Risk Stratification of COVID-19 Patients Discharged From the Emergency Department

NCT04629183 | Completed

• 1 other identifier: COVID-ED-IntRisk
• Study Type: observational
• Target: 742
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Covid19

Keywords

emergency department; admission; discharge; risk

Outcome Measures

Primary Outcomes (1)

• composite outcome

  death (any cause), hospital admission (any cause)

  30 days

Secondary Outcomes (4)

• death (COVID-19)

  30 days

• death (other disease)

  30 days

• hospital admission (COVID-19)

  30 days

• hospital admission (other disease)

  30 days

Interventions

integrated clinical evaluation OTHER

30-day follow-up (telephone/database query) to define outcome Patients will receive standard care, independent of study participation.

Also known as: lung ultrasonosgraphy, chest radiography (standard care, clinical decision), blood testing (standard care, clinical decision)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• symptomatic COVID-19 confirmed by treating physician
• positive nasopharyngeal swab for SARS-CoV-2 (performed during the ED visit or within last 14 days)
• First ED visit for suspected or confirmed COVID-19 (within last 30 days)
• Home discharge from ED based on treating physician's or patient's decision

You may not qualify if:

• Age \<18 years
• Nursing home resident
• Already on home oxygen therapy
• Previous ED visit for suspected or confirmed COVID-19 (within last 30 days)
• Informed consent denial
• Follow-up not feasible

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• University of Turin, Italy: collaborator

Study Sites (7)

Ospedale Maria Vittoria, D.E.A.

Turin, Piedmont, 10128, Italy

Location

A.O.U.C. Azienda Ospedaliero-Universitaria Careggi, D.E.A.

Florence, Tuscany, 50134, Italy

Location

Ospedale U. Parini, Medicina e Chirurgia d'accettazione e Urgenza (MeCAU)

Aosta, Italy

Location

A.O. S. Croce e Carle, Medicina e Chirurgia d'Urgenza

Cuneo, 12100, Italy

Location

A.O.U. Careggi, Medicina e Chirurgia d'Urgenza e Accettazione

Florence, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette, S.C. Medicina d'Urgenza U (MECAU)

Torino, 10126, Italy

Location

Ospedale San Giovanni Bosco, Medicina e Chirurgia d'accettazione e urgenza (MeCAU)

Torino, Italy

Location

Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 32907855 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.

  PMID: 32348585 RESULT

MeSH Terms

Conditions

COVID-19; Emergencies

Interventions

X-Rays; Standard of Care; Hematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Fulvio Morello, MD, PhD

  A.O.U. Città della Salute e della Scienza di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Internal Medicine), S.C. Medicina d'Urgenza U (MECAU), Università degli Studi di Torino

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 16, 2020
• Study Start: October 10, 2020
• Primary Completion: January 11, 2021
• Study Completion: February 11, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)