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

COVID-19 Clinical Trial

— COVAMBU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684575
• Other study ID #: CHRD1921
• Status: Completed
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: April 25, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier René Dubos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Phone satisfaction questionnaire
Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy

Locations

Country	Name	City	State
France	Polyvalent, infectious and pulmonary medicine - GHCPO Beaumont/Oise	Beaumont-sur-Oise
France	Aval-emergency medicine department - Infectious diseases departement- Hospital René Dubos Pontoise	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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