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

Overview

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

Full Title of Study: “Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2021

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.

Interventions

  • Behavioral: decisions of limitations and stop processing
    • Compliance of the modalities of decisions of limitations and stop processing

Arms, Groups and Cohorts

  • Patient 2019
    • Patients hospitalized in selected centers during march and june 2019
  • Patient 2020
    • Patients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia)
  • Patient 2021
    • Patients hospitalized in selected centers during march and june 2021

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • Characteristics of the LAT procedure
    • Time Frame: at the end of patient’s hospitalization, an average of one month
    • formal elements of advance directives
  • Characteristics of units
    • Time Frame: day 0
    • number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study
  • Age of physicians
    • Time Frame: Day 0
    • measured in year
  • gendrer of physicians
    • Time Frame: Day 0
    • male or female
  • Exparience of physicians
    • Time Frame: Day 0
    • Measured in year of experience
  • Characteristics of physicians
    • Time Frame: Day 0
    • professional status
  • Age of patients
    • Time Frame: day 0
    • measured in year
  • patient’s history
    • Time Frame: day 0
    • comorbidities
  • COVID-19 patient’s status
    • Time Frame: day 0
    • COVID19 infection (yes or no)
  • Characteristics of hospitalization’s patients
    • Time Frame: day 0
    • hospitalization reason
  • Characteristics of affected organ
    • Time Frame: day 0
    • organ failure
  • Characteristics of patients
    • Time Frame: day 0
    • severity score
  • final patient status
    • Time Frame: day 0
    • fate
  • patient’s environnement
    • Time Frame: day 0
    • family presence or relatives

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Virginie Guastella, Principal Investigator, University Hospital, Clermont-Ferrand
  • Overall Contact(s)
    • Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr

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