An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations

Completed · Not applicable

Conditions studied: Communication, Heart Failure

In brief

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.

Key facts

Study ID

NCT01459744

Run by

Icahn School of Medicine at Mount Sinai

People needed

562

Starts

2011-09-01

Expected to finish

2016-09-01

Last updated by the study team

2016-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Patient does not currently have a ventricular assist device
• Age > 18
• Fluent in English
• Consistent and reliable access to a phone
• For Inpatient:
• Has had at least 1 other heart failure in the last year, OR
• Meets all three of the following criteria at time of admission:
• BUN > 43
• SBP ≤ 115
• CR > 2.75 OR
• Was on inotropes OR intravenous diuretics OR intravenous heart failure treatments in emergency department OR in outpatient setting prior to the current hospital admission
• For Outpatient
• Has had 2 or more heart failure related admissions in the last year OR
• Has class IV heart failure in the outpatient setting OR
• Has Class III heart failure in outpatient setting AND 1 heart failure related admission in the last year OR
• Has Class III heart failure in outpatient setting AND 2 of the following 4 conditions:
• Age ≥ 70
• BUN ≥ 43
• Cr ≥ 2.75
• SBP≤115 OR
• Is on inotropes (e.g., dobutamine, milrinone) OR intravenous diuretics OR intravenous heart failure treatments in emergency department OR in outpatient setting
• Caregivers:

Where it is running

• University of Colorado - Denver — Denver, Colorado, United States
• Yale New-Haven Hospital — New Haven, Connecticut, United States
• Mayo Medical Center — Rochester, Minnesota, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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