Clinical trial NCT04341519: Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers
Official title: "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corona Virus Infection
Post-traumatic Stress Disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 1464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Family members, Patients hospitalized in ICU for COVID19 infection. Healthcare providers involved in care of patients hospitalized in ICU for COVID19 infection.

Brief summary: Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus.

The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients.

PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).


Eligibility criteria: Inclusion Criteria:

* Patients:

  * Age\>18y
  * Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic
  * Having received invasive or noninvasive mechanical ventilation
  * Non-opposition to participate to the telephone interviews.

Family members:

* Age\>18y
* Non-opposition to participate to the telephone interviews
* One family member per patient: the family member the most implicated in the patient's care

Healthcare providers:

* All nurses and physicians (including those in training) in the participating ICUs during the COVID-19 pandemic

Exclusion Criteria:

* Patients:

  * Language barrier to be able to respond to the telephone interview
  * Cognitive disorders disabling patients to respond to the telephone interview
  * Person under legal protection (1121-8 of CSP, Public Health Code) Failure to obtain the non-opposition

Family members:

* Language barrier to be able to respond to the telephone interview
* Person under legal protection (1121-8 of CSP, Public Health Code)
* Failure to obtain the non-opposition

Healthcare providers:

Failure to obtain the non-opposition

Primary outcomes:
measure: PTSD Family members sup 22
timeFrame: 90 days
Secondary outcomes:
measure: PTSD Family members
timeFrame: 90 days
measure: PTSD Patients
timeFrame: 90 days
measure: PTSD healthcare providers
timeFrame: 2 months after official end of the Covid-19 peak
measure: HADS Family members
timeFrame: 90 days
measure: HADS Patients
timeFrame: 90 days
measure: SF36 Patients
timeFrame: 90 days
measure: Questionnaire Family members
timeFrame: 90 days
measure: Questionnaire Patients
timeFrame: 90 days
measure: Questionnaire healthcare providers
timeFrame: 2 months after official end of the Covid-19 peak
measure: MBI healthcare providers
timeFrame: 2 months after official end of the Covid-19 peak
measure: Karasec instrument healthcare providers
timeFrame: 2 months after official end of the Covid-19 peak
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint-Louis Hospital
state: Ile De France
city: Paris
country: France
facility: Cochin
city: Paris
country: France
facility: Pitié Salpetrière
Study officials:
affiliation: APHP
name: Elie AZOULAY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azoulay E, Resche-Rigon M, Megarbane B, Reuter D, Labbe V, Cariou A, Geri G, Van der Meersch G, Kouatchet A, Guisset O, Bruneel F, Reignier J, Souppart V, Barbier F, Argaud L, Quenot JP, Papazian L, Guidet B, Thiery G, Klouche K, Lesieur O, Demoule A, Guitton C, Capellier G, Mourvillier B, Biard L, Pochard F, Kentish-Barnes N. Association of COVID-19 Acute Respiratory Distress Syndrome With Symptoms of Posttraumatic Stress Disorder in Family Members After ICU Discharge. JAMA. 2022 Mar 15;327(11):1042-1050. doi: 10.1001/jama.2022.2017.