Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 28
- 主要终点
- Proportion of Patients Saying "Yes" to ICD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-hospitalized patients with ejection fraction ≤35%
- •New York Heart Association class I-III heart failure,
- •Eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death
- •Self-identified race as black
- •Provision of informed consent to participate in the study.
排除标准
- •Life expectancy <12 months
- •Listed for Orthotropic Heart Transplantation (OHT)
- •Transplant (OHT) or OHT imminent within 12 months,
- •History of ventricular fibrillation or sustained ventricular tachycardia without reversible causes
- •ICD already implanted
- •Myocardial infarction within the last 40 days,
- •Coronary revascularization within the last 3 months,
- •Patients who are unable to understand the study procedures due to cognitive or language barriers.
- •Inpatients will be excluded from the study because decision-making processes are thought to be appreciably different in inpatients as compared with outpatients.
- •Plan for subcutaneous ICD (Sub-Q ICD)
结局指标
主要结局
Proportion of Patients Saying "Yes" to ICD
时间窗: 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)
次要结局
- Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video(7 days)
- Changes in Patient Knowledge (Pre and Post Intervention)(Baseline preintervention and Baseline (approximately 20mins later) post intervention)
- Changes in Decisional Conflict (Pre and Post)(Baseline pre intervention and 1 week post intervention)
- ICD Receipt Within 90 Days of Enrollment.(3 Months)
- Time Spent With Patients by Providers in Each Arm of the Study(Baseline)
- Patient Knowledge(1 week)