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

This study is currently recruiting participants.
Verified September 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01807130
First received: March 5, 2013
Last updated: September 10, 2013
Last verified: September 2013

March 5, 2013
September 10, 2013
September 2013
September 2014   (final data collection date for primary outcome measure)
Rate of adherence (%) to ACC/AHA HF guideline recommended HF therapies among patients randomized to the registry compared to the intervention [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01807130 on ClinicalTrials.gov Archive Site
  • Adherence to ACC/AHA guideline recommended therapies by sex and race compared to standard referral processes among patients with ejection fraction (EF) ≤ 35% and symptomatic HF. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Repeated Measures Analysis of Adherence to ACC/AHA HF Guidelines [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
    To determine the time-frame over which the intervention has a treatment effect, repeated measures analysis will be performed at 3 months, 6 months, and 12 months after the intervention is made. The goal of this analysis to to determine how quickly adherence is achieved with the intervention and whether adherence is maintained long-term.
Same as current
Not Provided
Not Provided
 
Automated MEdical Record Driven Implantable CArdioverter-defibrillator Heart Failure Trial (AMERICA-HF)
Automated MEdical Record Driven Implantable CArdioverter-defibrillator Heart Failure Trial (AMERICA-HF)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Heart Failure
  • Other: 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.
  • 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.
  • Placebo Comparator: 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.
    Intervention: Other: Placebo (Registry Arm)
  • Experimental: 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.
    Intervention: Other: Automated HF/EP Referral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
September 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Brett D Atwater, MD 9196848111 brett.atwater@duke.edu
United States
 
NCT01807130
Pro00042120
Yes
Duke University
Duke University
Not Provided
Principal Investigator: Brett D Atwater, MD Duke University
Principal Investigator: Jason I Koontz, MD/PhD Duke University
Duke University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP