Sudden Cardiac Arrest
Conditions
Brief summary
The investigators will examine whether an educational video increases patient knowledge about heart failure and the risk of sudden cardiac arrest and leads to greater satisfaction with information provided as compared to usual care. Additionally, the investigators will look at whether racial concordance (physician and patient being of the same race) improves satisfaction with the patient's treatment decision and disease knowledge. Our hypothesis is that a video in which participants are of the same race as the patient will provide better education and more satisfaction with the treatment decision and may lead to more patients choosing ICD therapy.
Interventions
None listed
Sponsors
Medtronic
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Class I primary prevention indications for an implantable cardioverter defibrillator (ICD). These include: * Patients with ejection fraction \<35% due to prior myocardial infarction (MI) who are at least 40 days post-MI and with New York Heart Association (NYHA) functional class II or III;OR * Patients with nonischemic dilated cardiomyopathy (DCM) who have an LVEF \< 35% and who meet criteria for NYHA functional class II or III; OR * Patients with left ventricular dysfunction due to prior MI who are at least 40 days post-MI, have an left ventricular ejection fraction (LVEF) \<30% and are in NYHA functional class I-III; OR * Patients with nonsustained ventricular tachycardia (VT) due to prior MI, LVEF \<40%, and with inducible ventricular fibrillation (VF) or sustained VT at electrophysiological study; AND * Self identified race as black/African American or white/Caucasian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision to Receive an ICD | 1 week post intervention | At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | one week post intervention | At one week post-intervention, patients were asked 9 questions from a modified decisional conflict scale to assess overall decisional conflict and three subscales (decision uncertainty; factors contributing to uncertainty; and perceived effective decision making). Overall scores range from 9 (no decisional conflict) to 45 (high decisional conflict). |
| Receipt of an ICD | 3 months | Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Knowledge Scores About ICD Therapy One Week Post Intervention. | one week post intervention | We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred at 3 centers: Duke University Medical Center, Alamance Regional Hospital; and Southeast Regional Medical Center in North Carolina. Patients were enrolled during 2011.
Participants by arm
| Arm | Count |
|---|---|
| Black Patients Patients who self-identified as African American | 22 |
| White Patients Patients who self-identified as White | 37 |
| Total | 59 |
Baseline characteristics
| Characteristic | Black Patients | White Patients | Total |
|---|---|---|---|
| Age, Continuous | 52.4 Years STANDARD_DEVIATION 11.4 | 61.7 Years STANDARD_DEVIATION 17.5 | 58.2 Years STANDARD_DEVIATION 16 |
| Randomization Allocation Usual Care | 7 participants | 13 participants | 20 participants |
| Randomization Allocation Video | 15 participants | 24 participants | 39 participants |
| Sex: Female, Male Female | 8 Participants | 14 Participants | 22 Participants |
| Sex: Female, Male Male | 14 Participants | 23 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Decision to Receive an ICD
At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure.
Time frame: 1 week post intervention
Population: All patients with available data at one week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Video | Decision to Receive an ICD | 28 Participants |
| Standard of Care | Decision to Receive an ICD | 14 Participants |
Secondary
Decisional Conflict Scale
At one week post-intervention, patients were asked 9 questions from a modified decisional conflict scale to assess overall decisional conflict and three subscales (decision uncertainty; factors contributing to uncertainty; and perceived effective decision making). Overall scores range from 9 (no decisional conflict) to 45 (high decisional conflict).
Time frame: one week post intervention
Population: Patients with data at one week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video | Decisional Conflict Scale | 35.0 units on a scale | Standard Deviation 2.9 |
| Standard of Care | Decisional Conflict Scale | 34.1 units on a scale | Standard Deviation 3.5 |
Secondary
Receipt of an ICD
Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.
Time frame: 3 months
Population: All patients with data at 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Video | Receipt of an ICD | 14 participants |
| Standard of Care | Receipt of an ICD | 33 participants |
Other Pre-specified
Mean Knowledge Scores About ICD Therapy One Week Post Intervention.
We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge.
Time frame: one week post intervention
Population: Mean scores were calculated with one point for each correct answer out of 13 questions for all patients with data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video | Mean Knowledge Scores About ICD Therapy One Week Post Intervention. | 9.9 units on a scale | Standard Deviation 2.5 |
| Standard of Care | Mean Knowledge Scores About ICD Therapy One Week Post Intervention. | 10.4 units on a scale | Standard Deviation 3 |