Results Summary
What was the research about?
Sudden cardiac death happens when the heart stops beating or beats abnormally. It’s a leading cause of death in the United States. An implantable cardiac defibrillator, or ICD, can improve survival for people at high risk for sudden cardiac death. An ICD is a device placed under the skin and connected to the heart to correct irregular heartbeats.
Black patients have the highest rates of sudden cardiac death but are much less likely than White patients to receive an ICD. Although researchers are unsure of the reasons for this difference, studies have shown that Black patients are more likely than White patients to decline treatment for heart problems.
In this study, the research team wanted to learn whether an educational video affected decisions to get an ICD among Black patients at risk for sudden cardiac death. The team compared patients who viewed the video versus patients who received usual care. Usual care included patients talking with their doctors about ICDs and viewing informational handouts to discuss the decision. The team also looked at whether results differed when Black patients viewed a video with Black versus White patients and doctors.
What were the results?
Overall, groups viewing the educational video and receiving usual care didn’t differ in:
- The percentage of patients who decided to get an ICD or who had an ICD implanted within 90 days
- How conflicted patients felt about their decisions
These results didn’t differ based on whether patients viewed a video with Black or White patients and doctors.
Compared with patients who received usual care, patients who viewed the video had higher knowledge of heart failure and ICDs and spent less time with their doctors.
Who was in the study?
The study included 343 adult Black patients with chronic heart failure receiving care from medical centers across the United States. The average age was 60, and 63 percent were women.
What did the research team do?
The research team assigned patients by chance to one of two groups. In the first group, patients viewed a video. The video showed stories from real patients with ICDs and comments from doctors to help patients with the decision. Patients talked with their own doctors after watching the video. In this group, the team also assigned patients by chance to view the video with White people or Black people in it.
In the second group, patients received usual care.
Seven days after patients met with their doctors, the research team asked the patients if they decided to get an ICD and about decision conflict. The team surveyed patients about ICD knowledge and heart failure. The team called patients 90 days later to see if they received an ICD.
Patients with ICDs, doctors, and members of patient advocacy groups helped design the study and review results.
What were the limits of the study?
Being observed may have changed doctors’ behavior and could have affected study results.
Future research could explore other ways to increase use of ICDs in Black patients.
How can people use the results?
Doctors can use these results when considering how to discuss ICDs with their patients.
Professional Abstract
Objective
To compare the effectiveness of video-assisted decision support versus usual care in increasing acceptance of implantable cardiovascular defibrillators (ICDs) among Black patients with chronic heart failure
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 343 adult Black patients with chronic systolic heart failure from 14 academic health centers and private practices in the United States |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient decision to receive an ICD Secondary: patient decisional conflict, change in knowledge about ICDs, ICD implantation within 90 days, time spent with clinician |
| Timeframe | 1-week follow-up for primary outcome |
An ICD can improve survival for patients with chronic systolic heart failure at high risk for sudden cardiac death. Black patients with chronic systolic heart failure have the highest rates of sudden cardiac death but are much less likely than White patients to receive an ICD. Although researchers are unsure of the reasons for this disparity, studies have shown that Black patients are more likely than White patients to decline treatment for heart problems. This randomized controlled trial compared the effectiveness of video-assisted decision support versus usual care in increasing the number of Black patients with chronic heart failure who decide to get an ICD.
Researchers randomized patients to one of two groups:
- Video-assisted decision support. Patients viewed brief videos that contained narratives from actual patients with ICDs and clinician commentary to help patients make decisions about ICD implantation. Within this group, researchers also randomized patients to view either a version of the video with White patients and clinicians, or a racially concordant version with Black patients and clinicians. Patients also received clinician counseling.
- Usual care. A clinician provided counseling and informational handouts to discuss the decision.
The study included 343 adult Black patients with heart failure receiving care from academic medical centers or private practices across the United States. The average age was 60, and 63% were female.
Seven days after patients met with their clinician, researchers asked patients if they decided to get an ICD and about their decisional conflict. Patients also completed a survey about ICD knowledge and heart failure before and after intervention. Researchers called 90 days after intervention to see if patients had received an ICD. Lastly, researchers reviewed the amount of time patients spent with their clinician.
Patients with ICDs, clinicians, and patient advocacy groups helped design the study and review results.
Results
Compared with the group receiving usual care, the group that received video-assisted decision support did not differ in the proportion of patients who decided to get an ICD, had decisional conflict, or had an ICD implanted within 90 days. These outcomes did not differ based on whether patients viewed the race-concordant video.
Compared with the group receiving usual care, the group that received video-assisted decision support had significantly higher knowledge of heart failure and ICDs and spent less time with their clinician (both p<0.05).
Limitations
Being observed may have influenced clinicians’ behavior. Results may have differed if they had not been observed directly.
Conclusions and Relevance
In this study, compared with usual care, video-assisted decision support—with or without race-concordant videos—did not affect the number of Black patients who decided to get an ICD. Video-assisted decision support increased patients’ knowledge about ICDs and decreased the amount of time they spent with clinicians.
Future Research Needs
Future research could explore other ways to increase uptake of ICDs among Black patients.
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- Reviewers praised the researchers on describing the factors that are likely to contribute to Black patients being more likely to decline some evidence-based treatments but recommended that the researchers also acknowledge the importance of structural racism within the US health care system and how this has contributed to distrust of the health system by some Black patients. The researchers added a section on structural racism and its impacts on health disparities and doctor-patient shared decision making.
- The reviewers asked for clarification on which study participants, patients or clinicians, were blinded to intervention status, and when. The researchers explained that patients were blinded to the difference between the two videos but the clinicians were not. The statistical analysis was blinded until data collection was closed. The researchers added to their study limitations the possible effect of lack of blinding on the study results.
- Some reviewers questioned the researchers’ recommendations to disseminate the decision support videos presented in this study given the lack of significant effect. The researchers noted that decisional conflict was reduced and trended toward statistical significance, and there was no evidence of harm related to this intervention. Therefore, the researchers felt it was reasonable to consider disseminating the intervention given the acknowledged need for a decision support tool to help patients better understand the benefits of implantable cardioverter-defibrillator therapy to prevent cardiac arrest.