Evaluation of the Outcome of COVID-19 Patients Discharged Home on Oxygen Therapy (COVAMBU)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phone satisfaction questionnaire
Sponsored by
About this trial
This is an interventional other trial for COVID-19 focused on measuring COVID-19, Oxygen therapy, Early return
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
Sites / Locations
- Polyvalent, infectious and pulmonary medicine - GHCPO Beaumont/Oise
- Aval-emergency medicine department - Infectious diseases departement- Hospital René Dubos Pontoise
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Phone satisfaction questionnaire
Arm Description
Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05684575
Brief Title
Evaluation of the Outcome of COVID-19 Patients Discharged Home on Oxygen Therapy
Acronym
COVAMBU
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
April 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital NOVO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Oxygen therapy, Early return
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phone satisfaction questionnaire
Arm Type
Other
Arm Description
Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy
Intervention Type
Other
Intervention Name(s)
Phone satisfaction questionnaire
Intervention Description
Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy
Primary Outcome Measure Information:
Title
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
Description
Assessment of mortality (all causes) at 30 days of hospital discharge (D30) : number of died patients
Time Frame
At 30 days of hospital discharge (D30)
Secondary Outcome Measure Information:
Title
Assessment of the risk of early re-hospitalization of patients following their return home
Description
Number of re-hospitalizations at 7 days from hospital discharge (D7)
Time Frame
At 7 days from hospital discharge (D7)
Title
Assessment of patients' satisfaction with their care and return home
Description
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
Time Frame
At the end of the study, an average of 10 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Celeste Lambert
Organizational Affiliation
Hospital René Dubos Pontoise
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyvalent, infectious and pulmonary medicine - GHCPO Beaumont/Oise
City
Beaumont-sur-Oise
ZIP/Postal Code
95260
Country
France
Facility Name
Aval-emergency medicine department - Infectious diseases departement- Hospital René Dubos Pontoise
City
Pontoise
ZIP/Postal Code
95300
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Outcome of COVID-19 Patients Discharged Home on Oxygen Therapy
We'll reach out to this number within 24 hrs