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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Video 1 | Experimental | African American/ Black Video |
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| Educational Video 2 | Experimental | Caucasian Video |
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| Usual Care (no video) 3 | Experimental | Standard Care/ No video |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Video1 | Other |
| ||
| Educational Video 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Saying "Yes" to ICD | 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) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video | Proportion of patients who watched a racially concordant video and who decided by 7 days to receive an ICD | 7 days |
| Changes in Patient Knowledge (Pre and Post Intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision | In-depth phone interview | 3 Month |
| In-depth Qualitative Interviews Focused on Impact of the Video on the Decision |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Thomas, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94143 | United States | ||
| Medstar Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37011387 | Derived | Thomas KL, Al-Khatib SM, Kosinski AS, Sears SF Jr, Allen LaPointe NM, Jackson LR 2nd, Matlock DD, Haithcock D, Colley BJ 3rd, Hirsh DS, Peterson ED. Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial. Ann Intern Med. 2023 May;176(5):615-623. doi: 10.7326/M22-2934. Epub 2023 Apr 4. | |
| 31785550 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Racially Concordant Video | Participants watching a video in which actors are primarily of the same race (Black/African American) as the participant |
| FG001 | Racially Discordant Video |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2020 | Sep 16, 2020 |
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| Usual Care 3 | Other |
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Difference in Knowledge Questionnaire scores before and after receiving the intervention. Range of 0 to 13, with higher score indicating greater knowledge about ICDs. |
| Baseline preintervention and Baseline (approximately 20mins later) post intervention |
| Changes in Decisional Conflict (Pre and Post) | Difference in Decisional Conflict Scale score from baseline pre-intervention to 1 week post-intervention, range of 0-100 with higher value indicating greater conflict about the decision to receive an ICD. | Baseline pre intervention and 1 week post intervention |
| ICD Receipt Within 90 Days of Enrollment. | Number of participants receiving ICD implant within 90 days of enrollment as assessed by medical record review. | 3 Months |
| Time Spent With Patients by Providers in Each Arm of the Study | Number of minutes spent with patients during baseline visit as measured by baseline questionnaire timer | Baseline |
| Patient Knowledge | Assessment of knowledge retention at one week through re-administration of baseline Knowledge Questionnaire. Scale of 0-13, with higher score indicating more knowledge about ICDs. | 1 week |
In-depth phone interview
| 3 Month |
| In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision | In-depth phone interview | 1 week |
| In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD | In-depth phone interview | 3 Month |
| In-depth Qualitative Interviews Focused on Impact of the Video on the Decision | In-depth phone interview | 1 week |
| In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD | In-depth phone interview | 3 Month |
| In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD | In-depth phone interview | 1 week |
| In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD Therapy | In-depth phone interview | 1 week |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Georgia Arrhythmia Consultants and Research Institute | Macon | Georgia | 31201 | United States |
| Medstar Health Research Institute | Baltimore | Maryland | 21237 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Jackson Heart | Jackson | Mississippi | 39216 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| South Carolina Heart | Columbia | South Carolina | 29204 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Thomas KL, Sullivan LT 2nd, Al-Khatib SM, LaPointe NA, Sears S, Kosinski AS, Jackson LR 2nd, Kutyifa V, Peterson ED. Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) trial: Rational, design and methodology. Am Heart J. 2020 Feb;220:59-67. doi: 10.1016/j.ahj.2019.10.011. Epub 2019 Nov 11. |
Participants watching a video in which actors are primarily not of the same race (not Black/African American) as the participant.
