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

Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments

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

Study Overview

• Status: Unknown
• Conditions: Patient Hospitalized in Disease Infectious Unit; Patient Hospitalized in Intensive Reanimation Unit; Patient Hopsitalized in Internal Medicine Unit
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Viginie Guastella
  • Lyon, France, 69000
    • Not yet recruiting
    • Hospices Civiles de Lyon
    • Sub-Investigator: Laurent ARGAUD
    • Contact: Jean-Christophe Richard; Email: j-christophe.richard@chu-lyon.fr
    • Sub-Investigator: Jean-Christophe RICHARD
    • Sub-Investigator: Pascal SEVE
    • Sub-Investigator: Arnaud HOT
    • Sub-Investigator: André BOIBIEUX
  • Vichy, France, 03000
    • Not yet recruiting
    • CH de Vichy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decisions of limitations and therapeutic stops	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	at the end of patient's hospitalization, an average of one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of the notification of LAT procedure	notification of the decision, the conclusions of the discussions, the opinion of the consultant and the arguments given to justify the LAT	at the end of patient's hospitalization, an average of one month
Characteristics of the LAT procedure (persons who participated to the collegial discussion)	number and status of caregivers who participated to the collegial discussion	at the end of patient's hospitalization, an average of one month
Characteristics of consultant's reasoned opinion for the LAT procedure	formal elements of the consultant's reasoned opinion ( legal term) in the file	at the end of patient's hospitalization, an average of one month
Characteristics of the LAT procedure	formal elements of advance directives	at the end of patient's hospitalization, an average of one month
Characteristics of units	number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study	day 0
Age of physicians	measured in year	Day 0
gendrer of physicians	male or female	Day 0
Exparience of physicians	Measured in year of experience	Day 0
Characteristics of physicians	professional status	Day 0
Age of patients	measured in year	day 0
patient's history	comorbidities	day 0
COVID-19 patient's status	COVID19 infection (yes or no)	day 0
Characteristics of hospitalization's patients	hospitalization reason	day 0
Characteristics of affected organ	organ failure	day 0
Characteristics of patients	severity score	day 0
final patient status	fate	day 0
patient's environnement	family presence or relatives	day 0

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Virginie Guastella, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: COVID 19; ethics; Limitations and stops of processing Active Therapeutic; Sanitary Crisis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2020_GUASTELLA_COVID-19-LAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No