NCT04485624

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,693

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

July 15, 2020

Last Update Submit

December 10, 2021

Conditions

Keywords

VaccinationImmunisationOpportunisticChildYoung personPaediatric Emergency Department

Outcome Measures

Primary Outcomes (1)

  • Percentage of children/young people attending the PED who have received all of their age-appropriate vaccinations.

    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 Outcomes (3)

  • Accuracy of parent/carer recall of the vaccination status of children/young people attending the PED.

    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.

    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.

    Through study completion (estimated one year)

Study Arms (1)

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.

Other: No intervention

Interventions

Observational study

Attendees at Paediatric Emergency Department 1 (PED1)

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children and young people accessing PED

You may qualify if:

  • 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

You may not qualify if:

  • life threatening illness or injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paediatric Emergency Department, North Manchester General Hospital

Manchester, Greater Manchester, M8 5RB, United Kingdom

Location

Related Publications (1)

  • Isba R, Brennan L, Egboko F, Edge R, Davies N, Knight J. Unmet vaccination need among children under the age of five attending the paediatric emergency department: a cross-sectional study in a large UK district general hospital. BMJ Open. 2023 Jun 26;13(6):e072053. doi: 10.1136/bmjopen-2023-072053.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Consultant in Paediatric Public Health Medicine

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 24, 2020

Study Start

January 24, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

December 30, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
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.
Access Criteria
Anonymised data will be made available following reasonable request.

Locations