EmergenciesNCT04893122
Impact of Pandemic of Presentation to Emergency Department and Admissions
An observational study of Emergencies, run by University of Southampton.
Trial summary
Observational study assessing the impact of the COVID-19 pandemic on presentations and admission to hospital in children and young adults. Read more about this study
- Who is it for?
- Ages 0 years to 24 hours
- Conditions the study is for
- Emergencies
- What is being tested?
- COVID-19 pandemic
- How many people
- 166,459 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 31 Mar 2021
- Phase
- Observational
- 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 years to 24 hours
- All sexes
- No healthy volunteers
- Child
Study population: Children and young adults aged 0 to 24 years who have presented +/- admitted to the emergency department at University Hospital Southampton NHS Foundation Trust between the 1st of April 2016 and 31st of March 2021. Some children presented to paediatric assessment unit prior to September 2019; after that the patient pathway was merged with the emergency department.
Who may be able to join
- Children and young adults aged 0 to 24 years
- Presented +/- admitted to the emergency department at University Hospital Southampton NHS Foundation Trust between the 1st of April 2016 and 31st of March 2021
Who cannot join
None listed.
About this study
Official title: Impact of the COVID-19 Pandemic on Emergency Department Attendances and Admissions in Southampton for Children and Young Adults
Observational study assessing the impact of the COVID-19 pandemic on presentations and admission to hospital in children and young adults.
Read the detailed description
The COVID-19 pandemic has had a major impact on healthcare utilisation and delivery for children and young adults. This is despite these groups experiencing minimal morbidity and almost no mortality as a direct result of the pandemic. The immediate impact of the first lockdown in April 2020 has been well documented. A number of studies show a marked reduction in presentations of children and young adults to the emergency department.
The question is now, are these trends continuing and are they particularly impacting on specific groups and on specific presentations? With these data, services can be modified to minimise any potential for deleterious effects. It may also be possible to target groups who are not utilising health services as the investigators would expect.
The investigators will use fully anonymised routine data on presentations and admission of 0 to 24 years olds to University Hospital Southampton NHS Foundation Trust. Data will be graphed to show trends in activity before and after the start of the pandemic. An interrupted time series regression analysis will be used to assess the significance of any changes in trends.
- Conditions
- Emergencies
- Being tested
- COVID-19 pandemic
- Keywords
- emergencies, children, adolescents, young adult
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 pandemicOther
Study focuses on the impact of the COVID-19 pandemic on emergency attendances and admissions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance in emergency department or paediatric assessment unit
Attendance at the emergency department in Southampton defined as being booked onto the emergency department admission system.
Measured: 5 years from April 2016
Secondary outcomes (1)
Emergency admission to hospital
Admission to University Hospital Southampton NHS Foundation Trust defined as being in hospital for more than four hours. Participants will be divided into the same subgroups as per attendances.
Measured: 5 years from April 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Apr 2016
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 166,459 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893122
- Sponsor's protocol ID
- 63328
- Status last verified
- May 2022
- First submitted
- 14 May 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No ethics approval.
Publications
Solanke F, Easton S, Selby A, James D, Roberts G. Impact of COVID-19 pandemic on emergency department attendances for young people. Arch Dis Child. 2023 May 3;107(10):e1-e7. doi: 10.1136/archdischild-2021-323389.
PubMed 35551049
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on Emergency Department Attendances and Admissions in Southampton for Children and Young Adults
- ClinicalTrials.gov ID
- NCT04893122
- Acronym / sponsor ID
- 63328
- Conditions
- Emergencies
- Keywords
- emergencies, children, adolescents, young adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166,459 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 19 May 2021 (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.
Observational study assessing the impact of the COVID-19 pandemic on presentations and admission to hospital in children and young adults.
Detailed description
The COVID-19 pandemic has had a major impact on healthcare utilisation and delivery for children and young adults. This is despite these groups experiencing minimal morbidity and almost no mortality as a direct result of the pandemic. The immediate impact of the first lockdown in April 2020 has been well documented. A number of studies show a marked reduction in presentations of children and young adults to the emergency department.
The question is now, are these trends continuing and are they particularly impacting on specific groups and on specific presentations? With these data, services can be modified to minimise any potential for deleterious effects. It may also be possible to target groups who are not utilising health services as the investigators would expect.
The investigators will use fully anonymised routine data on presentations and admission of 0 to 24 years olds to University Hospital Southampton NHS Foundation Trust. Data will be graphed to show trends in activity before and after the start of the pandemic. An interrupted time series regression analysis will be used to assess the significance of any changes in trends.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 years to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and young adults aged 0 to 24 years who have presented +/- admitted to the emergency department at University Hospital Southampton NHS Foundation Trust between the 1st of April 2016 and 31st of March 2021. Some children presented to paediatric assessment unit prior to September 2019; after that the patient pathway was merged with the emergency department.
Key inclusion criteria (2 listed)
- Children and young adults aged 0 to 24 years
- Presented +/- admitted to the emergency department at University Hospital Southampton NHS Foundation Trust between the 1st of April 2016 and 31st of March 2021
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| COVID-19 pandemicStudy focuses on the impact of the COVID-19 pandemic on emergency attendances and admissions. | Other | – |
Primary outcome
Attendance in emergency department or paediatric assessment unit
Time frame: 5 years from April 2016
Attendance at the emergency department in Southampton defined as being booked onto the emergency department admission system.
1 secondary outcome
Emergency admission to hospital
Time frame: 5 years from April 2016
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 24 May 2022.
- Derived from this study: PubMed 35551049Solanke F, Easton S, Selby A, James D, Roberts G. Impact of COVID-19 pandemic on emergency department attendances for young people. Arch Dis Child. 2023 May 3;107(10):e1-e7. doi: 10.1136/archdischild-2021-323389.
- Individual participant dataSharing planned: No. No ethics approval.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by University of Southampton.
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 2 inclusion and 0 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Attendance in emergency department or paediatric assessment unit (time frame: 5 years from April 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893122, which also lists 1 linked publication.
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 24 May 2022.