Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments (COVID-19-LAT)
- Conditions
- Patient Hospitalized in Intensive Reanimation UnitPatient Hopsitalized in Internal Medicine UnitPatient Hospitalized in Disease Infectious Unit
- Interventions
- Behavioral: decisions of limitations and stop processing
- Registration Number
- NCT04452487
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2500
- 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.
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient 2019 decisions of limitations and stop processing Patients hospitalized in selected centers during march and june 2019 Patient 2020 decisions of limitations and stop processing Patients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia) Patient 2021 decisions of limitations and stop processing Patients hospitalized in selected centers during march and june 2021
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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
gendrer of physicians Day 0 male or female
Characteristics of physicians Day 0 professional status
patient's history day 0 comorbidities
Characteristics of affected organ day 0 organ failure
Characteristics of patients day 0 severity score
COVID-19 patient's status day 0 COVID19 infection (yes or no)
Exparience of physicians Day 0 Measured in year of experience
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 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
Age of patients day 0 measured in year
final patient status day 0 fate
Characteristics of the LAT procedure at the end of patient's hospitalization, an average of one month formal elements of advance directives
Characteristics of hospitalization's patients day 0 hospitalization reason
patient's environnement day 0 family presence or relatives
Trial Locations
- Locations (3)
Hospices Civiles de Lyon
🇫🇷Lyon, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CH de Vichy
🇫🇷Vichy, France