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

Duke University

Status: Terminated

Conditions: Heart Failure

Treatments: Other: Placebo (Registry Arm); Other: Automated HF/EP Referral

Study type: Interventional

Funder types: Other

Identifiers

NCT01807130

Pro00042120

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 2 patient groups, including a placebo group

Registry

Placebo Comparator group

Description:

Patients randomized to the registry arm will be followed per usual standard of care by their primary providers. Those providers may refer to subspecialty HF or electrophysiology care as they see fit.

Treatment:

Other: Placebo (Registry Arm)

Intervention

Experimental group

Description:

Patients in the intervention arm without compelling contraindications to HF therapies will be referred automatically to specialists in HF or electrophysiology with recommendations to consider those therapies that are not in compliance with guidelines.

Treatment:

Other: Automated HF/EP Referral