COVID-19 Impact on the Lombardy Region's Emergency System

Covid19 Clinical Trial

Official title:

Tsunami Project - Description and Prediction of COVID-19 Impact on the Lombardy Region's Emergency System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669925
• Other study ID #: Tsunami
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: January 15, 2022

Study information

• Verified date: December 2021
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study has 3 main goals:

• to quantitavely describe the Covid-19 impact on the organization and functioning of the Lombardy's emergency system;

• to create statistical model able to predict the flow of patients to the emergency room during the epidemic period and their destination (ex: discharge, hospitalization, death);

• to value the impact on the non Covid-19 patients, both for their possibility to receive medical treatment and as an outcome on their health

Description:

The aim of this study is to evaluate the impact that Covid-19 had on the Emergency System of Lombardy. For instance, it affected the job organization and the possibility of responding to general health needs.

First of all, the study will consider the calls to the Emergency Medical Service, the number of accesses to the Emergency Department, the waiting time before hospitalization, the ED output home (discharge, hospitalization, death, self-discharge before the end of the visit).

Secondly, a statistical model will be implemented, in order to predict the number of patients in need of hospitalization for each day during the pandemic period. This model could help the re-organization of the hospital itself in case of a new Covid-19 outbreak.

Finally, it will evaluate the impact on non-Covid patients, to see the difference in the mortality trends and their possiblity to be cured in a proper way.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: January 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18y

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Emergencies

Locations

Country	Name	City	State
Italy	Ospedale Papa Giovanni XXIII	Bergamo
Italy	Presidio Ospedaliero di Lodi	Lodi
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan
Italy	Ospedale San Carlo Borromeo	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily calls to the Emergency System	The number of calls to the Lombardy Emergency System will be evaluated daily during the study period	jan 2020 - dec 2020
Primary	Daily count of Emergency Department visits	The number of people accessing to each ED will be evaluated daily	jan 2020 - dec 2020
Primary	Daily average boarding time	The average time between the end of the ED visit and the hospital admission will be measured daily	jan 2020 - dec 2020
Primary	Outcome at ED discharge	Distribution of the ED outcome (home discharge, hospitalization, death, self-discharge before the end of the visit)	jan 2020 - dec 2020
Primary	Mortality	Daily mortality for any cause	jan 2020 - dec 2020