HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With a SARS-CoV-2 Infection

Sponsor

University Hospital, Angers (Other)

Overall Status

Completed

CT.gov ID

NCT04338841

Collaborator

(none)

3,133

Enrollment

Locations

Arms

2.3

Actual Duration (Months)

108

Patients Per Site

47.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection	Other: HOME-CoV rule implementation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3133 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Quasi-experimental before and after multicentre prospective studyQuasi-experimental before and after multicentre prospective study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 9, 2020

Actual Primary Completion Date :

Jun 17, 2020

Actual Study Completion Date :

Jun 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Phase1: Before HOME-CoV rule implementation Observational assessment of current practices: no recommendation is performed. 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.
Experimental: Phase 2: After HOME-CoV rule implementation Observational assessment of practices after implementation of the rule: physicians are recommended to apply the HOME-CoV rule but still free to use other determinants in their decision. 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.	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.

Arm

Intervention/Treatment

No Intervention: Phase1: Before HOME-CoV rule implementation

Observational assessment of current practices: no recommendation is performed. 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.

Experimental: Phase 2: After HOME-CoV rule implementation

Observational assessment of practices after implementation of the rule: physicians are recommended to apply the HOME-CoV rule but still free to use other determinants in their decision. 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.

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.

Outcome Measures

Primary Outcome Measures

the composite rate of adverse outcomes [day 7]
Adverse outcomes include intubation with mechanical ventilation requirement and death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 7 days after inclusion.
The rate of hospitalization [24 hours]
The rate of patients hospitalized after admission to the emergency room including patients discharged home more than 24 hours after admission. It will be analyzed in a hierarchical approach, only if first primary objective is positive i.e. non-inferiority of HOME-CoV strategy versus current practice on the rate of adverse outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Universitaire Saint-Luc	Bruxelles	Belgium
2	CHU de Liège	Liege	Belgium
3	Ch Argenteuil	Argenteuil	France
4	CH Cholet	Cholet	France
5	CHU Clermont Ferrand	Clermont Ferrand	France
6	Ch Colmar	Colmar	France
7	CH Alpes Lemant	Contamine-sur-Arve	France
8	CHU Dijon	Dijon	France
9	CH Le Mans	Le Mans	France
10	CH Libourne	Libourne	France
11	CH Limoges	Limoges	France
12	Ch Longjumeau	Longjumeau	France
13	Chu Montpellier	Montpellier	France
14	Centre Hospitalier Universitaire de Nantes	Nantes	France
15	CH Niort	Niort	France
16	Hopital Paris Saint Joseph	Paris	France
17	Hopital Saint Antoine	Paris	France
18	Hôpital Bichat	Paris	France
19	Hôpital Lariboisière	Paris	France
20	CHU de Poitiers	Poitiers	France	86000
21	CH Reims	Reims	France
22	Ch Remiremont	Remiremont	France
23	Chu Rennes	Rennes	France
24	CHU de Rouen	Rouen	France
25	CHU de St Etienne	Saint Etienne	France	42000
26	CH de Saint-Brieuc	Saint-Brieuc	France
27	Ch Troyes	Troyes	France
28	CH VICHY	Vichy	France
29	CH Princesse Grace	Monaco	Monaco