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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Anxiety; Post Traumatic Stress Disorder
• Intervention / Treatment: Other: Post traumatic, Anxiety and depression evaluation

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion DOUPLAT, MD; Phone Number: + 33 04.78.86.28.54; Email: marion.douplat@chu-lyon.fr
• Study Contact Backup: Name: Julien BERTHILLER; Phone Number: + 33 04 72 11 80 67; Email: julien.berthiller@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69003
    • Recruiting
    • Service des urgences, Hôpital Edouard Herriot, Hospices Civils de Lyon
    • Contact: Laurent JACQUIN, MD
    • Principal Investigator: Laurent JACQUIN, MD
  • Lyon, France, 69004
    • Recruiting
    • service des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
    • Contact: Bénédicte CLEMENT, MD
    • Principal Investigator: Bénédicte CLEMENT, MD
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Service d'accueil des urgences, Hôpital Lyon Sud, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evaluation arm	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Family; HADS; IES-R; Limitation or discontinuation of treatment
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Trauma and Stressor Related Disorders; COVID-19; Emergencies; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 69HCL20_0678

Drug and device information, study documents

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