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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04785807
Acronym
COVER ACC
Enrollment
140
Registered
2021-03-08
Start date
2021-03-30
Completion date
2023-07-30
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Covid19, Post Traumatic Stress Disorder

Keywords

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

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.

Interventions

OTHERPost 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post traumatic syndrome evaluated thanks to the Revised impact event scale (IES-R)30 days after limitation or discontinuation of treatment announcementThe 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

MeasureTime frameDescription
Depression level at day 7, assessed using the Hospitalized Anxiety and Depression Scale7 days after inclusionEvaluation 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)30 days after inclusionEvaluation 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.
Anxiety level at day 7, assessed using the Hospitalized Anxiety and Depression Scale-(HADS)7 days after inclusionEvaluation 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.
Description of socio-demographic factors30 days after inclusionIn 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 factors30 days after inclusionIn order to determine anxiety and depression risk factors, the factors linked to the patient (COVID infection, death) will be described.
Depression level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)30 days after inclusionEvaluation 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.

Countries

France

Contacts

Primary ContactMarion DOUPLAT, MD
marion.douplat@chu-lyon.fr04.78.86.28.54
Backup ContactJulien BERTHILLER
julien.berthiller@chu-lyon.fr04 72 11 80 67

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026