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

NCT04586140 | Completed

• 1 other identifier: ETHICOVID
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Ethics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marie-Lorraine de WARREN, Nurse

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 14, 2020
• Study Start: November 9, 2020
• Primary Completion: December 9, 2020
• Study Completion: March 6, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

FR (1)