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| Name | Class |
|---|---|
| University of Turin, Italy | OTHER |
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Risk stratification of COVID-19 patients is essential to define their appropriate treatment setting. So far, available studies have focused on morbidity and mortality prediction in patients admitted to hospital. In the Emergency Department (ED), decision on home discharge versus hospital admission for COVID-19 is cumbersome. While facing a dramatic second wave of SARS-CoV-2, shortage of hospital beds has further increased the challenge.
The present study will prospectively evaluate the clinical outcomes of patients discharged from the ED. Stratification will be based on a composite of demographic, clinical and lung imaging variables. Results will be used to develop standardized decision rules for safe home discharge of patients with COVID-19 evaluated in the ED.
Patients with inclusion criteria and without exclusion criteria, evaluated in the participating EDs, will be enrolled in the study. Patients will undergo standard medical evaluation by the attending physician(s), following local guidelines and best medical practice, independent of participation to the study.
The following data will be recorded, when available:
Upon discharge, patients will be encouraged to contact emergency medical services or return the ED if needed, in case of clinical worsening.
The following endpoint will be assessed at 30 days after ED discharge, through standardized telephone interview and healthcare/other database query: any further hospital admission (for COVID-19 or other disease), death (for COVID-19 or other disease), respiratory failure/ventilation/intensive care admission (only for hospitalized COVID-19 patients).
Data analysis will focus on the outcome incidence in the study cohort, stratified by a composite of demographic/clinical, biochemical and imaging variables. A key stratification tool will be the 4C mortality score (BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3339). Additional integration of study variables will be evaluated to improve stratification and prediction.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| integrated clinical evaluation | Other | 30-day follow-up (telephone/database query) to define outcome Patients will receive standard care, independent of study participation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome | death (any cause), hospital admission (any cause) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| death (COVID-19) | death for COVID-19 | 30 days |
| death (other disease) | death for disease other than COVID-19 | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (>18 years) subjected to a first ED visit for physician-confirmed COVID-19, discharged from the ED based on attending physician's or patient's decision (independent from study participation). Patients will provide their informed consent to participation (thus allowing clinical data recording and 30-day follow-up).
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| Name | Affiliation | Role |
|---|---|---|
| Fulvio Morello, MD, PhD | A.O.U. Città della Salute e della Scienza di Torino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Maria Vittoria, D.E.A. | Turin | Piedmont | 10128 | Italy | ||
| A.O.U.C. Azienda Ospedaliero-Universitaria Careggi, D.E.A. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Pivetta E, Goffi A, Tizzani M, Locatelli SM, Porrino G, Losano I, Leone D, Calzolari G, Vesan M, Steri F, Arianna A, Capuano M, Gelardi M, Silvestri G, Dutto S, Avolio M, Cavallo R, Bartalucci A, Paglieri C, Morello F, Richiardi L, Maule MM, Lupia E, on behalf of the Molinette MedUrg Group on Lung Ultrasound. Lung ultrasound for the diagnosis of SARS-CoV-2 pneumonia in the Emergency Department. https://doi.org/10.1016/j.annemergmed.2020.10.008 | ||
| 32907855 | Result | Knight SR, Ho A, Pius R, Buchan I, Carson G, Drake TM, Dunning J, Fairfield CJ, Gamble C, Green CA, Gupta R, Halpin S, Hardwick HE, Holden KA, Horby PW, Jackson C, Mclean KA, Merson L, Nguyen-Van-Tam JS, Norman L, Noursadeghi M, Olliaro PL, Pritchard MG, Russell CD, Shaw CA, Sheikh A, Solomon T, Sudlow C, Swann OV, Turtle LC, Openshaw PJ, Baillie JK, Semple MG, Docherty AB, Harrison EM; ISARIC4C investigators. Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score. BMJ. 2020 Sep 9;370:m3339. doi: 10.1136/bmj.m3339. | |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D059039 | Standard of Care |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| hospital admission (COVID-19) | subsequent hospital admission for COVID-19 | 30 days |
| hospital admission (other disease) | subsequent hospital admission for disease other than COVID-19 | 30 days |
| Florence |
| Tuscany |
| 50134 |
| Italy |
| Ospedale U. Parini, Medicina e Chirurgia d'accettazione e Urgenza (MeCAU) | Aosta | Italy |
| A.O. S. Croce e Carle, Medicina e Chirurgia d'Urgenza | Cuneo | 12100 | Italy |
| A.O.U. Careggi, Medicina e Chirurgia d'Urgenza e Accettazione | Florence | Italy |
| A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette, S.C. Medicina d'Urgenza U (MECAU) | Torino | 10126 | Italy |
| Ospedale San Giovanni Bosco, Medicina e Chirurgia d'accettazione e urgenza (MeCAU) | Torino | Italy |
| Result |
| Liu RB, Tayal VS, Panebianco NL, Tung-Chen Y, Nagdev A, Shah S, Pivetta E, Henwood PC, Nelson MJ, Moore CL. Ultrasound on the Frontlines of COVID-19: Report From an International Webinar. Acad Emerg Med. 2020 Jun;27(6):523-526. doi: 10.1111/acem.14004. Epub 2020 Jun 9. No abstract available. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |