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

This study is not yet open for participant recruitment.
Verified March 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01807130
First received: March 5, 2013
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure
 Other: Automated HF/EP Referral
Other: Placebo (Registry Arm)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Automated MEdical Record Driven Implantable CArdioverter-defibrillator Heart Failure Trial (AMERICA-HF)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807130

Contacts
Contact: Brett D Atwater, MD 9196848111 brett.atwater@duke.edu

Locations
United States, North Carolina
Duke University Health System Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Brett D Atwater, MD     919-684-8111     brett.atwater@duke.edu    
Principal Investigator: Brett D Atwater, MD            
Principal Investigator: Jason I Koontz, MD/PhD            
Sub-Investigator: Albert Y Sun, MD            
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Brett D Atwater, MD Duke University
Principal Investigator: Jason I Koontz, MD/PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01807130     History of Changes
Other Study ID Numbers: Pro00042120
Study First Received: March 5, 2013
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Heart Failure
Medical Therapy
ICD
CRT

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013