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

NCT01807130 | Terminated DMC

• 1 other identifier: Pro00042120
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of adherence (%) to ACC/AHA HF guideline recommended HF therapies among patients randomized to the registry compared to the intervention

  12 month follow-up

Secondary Outcomes (2)

• 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

• Repeated Measures Analysis of Adherence to ACC/AHA HF Guidelines

  3, 6, 12 months

Study Arms (2)

Registry

PLACEBO COMPARATOR

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)

Intervention

EXPERIMENTAL

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

Interventions

Automated HF/EP Referral 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.

Intervention

Placebo (Registry Arm) OTHER

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

Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Inability to speak English
• Inability to provide verbal consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Brett D Atwater, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Jason I Koontz, MD/PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 8, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-08

Locations

US (1)