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临床试验/NCT01020513
NCT01020513撤回不适用

Subcutaneous Recombinant Human Hyaluronidase: Workflow Analysis and Emergency Department Design

University of California, San Diego0 个研究点开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
elapsed time in Emergency Department

研究概览

简要总结

This is an observational study examining the workflow dynamics and training requirements that support effective use of subcutaneous hydration delivery (a newly FDA approved Baxter product) compared to standard intravenous hydration/medication delivery. Emergency departments already using both Subcutaneous Recombinant Human Hyaluronidase and standard IV hydration will be enrolled. Patients will be receiving the hydration method selected by their emergency department physician and the investigators will then observe:

  1. Patient Throughput
  • Efficiency of patient care and treatment areas
  • Safety of patient care and treatment areas
  • Support Service processes that impact patient flow
  1. Clinical Outcomes
  • Time to conversion from dehydration to hydration'
  • Rate of complications
  1. Satisfaction
  • Staff satisfaction with Subcutaneous hydration vs. Intravenous hydration
  • Patient satisfaction with Subcutaneous hydration vs. Intravenous hydration

详细描述

SPECIFIC AIMS This study examines the operational consequences and training requirements for implementing subcutaneous hydration vs. standard intravenous hydration in emergency departments.

B. BACKGROUND AND SIGNIFICANCE Emergency departments across the nation are overcrowded. Emergency department visits hit a new high in 2005, with more than 115 million visits, an increase of 5 million visits over the previous year, and a 20 percent increase over 10 years. During the same period the number of hospital EDs decreased more than 9 percent from 4,176 to 3,795. A consequence of the increase in demand occurring during a decrease in capacity, according to the American College of Emergency Physicians is that 60 percent of EDs report that the overcrowding has forced their facilities to divert patients and though more than 70 percent of hospitals reported having a goal of admitting patients within two hours of arrival in the emergency department, almost half of that group routinely fails.

Overcrowding not only results in delayed treatment, long patient waiting time, overburdened working staff, patient elopement, and low throughput, it also results in increased medical errors due to overloading and significant legal and financial risks.

These issues have led to a number of initiatives with, potentially the most profound being the 2007 Joint Commission requirement ( Leadership Standard, LD.3.15) requiring hospital leadership to:"... develop and implement plans to identify and mitigate impediments to efficient patient flow throughout the hospital".

Developing processes and procedures that can improve patient flow in EDs, improve efficiency and reduce crowding is in all parties interests.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Triaged as stage 3 or more (less acute)

排除标准

  • Triaged as stage 2 or less (more acute), AND arriving for purposes of forensic/criminal evaluations

结局指标

主要结局

elapsed time in Emergency Department

时间窗: elapsed time in the Emergency Department is measured from the point a patient enters until they leave

it is hypothesized patients hydrated via Subcutaneous Recombinant Human Hyaluronidase will progress to discharge from the emergency department faster then will patients hydrated via I.V.

次要结局

未报告次要终点

研究者

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

John Fontanesi

Professor

University of California, San Diego

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