Operation of the GHPSJ Clinical Ethical Reflection Assistance Group During the COVID-19 Period (ETHICOVID)

Operation of the Groupe Hospitalier Paris Saint-Joseph Clinical Ethical Reflection Assistance Group During the COVID-19

Between March and May 2020, Ile-de-France hospitals faced an influx of patients infected with the COVID 19 virus. Faced with the scale of the pandemic, the aggressiveness of this pathology, severe respiratory complications and the shortage of resuscitation beds , the teams had to make difficult decisions on the therapeutic strategy, the orientation of patients in the event of respiratory distress and their intensive care status. To do this, each establishment reflected in an emergency context on procedures for collegial deliberation and assistance in ethical reflection, based on the recommendations of the National Consultative Ethics Committee and learned societies such as the French Society. of Anesthesia and Resuscitation or the French Society of Support and Palliative Care.

Some hospitals had already institutionalized the ethical approach upstream of the health crisis. For example, the Groupe d'Aide à la Réflexion Éthique Clinique (GAREC) was created in November 2005 within the Paris Saint-Joseph Hospital Group. GAREC is a collegial and multidisciplinary entity, made up of 8 members who intervene at the request of caregivers when a clinical situation turns out to be ethically complex. He gives an advisory opinion, the decision belonging to the referring physician.

At the start of the COVID period, GAREC changed its structure, organization and operation in order to respond to the multiple issues posed by the complexity of the health situation.

This study seeks to analyze the adaptation mechanisms put in place by this group during the epidemic period as well as the nature of the benefit provided to the caregivers who requested it, to the patients and to their relatives.

• Adaptation mechanisms: during the COVID period, GAREC was extended to other paramedical professions (psychologists, nurses), thus increasing from 8 to 15 members. It has set up 2 weekly meetings, an on-call duty and on-call duty. The requests were made easier: they could be done by phone, by email, day or night. Several questions emerge: What were the motivations for enlarging the group? How were the members integrated into this group? What were its operating methods? How and by whom was it seized? For what purpose? Were the intervention teams multidisciplinary?
• Nature of the benefit provided by GAREC: it will be approached by semi-structured interviews via a qualitative research method.

This work is part of a broader reflective perspective:

• What representation of ethics underlies this device?
• Does the institutionalization of ethics help to enhance or make invisible what ethics owes to daily healthcare practices?
• To what extent does the institutionalization of clinical ethics make health institutions more human and virtuous?
• Under what conditions can a device like GAREC go beyond the role of ethical guarantor and transform the institution and nursing practices in the service of a collective reflective approach? This study will be carried out on patient data usually collected as part of their care and on data collected through semi-structured interviews with healthcare professionals. As such, it fits into the perspective of grounded theory.

Study Overview

• Status: Completed
• Conditions: Covid19; Ethics

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

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

Patients hospitalized for COVID-19 infection who benefited from GAREC's intervention between 03/25/2020 and 05/07/2020.

Description

Inclusion Criteria:

• Patients:

  • Major
  • Hospitalized for a COVID-19 infection and for which GAREC intervened between 03/25/20 and 05/07/20

• Caregivers:

  • GAREC members (between 8 and 15 caregivers)
  • Having called on GAREC (between 10 and 20 caregivers)

Exclusion Criteria:

• Patients

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection
  • Patient objecting to the use of their data for this research
• Caregivers o Caregiver opposing the use of their data for this research

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with COVID-19 infection; This study will be carried out on patient data usually collected as part of their care. The patients were infected with COVID-19 and hospitalized between 03/25/2020 and 05/07/2020, and who benefited from GAREC's intervention.
Nursing staff AND GAREC Members; This study also concerns data collected in the context of semi-structured interviews with health professionals, in a prospective manner. These are caregivers who are members of GARED or who called on GAREC between 25/03/2020 and 07/05/2020.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interest of GAREC	This outcome is to evaluate the benefit of nursing staff in the ethical process. In a qualitative study like this, no primary endpoint is established.	Year 1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Marie-Lorraine de WARREN, Nurse, Groupe hospitalier Paris saint Joseph

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ETHICOVID

Drug and device information, study documents

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