Clinical trial NCT05684575: Evaluation of the Outcome of COVID-19 Patients Discharged Home on Oxygen Therapy
Official title: Early Return of COVID-19 Patients to Home on Oxygen: Evaluation of a New Strategy Based on the City/hospital Link
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Oxygen therapy
Early return
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At 30 days of hospital discharge (D30)
Secondary outcomes:
measure: Assessment of the risk of early re-hospitalization of patients following their return home
timeFrame: At 7 days from hospital discharge (D7)
measure: Assessment of patients' satisfaction with their care and return home
timeFrame: At the end of the study, an average of 10 month
Other outcomes:
Locations:
city: Beaumont-sur-Oise
country: France
facility: Polyvalent, infectious and pulmonary medicine - GHCPO Beaumont/Oise
city: Pontoise
country: France
facility: Aval-emergency medicine department - Infectious diseases departement- Hospital René Dubos Pontoise
Study officials:
affiliation: Hospital René Dubos Pontoise
name: Dr Celeste Lambert
role: PRINCIPAL_INVESTIGATOR
References: