
Primary
Proportion of Patients Saying Yes to ICD
Proportion of patients who have decided by 7 days to receive an ICD among patients randomized to the video intervention compared with health care provider counseling (usual care)
Time frame: 7 days
Population: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Video | Proportion of Patients Saying Yes to ICD | Yes, want an ICD | 123 Participants |
| Video | Proportion of Patients Saying Yes to ICD | No or unsure about an ICD | 87 Participants |
| Usual Care (no Video) | Proportion of Patients Saying Yes to ICD | Yes, want an ICD | 60 Participants |
| Usual Care (no Video) | Proportion of Patients Saying Yes to ICD | No or unsure about an ICD | 41 Participants |
Secondary
Changes in Decisional Conflict (Pre and Post)
Difference in Decisional Conflict Scale score from baseline pre-intervention to 1 week post-intervention, range of 0-100 with higher value indicating greater conflict about the decision to receive an ICD.
Time frame: Baseline pre intervention and 1 week post intervention
Population: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified time point. Video arms were combined into a single group to measure the impact of video vs. no video.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Video | Changes in Decisional Conflict (Pre and Post) | Score baseline pre-intervention | 34.4 score on a scale |
| Video | Changes in Decisional Conflict (Pre and Post) | Score 1 week post-intervention | 25.0 score on a scale |
| Usual Care (no Video) | Changes in Decisional Conflict (Pre and Post) | Score baseline pre-intervention | 37.5 score on a scale |
| Usual Care (no Video) | Changes in Decisional Conflict (Pre and Post) | Score 1 week post-intervention | 25.0 score on a scale |
Secondary
Changes in Patient Knowledge (Pre and Post Intervention)
Difference in Knowledge Questionnaire scores before and after receiving the intervention. Range of 0 to 13, with higher score indicating greater knowledge about ICDs.
Time frame: Baseline preintervention and Baseline (approximately 20mins later) post intervention
Population: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video | Changes in Patient Knowledge (Pre and Post Intervention) | Pre-intervention knowledge score | 6.0 score on a scale | Standard Deviation 2.6 |
| Video | Changes in Patient Knowledge (Pre and Post Intervention) | Post-intervention knowledge score | 9.0 score on a scale | Standard Deviation 1.9 |
| Usual Care (no Video) | Changes in Patient Knowledge (Pre and Post Intervention) | Pre-intervention knowledge score | 6.1 score on a scale | Standard Deviation 2.8 |
| Usual Care (no Video) | Changes in Patient Knowledge (Pre and Post Intervention) | Post-intervention knowledge score | 8.4 score on a scale | Standard Deviation 2.4 |
Secondary
ICD Receipt Within 90 Days of Enrollment.
Number of participants receiving ICD implant within 90 days of enrollment as assessed by medical record review.
Time frame: 3 Months
Population: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified timepoint. Video arms were combined into a single group to measure the impact of video vs. no video.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video | ICD Receipt Within 90 Days of Enrollment. | 142 Participants |
| Usual Care (no Video) | ICD Receipt Within 90 Days of Enrollment. | 74 Participants |
Secondary
Patient Knowledge
Assessment of knowledge retention at one week through re-administration of baseline Knowledge Questionnaire. Scale of 0-13, with higher score indicating more knowledge about ICDs.
Time frame: 1 week
Population: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified timepoint. Video arms were combined into a single group to measure the impact of video vs. no video.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Video | Patient Knowledge | 9.0 score on a scale |
| Usual Care (no Video) | Patient Knowledge | 8.0 score on a scale |
Secondary
Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video
Proportion of patients who watched a racially concordant video and who decided by 7 days to receive an ICD
Time frame: 7 days
Population: All participants randomized to video arm for whom outcome data is available. Usual care arm is excluded from this outcome to measure the impact of racial concordance among those viewing a video.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Video | Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video | Yes, want an ICD | 54 Participants |
| Video | Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video | No or unsure about an ICD | 48 Participants |
| Usual Care (no Video) | Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video | Yes, want an ICD | 69 Participants |
| Usual Care (no Video) | Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video | No or unsure about an ICD | 39 Participants |
Secondary
Time Spent With Patients by Providers in Each Arm of the Study
Number of minutes spent with patients during baseline visit as measured by baseline questionnaire timer
Time frame: Baseline
Population: Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Video | Time Spent With Patients by Providers in Each Arm of the Study | 18.0 minutes |
| Usual Care (no Video) | Time Spent With Patients by Providers in Each Arm of the Study | 20.0 minutes |
Other Pre-specified
In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision
In-depth phone interview
Time frame: 3 Month
Other Pre-specified
In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision
In-depth phone interview
Time frame: 1 week
Other Pre-specified
In-depth Qualitative Interviews Focused on Impact of the Video on the Decision
In-depth phone interview
Time frame: 1 week
Other Pre-specified
In-depth Qualitative Interviews Focused on Impact of the Video on the Decision
In-depth phone interview
Time frame: 3 Month
Other Pre-specified
In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD
In-depth phone interview
Time frame: 3 Month
Other Pre-specified
In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD
In-depth phone interview
Time frame: 1 week
Other Pre-specified
In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD
In-depth phone interview
Time frame: 3 Month
Other Pre-specified
In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD Therapy
In-depth phone interview
Time frame: 1 week