HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With a SARS-CoV-2 Infection
NCT ID: NCT04338841
Last Updated: 2020-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3133 participants
INTERVENTIONAL
2020-04-09
2020-06-17
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Delphine DOUILLET
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
Locations
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Clinique Universitaire Saint-Luc
Brussels, , Belgium
CHU de Liège
Liège, , 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
CH de Saint-Brieuc
Saint-Brieuc, , France
CHU de St Etienne
Saint-Etienne, , France
Ch Troyes
Troyes, , France
CH VICHY
Vichy, , France
CH Princesse Grace
Monaco, , Monaco
Countries
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References
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Douillet D, Penaloza A, Mahieu R, Morin F, Chauvin A, Gennai S, Schotte T, Montassier E, Thiebaud PC, Ghuysen Francois A, Dall'acqua D, Benhammouda K, Bissokele P, Violeau M, Joly LM, Andrianjafy H, Soulie C, Savary D, Riou J, Roy PM; Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Study Group. Outpatient Management of Patients With COVID-19: Multicenter Prospective Validation of the Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Rule to Discharge Patients Safely. Chest. 2021 Oct;160(4):1222-1231. doi: 10.1016/j.chest.2021.05.008. Epub 2021 May 15.
Douillet D, Mahieu R, Boiveau V, Vandamme YM, Armand A, Morin F, Savary D, Dubee V, Annweiler C, Roy PM; HOME-CoV expert group. Outpatient management or hospitalization of patients with proven or suspected SARS-CoV-2 infection: the HOME-CoV rule. Intern Emerg Med. 2020 Nov;15(8):1525-1531. doi: 10.1007/s11739-020-02483-0. Epub 2020 Sep 4.
Other Identifiers
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2020-A00831-38
Identifier Type: -
Identifier Source: org_study_id
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