The Implementation of a Gastroenteritis Education Program
Primary Purpose
Gastroenteritis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Standard gastroenteritis education
Extensive gastroenteritis education
Sponsored by
About this trial
This is an interventional other trial for Gastroenteritis focused on measuring Pediatrics, Gastroenteritis, Education
Eligibility Criteria
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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Change in parental knowledge as assessed on a gastroenteritis/dehydration questionnaire.
Secondary Outcome Measures
Mean score on the caregiver gastroenteritis questionnaire (CGQ)
Number of repeat ED visits for the specific diagnoses of "gastroenteritis", "diarrhea", "vomiting" or "dehydration"
Full Information
NCT ID
NCT00311831
First Posted
April 4, 2006
Last Updated
April 16, 2018
Sponsor
The Hospital for Sick Children
Collaborators
Paediatric Consultants Educational Research Grant
1. Study Identification
Unique Protocol Identification Number
NCT00311831
Brief Title
The Implementation of a Gastroenteritis Education Program
Official Title
The Implementation of a Gastroenteritis Education Program
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Paediatric Consultants Educational Research Grant
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
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).
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
Pediatrics, Gastroenteritis, Education
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Standard gastroenteritis education
Intervention Description
Subjects in this arm of the study will receive an educational handout on gastroenteritis education.
Intervention Type
Behavioral
Intervention Name(s)
Extensive gastroenteritis education
Intervention Description
Subjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mean score on the caregiver gastroenteritis questionnaire (CGQ)
Time Frame
One year
Title
Number of repeat ED visits for the specific diagnoses of "gastroenteritis", "diarrhea", "vomiting" or "dehydration"
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B Freedman, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20825796
Citation
Freedman SB, Couto M, Spooner L, Haladyn JK. The implementation of a gastroenteritis education program. Am J Emerg Med. 2011 Mar;29(3):271-7. doi: 10.1016/j.ajem.2009.09.032. Epub 2010 Mar 26.
Results Reference
derived
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The Implementation of a Gastroenteritis Education Program
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