Sudden Cardiac ArrestVIVID-01NCT00918125
Educational Videos to Improve Patient Decision Making and Race Disparities in Implantable Cardioverter Defibrillator Use
An observational study of Sudden Cardiac Arrest, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sudden Cardiac Arrest
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Apr 2012
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alamance Regional Medical Center
Burlington, North Carolina, 27215
Duke University Medical Center
Durham, North Carolina, 27715
About this study
Official title: The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)
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.
- Conditions
- Sudden Cardiac Arrest
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week post intervention
Secondary outcomes (2)
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).
Measured: one week post intervention
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac ArrestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Eric D Peterson, MD, MPH, Principal investigator, DCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918125
- Sponsor's protocol ID
- Pro00011117
- Other IDs
- 1U18HS016964
- Acronym
- VIVID-01
- Status last verified
- Apr 2013
- First submitted
- 10 Jun 2009
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23816035
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Educational Videos to Improve Patient Decision Making and Racial Disparities in the Implantation of Implantable Cardioverter Defibrillators (ICDs)
- ClinicalTrials.gov ID
- NCT00918125
- Acronym / sponsor ID
- VIVID-01 / Pro00011117
- Conditions
- Sudden Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 5 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decision to Receive an ICD
Time frame: 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.
2 secondary outcomes
Decisional Conflict Scale
Time frame: one week post intervention
Receipt of an ICD
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23816035Thomas 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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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.
Eric D Peterson, MD, MPH principal investigator
DCRI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Arrest, run by Duke University at 2 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 0 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 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 5 Apr 2013). 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?
Decision to Receive an ICD (time frame: 1 week post intervention). 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 NCT00918125, which also lists 1 linked publication.
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 19 Oct 2015.