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Clinical Trials/NCT01807130
NCT01807130
Terminated
N/A

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

Duke University1 site in 1 country77 target enrollmentSeptember 2013
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Duke University
Enrollment
77
Locations
1
Primary Endpoint
Rate of adherence (%) to ACC/AHA HF guideline recommended HF therapies among patients randomized to the registry compared to the intervention
Status
Terminated
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Repeated Measures Analysis of Adherence to ACC/AHA HF Guidelines(3, 6, 12 months)
  • 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.(12 months)

Study Sites (1)

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