Status:
COMPLETED
An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Conditions:
Communication
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Wh...
Detailed 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. Wh...
Eligibility Criteria
Inclusion
- 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:
- 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:
- Age \> 18
- Fluent in English
- Consistent and reliable access to a phone
- Exclusion Criteria for patients:
- Not having an ICD
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT01459744
Start Date
September 1 2011
End Date
September 1 2016
Last Update
October 6 2016
Active Locations (6)
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1
University of Colorado - Denver
Denver, Colorado, United States, 80045
2
Yale New-Haven Hospital
New Haven, Connecticut, United States, 06510
3
Mayo Medical Center
Rochester, Minnesota, United States, 55905
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029