Pediatric ALLNCT03494998
Refining and Testing the Diagnostic Accuracy of PAT-POPS
An observational study of Pediatric ALL, run by Pennine Acute Hospitals NHS Trust at 3 sites in United Kingdom.
Trial summary
Increasing attendances by children (aged 0-16 years) at UK emergency departments (EDs) is putting pressure on the National Health Service (NHS). Health professionals make complex judgements on whether children attending EDs can be sent home safely or require admission. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- PAT-POPS
- How many people
- 80,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 8 Feb 2018to 31 Jan 2019
- 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 Up to 16 years
- All sexes
- Child
Study population: The study is designed in such a way that all patients, within the age range, will be enrolled into the study upon arrival at the Emergency Department. Therefore, the study population will be recruited consecutively and data collection has been planned prospectively.
Who may be able to join
- Children and young people aged 0-16 years of age who attend the Emergency Department
Who cannot join
- Patients who are confirmed dead on arrival at the Emergency Department
- Patients who attend the Emergency Department in cardio-respiratory arrest
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Fairfield General Hospital
Bury, BL9 7TD
Samah Riaz, 016177882968, samah.riaz@pat.nhs.uk
- Recruiting
The Royal Oldham Hospital
Oldham, OL1 2JH
Samah Riaz, 016177882968, samah.riaz@pat.nhs.uk
- Recruiting
Rochdale Infirmary
Rochdale, OL12 2JH
Samah Riaz, 016177882968, samah.riaz@pat.nhs.uk
About this study
Official title: Refining and Testing the Diagnostic Accuracy of an Assessment Tool (PAT-POPS) to Predict Admission and Discharge of Children and Young People Who Attend an Emergency Department
Increasing attendances by children (aged 0-16 years) at UK emergency departments (EDs) is putting pressure on the National Health Service (NHS). Health professionals make complex judgements on whether children attending EDs can be sent home safely or require admission. The Pennine Acute Hospitals (PAT) Paediatric Observation Priority Score (PAT-POPS) was developed as an ED-specific screening tool for this purpose. A preliminary study showed it to be a potentially effective tool for deciding admission of children from the ED. Therefore, the focus of this study is to refine the original screening tool.
- Conditions
- Pediatric ALL
- Being tested
- PAT-POPS
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAT-POPSDiagnostic test
Emergency Department-specific screening tool
| Study group | Role | What they receive |
|---|---|---|
| Children and young people | Aged 0-16 years Receives: Diagnostic Test: PAT-POPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission or discharge
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start8 Feb 2018
- Primary completion31 Jan 2019 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies 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
- Prospective
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennine Acute Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, University of Salford, University of Manchester
- Responsible party
- Principal investigator, Andrew Rowland, Pennine Acute Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494998
- Sponsor's protocol ID
- 213469
- Status last verified
- Apr 2018
- First submitted
- 26 Feb 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining and Testing the Diagnostic Accuracy of an Assessment Tool (PAT-POPS) to Predict Admission and Discharge of Children and Young People Who Attend an Emergency Department
- ClinicalTrials.gov ID
- NCT03494998
- Acronym / sponsor ID
- 213469
- Conditions
- Pediatric ALL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80,000 participants (estimated)
- Lead sponsor
- Pennine Acute Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, University of Salford, University of Manchester
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 11 Apr 2018 (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.
Increasing attendances by children (aged 0-16 years) at UK emergency departments (EDs) is putting pressure on the National Health Service (NHS). Health professionals make complex judgements on whether children attending EDs can be sent home safely or require admission. The Pennine Acute Hospitals (PAT) Paediatric Observation Priority Score (PAT-POPS) was developed as an ED-specific screening tool for this purpose. A preliminary study showed it to be a potentially effective tool for deciding admission of children from the ED. Therefore, the focus of this study is to refine the original screening tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and young people | – | Diagnostic Test: PAT-POPSAged 0-16 years |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- The study is designed in such a way that all patients, within the age range, will be enrolled into the study upon arrival at the Emergency Department. Therefore, the study population will be recruited consecutively and data collection has been planned prospectively.
Key inclusion criteria (1 listed)
- Children and young people aged 0-16 years of age who attend the Emergency Department
Key exclusion criteria (2 listed)
- Patients who are confirmed dead on arrival at the Emergency Department
- Patients who attend the Emergency Department in cardio-respiratory arrest
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 |
|---|---|---|
| PAT-POPSEmergency Department-specific screening tool | Diagnostic test | Children and young people |
Primary outcome
Admission or discharge
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL, run by Pennine Acute Hospitals NHS Trust at 3 sites in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission or discharge (time frame: 12 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 11 Apr 2018.