Pediatric ReadinessNCT06257524
Pediatric Readiness Intervention in Manitoba
A study testing Education and training in people with Pediatric Readiness, run by University of Manitoba at 1 site in Canada.
Trial summary
The goal of this clinical trial is to improve emergency care of children in Manitoba by increasing the weighted pediatric readiness scores (WPRS) of the general EDs through the implementation of provincially derived interventional measures (PDIM). Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Readiness
- What is being tested?
- Education and training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2022to 31 May 2025
- Phase
- Interventional
- 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 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- General ED located in Manitoba
- Offering emergency care to children aged 0-18 years during the study period
- Participated in the baseline evaluation of WPRS of the general EDs in Manitoba in 2019-2021
Who cannot join
- General EDs not providing emergency care to children aged 0-18 years during the study period.
- General EDs with no baseline WPRS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Pediatric Readiness of Emergency Departments in Manitoba, Canada: a Randomized Controlled Trial and Survey Sampling
The goal of this clinical trial is to improve emergency care of children in Manitoba by increasing the weighted pediatric readiness scores (WPRS) of the general EDs through the implementation of provincially derived interventional measures (PDIM). Investigators want to test the effects of PDIM on the general EDs in Manitoba. The main questions it aims to answer are:
- What is the magnitude and direction of the effect of implementing PDIM on baseline WPRS of the general EDs, if any?
- Which implementation strategies effectively support the full incorporation of PDIM to increase the WPRS of general EDs across Manitoba? The participating general EDs will be asked to
- Gather individuals providing emergency care in their centers for training and education around PDIM.
- Select a lead person who will act as the general ED Champion.
Read the detailed description
Description Investigators defined the inclusion and exclusion criteria using the PICO framework. They will implement a prospective single-blinded RCT involving 17 gEDs. The entire study will be coordinated at the Children's Hospital Research Institute of Manitoba. Investigators will assess for compliance in a scheduled pattern after the education and training sessions using a checklist. They will also sample all the 17 gEDs via RedCap link, post intervention.
PDIM is composed of 3 components. (1) Customized report to the gEDs and discussion with the gEDs on the gaps identified (1.5hrs/session x 2). (2) Pediatric resource toolkits availability via Translating Emergency Knowledge for Kids (TREKK). (3) Ongoing interactions, and intensive training (2.5hrs/session x 1) and education sessions. The gEDs in the control group will receive only the first component of the 3 components of PDIM.
Randomization Investigators have completed the randomization of anonymized 17 of the 28 gEDs. Randomization was performed using an R statistical software program into intervention (n=9) versus control (n=8), in a ratio of 1:1 within pairs. The gEDs were paired using a hierarchical cluster analysis based on the baseline WPRS, ED volume and ED location.
Survey The validated survey (n/100) will collect information around the six domains of the gEDs post intervention including coordination of patient care, ED staffing and training, quality improvement, patient safety, policies and procedures, and availability of pediatric equipment/supplies.
Data management and statistical analysis Phase 1 Frequentist approach - The investigators will perform a meta-analysis to generate a forest plot showing the mean change in WPRS of gEDs with 95% CI. The association between the change in WPRS and types of intervention will be examined in random-effects models.
Phase 2 \& Phase 3 Frequentist approach - Investigators will perform a descriptive analysis on the baseline characteristics of participating gEDs. The difference in baseline characteristics of the gEDs between intervention and control groups will be assessed using Pearson χ2 or Fisher exact test for categorical data and t-test/Mann-Whitney U for continuous variables. The difference between the baseline WPRS and post intervention WPRS of the gEDs will be compared using paired-sample t-tests.
Bayesian approach - The intervention effect will be estimated using a vague prior called Cauchy, as will the other parameters in the fully Bayesian model. Investigators will report the posterior probability of a positive finding using a threshold effect size greater than 5, Pr(Effect > 0 | data), and also with an effect size greater than 7, Pr(Effect > 7 | data).
