Patient Hopsitalized in Internal Medicine Unit Clinical Trial
— COVID-19-LATOfficial title:
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
| Status | Recruiting |
| Enrollment | 2500 |
| Est. completion date | June 2021 |
| Est. primary completion date | June 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Clermont-Ferrand | Clermont-Ferrand | |
| France | Hospices Civiles de Lyon | Lyon | |
| France | CH de Vichy | Vichy |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Characteristics of the LAT procedure | formal elements of advance directives | at the end of patient's hospitalization, an average of one month | |
| Secondary | Characteristics of units | number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study | day 0 | |
| Secondary | Age of physicians | measured in year | Day 0 | |
| Secondary | gendrer of physicians | male or female | Day 0 | |
| Secondary | Exparience of physicians | Measured in year of experience | Day 0 | |
| Secondary | Characteristics of physicians | professional status | Day 0 | |
| Secondary | Age of patients | measured in year | day 0 | |
| Secondary | patient's history | comorbidities | day 0 | |
| Secondary | COVID-19 patient's status | COVID19 infection (yes or no) | day 0 | |
| Secondary | Characteristics of hospitalization's patients | hospitalization reason | day 0 | |
| Secondary | Characteristics of affected organ | organ failure | day 0 | |
| Secondary | Characteristics of patients | severity score | day 0 | |
| Secondary | final patient status | fate | day 0 | |
| Secondary | patient's environnement | family presence or relatives | day 0 |