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Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments (COVID-19-LAT) (COVID-19-LAT)

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ClinicalTrials.gov Identifier: NCT04452487
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
This survey is performed to examine if during the Covid's crisis, the practitionner's have respected the modalities of the law about the end of life, in particular concerning limitations and stop of therapeutics

Condition or disease Intervention/treatment
Patient Hospitalized in Disease Infectious Unit Patient Hospitalized in Intensive Reanimation Unit Patient Hopsitalized in Internal Medicine Unit Behavioral: decisions of limitations and stop processing

Detailed Description:

In the current legislativ context notably the Clayes Leonetti law, a very large majority of ICU (Intensive Care Unit) patients die with the establishement of a procedure for the limitation and cessation of therapeutics (LAT). During a viral pandemic, medical resources can be saturated, limiting reflexive abilities in favour of binary decisions. This sorting of patients leads to LAT that could be performed without the elementary modalities stated by the law. Thus, arbitrary medical decisions made alone could expose patients to unjustified " loss of luck ". Increasing the resources mobilized during a pandemic must not make us forget the quality of care provided for the benefit of quantity. In therefore seems legitimate to keep the LAT modalities to ensure our ethical principles. No work in the literature based on actual facts explores the impact of a pandemic on compliance with and maintenance of ethical principles and the legisltaive framework, in particular as regards the procedures of the application of LAT.

The purpose of this study is to assess whether the terms of the LAT are being complied during a pandemic for patients with or without Covid.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
Patient 2019
Patients hospitalized in selected centers during march and june 2019
Behavioral: decisions of limitations and stop processing
Compliance of the modalities of decisions of limitations and stop processing

Patient 2020
Patients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia)
Behavioral: decisions of limitations and stop processing
Compliance of the modalities of decisions of limitations and stop processing

Patient 2021
Patients hospitalized in selected centers during march and june 2021
Behavioral: decisions of limitations and stop processing
Compliance of the modalities of decisions of limitations and stop processing




Primary Outcome Measures :
  1. decisions of limitations and therapeutic stops [ Time Frame: at the end of patient's hospitalization, an average of one month ]
    The conformity of the modalities of the decisions of limitations and therapeutic stops will be evaluated by a composite criterion defined by the simultaneous presence of the 3 main modalities imposed by the Clayes-Leonetti law to achieve a limitation that are : An outside consultant's opinion ( required if no advance directives), the caregiver collegial discussion or adherence to patient advance directives, notification of decision in the medical record


Secondary Outcome Measures :
  1. Characteristics of the notification of LAT procedure [ Time Frame: at the end of patient's hospitalization, an average of one month ]
    notification of the decision, the conclusions of the discussions, the opinion of the consultant and the arguments given to justify the LAT

  2. Characteristics of the LAT procedure (persons who participated to the collegial discussion) [ Time Frame: at the end of patient's hospitalization, an average of one month ]
    number and status of caregivers who participated to the collegial discussion

  3. Characteristics of consultant's reasoned opinion for the LAT procedure [ Time Frame: at the end of patient's hospitalization, an average of one month ]
    formal elements of the consultant's reasoned opinion ( legal term) in the file

  4. Characteristics of the LAT procedure [ Time Frame: at the end of patient's hospitalization, an average of one month ]
    formal elements of advance directives

  5. Characteristics of units [ Time Frame: day 0 ]
    number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study

  6. Age of physicians [ Time Frame: Day 0 ]
    measured in year

  7. gendrer of physicians [ Time Frame: Day 0 ]
    male or female

  8. Exparience of physicians [ Time Frame: Day 0 ]
    Measured in year of experience

  9. Characteristics of physicians [ Time Frame: Day 0 ]
    professional status

  10. Age of patients [ Time Frame: day 0 ]
    measured in year

  11. patient's history [ Time Frame: day 0 ]
    comorbidities

  12. COVID-19 patient's status [ Time Frame: day 0 ]
    COVID19 infection (yes or no)

  13. Characteristics of hospitalization's patients [ Time Frame: day 0 ]
    hospitalization reason

  14. Characteristics of affected organ [ Time Frame: day 0 ]
    organ failure

  15. Characteristics of patients [ Time Frame: day 0 ]
    severity score

  16. final patient status [ Time Frame: day 0 ]
    fate

  17. patient's environnement [ Time Frame: day 0 ]
    family presence or relatives



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient hospitalized in disease infectious Unit, or Patient hospitalized in intensive reanimation Unit, or Patient hopsitalized in Internal medicine Unit.
Criteria

Inclusion Criteria:

  • Hospitalized major patient
  • Infected or not with Covid-19
  • having a management with a LAT defined by an anticipated or factual restriction of a therapeutic resource ( organ replacement, specific treatment) while his or her state of health requires or may require it, leading or not a death. The patient's death occurs either after a cariac massagewhich corresponds to a maximum management with therapeutic failure or within the framework or in the context of brain death, in these cases there is no LAT ; either without cardiac massage and in this case there is de facto a LAT wether or not it is performed according to legisltaive procedures. All patients who die will beclassified according to this diagram for the inclusion criterion. For surviving patients, an analysis of the record in search of LAT elments will be performed. In the absence of LAT elment in the record, i twill be considered that the patient did not have LAT and therfore will not be included.

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452487


Contacts
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Contact: Lise LACLAUTRE +33473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise Laclautre    +33473754963    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Viginie Guastella         
Hospices Civiles de Lyon Not yet recruiting
Lyon, France, 69000
Contact: Jean-Christophe Richard       j-christophe.richard@chu-lyon.fr   
Sub-Investigator: Jean-Christophe RICHARD         
Sub-Investigator: Pascal SEVE         
Sub-Investigator: Laurent ARGAUD         
Sub-Investigator: Arnaud HOT         
Sub-Investigator: André BOIBIEUX         
CH de Vichy Not yet recruiting
Vichy, France, 03000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Virginie Guastella University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04452487    
Other Study ID Numbers: 2020_GUASTELLA_COVID-19-LAT
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
COVID 19
Limitations and stops of processing Active Therapeutic
ethics
Sanitary Crisis
Additional relevant MeSH terms:
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Infection
Communicable Diseases