Sample size estimation - Investigators assumed an optimistic prior for the intervention effect to be a Cauchy distribution centered at 10, representing 80% certainty that the effect size is between 7 and 10.
Significance of research:
Implementing PDIM will help address the gaps identified in the gEDs in Manitoba. This study has the potential of increasing overall WPRS, which has been shown to have a strong inverse correlation with pediatric mortality. It will improve acute care for children regardless of the location of the gED in Manitoba.
- Conditions
- Pediatric Readiness
- Being tested
- Education and training
- Keywords
- Pediatric readiness, emergency department, Manitoba, RCT
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and trainingOther
Pediatric resource toolkits availability via TREKK for Kids Ongoing interactions, and intensive training and education sessions
| Study group | Role | What they receive |
|---|---|---|
| PDIM component 1, 2, and 3 | Experimental | Intervention component 2 to be tested. Pediatric resources toolkits availability via Translating Emergency Knowledge for Kids network (TREKK). Investigators will provide resource toolkits to support clinical care in pediatric sepsis, seizure, diabetes ketoacidosis, dehydration, hypovolemic shock, and respiratory conditions.
Intervention component 3 to be tested: Ongoing interactions, and intensive training and education sessions. Investigators will hold training and education sessions at the sites. These will include (a) One on-site training (for 4-4.5 hours) with simulation sessions. Receives: Other: Education and training |
| PDIM component 1 | Active comparator | Customized report to the general EDs and discussion with the general EDs on the gaps identified. Investigators will discuss customized baseline WPRS with each general ED, including implications of the gaps identified relative to their local context and the general ED priorities (1.5hrs/session x 2). Receives: Other: Education and training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted Pediatric Readiness Scores
To be measured using the Manitoba Pediatric Readiness Initiative for Emergency department Survey
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start2 Oct 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ReadinessStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation, Children's Hospital Research Institute of Manitoba, AstraZeneca
- Responsible party
- Principal investigator, Alex Aregbesola, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257524
- Sponsor's protocol ID
- HS25688 (H2022:305)
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pediatric Readiness of Emergency Departments in Manitoba, Canada: a Randomized Controlled Trial and Survey Sampling
- ClinicalTrials.gov ID
- NCT06257524
- Acronym / sponsor ID
- HS25688 (H2022:305)
- Conditions
- Pediatric Readiness
- Keywords
- Pediatric readiness, emergency department, Manitoba, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation, Children's Hospital Research Institute of Manitoba, AstraZeneca
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 14 Feb 2024 (actual)
- 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 goal of this clinical trial is to improve emergency care of children in Manitoba by increasing the weighted pediatric readiness scores (WPRS) of the general EDs through the implementation of provincially derived interventional measures (PDIM). Investigators want to test the effects of PDIM on the general EDs in Manitoba. The main questions it aims to answer are:
- What is the magnitude and direction of the effect of implementing PDIM on baseline WPRS of the general EDs, if any?
- Which implementation strategies effectively support the full incorporation of PDIM to increase the WPRS of general EDs across Manitoba? The participating general EDs will be asked to
- Gather individuals providing emergency care in their centers for training and education around PDIM.
- Select a lead person who will act as the general ED Champion.
Detailed description
Description Investigators defined the inclusion and exclusion criteria using the PICO framework. They will implement a prospective single-blinded RCT involving 17 gEDs. The entire study will be coordinated at the Children's Hospital Research Institute of Manitoba. Investigators will assess for compliance in a scheduled pattern after the education and training sessions using a checklist. They will also sample all the 17 gEDs via RedCap link, post intervention.
PDIM is composed of 3 components. (1) Customized report to the gEDs and discussion with the gEDs on the gaps identified (1.5hrs/session x 2). (2) Pediatric resource toolkits availability via Translating Emergency Knowledge for Kids (TREKK). (3) Ongoing interactions, and intensive training (2.5hrs/session x 1) and education sessions. The gEDs in the control group will receive only the first component of the 3 components of PDIM.
