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Completed

NCT Number: NCT05684575

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyvalent, infectious and pulmonary medicine - GHCPO Beaumont/Oise, Beaumont-sur-Oise, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phone satisfaction questionnaire

Other

Evaluation of the outcome of Covid-19 patients discharged home on oxygen therapy

Primary outcomes

  1. 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

    Time frame: At 30 days of hospital discharge (D30)

    Assessment of mortality (all causes) at 30 days of hospital discharge (D30) : number of died patients

Secondary outcomes

  1. Assessment of the risk of early re-hospitalization of patients following their return home

    Time frame: At 7 days from hospital discharge (D7)

    Number of re-hospitalizations at 7 days from hospital discharge (D7)

  2. Assessment of patients' satisfaction with their care and return home

    Time frame: At the end of the study, an average of 10 month

    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

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: COVAMBU

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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