Acute Decompensate Heart Failure National Registry ( ADHERE) Emergency Module (EM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Scios, Inc.
- 入组人数
- 18,920
- 主要终点
- The registry will capture information about the medical care that the patient has received including hospital/ emergency department course, major procedures, medication received, emergency room disposition and in hospital death
研究概览
简要总结
The purpose of this study is to collect data on the medical management of patients presenting to the Emergency Department who are treated for Acute Decompensated Heart Failure (ADHF) in a hospital setting that has incorporated a disease management program for heart failure.
详细描述
This is an Observational (individuals are observed or certain outcomes are measured. no attempt is made to affect the outcome), multi-center registry study of patients presenting to the Emergency Department (ED) for treatment of known or suspected Acute Decompensated Heart Failure (ADHF). Data will be collected on the medical management of patients presenting to the ED who are treated for ADHF in a hospital setting incorporating a disease management program for heart failure. The study will evaluate change in clinical management and outcomes of ADHF patients treated in the ED after ED implementation of three or more components of a disease management program for heart failure. The results are intended to assist hospitals in evaluating and improving quality of care for patients with ADHF by tracking quality indicators and providing site-specific benchmark reports and national benchmark reports. This registry considers patients treated with any therapy for ADHF
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years at the time of ED treatment
- •Received or is eligible to receive a principal ED and/or hospital discharge diagnosis of ADHF
- •ADHF is present as determined clinically by the patient care team and as documented in the DRG (Diagnosis-related Group) or APC (Ambulatory Payment Classifications) codes, and ADHF is the focus of treatment
- •If required by site IRB/IEC patient (or legally acceptable representative) must be able to give informed consent for participation
排除标准
- •ADHF is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this ED or hospital episode
- •Patient was not treated in ED during this episode of care
- •Participation in any clinical trial that precludes use of a Disease Management Program (specific component of the disease are managed in an integrated manner by a team of physicians, pharmacists, nurses and communication experts)
结局指标
主要结局
The registry will capture information about the medical care that the patient has received including hospital/ emergency department course, major procedures, medication received, emergency room disposition and in hospital death
时间窗: Data will be collected, beginning with care in the Emergency Department and ending with the patient's Discharge from the Emergency Department or hospital discharge, transfer to another hospital, or in-hospital death.
次要结局
- Baseline demographic information (age,sex, gender,race), initial evaluation, laboratory results and medical history.(From admission to the emergency depatment until discharge)