Development and Validation of a Regional Multi-scale Syst... | NCT03051737

Status Module

Record Verification Date

Mar 2022

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

Jun 1, 2021Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Feb 6, 2017

First Submission Date that Met QC Criteria

Feb 9, 2017

First Posted Date

Feb 14, 2017Actual

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

Mar 21, 2022

Last Update Posted Date

Mar 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective of this retrospective study is to validate a prediction system of emergencies department (ED) attendance on a wide range of time and the need for hospitalization, at various levels of perimeter (with all emergency departments or one ED in particular), with all patients or with one sub-group of patients (age, gravity, care).

Detailed Description

As secondary objectives, the study aims:

to measure the influence of different factors as environmental or structural and to identify the modifiable factors, then to allow us to test by simulation, impact of various interventions (for example: opening of hospitals and reinforcement of ED teams) on arrival flows or regenerated tension inside ED teams.
to study the relation between the flows (arrival patients, hospitalized patients) and the time of ED visit or the indicators of tension of ED team.
Typology of ED in the region of Paris permitting afterward comparison the benchmarking type between similar structures.

This retrospective study will be performed on database: individual data in the region of Paris of summation of ED visits and data on the structures of health cares, as well as environmental data (principal given cares, weather, moves, circulations, pollution, strikes, vacations, etc.)

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

18,000,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction of emergency department visits	Calculated base on regional database: individual data of summation of ED visits in the region of Paris and structural data of health cares	throughout the study, an average of 18 months

Secondary Outcomes

Measure	Description	Time Frame
Prediction by age	By sub-group of child or senior	throughout the study, an average of 18 months
Prediction by lever of gravity		throughout the study, an average of 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects have been recorded as patients in emergency departments between 2010 and 2015.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adults or children who have been recorded as patients in emergency departments between 2010 and 2015 are all eligibles with unlimited number of care.

85 Health Facilities in Ile de France who have emergency departments will participate the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mathias WARGON, MD	Contact	+33 1 49 83 10 86		m.wargon@ch-bry.org

Overall Officials

Name	Affiliation	Role
Mathias WARGON, MD	Emergency Department - Bry sur Marne Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency Department - Bry sur Marne Hospital	Recruiting	Bry-sur-Marne	Val-de-Marne	94360	France

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

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms