Vaccination Coverage Amongst Children/Young People Attending the PED

December 10, 2021 updated by: Rachel Isba, Lancaster University

Do Children and Young People Attending the Paediatric Emergency Department Have Lower Levels of Vaccination Coverage Than Their Peers in the Local General Population?

In the United Kingdom (UK), most childhood vaccinations are given in the community, although uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance offers an opportunity to check the vaccination status of children and young people (CYP) and all parents/carers should be asked about this routinely. Those not up-to-date with vaccinations could then be signposted to existing services or perhaps offered a vaccine in the PED.

CYP attending the PED may also have lower vaccination coverage than their peers, so may benefit even more from interventions to increase uptake. However, recall by parents/carers is not always sufficiently accurate to identify those who have not yet received all their age-appropriate vaccinations. The most complete record of an individual's vaccination history is held within their primary care records. However, these records are often in a separate computer system that is inaccessible from the hospital's main computer system, although some information (including vaccination) may be accessed from within the hospital via a third system.

This study aims to see if CYP attending the PED are under-vaccinated compared to their peers and assess the accuracy of parent/carer recall. The results of this study will then be used to inform recommendations for developing better ways to access accurate vaccination data during a PED consultation. If such a system existed, under-vaccinated children could be identified routinely during an attendance, and an intervention offered if appropriate. This would be particularly useful if there was an outbreak of a vaccine-preventable disease such measles.

All CYP (< 16 years old) attending a PED in a district general hospital in Manchester will be invited to participate. CYP/their parent/carer will be asked to provide consent for their vaccination records to be accessed as well as being asked if the child/young person is up-to-date with all their vaccinations. Approximately 1000 participants will be enrolled.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2693

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M8 5RB
        • Paediatric Emergency Department, North Manchester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and young people accessing PED

Description

Inclusion Criteria:

  • attending the study site PED; under the age of 16 at the time of attendance; able to give consent or accompanied by someone able to give consent

Exclusion Criteria:

  • life threatening illness or injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Attendees at Paediatric Emergency Department 1 (PED1)

These participants will be recruited from the children and young people (under the age of 16) attending the PED of a large district general hospital.

There was going to be a second group recruited but COVID meant that the site was not able to support non-COVID studies by the time the necessary approvals were in place.

Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of children/young people attending the PED who have received all of their age-appropriate vaccinations.
Time Frame: Through study completion (estimated one year)
The % of children and young people attending the PED who have received all of their age-appropriate vaccinations will be compared to their peers in the local general population.
Through study completion (estimated one year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of parent/carer recall of the vaccination status of children/young people attending the PED.
Time Frame: Through study completion (estimated one year)
The accuracy of parent/carer recall of the vaccination status of children/young people attending the PED will be made by comparing their responses to electronic community records.
Through study completion (estimated one year)
Percentage of children attending the PED who have received two doses of MMR by the age of 5 years.
Time Frame: Through study completion (estimated one year)
The % of children attending the PED who have received two doses of the Measles, Mumps, and Rubella vaccine (MMR) by the age of 5 years will be compared to their peers in the local general population.
Through study completion (estimated one year)
Percentage of children attending the PED who have received at least one dose of MMR by the age of 2 years.
Time Frame: Through study completion (estimated one year)
The % of children attending the PED who have received at least one dose of MMR by the age of 2 years will be compared to their peers in the local general population.
Through study completion (estimated one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 30, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Results of study intended to be published in an open access journal within a year of completion of analysis of data.

Anonymised data will be shared under certain circumstances; no patient-identifiable data will be available to other researchers.

IPD Sharing Access Criteria

Anonymised data will be made available following reasonable request.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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