Covid19ETHICOVIDNCT04586140
Operation of the GHPSJ Clinical Ethical Reflection Assistance Group During the COVID-19 Period
An observational study of Covid19 and Ethics, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2020to 6 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for COVID-19 infection who benefited from GAREC's intervention between 03/25/2020 and 05/07/2020.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start9 Nov 2020
- Primary completion9 Dec 2020
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Lorraine de WARREN, Nurse, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586140
- Sponsor's protocol ID
- ETHICOVID
- Acronym
- ETHICOVID
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operation of the Groupe Hospitalier Paris Saint-Joseph Clinical Ethical Reflection Assistance Group During the COVID-19
- ClinicalTrials.gov ID
- NCT04586140
- Acronym / sponsor ID
- ETHICOVID / ETHICOVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for COVID-19 infection who benefited from GAREC's intervention between 03/25/2020 and 05/07/2020.
Key inclusion criteria (6 listed)
- Patients:
- Caregivers:
Key exclusion criteria (6 listed)
- Patients
- Caregivers o Caregiver opposing the use of their data for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interest of GAREC
Time frame: Year 1
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Lorraine de WARREN, Nurse principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Ethics, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interest of GAREC (time frame: Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.