Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Corona Virus Infection, Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: PTSD
* Behavioral: Burnout


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Family members<br>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 3 groups of Family members will be enrolled in the study corresponding to patients with COVID-19, patients with seasonal flu and patients with community acquired pneumonia (See below). 1 family member per patient will be recruited. | Behavioral: PTSD<br>* family members: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days Patients: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days<br>|
| Patients<br>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. 3 groups of patients will be enrolled in the study: patients with COVID-19, patients with seasonal flu and patients with community acquired pneumonia. COVID group : Patients admitted to the ICU for acute respiratory failure and having a positive 2019-nCOV RT PCR in a respiratory / nasal swab sample (GROUP COVID-19) Group FLU : patients admitted to the ICU for acute respiratory failure and having a confirmed influenza pneumonia Group CAP (Community-acquired pneumonia) : patients admitted to the ICU for acute respiratory failure and having a clinically or microbiologically documental community acquired pneumonia with negative COVID-19 and Influenza PCRs. | Behavioral: PTSD<br>* family members: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days Patients: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days<br>|
| healthcare providers<br>Two months after the official end of the COVID-19 peak in France, the local investigator will receive a set of 100 questionnaires. He/she will be responsible for proposing survey participation to volunteer healthcare providers. Those who are interested will be given the information letter and the questionnaires in an envelope. Once completed anonymously, they will seal the envelope and give it to the local investigator who will then send us all completed questionnaires by registered post. | Behavioral: Burnout<br>* Symptoms of burnout as assessed by the Maslash Burnout Inventory<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Family members sup 22 | Proportion of Family members with IES-R> 22 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 of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411 | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Family members | Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) | 90 days | 
| PTSD Patients | Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) | 90 days | 
| PTSD healthcare providers | Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) | 2 months after official end of the Covid-19 peak | 
| HADS Family members | Among Family members Symptoms of anxiety and depression using the HADS scale | 90 days | 
| HADS Patients | Among Patients Symptoms of anxiety and depression using the HADS scale | 90 days | 
| SF36 Patients | Among Patients Mental and physical health-related quality of life as assessed by the SF36 | 90 days | 
| Questionnaire Family members | Among Family members Questionnaire describing their experience of the patient's ICU hospitalization | 90 days | 
| Questionnaire Patients | Among Patients Questionnaire describing their experience of the patient's ICU hospitalization | 90 days | 
| Questionnaire healthcare providers | Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization | 2 months after official end of the Covid-19 peak | 
| MBI healthcare providers | Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers | 2 months after official end of the Covid-19 peak | 
| Karasec instrument healthcare providers | Job Strain as assessed by the Karasec instrument | 2 months after official end of the Covid-19 peak |