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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04485624
Other study ID # IRAS278815
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 24, 2021
Est. completion date November 30, 2021

Study information

Verified date December 2021
Source Lancaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2693
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
Observational study

Locations

Country Name City State
United Kingdom Paediatric Emergency Department, North Manchester General Hospital Manchester Greater Manchester

Sponsors (2)

Lead Sponsor Collaborator
Lancaster University Pennine Acute Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Accuracy of parent/carer recall of the vaccination status of children/young people attending the PED. 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)
Secondary Percentage of children attending the PED who have received two doses of MMR by the age of 5 years. 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)
Secondary Percentage of children attending the PED who have received at least one dose of MMR by the age of 2 years. 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)