Patient and Physician Survey Determinants of Appropriate ICD Utilization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Todd M. Koelling, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01514773
First received: January 17, 2012
Last updated: January 20, 2012
Last verified: January 2012

January 17, 2012
January 20, 2012
August 2011
August 2012   (final data collection date for primary outcome measure)
Patient Determinants of Appropriate ICD Utilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01514773 on ClinicalTrials.gov Archive Site
Physician Determinants of Appropriate ICD Utilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case Control
Not Provided
Not Provided
Non-Probability Sample

University of Michigan Health System Ambulatory Heart Failure Registry

Heart Failure, Systolic
Not Provided
  • ICD placement
    Those subjects who have an ICD.
  • No ICD placement
    Those subjects who have not had an ICD placed.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
August 2013
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Judith Grossi, MS (734) 232-6367 jgrossi@umich.edu
Contact: Todd M Koelling, MD (734) 936-5265 tkoellin@umich.edu
United States
 
NCT01514773
HUM00050147
No
Todd M. Koelling, M.D., University of Michigan
Todd M. Koelling, M.D.
Medtronic
Principal Investigator: Todd M Koelling, MD University of Michigan
University of Michigan
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP