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临床试验/NCT01807130
NCT01807130终止不适用

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

Duke University2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
77
试验地点
2
主要终点
Rate of adherence (%) to ACC/AHA HF guideline recommended HF therapies among patients randomized to the registry compared to the intervention

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 12 month follow-up

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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