Patient and Physician Survey Determinants of Appropriate ICD Utilization

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Systolic

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 Type: Observational
• Enrollment (Actual): 452

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

University of Michigan Health System Ambulatory Heart Failure Registry

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ICD placement; Those subjects who have an ICD.
No ICD placement; Those subjects who have not had an ICD placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Todd M Koelling, MD
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): August 30, 2013
• Study Completion (Actual): August 30, 2013

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: ICD; defibrillator; implantable cardioverter defibrillator; sudden cardiac death; congestive heart failure; Ischemic cardiomyopathy; left ventricular systolic dysfunction; systolic heart failure; Nonischemic cardiomyopathy; ICD utilization; ICD implantation; defibrillator therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Murmurs; Heart Failure; Systolic Murmurs; Heart Failure, Systolic
• Other Study ID Numbers: HUM00050147