Clinical trial NCT01514773: Patient and Physician Survey Determinants of Appropriate ICD Utilization
Official title: Patient and Physician Knowledge and Attitudes Toward Defibrillator Therapy Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2012-01-23
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of Michigan Health System Ambulatory Heart Failure Registry

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients having undergone heart transplantation
* Patients having undergone placement of a left ventricular assist device
* Patients with congenital heart disease

Primary outcomes:
measure: Patient Determinants of Appropriate ICD Utilization
timeFrame: 1 year
Secondary outcomes:
measure: Physician Determinants of Appropriate ICD Utilization
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Todd M Koelling, MD
role: PRINCIPAL_INVESTIGATOR
References: