Covid19COVER ACCNCT04785807
STRESS From in Charge Relative Facing the Announcement of Decisions Limiting or Stopping Treatments in Emergency Room During the COVID-19 Epidemic
A study testing Post traumatic, Anxiety and depression evaluation in people with Covid19 and Post Traumatic Stress Disorder, run by Hospices Civils de Lyon at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Post Traumatic Stress Disorder, Anxiety
- What is being tested?
- Post traumatic, Anxiety and depression evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Mar 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Person of trust, family or close friend unable to understand or write in French.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Service des urgences, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69003
Laurent JACQUIN, MD
Laurent JACQUIN, MD
- Recruiting
service des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, 69004
Bénédicte CLEMENT, MD
Bénédicte CLEMENT, MD
- Recruiting
Service d'Accueil des Urgences, Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69310
Marion DOUPLAT, MD, marion.douplat@chu-lyon.fr
Marion DOUPLAT, MD
About this study
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
- Being tested
- Post traumatic, Anxiety and depression evaluation
- Keywords
- HADS, IES-R, Family, Limitation or discontinuation of treatment
- Medical subject headings
- COVID-19, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post traumatic, Anxiety and depression evaluationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Evaluation arm | Experimental | Not described Receives: Other: Post traumatic, Anxiety and depression evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start30 Mar 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785807
- Sponsor's protocol ID
- 69HCL20_0678
- Acronym
- COVER ACC
- Status last verified
- Jun 2022
- First submitted
- 23 Feb 2021
- Last updated
- 28 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRESS From in Charge Relative Facing the Announcement of Decisions Limiting or Stopping Treatments in Emergency Room During the COVID-19 Epidemic
- ClinicalTrials.gov ID
- NCT04785807
- Acronym / sponsor ID
- COVER ACC / 69HCL20_0678
- Conditions
- Covid19, Post Traumatic Stress Disorder, Anxiety
- Keywords
- HADS, IES-R, Family, Limitation or discontinuation of treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation arm | Experimental | Other: Post traumatic, Anxiety and depression evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Person of trust, family or close friend unable to understand or write in French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post traumatic, Anxiety and depression evaluationFamily 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 | Other | Evaluation arm |
Primary outcome
Post traumatic syndrome evaluated thanks to the Revised impact event scale (IES-R)
Time frame: 30 days after limitation or discontinuation of treatment announcement
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.
6 secondary outcomes
Anxiety level at day 7, assessed using the Hospitalized Anxiety and Depression Scale-(HADS)
Time frame: 7 days after inclusion
Depression level at day 7, assessed using the Hospitalized Anxiety and Depression Scale
Time frame: 7 days after inclusion
Anxiety level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)
Time frame: 30 days after inclusion
Depression level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)
Time frame: 30 days after inclusion
Description of socio-demographic factors
Time frame: 30 days after inclusion
Description of clinical factors
Time frame: 30 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post traumatic, Anxiety and depression evaluation in people with Covid19 and Post Traumatic Stress Disorder, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marion DOUPLAT, MD (04.78.86.28.54 ext. + 33, marion.douplat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post traumatic syndrome evaluated thanks to the Revised impact event scale (IES-R) (time frame: 30 days after limitation or discontinuation of treatment announcement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.