Heart Failure, SystolicNCT01514773
Patient and Physician Survey Determinants of Appropriate ICD Utilization
An observational study of Heart Failure, Systolic, run by Todd M Koelling, MD at 1 site in United States.
Trial summary
To better understand the reasons for underutilization of defibrillator therapy in selected populations, the investigators propose a study to assess heart failure patient knowledge and attitudes toward device therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 30 Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University of Michigan Health System Ambulatory Heart Failure Registry
Who may be able to join
- Age ≥ 18 years old
- Left ventricular ejection fraction ≤ 35%
- Previous diagnosis of heart failure with current NYHA Class II-III symptoms
- Established UMHS patient with at least two outpatient visits in the past two years to either Primary Care or Cardiology, OR, at least one inpatient admission in the past two years along with at least one outpatient visit within the past 13 months to Primary Care or Cardiology
Who cannot join
- Patients having undergone heart transplantation
- Patients having undergone placement of a left ventricular assist device
- Patients with congenital heart disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Patient and Physician Knowledge and Attitudes Toward Defibrillator Therapy Survey Study
To better understand the reasons for underutilization of defibrillator therapy in selected populations, the investigators propose a study to assess heart failure patient knowledge and attitudes toward device therapy. By carefully studying populations of patients with systolic heart failure, the investigators aim to identify the underlying reasons for implantable cardioverter defibrillators (ICD) non-utilization in patients with symptomatic systolic heart failure.
Read the detailed description
Several multi-center randomized trials have demonstrated the benefit of implantable cardioverter defibrillators (ICDs) for the primary prevention of sudden cardiac death among patients with ischemic and nonischemic cardiomyopathy. Guideline documents for the treatment of heart failure have recommended defibrillator placement for patients with symptomatic heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Despite these recommendations, observational studies have documented low ICD utilization among patients with heart failure. Recent studies have demonstrated patient specific characteristics that are associated with low ICD utilization (advanced age, female gender, black race, heart failure etiology, uninsured patients and patients cared for by general practitioners). Whether patient knowledge or attitudes regarding defibrillator therapy influence the rate of defibrillator placement is unknown. By carefully surveying populations of patients with systolic heart failure, we aim to further the understanding of the patient factors that determine why an ICD may or may not be used in the appropriate clinical setting. Additionally, 150 physicians will be enrolled into the study for the purpose of measuring attitudes and beliefs regarding defibrillator treatment for the physicians providing care to the patients in the study.
- Conditions
- Heart Failure, Systolic
- Keywords
- left ventricular systolic dysfunction, implantable cardioverter defibrillator, systolic heart failure, congestive heart failure, Ischemic cardiomyopathy, Nonischemic cardiomyopathy, ICD, ICD utilization, ICD implantation, defibrillator, defibrillator therapy, sudden cardiac death
- Medical subject headings
- Heart Failure, Systolic, Ventricular Dysfunction, Left, Heart Failure, 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 |
|---|---|---|
| ICD placement | Those subjects who have an ICD. | |
| No ICD placement | Those subjects who have not had an ICD placed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Determinants of Appropriate ICD Utilization
Specifically, we will assess patients for knowledge deficits regarding the clinical effects of ICD therapy. We will assess patients for their opinions regarding their risk of death, and whether they are willing to trade time to avoid discomfort of their illness or ICD shocks. We will ask patients about their thoughts about financial concerns regarding ICD therapy and their trust in technology, their physician and the medical system. We will also ask patients about their opinions regarding cosmetic issues created by ICD placement.
Measured: 1 year
Secondary outcomes (1)
Physician Determinants of Appropriate ICD Utilization
Measure physician knowledge and attitudes regarding defibrillator therapy for the physicians providing care to the patients in the study and assess the relationship between these measures and appropriate defibrillator utilization. We will assess physicians understanding of ICD clinical effects, costs, and risks of complications.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startAug 2011
- Primary completion30 Aug 2013
- Study completion30 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Todd M Koelling, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Todd M Koelling, MD, University of Michigan
- Investigators
- Todd M Koelling, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514773
- Sponsor's protocol ID
- HUM00050147
- Status last verified
- Mar 2017
- First submitted
- 17 Jan 2012
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Physician Knowledge and Attitudes Toward Defibrillator Therapy Survey Study
- ClinicalTrials.gov ID
- NCT01514773
- Acronym / sponsor ID
- HUM00050147
- Conditions
- Heart Failure, Systolic
- Keywords
- left ventricular systolic dysfunction, implantable cardioverter defibrillator, systolic heart failure, congestive heart failure, Ischemic cardiomyopathy, Nonischemic cardiomyopathy, ICD, ICD utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Todd M Koelling, MDUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Aug 2011 (actual)
- Primary completion
- 30 Aug 2013 (actual)
- Study completion
- 30 Aug 2013 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To better understand the reasons for underutilization of defibrillator therapy in selected populations, the investigators propose a study to assess heart failure patient knowledge and attitudes toward device therapy. By carefully studying populations of patients with systolic heart failure, the investigators aim to identify the underlying reasons for implantable cardioverter defibrillators (ICD) non-utilization in patients with symptomatic systolic heart failure.
Detailed description
Several multi-center randomized trials have demonstrated the benefit of implantable cardioverter defibrillators (ICDs) for the primary prevention of sudden cardiac death among patients with ischemic and nonischemic cardiomyopathy. Guideline documents for the treatment of heart failure have recommended defibrillator placement for patients with symptomatic heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Despite these recommendations, observational studies have documented low ICD utilization among patients with heart failure. Recent studies have demonstrated patient specific characteristics that are associated with low ICD utilization (advanced age, female gender, black race, heart failure etiology, uninsured patients and patients cared for by general practitioners). Whether patient knowledge or attitudes regarding defibrillator therapy influence the rate of defibrillator placement is unknown. By carefully surveying populations of patients with systolic heart failure, we aim to further the understanding of the patient factors that determine why an ICD may or may not be used in the appropriate clinical setting. Additionally, 150 physicians will be enrolled into the study for the purpose of measuring attitudes and beliefs regarding defibrillator treatment for the physicians providing care to the patients in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD placement | – | –Those subjects who have an ICD. |
| No ICD placement | – | –Those subjects who have not had an ICD placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University of Michigan Health System Ambulatory Heart Failure Registry
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Left ventricular ejection fraction ≤ 35%
- Previous diagnosis of heart failure with current NYHA Class II-III symptoms
- Established UMHS patient with at least two outpatient visits in the past two years to either Primary Care or Cardiology, OR, at least one inpatient admission in the past two years along with at least one outpatient visit within the past 13 months to Primary Care or Cardiology
Key exclusion criteria (3 listed)
- Patients having undergone heart transplantation
- Patients having undergone placement of a left ventricular assist device
- Patients with congenital heart disease
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
Patient Determinants of Appropriate ICD Utilization
Time frame: 1 year
Specifically, we will assess patients for knowledge deficits regarding the clinical effects of ICD therapy. We will assess patients for their opinions regarding their risk of death, and whether they are willing to trade time to avoid discomfort of their illness or ICD shocks. We will ask patients about their thoughts about financial concerns regarding ICD therapy and their trust in technology, their physician and the medical system. We will also ask patients about their opinions regarding cosmetic issues created by ICD placement.
1 secondary outcome
Physician Determinants of Appropriate ICD Utilization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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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.
Todd M Koelling, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Systolic, run by Todd M Koelling, MD at 1 site 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 4 inclusion and 3 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 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Determinants of Appropriate ICD Utilization (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2017.