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NCT Number: NCT01514773

Patient and Physician Survey Determinants of Appropriate ICD Utilization

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.

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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Todd M Koelling, MD

Other

Collaborators

  • Medtronic

Registry information

Official study title

Patient and Physician Knowledge and Attitudes Toward Defibrillator Therapy Survey Study

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2012
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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