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

NCT04785807 | Unknown

• 1 other identifier: 69HCL20_0678
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19; Post Traumatic Stress Disorder; Anxiety

Keywords

HADS; IES-R; Family; Limitation or discontinuation of treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Anxiety level at day 7, assessed using the Hospitalized Anxiety and Depression Scale-(HADS)

  7 days after inclusion

• Depression level at day 7, assessed using the Hospitalized Anxiety and Depression Scale

  7 days after inclusion

• Anxiety level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)

  30 days after inclusion

• Depression level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)

  30 days after inclusion

• Description of socio-demographic factors

  30 days after inclusion

Study Arms (1)

Evaluation arm

EXPERIMENTAL

Other: Post traumatic, Anxiety and depression evaluation

Interventions

Post traumatic, Anxiety and depression evaluation OTHER

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

Evaluation arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Service des urgences, Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

service des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

Service d'Accueil des Urgences, Hôpital Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Stress Disorders, Post-Traumatic; Anxiety Disorders

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; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Marion DOUPLAT, MD

CONTACT

04.78.86.28.54; marion.douplat@chu-lyon.fr

Julien BERTHILLER

CONTACT

04 72 11 80 67; julien.berthiller@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 8, 2021
• Study Start: March 30, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

FR (3)