Emergency Service, HospitalNCT04338672
The Impact of the Covid-19 Outbreak on Emergency Room Attendances of Surgical Patients
An observational study of Emergency Service, Hospital and General Surgery, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency Service, Hospital, General Surgery
- What is being tested?
- COVID-19 Pandemic
- How many people
- 10,000 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Apr 2020to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients aged >18 years old who attended the emergency department of Sheba Medical Center between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Who may be able to join
- All patients visiting the ER of Sheba Medical Center between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Who cannot join
- Patients less than 18 years of age
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Roi Anteby, MD, +972545882207, roi.anteby@sheba.health.gov.il
About this study
Official title: The Impact of the Coronavirus Disease 2019 (Covid-19) Outbreak on Emergency Room Attendances of Surgical Patients at a Tertiary Medical Center
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.
Read the detailed 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.
- Conditions
- Emergency Service, Hospital, General Surgery
- Being tested
- COVID-19 Pandemic
- Keywords
- Emergency, Surgery, Covid-19
- Medical subject headings
- Emergencies, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 PandemicOther
Exposure: the novel coronavirus disease (Covid-19) outbreak
| Study group | Role | What they receive |
|---|---|---|
| Pandemic Period | Patients who presented to the emergency department at our medical institute Sheba Medical Center between January 1 - March 31 in 2020. Receives: Other: COVID-19 Pandemic | |
| Pre Pandemic Period | Patients who presented to the emergency department at our medical institute Sheba Medical Center between January 1 - March 31 in the following years: 2017, 2018, 2019, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of emergency visits needing surgical consult
Measured: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
The ratio of severe presentations to non-severe presentations
Measured: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Secondary outcomes (2)
The impact of age on ED attendance rates
Measured: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Differences in ED surgical visits (in terms of capacity and severity) of surgical patients depending on the presentation and the co morbidity
Measured: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start5 Apr 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Emergency Service, HospitalStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338672
- Sponsor's protocol ID
- SMC-20-7078-YZ-CTIL
- Status last verified
- Apr 2020
- First submitted
- 4 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heiber M, Lou WY. Effect of the SARS outbreak on visits to a community hospital emergency department. CJEM. 2006 Sep;8(5):323-8. doi: 10.1017/s148180350001397x.
PubMed 17338843Chen 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. doi: 10.1097/00005650-200502000-00010.
PubMed 15655430Anteby R, Zager Y, Barash Y, Nadler R, Cordoba M, Klang E, Klein Y, Ram E, Gutman M, Horesh N. The Impact of the Coronavirus Disease 2019 Outbreak on the Attendance of Patients with Surgical Complaints at a Tertiary Hospital Emergency Department. J Laparoendosc Adv Surg Tech A. 2020 Sep;30(9):1001-1007. doi: 10.1089/lap.2020.0465. Epub 2020 Jun 23.
PubMed 32589496
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Coronavirus Disease 2019 (Covid-19) Outbreak on Emergency Room Attendances of Surgical Patients at a Tertiary Medical Center
- ClinicalTrials.gov ID
- NCT04338672
- Acronym / sponsor ID
- SMC-20-7078-YZ-CTIL
- Conditions
- Emergency Service, Hospital, General Surgery
- Keywords
- Emergency, Surgery, Covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pandemic Period | – | Other: COVID-19 PandemicPatients who presented to the emergency department at our medical institute Sheba Medical Center between January 1 - March 31 in 2020. |
| Pre Pandemic Period | – | –Patients who presented to the emergency department at our medical institute Sheba Medical Center between January 1 - March 31 in the following years: 2017, 2018, 2019, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged >18 years old who attended the emergency department of Sheba Medical Center between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Key inclusion criteria (1 listed)
- All patients visiting the ER of Sheba Medical Center between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Key exclusion criteria (1 listed)
- Patients less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 PandemicExposure: the novel coronavirus disease (Covid-19) outbreak | Other | Pandemic Period |
Primary outcome
Rates of emergency visits needing surgical consult
Time frame: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
The ratio of severe presentations to non-severe presentations
Time frame: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
2 secondary outcomes
The impact of age on ED attendance rates
Time frame: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Differences in ED surgical visits (in terms of capacity and severity) of surgical patients depending on the presentation and the co morbidity
Time frame: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 17338843Heiber M, Lou WY. Effect of the SARS outbreak on visits to a community hospital emergency department. CJEM. 2006 Sep;8(5):323-8. doi: 10.1017/s148180350001397x.
- Background: PubMed 15655430Chen 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. doi: 10.1097/00005650-200502000-00010.
- Derived from this study: PubMed 32589496Anteby R, Zager Y, Barash Y, Nadler R, Cordoba M, Klang E, Klein Y, Ram E, Gutman M, Horesh N. The Impact of the Coronavirus Disease 2019 Outbreak on the Attendance of Patients with Surgical Complaints at a Tertiary Hospital Emergency Department. J Laparoendosc Adv Surg Tech A. 2020 Sep;30(9):1001-1007. doi: 10.1089/lap.2020.0465. Epub 2020 Jun 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Service, Hospital and General Surgery, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roi Anteby, MD (19293011120, roi.anteby@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of emergency visits needing surgical consult (time frame: January 1 - March 31 in the following years: 2017, 2018, 2019, 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338672, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.