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临床试验/NCT03302910
NCT03302910已完成不适用

Using Short Stay Units Instead of Routine Admission to Improve Patient Centered Health Outcomes for AHF Patients

Indiana University22 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2017年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
194
试验地点
22
主要终点
Days Alive and Out of Hospital

研究概览

简要总结

The majority of the over one million annual AHF hospitalizations originate from the emergency department. Admitting and re-admitting lower risk AHF patients who don't need prolonged hospitalization may increase their risk for poor outcomes and decrease their quality of life: Safe alternatives to hospitalization from the ED are needed. We propose a strategy-of-care, short stay unit management of AHF (i.e. less than 24 hours), will lead to improved outcomes for lower risk AHF patients.

详细描述

Nearly 85% of acute heart failure (AHF) patients who present to the emergency department (ED) with acute heart failure (AHF) are hospitalized. Once hospitalized, within 30 days post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies have all failed. The evidence for existing AHF therapies are poor: No currently used AHF treatment is known to improve outcomes. ED treatment is largely the same today as 40 years ago. Hospitalizing patients who don't need it may contribute to adverse outcomes. Hospitalization is not benign; patients enter a vulnerable phase post-discharge, at increased risk for morbidity and mortality. Patients would prefer to be home, not hospitalized. Furthermore, hospitalization and re-hospitalization for AHF predominantly affects patients of lower socioeconomic status (SES). Avoiding hospitalization in patients who don't need it may improve outcomes and quality of life, while reducing costs.

Short stay unit (SSU: less than 24 hours) management of AHF is effective for lower risk patients. However, it's only been studied in small studies or retrospective analyses. In addition, some have considered the SSU 'cheating' for hospitals trying to avoid 30 day readmission penalties, since SSU or observation didn't count as an admission. However, this quality measure is now changing. A robust clinical effectiveness trial would demonstrate the effectiveness of this patient-centered strategy.

Using a multi-center, randomized controlled design, this clinical effectiveness trial will test whether Short Stay Unit AHF management for < 24 hours increases days-alive-and-out-of-hospital, Quality of Life assessment (QoL), caregiver burden, and costs compared to inpatient management.

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
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Days Alive and Out of Hospital

时间窗: 30 day outcome

To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care

次要结局

  • Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 day outcome)

研究者

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

PETER S PANG

Associate Professor

Indiana University

研究点 (22)

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