An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations

Summary

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.

Conditions

• Communication
• Heart Failure

Interventions

BEHAVIORAL

Communication training for cardiologists.

Communication training: a 90 minute workshop to discuss ways to improve communication in patients with serious illness. Reminders to Cardiologists. Cardiologists will receive reminders to prompt them to have conversations relating to ICD management with patients enrolled in the study. Audit and feedback. Cardiologists will receive feedback on their rates of conversation as well as data on patient/family satisfaction with their communication skills.

OTHER

Control arm

Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Colorado, Denver

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Montefiore Medical Center

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Nathan E. Goldstein, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• United States

Study Locations