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临床试验/NCT02674438
NCT02674438已完成3 期

Comparison of Outcomes and Access to Care for Heart Failure Trial

Institute for Clinical Evaluative Sciences2 个研究点 分布在 1 个国家目标入组 5,452 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
5,452
试验地点
2
主要终点
Co-primary outcome: 30 day early events

研究概览

简要总结

Heart failure is a condition where the heart pump does not function normally causing the lungs to become congested. The primary symptom of heart failure is shortness of breath, and this often leads to patients visiting the emergency department for care. Decision-making in the emergency department is a high-stakes situation, where there is a need for decision support to guide clinicians to make better decisions about admission to hospital or discharge home. Many low-risk patients who could potentially be managed at home are admitted to hospital whereas some patients who are thought safe to discharge are actually high risk and will have adverse outcomes if they are discharged home from the emergency department.

In this trial, the investigators will study a new strategy for heart failure care, comprised of a computer algorithm to help doctors make decisions in the emergency department about the risk of their patient. For low-risk patients who are discharged home from the emergency department or after a short hospital stay, patients will be referred to a rapid follow-up clinic where the heart specialist team will rapidly assess and treat patients.

详细描述

Overview: Randomized intervention trial to examine the impact of an acute heart failure strategy, which incorporates risk stratification and rapid outpatient care after discharge.

Study Population: Patients presenting to the emergency department with heart failure will be eligible for study inclusion.

Inclusion and Exclusion Criteria for the Study:

  1. Age 18 years or older
  2. Presents to the emergency department with acute heart failure diagnosed clinically and verified by a primary diagnosis of heart failure (ICD-10-CA code I50) on the emergency department facesheet.

Exclusion criteria:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

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

  • Patient presenting to an emergency department with heart failure

排除标准

  • Palliative or DNR
  • Dialysis dependent
  • Non-Ontario resident

结局指标

主要结局

Co-primary outcome: 30 day early events

时间窗: 30 days

Time to composite of death or cardiovascular hospitalization (nonelective, los \> 1 day)

Co-primary outcome: 20 month extended events

时间窗: 20 month follow-up

Time to composite of death or cardiovascular hospitalization (nonelective, los \> 1 day)

次要结局

  • All-cause death(20 months)
  • Cardiovascular hospitalization(20 months)
  • Heart failure hospitalization(20 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Lee

Senior Scientist

Institute for Clinical Evaluative Sciences

研究点 (2)

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