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Sponsors and Collaborators: |
The Hospital for Sick Children Paediatric Consultants Educational Research Grant |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00311831 |
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.
Condition | Intervention | Phase |
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Gastroenteritis |
Behavioral: Standard gastroenteritis education Behavioral: Extensive gastroenteritis education |
Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Implementation of a Gastroenteritis Education Program |
Enrollment: | 105 |
Study Start Date: | March 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Behavioral: Standard gastroenteritis education
Subjects in this arm of the study will receive an educational handout on gastroenteritis education.
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2: Experimental |
Behavioral: Extensive gastroenteritis education
Subjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor.
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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:
Fewer ED visits may additionally translate into fewer investigations and intravenous requirements.
Thus we will compare improvement in caregiver knowledge of gastroenteritis and dehydration and number of emergency department visits at one year in the two treatment groups.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | Stephen B Freedman, MD | The Hospital for Sick Children, Toronto Canada |
Responsible Party: | The Hospital for Sick Children ( Stephen Freedman/Principal Investigator ) |
Study ID Numbers: | 1000008727 |
Study First Received: | April 4, 2006 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00311831 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Pediatrics Gastroenteritis Education |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |