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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

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:

  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.

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 groups in NCT00311831
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Behavioral: Standard gastroenteritis education
2ExperimentalNot described
Receives: Behavioral: Extensive gastroenteritis education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Mean score on the caregiver gastroenteritis questionnaire (CGQ)

    Measured: One year

  2. 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.

  1. First posted6 Apr 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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)
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

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.

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