International Big Data Centre in Emergency Medicine

February 21, 2023 updated by: Abdelouahab Bellou, Guangdong Provincial People's Hospital

Institute of Sciences in Emergency Medicine - International Big Data Centre in Emergency Medicine

This observational study aims to use electronic health records to build an International Big Data Centre in Emergency Medicine, within the Institute of Sciences in Emergency Medicine (ISEM) at the Guangdong Provincial People's Hospital. The main questions it seeks to answer are not limited to the following:

  • Identify the relationship between Emergency Department Length of Stay (EDLOS), Mortality, and Adverse Events (AE)
  • Identify the risk factors associated with high mortality and AE rate among patients who experience prolonged EDLOS
  • Other research questions related to emergency medicine, such as building prediction and cluster models for acute diseases

Study Overview

Status

Recruiting

Conditions

Detailed Description

The relationship between the emergency department length-of-stay (EDLOS), mortality, and adverse events (AE) rate remains unclear and underestimated. EDLOS is the time elapsed between the time of arrival and the time of the release of a patient admitted to ED. Mortality is defined as short-term (14 hours, 48 hours, 7 days, 15 days) and 30 days death of patients managed in the ED discharged or admitted. An AE is an event that can result whether from medical mismanagement or happen by accident and causes physical and mental harm to the patient during the stay and remains after leaving. To separate the mismanagement from accidental causes i.e., compliant management but the unfortunate situation or persons, this study will refer to indicators that are objectively measurable and can be compared at different times throughout the patient's stay in the ED.

The hypothesis is that a prolonged stay of the patients in the ED especially without diagnosis or decision of admission is associated with increased mortality and AEs. This project will test this hypothesis through a prospective international multicenter study in contributing to whether a prolonged EDLOS is associated with an increased rate of adverse outcomes.

Study Type

Observational

Enrollment (Anticipated)

500000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be everybody who visited the Emergency Department.

Description

Inclusion Criteria:

  • Every patient who ever visited Emergency Department from 2011-2022

Exclusion Criteria:

  • Patients with missing demographic (age, gender, etc.) and triage data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
All ED Patient
All patients visited the emergency department during the period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Mortality
Time Frame: From date of ED triage until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month
IHM
From date of ED triage until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: From date of ED triage until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month
AE
From date of ED triage until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Abdelouahab Bellou, MD, PhD, MSc, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 13, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-N-2022-105-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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