Refining and Testing the Diagnostic Accuracy of PAT-POPS | NCT03494998

Studies
Refining and Testing the Diagnostic Accuracy of PAT-POPS

NCT03494998

Sponsor

Pennine Acute Hospitals NHS Trust

Status

Unknown status

Last Update Posted

Apr 11, 2018Actual

Enrollment

80,000Estimated

Phase

Not provided

Conditions

Pediatric ALL

Interventions

PAT-POPS

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2018Actual

Primary Completion Date

Jan 31, 2019Estimated

Completion Date

Jan 31, 2019Estimated

First Submitted Date

Feb 26, 2018

First Submission Date that Met QC Criteria

Apr 10, 2018

First Posted Date

Apr 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2018

Last Update Posted Date

Apr 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew Rowland, Consultant in Paediatric Emergency Medicine, Pennine Acute Hospitals NHS TrustPrincipal Investigator

Lead Sponsor

Pennine Acute Hospitals NHS TrustOTHER

Collaborators

Name	Class
University Hospitals, Leicester	OTHER
University of Salford	OTHER
University of Manchester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children and young people		Aged 0-16 years	Diagnostic Test: PAT-POPS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PAT-POPS	Diagnostic Test	Emergency Department-specific screening tool	Children and young people

Measure	Description	Time Frame
Admission or discharge		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children and young people aged 0-16 years of age who attend the Emergency Department

Exclusion Criteria:

Patients who are confirmed dead on arrival at the Emergency Department
Patients who attend the Emergency Department in cardio-respiratory arrest

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fairfield General Hospital	Recruiting	Bury		BL9 7TD	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided