Sudden Cardiac DeathVIVIDNCT02819973
Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy
A study testing Educational Video1 and Educational Video 2 in people with Sudden Cardiac Death and Heart Failure, run by Duke University at 14 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sudden Cardiac Death, Heart Failure
- What is being tested?
- Educational Video1 and Educational Video 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 14 sitesUnited States
- Study dates
- Jul 2016to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-hospitalized patients with ejection fraction ≤35%
- New York Heart Association class I-III heart failure,
- Age >21
- Eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death
- Self-identified race as black
- Provision of informed consent to participate in the study.
Who cannot join
- Life expectancy <12 months
- Listed for Orthotropic Heart Transplantation (OHT)
- Transplant (OHT) or OHT imminent within 12 months,
- History of ventricular fibrillation or sustained ventricular tachycardia without reversible causes
- ICD already implanted
- Myocardial infarction within the last 40 days,
Show all 10Show fewer
- Coronary revascularization within the last 3 months,
- Patients who are unable to understand the study procedures due to cognitive or language barriers.
- Inpatients will be excluded from the study because decision-making processes are thought to be appreciably different in inpatients as compared with outpatients.
- Plan for subcutaneous ICD (Sub-Q ICD)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Medstar Health Research Institute
Baltimore, Maryland, 21237
Cooper University Hospital
Camden, New Jersey, 08103
South Carolina Heart
Columbia, South Carolina, 29204
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Jackson Heart
Jackson, Mississippi, 39216
Georgia Arrhythmia Consultants and Research Institute
Macon, Georgia, 31201
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
University of California at San Francisco
San Francisco, California, 94143
Montefiore Medical Center
The Bronx, New York, 10467
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs
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.
Read the detailed description
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.
- Conditions
- Sudden Cardiac Death, Heart Failure
- Being tested
- Educational Video1, Educational Video 2, Usual Care 3
- Keywords
- Patient Education, ICD, Implantable Cardioverter Defibrillator, Video, Decision, Decision making
- Medical subject headings
- Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video1Other
Educational Video 2Other
Usual Care 3Other
| Study group | Role | What they receive |
|---|---|---|
| Educational Video 1 | Experimental | African American/ Black Video Receives: Other: Educational Video1 |
| Educational Video 2 | Experimental | Caucasian Video Receives: Other: Educational Video 2 |
| Usual Care (no video) 3 | Experimental | Standard Care/ No video Receives: Other: Usual Care 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days
Secondary outcomes (6)
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
Measured: 7 days
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion28 Jan 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Kevin Thomas, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819973
- Sponsor's protocol ID
- Pro00071154
- Acronym
- VIVID
- Status last verified
- Mar 2021
- First submitted
- 13 Jun 2016
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37011387Thomas 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.
PubMed 31785550
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs
- ClinicalTrials.gov ID
- NCT02819973
- Acronym / sponsor ID
- VIVID / Pro00071154
- Conditions
- Sudden Cardiac Death, Heart Failure
- Keywords
- Patient Education, ICD, Implantable Cardioverter Defibrillator, Video, Decision, Decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jul 2016
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 21 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Educational Video 1 | Experimental | Other: Educational Video1African American/ Black Video |
| Educational Video 2 | Experimental | Other: Educational Video 2Caucasian Video |
| Usual Care (no video) 3 | Experimental | Other: Usual Care 3Standard Care/ No video |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-hospitalized patients with ejection fraction ≤35%
- New York Heart Association class I-III heart failure,
- Age >21
- Eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death
- Self-identified race as black
Key exclusion criteria (10 listed)
- Life expectancy <12 months
- Listed for Orthotropic Heart Transplantation (OHT)
- Transplant (OHT) or OHT imminent within 12 months,
- History of ventricular fibrillation or sustained ventricular tachycardia without reversible causes
- ICD already implanted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Video1 | Other | Educational Video 1 |
| Educational Video 2 | Other | Educational Video 2 |
| Usual Care 3 | Other | Usual Care (no video) 3 |
Primary outcome
Proportion of Patients Saying "Yes" to ICD
Time frame: 7 days
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)
6 secondary outcomes
Proportion of Individuals Saying Yes to ICD Implant in the Racially Concordant Video
Time frame: 7 days
Changes in Patient Knowledge (Pre and Post Intervention)
Time frame: Baseline preintervention and Baseline (approximately 20mins later) post intervention
Changes in Decisional Conflict (Pre and Post)
Time frame: Baseline pre intervention and 1 week post intervention
ICD Receipt Within 90 Days of Enrollment.
Time frame: 3 Months
Time Spent With Patients by Providers in Each Arm of the Study
Time frame: Baseline
Patient Knowledge
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37011387Thomas 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.
- Derived from this study: PubMed 31785550Thomas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Thomas, MD principal investigator
Duke University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video1 and Educational Video 2 in people with Sudden Cardiac Death and Heart Failure, run by Duke University at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Saying "Yes" to ICD (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.