NCT03234777

Brief Summary

Diarrhea and vomiting in children is a common reason to visit the emergency department. There has been a lot of research on how best to treat children with diarrhea and vomiting who visit the emergency department; however, the care children receive varies by healthcare provider and across hospitals. Additionally, there are things parents can do at home to help manage childhood diarrhea and vomiting and potentially avoid a trip to the emergency department. This shows an urgent need for knowledge translation, that is, efforts to align research knowledge and healthcare practice. Actively involving parents in healthcare decisions has the potential to bridge this gap; however, there is little research on the best ways to communicate complex health information to parents of sick kids. In 2013, a national needs assessment was conducted with parents seeking care for their kids in general emergency departments (trekk.ca). This survey showed that 39% of parents looked for information about their child's health prior to coming to the emergency department and that 44% of these parents looked for this information on the internet. This means that the development and evaluation of digital tools to give parents timely and effective child health information has the potential to reduce unnecessary emergency department visits, empower parents in health decision-making, and ultimately improve child health outcomes. In this project, parents will be actively involved in the evaluation of a digital tool, a whiteboard animation video, designed to communicate the best research evidence on the treatment and management of vomiting and diarrhea in children. In this pilot trial, parents in two emergency departments will be randomized to view the video or a sham video, and then provide quantitative and qualitative data on the potential effectiveness of the video, the perceived benefit and value of the knowledge translation intervention for pediatric vomiting and diarrhea, the feasibility of using iPads and an electronic data collection platform to conduct research with this population, the time required to complete data collection, and parents' willingness to participate in future, similar research.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2018

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

July 17, 2017

Last Update Submit

November 8, 2019

Conditions

Acute GastroenteritisPediatric ALLKnowledge Translation

Outcome Measures

Primary Outcomes (4)

  • knowledge questionnaire

    Measure 1 (quantitative) of potential effectiveness of the knowledge translation intervention

    0-14 days (x3)

  • Decision Regret Scale

    Measure 2 (quantitative) of potential effectiveness of the knowledge translation intervention

    0-14 days (x3)

  • Health care utilization

    Measure 3 (quantitative) of potential effectiveness of the knowledge translation intervention

    4-14 days

  • Perceived benefit and value of the knowledge translation intervention for pediatric AGE

    Measure 4 (qualitative) of potential effectiveness of the knowledge translation intervention

    0-14 days (x2) and qualitative interview (experimental group only) after post-intervention 2 questionnaire

Secondary Outcomes (9)

  • Consent rate

    3 months

  • Recruitment rate

    3 months

  • Data completion rate

    3 months

  • Satisfaction with electronic platform

    Assessed during qualitative interview (experimental group only) after post-intervention 2 questionnaire

  • Time (minutes) to complete study forms

    0-14 days

  • +4 more secondary outcomes

Study Arms (2)

Whiteboard animation video

EXPERIMENTAL

3 minute video on treatment, management of pediatric acute gastroenteritis

Behavioral: Whiteboard animation video

Regular video

SHAM COMPARATOR

3 minute video on hand washing for infection control

Behavioral: Regular video

Interventions

Whiteboard animation videoBEHAVIORAL

Developed via qualitative research with parents of children with acute gastroenteritis.

Whiteboard animation video
Regular videoBEHAVIORAL

Developed by CDC

Regular video

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent or caregiver of a child 16 years old or younger
  • Child is presenting to the ED with vomiting and diarrhea
  • Parent is fluent in English
  • Parent is willing to be contacted for follow-up data collection

You may not qualify if:

  • Child has significant chronic gastrointestinal problem or inflammatory bowel disease (i.e., Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis, chronic constipation)
  • Child is taking immunosuppressive therapy or known history of immunodeficiency
  • Child has undergone oral or gastrointestinal surgery within the preceding 7 days
  • Child has had a prior visit to ED for vomiting and diarrhea within the preceding 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Related Publications (2)

  • Hartling L, Elliott SA, Munan M, Scott SD. Web-Based Knowledge Translation Tool About Pediatric Acute Gastroenteritis for Parents: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 May 25;7:e45276. doi: 10.2196/45276.

    PMID: 37227758DERIVED

  • Albrecht L, Scott SD, Hartling L. Evaluating a knowledge translation tool for parents about pediatric acute gastroenteritis: a pilot randomized trial. Pilot Feasibility Stud. 2018 Aug 2;4:131. doi: 10.1186/s40814-018-0318-0. eCollection 2018.

    PMID: 30123522DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Andre Grace, PhD

    University of Alberta (Supervisor)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 31, 2017

Study Start

November 30, 2017

Primary Completion

March 10, 2018

Study Completion

March 10, 2018

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)