Patient and Physician Survey Determinants of Appropriate ICD Utilization
This study has been completed.
First Posted: January 23, 2012
Last Update Posted: March 17, 2017
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Information provided by (Responsible Party):
Todd M Koelling, MD, University of Michigan
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.
||Observational Model: Case-Control
Time Perspective: Other
||Patient and Physician Knowledge and Attitudes Toward Defibrillator Therapy Survey Study
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Physician Determinants of Appropriate ICD Utilization [ Time Frame: 1 year ]
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.
| Actual Study Start Date:
| Study Completion Date:
||August 30, 2013
| Primary Completion Date:
||August 30, 2013 (Final data collection date for primary outcome measure)
Those subjects who have an ICD.
No ICD placement
Those subjects who have not had an ICD placed.
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.
Information from the National Library of Medicine
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|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
University of Michigan Health System Ambulatory Heart Failure Registry
- 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
- Patients having undergone heart transplantation
- Patients having undergone placement of a left ventricular assist device
- Patients with congenital heart disease
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514773
|University of Michigan Health System
|Ann Arbor, Michigan, United States, 48109 |
Todd M Koelling, MD
||Todd M Koelling, MD
||University of Michigan
||Todd M Koelling, MD, Associate Professor, Director Heart Failure Program, University of Michigan
History of Changes
|Other Study ID Numbers:
||January 17, 2012
||January 23, 2012
|Last Update Posted:
||March 17, 2017
Keywords provided by Todd M Koelling, MD, University of Michigan:
left ventricular systolic dysfunction
implantable cardioverter defibrillator
systolic heart failure
congestive heart failure
sudden cardiac death
Additional relevant MeSH terms:
Heart Failure, Systolic