GastroenteritisPhase 3NCT00311831
The Implementation of a Gastroenteritis Education Program
A Phase 3 study testing Standard gastroenteritis education and Extensive gastroenteritis education in people with Gastroenteritis, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Standard gastroenteritis education and Extensive gastroenteritis education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Do not live in the metropolitan Toronto area
- Previously enrolled in this trial
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gastroenteritis
- Being tested
- Standard gastroenteritis education, Extensive gastroenteritis education
- Keywords
- Pediatrics, Gastroenteritis, Education
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard gastroenteritis educationBehavioural
Subjects in this arm of the study will receive an educational handout on gastroenteritis education.
Extensive gastroenteritis educationBehavioural
Subjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: Standard gastroenteritis education |
| 2 | Experimental | Not described Receives: Behavioral: Extensive gastroenteritis education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parental knowledge as assessed on a gastroenteritis/dehydration questionnaire.
Measured: This will be completed on day 1, at 1 month, at 6 months, and at 12 months
Secondary outcomes (2)
Mean score on the caregiver gastroenteritis questionnaire (CGQ)
Measured: One year
Number of repeat ED visits for the specific diagnoses of "gastroenteritis", "diarrhea", "vomiting" or "dehydration"
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Paediatric Consultants Educational Research Grant
- Responsible party
- Principal investigator, Stephen Freedman, The Hospital for Sick Children
- Investigators
- Stephen B Freedman, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311831
- Sponsor's protocol ID
- 1000008727
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2006
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20825796
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of a Gastroenteritis Education Program
- ClinicalTrials.gov ID
- NCT00311831
- Acronym / sponsor ID
- 1000008727
- Conditions
- Gastroenteritis
- Keywords
- Pediatrics, Gastroenteritis, Education
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Paediatric Consultants Educational Research Grant
- Study start
- Mar 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Standard gastroenteritis education |
| 2 | Experimental | Behavioral: Extensive gastroenteritis education |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Do not live in the metropolitan Toronto area
- Previously enrolled in this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard gastroenteritis educationSubjects in this arm of the study will receive an educational handout on gastroenteritis education. | Behavioural | 1 |
| Extensive gastroenteritis educationSubjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor. | Behavioural | 2 |
Primary outcome
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
2 secondary outcomes
Mean score on the caregiver gastroenteritis questionnaire (CGQ)
Time frame: One year
Number of repeat ED visits for the specific diagnoses of "gastroenteritis", "diarrhea", "vomiting" or "dehydration"
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 20825796Freedman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen B Freedman, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard gastroenteritis education and Extensive gastroenteritis education in people with Gastroenteritis, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.