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
  Purpose

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.


Condition
Heart Failure, Systolic

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Patient and Physician Knowledge and Attitudes Toward Defibrillator Therapy Survey Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICD placement
Those subjects who have an ICD.
No ICD placement
Those subjects who have not had an ICD placed.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

University of Michigan Health System Ambulatory Heart Failure Registry

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514773

Contacts
Contact: Judith Grossi, MS (734) 232-6367 jgrossi@umich.edu
Contact: Todd M Koelling, MD (734) 936-5265 tkoellin@umich.edu

Locations
United States, Michigan
University of Michigan Health System Enrolling by invitation
Ann Arbor, Michigan, United States, 48109
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Todd M Koelling, MD         
Sponsors and Collaborators
Todd M. Koelling, M.D.
Medtronic
Investigators
Principal Investigator: Todd M Koelling, MD University of Michigan
  More Information

No publications provided

Responsible Party: Todd M. Koelling, M.D., Associate Professor, Director Heart Failure Program, University of Michigan
ClinicalTrials.gov Identifier: NCT01514773     History of Changes
Other Study ID Numbers: HUM00050147
Study First Received: January 17, 2012
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
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

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014