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| ID | Type | Description | Link |
|---|---|---|---|
| 1U18HS016964 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White educational video | Patients will view an educational video that contains White physicians and patients. | ||
| African-American educational video | Patients will view an educational video that contains African-American physicians and patients. | ||
| Usual care | Patients will receive counseling about their condition and treatment options. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | one week post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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Patients eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death.
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| Name | Affiliation | Role |
|---|---|---|
| Eric D Peterson, MD, MPH | DCRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alamance Regional Medical Center | Burlington | North Carolina | 27215 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23816035 | Derived | Thomas KL, Zimmer LO, Dai D, Al-Khatib SM, Allen LaPointe NM, Peterson ED. Educational videos to reduce racial disparities in ICD therapy via innovative designs (VIVID): a randomized clinical trial. Am Heart J. 2013 Jul;166(1):157-63. doi: 10.1016/j.ahj.2013.03.031. Epub 2013 May 15. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Patients in this arm received standard of care (counseling from a physician). |
| FG001 | Video Intervention | Patients in this arm viewed an educational video on sudden cardiac arrest and ICDs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Black Patients | Patients who self-identified as African American |
| BG001 | White Patients | Patients who self-identified as White |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All patients with available data at one week | Posted | Number | Participants | 1 week post intervention |
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No adverse events were collected for this study, which was a purely educational intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Patients in this arm received standard of care (counseling from a physician). |
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Study terminated early and thus only 59 out of the proposed 90 patients were enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Thomas | Duke University Medical Center | 919-668-7857 | kevin.thomas@dm.duke.edu |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| 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. | 3 months |
| one week post intervention |
| Durham |
| North Carolina |
| 27715 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Randomization Allocation | Patients were randomized into three study arms, stratified by race: white video, black video or usual care | Number | participants |
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| Units |
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| Counts |
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| Participants |
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| 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). | Patients with data at one week | Posted | Mean | Standard Deviation | units on a scale | one week post intervention |
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| 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. | All patients with data at 3 months | Posted | Number | participants | 3 months |
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| 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. | Mean scores were calculated with one point for each correct answer out of 13 questions for all patients with data. | Posted | Mean | Standard Deviation | units on a scale | one week post intervention |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |