Automated MEdical Record Driven Implantable CArdioverter-defibrillator Heart Failure Trial (AMERICA-HF)

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:September 2013
End Date:September 2016
Contact:Brett D Atwater, MD

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Purpose and Objective: Heart failure therapies including beta-blockers, ACE-inhibitors,
aldosterone antagonists, implantable cardioverter-defibrillator (ICD) and cardiac
resynchronization therapy (CRT) devices have proven beneficial but are underused in eligible
patients. The investigators seek to determine if automating referral to cardiologists and
electrophysiologists through an intelligent electronic medical record system can improve
adherence to American College of Cardiology (ACC)/ American Heart Association (AHA) heart
failure guideline recommended therapies.

Study activities and population group: The AMERICA-HF trial will be a randomized,
single-center, single blinded study comparing standard-practice provider initiated
cardiovascular specialty referral to experimental automated medical record driven
cardiovascular specialty referral. An investigational program will automatically screen all
finalized electronic reports from clinically indicated transthoracic echocardiogram studies
performed in the Duke University Echo Lab system and create an automated query to obtain HF
ICD-9 codes. Eligible patients will be randomly assigned to participate in a registry
(n=125) or automated electronic medical record (EMR) based subspecialty care intervention
arm (n=125).

Data analysis: The primary endpoint is rate of adherence (%) to ACC/AHA HF guideline
recommended therapies at 3, 6, and 12 month follow-up among patients randomized to the
registry compared to the intervention. Differences in characteristics (including use of
guideline recommended therapies) will be tested using Pearson Chi-square tests for
categorical variables and Wilcoxon two-sample tests for continuous variables. Time to event
analysis will be performed for the secondary endpoints of hospitalization or death.

Inclusion Criteria:

- Left Ventricular Ejection Fraction ≤ 35% on transthoracic echocardiogram

- One of the following ICD-9 HF diagnostic codes 398.91, 428.0, 428.1, 428.2x, 428.3x,
428.4x, 428.9

Exclusion Criteria:

- Pregnancy

- Inability to speak English

- Inability to provide verbal consent
We found this trial at
Durham, North Carolina
Durham, NC
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