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

NCT ID: NCT01807130

Last Updated: 2014-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-09-30

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart Failure; Medical Therapy; ICD; CRT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Registry

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.

Group Type: PLACEBO_COMPARATOR

Placebo (Registry Arm)

Intervention Type: OTHER

Patients assigned to the registry will receive referral to specialists in HF or EP as deemed necessary by the patients physicians.

Intervention

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.

Group Type: EXPERIMENTAL

Automated HF/EP Referral

Intervention Type: OTHER

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

Interventions

Automated HF/EP Referral

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

Intervention Type: OTHER

Placebo (Registry Arm)

Patients assigned to the registry will receive referral to specialists in HF or EP as deemed necessary by the patients physicians.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett D Atwater, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Jason I Koontz, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00042120

Identifier Type: -

Identifier Source: org_study_id