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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT04452487

Collaborator

(none)

2,500

Enrollment

Locations

Anticipated Duration (Months)

833.3

Patients Per Site

69.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jun 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

decisions of limitations and therapeutic stops [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.