| FG002 | Usual Care (No Video) | Standard Care/ No video |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Racially Concordant Video | Participants watching a video in which actors are primarily of the same race (Black/African American) as the participant. |
| BG001 | Racially Discordant Video | Participants watching a video in which actors are primarily not of the same race (not Black/African American) as the participant |
| BG002 | Usual Care (no Video) | Standard Care/ No video |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Proportion of Patients Saying "Yes" to ICD | 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) | Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video. | Posted | Count of Participants | Participants | 7 days |
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| Secondary | Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video | Proportion of patients who watched a racially concordant video and who decided by 7 days to receive an ICD | All participants randomized to video arm for whom outcome data is available. Usual care arm is excluded from this outcome to measure the impact of racial concordance among those viewing a video. | Posted | Count of Participants | Participants | 7 days |
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| Secondary | Changes in Patient Knowledge (Pre and Post Intervention) | Difference in Knowledge Questionnaire scores before and after receiving the intervention. Range of 0 to 13, with higher score indicating greater knowledge about ICDs. | Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video. | Posted | Mean | Standard Deviation | score on a scale | Baseline preintervention and Baseline (approximately 20mins later) post intervention |
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| Secondary | Changes in Decisional Conflict (Pre and Post) | Difference in Decisional Conflict Scale score from baseline pre-intervention to 1 week post-intervention, range of 0-100 with higher value indicating greater conflict about the decision to receive an ICD. | Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified time point. Video arms were combined into a single group to measure the impact of video vs. no video. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline pre intervention and 1 week post intervention |
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| Secondary | ICD Receipt Within 90 Days of Enrollment. | Number of participants receiving ICD implant within 90 days of enrollment as assessed by medical record review. | Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified timepoint. Video arms were combined into a single group to measure the impact of video vs. no video. | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | Time Spent With Patients by Providers in Each Arm of the Study | Number of minutes spent with patients during baseline visit as measured by baseline questionnaire timer | Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded. Video arms were combined into a single group to measure the impact of video vs. no video. | Posted | Median | Inter-Quartile Range | minutes | Baseline |
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| Secondary | Patient Knowledge | Assessment of knowledge retention at one week through re-administration of baseline Knowledge Questionnaire. Scale of 0-13, with higher score indicating more knowledge about ICDs. | Among patients randomized to the video intervention compared with health care provider counseling (usual care) and having outcome data recorded at the specified timepoint. Video arms were combined into a single group to measure the impact of video vs. no video. | Posted | Median | Inter-Quartile Range | score on a scale | 1 week |
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| Other Pre-specified | In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision | In-depth phone interview | Not Posted | 3 Month | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | In-depth Qualitative Interviews Focused on Impact of the Video on the Decision | In-depth phone interview | Not Posted | 3 Month | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | In-depth Interview Focused on Barriers to ICD Placement Following the Initial Decision | In-depth phone interview | Not Posted | 1 week | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD | In-depth phone interview | Not Posted | 3 Month | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | In-depth Qualitative Interviews Focused on Impact of the Video on the Decision | In-depth phone interview | Not Posted | 1 week | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD | In-depth phone interview | Not Posted | 3 Month | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | In-depth Qualitative Interviews Focused on Influences on the Decision to Accept or Decline an ICD | In-depth phone interview | Not Posted | 1 week | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | In-depth Qualitative Interviews Focused on Knowledge of SCD and ICD Therapy | In-depth phone interview | Not Posted | 1 week | Participants |
This was an intervention of a decision-making tool in standard care. Patients were followed for 90 days.
This was an intervention of a decision-making tool in standard care. Death may have been reported spontaneously during attempts to contact a participant for a follow-up interview. No systematic efforts were made to collect adverse events, including mortality.
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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 | Educational Video 1 | African American/ Black Video Educational Video1 | 0 | 108 | 0 | 108 | 0 | 108 |
| EG001 | Educational Video 2 | Caucasian Video Educational Video 2 | 4 | 111 | 0 | 111 | 0 | 111 |
| EG002 | Usual Care (no Video) 3 | Standard Care/ No video Usual Care 3 | 0 | 111 | 0 | 111 | 0 | 111 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Thomas, MD | Duke Clinical Research Institute | 919-668-8700 | kevin.thomas@duke.edu |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 27, 2020 | Sep 16, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown |
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