Randomization Investigators have completed the randomization of anonymized 17 of the 28 gEDs. Randomization was performed using an R statistical software program into intervention (n=9) versus control (n=8), in a ratio of 1:1 within pairs. The gEDs were paired using a hierarchical cluster analysis based on the baseline WPRS, ED volume and ED location.
Survey The validated survey (n/100) will collect information around the six domains of the gEDs post intervention including coordination of patient care, ED staffing and training, quality improvement, patient safety, policies and procedures, and availability of pediatric equipment/supplies.
Data management and statistical analysis Phase 1 Frequentist approach - The investigators will perform a meta-analysis to generate a forest plot showing the mean change in WPRS of gEDs with 95% CI. The association between the change in WPRS and types of intervention will be examined in random-effects models.
Phase 2 \& Phase 3 Frequentist approach - Investigators will perform a descriptive analysis on the baseline characteristics of participating gEDs. The difference in baseline characteristics of the gEDs between intervention and control groups will be assessed using Pearson χ2 or Fisher exact test for categorical data and t-test/Mann-Whitney U for continuous variables. The difference between the baseline WPRS and post intervention WPRS of the gEDs will be compared using paired-sample t-tests.
Bayesian approach - The intervention effect will be estimated using a vague prior called Cauchy, as will the other parameters in the fully Bayesian model. Investigators will report the posterior probability of a positive finding using a threshold effect size greater than 5, Pr(Effect > 0 | data), and also with an effect size greater than 7, Pr(Effect > 7 | data).
Sample size estimation - Investigators assumed an optimistic prior for the intervention effect to be a Cauchy distribution centered at 10, representing 80% certainty that the effect size is between 7 and 10.
Significance of research:
Implementing PDIM will help address the gaps identified in the gEDs in Manitoba. This study has the potential of increasing overall WPRS, which has been shown to have a strong inverse correlation with pediatric mortality. It will improve acute care for children regardless of the location of the gED in Manitoba.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDIM component 1, 2, and 3 | Experimental | Other: Education and trainingIntervention component 2 to be tested. Pediatric resources toolkits availability via Translating Emergency Knowledge for Kids network (TREKK). Investigators will provide resource toolkits to support clinical care in pediatric sepsis, seizure, diabetes ketoacidosis, dehydration, hypovolemic shock, and respiratory conditions. Intervention component 3 to be tested: Ongoing interactions, and intensive training and education sessions. Investigators will hold training and education sessions at the sites. These will include (a) One on-site training (for 4-4.5 hours) with simulation sessions. |
| PDIM component 1 | Active comparator | Other: Education and trainingCustomized report to the general EDs and discussion with the general EDs on the gaps identified. Investigators will discuss customized baseline WPRS with each general ED, including implications of the gaps identified relative to their local context and the general ED priorities (1.5hrs/session x 2). |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- General ED located in Manitoba
- Offering emergency care to children aged 0-18 years during the study period
- Participated in the baseline evaluation of WPRS of the general EDs in Manitoba in 2019-2021
Key exclusion criteria (2 listed)
- General EDs not providing emergency care to children aged 0-18 years during the study period.
- General EDs with no baseline WPRS
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 |
|---|---|---|
| Education and trainingPediatric resource toolkits availability via TREKK for Kids Ongoing interactions, and intensive training and education sessions | Other | PDIM component 1, PDIM component 1, 2, and 3 |
Primary outcome
Weighted Pediatric Readiness Scores
Time frame: 9 months
To be measured using the Manitoba Pediatric Readiness Initiative for Emergency department Survey
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 13 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and training in people with Pediatric Readiness, run by University of Manitoba 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 13 Jun 2025. 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.
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?
Weighted Pediatric Readiness Scores (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.