Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
About 325,000 US adults die each year because their hearts stop working suddenly. This condition, called sudden cardiac death, happens when the heart stops beating or beats abnormally and cannot pump blood throughout the body. Sudden cardiac death is the leading cause of natural death in the United States. People who are at high risk for sudden cardiac death may need a device that corrects irregular heartbeats. Doctors place the device, called an implantable cardioverter defibrillator, or ICD, under the skin. They then connect the ICD to wires that they place in the heart. The ICD monitors for dangerous heart rates and sends a small electric pulse to restore the heart’s rhythm when needed. An ICD is the best way to prevent sudden cardiac death in high-risk patients.
African Americans have the highest rates of sudden cardiac death but are much less likely than whites to receive an ICD. Research studies also show that African Americans are more likely than whites to refuse recommended heart procedures or surgeries. Doctors and researchers don’t know why these differences among races occur. One possibility is that when communication between doctors and patients is poor, patients are less likely to choose the treatment that is best for them. Researchers want to understand whether an educational video improves knowledge and decision making about ICD treatment among African American patients at high risk for sudden cardiac death and their doctors. The study is also looking at whether patients who view a video featuring people of their same race have different results than patients who view a video showing people of a different race.
Who can this research help?
Information from this study can help doctors improve how they communicate about sudden cardiac death and ICD treatment with their African American patients.
What is the research team doing?
Researchers at 12 hospitals across the United States are enrolling 480 African American patients ages 21 and older who are at high risk for sudden cardiac death and eligible to receive an ICD. The research team is assigning patients by chance to one of three groups when patients arrive for a doctor’s appointment. Patients in the first group watch an educational video featuring African American patients and doctors before meeting with their doctor. Patients in the second group watch the same video featuring white patients and doctors. Patients in the third group receive usual care and advice from their doctors.
Patients in the study answer questions about their knowledge of sudden cardiac death and ICDs before and after the doctor’s appointment. A member of the research team carries out one-on-one interviews by phone with a sample of patients one week after their office visit and again after three months. Patients answer questions about their reasons for accepting or refusing an ICD, and whether the video affected their decision. The team then records how many patients in each group decide to receive an ICD within three months. The team will compare how many patients in each group decide to receive an ICD.
Patients, family members, doctors, and patient advocacy groups helped design the study and the videos.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | Black adults ages 21 and older who are at high risk for sudden cardiac death and eligible to receive an ICD |
| Interventions/ Comparators |
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| Outcomes |
Primary: percent of patients who decide to receive an ICD, percent of patients who decide to receive an ICD after watching an educational video featuring African-American patients and doctors Secondary: change in patient knowledge about sudden cardiac death and ICDs, change in uncertainty about whether to receive an ICD, receipt of ICD within 90 days of agreeing to receive ICD, factors that influenced decision to receive an ICD, barriers to ICD placement, effect of video on decision making, time patients spent with doctors |
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3-month follow-up for primary outcomes |
Project Details