Evaluation of the Outcome of COVID-19 Patients Discharged Home on Oxygen Therapy (COVAMBU)

Early Return of COVID-19 Patients to Home on Oxygen: Evaluation of a New Strategy Based on the City/Hospital Link

The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, or private providers. This organization coordinates the care to be implemented at home based on the city/hospital link. The coordinator of this organization was also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge.

The aim of this study is to evaluate this new organization, both in terms of its impact on patient outcomes (survival and re-hospitalization rates) and on patients' experiences and satisfaction with their care.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Phone satisfaction questionnaire

Detailed Description

The COVID-19 pandemic was responsible for an unprecedented hospital tension with multiple consequences (medical, economic, social...). The first scientific responses were found with unprecedented speed. Very quickly, innovative solutions and a complete reorganization of the health system were necessary to manage this crisis. In order to limit the number of patients hospitalized and/or the length of their hospitalization, most hospitals quickly set up systems to organize the early return of patients to their homes on oxygen. Studies evaluating telemedicine as a tool for monitoring oxygen-requiring patients at home have shown that it is effective and safe for monitoring these patients. Another retrospective study estimated the 30-day rehospitalization rate for patients with SARS-CoV-2 pneumonia after return home on oxygen with telephone monitoring by a nurse to be 8.5% (95% confidence interval, 6.2%-10.7%) and all-cause mortality to be 1.3% (95% confidence interval, 0.6%-2.5%).

The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, and a private provider. These organizations coordinate the care to be implemented at home based on the city/hospital link (oxygen provider, private nurse for the injection of anticoagulants and sometimes insulin and monitoring of vital parameters). These organizations were also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge, with the attending physician or, failing that, in the infectious diseases department of the Pontoise Hospital.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Beaumont-sur-Oise, France, 95260
    • Polyvalent, infectious and pulmonary medicine - GHCPO Beaumont/Oise
  • Pontoise, France, 95300
    • Aval-emergency medicine department - Infectious diseases departement- Hospital René Dubos Pontoise

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over 18 years of age

  • Patients with virologically proven COVID 19 (positive Polymerase Chain Reaction or antigenic test) or based on clinical and radiological evidence
  • Patients discharged from hospital or from the emergency room on oxygen between 1 and 5L at the time of discharge
  • Organization of discharge by a service provider (PRADO or private)

Exclusion Criteria:

• Patients discharged from the intensive care unit
• Oxygen-requiring patients > 5 Liters

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Phone satisfaction questionnaire; Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy	Other: Phone satisfaction questionnaire; Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the evolution of patients with COVID-19 who benefited from an early return home on oxygen organized by the PRADO or a private provider	Assessment of mortality (all causes) at 30 days of hospital discharge (D30) : number of died patients	At 30 days of hospital discharge (D30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the risk of early re-hospitalization of patients following their return home	Number of re-hospitalizations at 7 days from hospital discharge (D7)	At 7 days from hospital discharge (D7)
Assessment of patients' satisfaction with their care and return home	Evaluation of patients'satisfaction : Satisfaction questionnaire contains 5 questions : For Q1, patient answer : Very satisfied, Satisfied, Neither satisfied or unsatisfied, Unsatisfied or Very unsatisfied For Q2, patient answer : Very confident, Confident, Neither confident or anguished, Anguished or Very anguished For Q3, patient answer : Yes, I don't know or No For Q4 and Q5, patient answer : Yes or No	At the end of the study, an average of 10 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier René Dubos
• Investigators: Principal Investigator: Dr Celeste Lambert, Hospital René Dubos Pontoise

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Oxygen therapy; Early return
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CHRD1921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No