Official Title
HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study
Brief Summary

COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

Detailed Description

Definition of HOME-CoV rule:

The Delphi method is used to reach a consensus of a large panel of experts and to define an
easy-to-use clinical rule aiming to help emergency physicians in hospitalisation or
outpatient management decision making : the HOME-CoV rule.

The impact of the rule implementation is evaluated in a before and after study:

- before period: observational assessment of current practices

- implementation period : educational lectures, posters, and pocket cards showing and
explaining HOME-CoV rule are communicated to participating Emergency Departments.

- after period : observational assessment of practices

In each period, patients consulting Emergency Departments with suspected or probable COVID-19
are evaluated for potential inclusion. Clinical, biological and imaging data that may be
involved in decision-making about hospitalization are collected as well as the physician
final decision (hospitalization or outpatient management) and its main determinants.

A phone-call follow-up is performed and the clinical status according to the Ordinal Scale
for Clinical Improvement of COVID-19 from the World Heath Organization is collected on day 7
and day 28 following inclusion.

Completed
Coronavirus Infection

Other: HOME-CoV rule implementation

HOME-CoV rule is an easy-to-use clinical rule aiming to help emergency physicians in hospitalisation or outpatient management decision making. The definition of the rule is performed using the Delphi method to reach a consensus of a large panel of experts.
Between before and after period, educational lectures, posters, and pocket cards showing and explaining HOME-CoV rule are communicated to participating Emergency Departments.

Eligibility Criteria

Inclusion Criteria:

- Adult patient (≥ 18 years old)

- Admitted for COVID-19 infection confirmed by a positive SARS-CoV2 RT-PCR or considered
probable by the physician in charge of the patient.

- Not requiring care in intensive care unit or resuscitation unit or

- No subject of a limitation decision of active therapies,

- Free informed express consent to participate in the study orally given or signed by
the patient according to local legislation,

- Insurance cover according to local legislation;

Exclusion Criteria:

- Patient whose main diagnostic hypothesis in the emergency room is not a SARS-CoV-2
infection but another differential diagnosis,

- Patient admitted to the emergency room for 18 hours or more,

- Patient whose follow-up on D28 is impossible, whatever the reason,

- Patient with a poor understanding of the French language,

- Patient already included in the study,

- Person deprived of their liberty by judicial or administrative decision,

- Person under psychiatric care under duress,

- Person subject to a legal protection measure,

- Person unable to express consent.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Belgium
France
Monaco
Locations

Clinique Universitaire Saint-Luc
Bruxelles, Belgium

CHU de Liège
Liege, Belgium

Ch Argenteuil
Argenteuil, France

CH Cholet
Cholet, France

CHU Clermont Ferrand
Clermont Ferrand, France

Ch Colmar
Colmar, France

CH Alpes Lemant
Contamine-sur-Arve, France

CHU Dijon
Dijon, France

CH Le Mans
Le Mans, France

CH Libourne
Libourne, France

CH Limoges
Limoges, France

Ch Longjumeau
Longjumeau, France

Chu Montpellier
Montpellier, France

Centre Hospitalier Universitaire de Nantes
Nantes, France

CH Niort
Niort, France

Hopital Paris Saint Joseph
Paris, France

Hopital Saint Antoine
Paris, France

Hôpital Bichat
Paris, France

Hôpital Lariboisière
Paris, France

CHU de Poitiers
Poitiers, France

CH Reims
Reims, France

Ch Remiremont
Remiremont, France

Chu Rennes
Rennes, France

CHU de Rouen
Rouen, France

CHU de St Etienne
Saint Etienne, France

CH de Saint-Brieuc
Saint-Brieuc, France

Ch Troyes
Troyes, France

CH VICHY
Vichy, France

CH Princesse Grace
Monaco, Monaco

Delphine DOUILLET, Principal Investigator
University Hospital, Angers

University Hospital, Angers
NCT Number
Keywords
Covid-19
outpatient
expert consensus
decision-making
MeSH Terms
Infections
Communicable Diseases
Coronavirus Infections
COVID-19