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临床试验/NCT00311831
NCT00311831已完成3 期

The Implementation of a Gastroenteritis Education Program

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2006年3月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
105
试验地点
2
主要终点
Change in parental knowledge as assessed on a gastroenteritis/dehydration questionnaire.

研究概览

简要总结

The purpose of this study is to determine whether the caregivers of children presenting to the emergency department (ED) with acute gastroenteritis who receive extensive gastroenteritis education (standard education plus home nursing visit) will improve their gastroenteritis knowledge more than those who receive standard education (an information sheet) in the emergency department.

详细描述

Worldwide, diarrhea remains a leading cause of childhood morbidity and mortality, with 2.5 million deaths estimated to occur annually among children < 5 years of age. In the United States, acute gastroenteritis accounts for > 1.5 million outpatient visits, 200,000 hospitalizations and approximately 300 deaths/year. The incidence of diarrhea varies between one and 2.5 episodes per child per year. In Ontario, children account for over 28,000 Emergency Department visits for gastroenteritis annually, and the pediatric admission rate for gastroenteritis remains greater than 400/100,000. In a Toronto based report from 1978, viral gastroenteritis was found as the etiologic agent in the deaths of 21 children over a 5 year period. Over 10% of patients seen at The Hospital for Sick Children ED present with acute gastroenteritis (vomiting, diarrhea or both). Last year over 4500 children with these complaints were seen.

It has been suggested that education can improve caregiver knowledge, beliefs and practices related to gastroenteritis. Children of caregivers who are less knowledgeable about diarrhea, dehydration and oral rehydration have been found to be at increased risk for presenting to a hospital secondary to dehydration.

However, it has been difficult to determine if this will translate into a reduction in non-urgent ED use. Very few studies have evaluated education in the ED. When it has been studied, they have been unsuccessful in altering ED utilization habits. One possible explanation for the lack of success is that some interventions have attempted to teach the parents while they were awaiting discharge. At that point in time, the parents are tired, distracted, and probably anxious to leave, thereby diminishing the effect of the intervention. Furthermore, providing patients with information handouts is not the optimal approach to achieve patient/parent education.

This study will compare two interventions for caregivers of children with gastroenteritis: extensive gastroenteritis education (standard education plus home nursing visit) and standard education in the emergency department(an information sheet). By adding on a home health nurse visit 12 to 36 hours later, we hope to achieve several benefits:

  1. Increased parental knowledge regarding gastroenteritis. This includes etiology and prevention, signs and symptoms of dehydration, when to seek care, the appropriate use of oral rehydration solutions, re-feeding, and the role of medications (or lack thereof).
  2. Increased parental knowledge will hopefully translate into reduced resource use. This may translate into improved use for other non-acute illnesses such as fever and colds. Improved resource use may include a reduction in ED visits and potentially even primary care provider use.
  3. This may also translate into improved patient outcomes by avoiding dehydration, decreasing transmission and seeking medications for the illness. Fewer ED visits may additionally translate into fewer investigations and intravenous requirements.

研究设计

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

入排标准

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

入选标准

  • Caregiver of a child aged 3 months to 4 years of age, presenting to the emergency department with a diagnosis of gastroenteritis, which may be manifested by vomiting, diarrhea, or both
  • Age > 16 years
  • Ability to speak and read English

排除标准

  • Do not live in the metropolitan Toronto area
  • Previously enrolled in this trial

研究组 & 干预措施

1

Active Comparator

干预措施: Standard gastroenteritis education (Behavioral)

2

Experimental

干预措施: Extensive gastroenteritis education (Behavioral)

结局指标

主要结局

Change in parental knowledge as assessed on a gastroenteritis/dehydration questionnaire.

时间窗: This will be completed on day 1, at 1 month, at 6 months, and at 12 months

次要结局

  • Mean score on the caregiver gastroenteritis questionnaire (CGQ)(One year)
  • Number of repeat ED visits for the specific diagnoses of "gastroenteritis", "diarrhea", "vomiting" or "dehydration"(One year)

研究者

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

Stephen Freedman

Adjunct Scientist

The Hospital for Sick Children

研究点 (2)

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