STRESS From in Charge Relative Facing the Announcement of Decisions Limiting or Stopping Treatments in Emergency Room During the COVID-19 Epidemic

Anxiety Clinical Trial

— COVER ACC  

Official title:

STRESS From in Charge Relative Facing the Announcement of Decisions Limiting or Stopping Treatments in Emergency Room During the COVID-19 Epidemic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04785807
• Other study ID #: 69HCL20_0678
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: June 2022
• Source: Hospices Civils de Lyon
• Contact: Marion DOUPLAT, MD
• Phone: 04.78.86.28.54
• Email: marion.douplat[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the context of the COVID-19 pandemic, the emergency reception services had to be radically reorganized. In this tense environment, professionals must face ethical dilemmas, make referral decisions and prioritize patients. Due to the limited number of visits to many hospitals, interactions with relatives and families of patients are mainly conducted by phone. These limitations will continue as long as the context of uncertainty over the course of the pandemic persists. Limitation or discontinuation of treatment (LDT) announcements were therefore also impacted and the exceptional situation related to COVID-19 reinforces the difficulties encountered by professionals in usual time (place of announcement, inappropriate lack of time, etc.). Thus, LDTs are most often done over the phone without the families being able to go to the hospital. Because of this, these announcements can be more traumatic. Investigators have already highlighted in a recent study the lack of communication between caregivers and families in the context of LDT announcements and the context of COVID 19 exacerbated these aspects given the limitations of visits. The investigators therefore propose to study the experiences of families who are notified of a decision to limit or stop treatment by phone in the emergency room during the COVID-19 crisis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years old.
• Person of trust designated in writing or contact person if designated by the family or primary caregiver or failing that the family member or person of trust of an adult patient deemed unfit to receive the information (advanced dementia (lower MMS) to 10), disturbance of consciousness). Only one person per family will be included.
• having been informed of a LAT decision in the emergency room by telephone during the pandemic
• Having consented to participate in the study
• Affiliated with social security

Exclusion Criteria:

• Person of trust, family or close friend unable to understand or write in French.

Related Conditions & MeSH terms

• Anxiety
• COVID-19
• Covid19
• Emergencies
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Post traumatic, Anxiety and depression evaluation
Family member of person or trust of patient who had a limitation or discontinuation of treatments will be identified and asked to fulfilled a hospitalized anxiety and depression scale and the revised Impact Event scale 7 and 30 days after the limitation or discontinuation of treatments announcement

Locations

Country	Name	City	State
France	service des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon	Lyon
France	Service des urgences, Hôpital Edouard Herriot, Hospices Civils de Lyon	Lyon
France	Service d'Accueil des Urgences, Hôpital Lyon Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post traumatic syndrome evaluated thanks to the Revised impact event scale (IES-R)	The primary endpoint is the evaluation of Post traumatic syndrome among the family member or person of trust of a patient who received a limitation or discontinuation of treatment, 30 days after this announcement. The post traumatic syndrome will be evaluated thanks to the Revised impact event scale (IES-R) giving a score going from 0 to 88. The greater the score, the worse the outcome is.	30 days after limitation or discontinuation of treatment announcement
Secondary	Anxiety level at day 7, assessed using the Hospitalized Anxiety and Depression Scale-(HADS)	Evaluation of Anxiety among the family member or person of trust of a patient who received a limitation or discontinuation of treatment, 7 days after this announcement. Anxiety will be assessed using the Hospitalized Anxiety and Depression Scale, giving two scores (one for anxiety, one for depression) going from 0 to 21. The greater the score, the worse the outcome is.	7 days after inclusion
Secondary	Depression level at day 7, assessed using the Hospitalized Anxiety and Depression Scale	Evaluation of Depression among the family member or person of trust of a patient who received a limitation or discontinuation of treatment 7 days after this announcement, using the Hospitalized Anxiety and Depression Scale, giving two scores (one for anxiety, one for depression) going from 0 to 21. The greater the score, the worse the outcome is.	7 days after inclusion
Secondary	Anxiety level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)	Evaluation of Anxiety among the family member or person of trust of a patient who received a limitation or discontinuation of treatment 30 days after this announcement, using the Hospitalized Anxiety and Depression Scale, giving two scores (one for anxiety, one for depression) going from 0 to 21. The greater the score, the worse the outcome is.	30 days after inclusion
Secondary	Depression level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)	Evaluation of Depression among the family member or person of trust of a patient who received a limitation or discontinuation of treatment, 30 days after this announcement. Anxiety will be assessed using the Hospitalized Anxiety and Depression Scale, giving two scores (one for anxiety, one for depression) going from 0 to 21. The greater the score, the worse the outcome is.	30 days after inclusion
Secondary	Description of socio-demographic factors	In order to determine anxiety and depression risk factors, the individual socio-demographic factors such as recourse to psychological support, consumption of psychoactive substances (caffeine, tobacco, psychotropic drugs, anxiolytics) will be described.	30 days after inclusion
Secondary	Description of clinical factors	In order to determine anxiety and depression risk factors, the factors linked to the patient (COVID infection, death) will be described.	30 days after inclusion