An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations

Description

An Implantable Cardioverter-Defibrillator (ICD) is a device implanted in a patient's chest to monitor the heart rhythm and deliver shocks to terminate potentially lethal arrhythmias when necessary. While ICDs reduce sudden cardiac death, patients with ICDs eventually die of heart failure or other diseases. As patients near the end of life, physiologic changes (intrinsic and extrinsic to the heart) may affect the cardiac conduction system, leading to more arrhythmias and increasing the frequency of shocks. Because ICD shocks can cause pain and anxiety and may not prolong a life of acceptable quality, it is appropriate to consider deactivating the shocking function of ICDs as patients' clinical status worsens and death is near. This will be a randomized controlled trial of a physician centered counseling and education intervention to improve clinician-patient communication about the management of ICDs.

Study Start Date

September 2011

Estimated Completion Date

September 2016

Interventions

  • Behavioral: Communication training for cardiologists.
  • Other: Control arm
  • Other: Control

Specialties

  • Cardiology: Arrhythmias/EP,Heart Failure
  • Surgery: Cardiac Surgery
  • Physician Assistant: Cardiology

MeSH Terms

  • Cardioverter-Defibrillator
  • Heart Failure

Study ID

Mount Sinai School of Medicine -- 09-0618

Status

Unknown

Trial ID

NCT01459744

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

1200

Sponsor

Mount Sinai School of Medicine

Inclusion Criteria

    Clinicians:
  • At all sites, a core group of approximately 10 heart failure clinicians (physicians, nurses) care exclusively for patients with advanced heart failure in both inpatient and outpatient settings
  • all of these clinicians are eligible.. Patients:
  • Score on the Seattle Heart Failure Model or 2 or more heart failure admission in the last year
  • Not being a candidate for life-sustaining therapies such as cardiac transplant or ventricular assist device
  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone. Caregivers:
  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone Exclusion Criteria for patients:
  • Not having an ICD

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (12)

Study Location Distance Name Phone Email
Yale NewHaven Hospital - New Haven, Connecticut 18.2 miles None None None
Yale NewHaven Hospital - New Haven, Connecticut 18.2 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles None None None
Montefiore Medical Center - Bronx, New York 49.1 miles None None None
Montefiore Medical Center - Bronx, New York 49.1 miles None None None
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles None None None
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles None None None
Mayo Medical Center - Rochester, Minnesota 997.5 miles None None None
Mayo Medical Center - Rochester, Minnesota 997.5 miles None None None
University of Colorado Denver - Denver, Colorado 1,658.2 miles None None None
University of Colorado Denver - Denver, Colorado 1,658.2 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.