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The Implementation of a Gastroenteritis Education Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00311831
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Gastroenteritis Behavioral: Standard gastroenteritis education Behavioral: Extensive gastroenteritis education Phase 3

Detailed Description:

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.

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: The Implementation of a Gastroenteritis Education Program
Study Start Date : March 2006
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1 Behavioral: Standard gastroenteritis education
Subjects in this arm of the study will receive an educational handout on gastroenteritis education.
Experimental: 2 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.

Outcome Measures

Primary Outcome Measures :
  1. Change in parental knowledge as assessed on a gastroenteritis/dehydration questionnaire. [ Time Frame: This will be completed on day 1, at 1 month, at 6 months, and at 12 months ]

Secondary Outcome Measures :
  1. Mean score on the caregiver gastroenteritis questionnaire (CGQ) [ Time Frame: One year ]
  2. Number of repeat ED visits for the specific diagnoses of "gastroenteritis", "diarrhea", "vomiting" or "dehydration" [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311831

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Paediatric Consultants Educational Research Grant
Principal Investigator: Stephen B Freedman, MD The Hospital for Sick Children, Toronto Canada
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Freedman, Adjunct Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00311831     History of Changes
Other Study ID Numbers: 1000008727
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Stephen Freedman, The Hospital for Sick Children:

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases