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

Primary Purpose

Covid19, Post Traumatic Stress Disorder, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Post traumatic, Anxiety and depression evaluation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring HADS, IES-R, Family, Limitation or discontinuation of treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service des urgences, Hôpital Edouard Herriot, Hospices Civils de LyonRecruiting
  • service des urgences, Hôpital de la Croix-Rousse, Hospices Civils de LyonRecruiting
  • Service d'Accueil des Urgences, Hôpital Lyon Sud, Hospices Civils de LyonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluation arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 23, 2021
Last Updated
June 27, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04785807
Brief Title
STRESS From in Charge Relative Facing the Announcement of Decisions Limiting or Stopping Treatments in Emergency Room During the COVID-19 Epidemic
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Post Traumatic Stress Disorder, Anxiety
Keywords
HADS, IES-R, Family, Limitation or discontinuation of treatment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evaluation arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Post traumatic, Anxiety and depression evaluation
Intervention Description
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
Primary Outcome Measure Information:
Title
Post traumatic syndrome evaluated thanks to the Revised impact event scale (IES-R)
Description
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.
Time Frame
30 days after limitation or discontinuation of treatment announcement
Secondary Outcome Measure Information:
Title
Anxiety level at day 7, assessed using the Hospitalized Anxiety and Depression Scale-(HADS)
Description
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.
Time Frame
7 days after inclusion
Title
Depression level at day 7, assessed using the Hospitalized Anxiety and Depression Scale
Description
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.
Time Frame
7 days after inclusion
Title
Anxiety level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
30 days after inclusion
Title
Depression level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
30 days after inclusion
Title
Description of socio-demographic factors
Description
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.
Time Frame
30 days after inclusion
Title
Description of clinical factors
Description
In order to determine anxiety and depression risk factors, the factors linked to the patient (COVID infection, death) will be described.
Time Frame
30 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion DOUPLAT, MD
Phone
04.78.86.28.54
Ext
+ 33
Email
marion.douplat@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BERTHILLER
Phone
04 72 11 80 67
Ext
+ 33
Email
julien.berthiller@chu-lyon.fr
Facility Information:
Facility Name
Service des urgences, Hôpital Edouard Herriot, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent JACQUIN, MD
First Name & Middle Initial & Last Name & Degree
Laurent JACQUIN, MD
Facility Name
service des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte CLEMENT, MD
First Name & Middle Initial & Last Name & Degree
Bénédicte CLEMENT, MD
Facility Name
Service d'Accueil des Urgences, Hôpital Lyon Sud, Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion DOUPLAT, MD
Email
marion.douplat@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marion DOUPLAT, MD

12. IPD Sharing Statement

Learn more about this trial

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

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