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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04338672
Other study ID # SMC-20-7078-YZ-CTIL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2020
Est. completion date April 1, 2022

Study information

Verified date April 2020
Source Sheba Medical Center
Contact Roi Anteby, MD
Phone 19293011120
Email roi.anteby@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since December 2019, when the novel coronavirus disease (Covid-19) spread throughout the world, data have been needed on the effects of the pandemic on various aspects of healthcare systems. Recommendations for social distancing and quarantine decrees made by local governments, alongside the general public fear from the spread of the virus, are presumed to have markedly affected the trends in hospitals visits. Understanding the exact nature of the effect is critical for better anticipating and preparing health systems in the event of future outbreaks and in the post outbreak period. Therefore we intend to To identify retrospectively all patients who presented to the emergency department at our medical institute between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020. We will examine the impact of COVID-19 on the rates of surgical emergency visits, ratio of surgical visits to non-surgical visits, the ratio of severe presentations to non-severe presentations, and the impact of age on ED attendance.


Description:

Since December 2019, when the novel coronavirus disease (Covid-19) spread throughout the world, data have been needed on the effects of the pandemic on various aspects of healthcare systems. Recommendations for social distancing and quarantine decrees made by local governments, alongside the general public fear from the spread of the virus, are presumed to have markedly affected the trends in hospitals visits. Understanding the exact nature of the effect is critical for better anticipating and preparing health systems in the event of future outbreaks and in the post outbreak period. Additionally, deferring hospitals visits can potentially put patients at increased risk for morbidity and mortality, especially in postsurgical patients. Evaluating the impact of the pandemic on patient volume can guide decision-making in future scenarios.

Previous infectious disease outbreaks have been shown to impact ED volumes: The US Hantavirus outbreak in 1993 led to a 2-fold increase in ED visits; Escherichia coli 0157:H7 outbreak in Washington state in 1993 increased ED visits by 17%; However, the 2003 SARS outbreaks in Hong Kong, Taiwan, and Toronto reduced tertiary care ED visits by up to 47 percent.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date April 1, 2022
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients visiting the ER of Sheba Medical Center between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020

Exclusion Criteria:

- Patients less than 18 years of age

Study Design


Related Conditions & MeSH terms


Intervention

Other:
COVID-19 Pandemic
Exposure: the novel coronavirus disease (Covid-19) outbreak

Locations

Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Chen WK, Cheng YC, Chung YT, Lin CC. The impact of the SARS outbreak on an urban emergency department in Taiwan. Med Care. 2005 Feb;43(2):168-72. — View Citation

Heiber M, Lou WY. Effect of the SARS outbreak on visits to a community hospital emergency department. CJEM. 2006 Sep;8(5):323-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of emergency visits needing surgical consult January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Primary The ratio of severe presentations to non-severe presentations January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Secondary The impact of age on ED attendance rates January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Secondary Differences in ED surgical visits (in terms of capacity and severity) of surgical patients depending on the presentation and the co morbidity January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
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