Coronavirus Infection Clinical Trial
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
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).
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.
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