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

Assistance Publique - Hôpitaux de Paris1,464 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,464

Conditions

Corona Virus Infection Post-traumatic Stress Disorder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 90 days

Secondary Outcomes

PTSD Family members

Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Time frame: 90 days

PTSD Patients

Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Time frame: 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)

Time frame: 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

Time frame: 90 days

HADS Patients

Among Patients Symptoms of anxiety and depression using the HADS scale

Time frame: 90 days

SF36 Patients

Among Patients Mental and physical health-related quality of life as assessed by the SF36

Time frame: 90 days

Questionnaire Family members

Among Family members Questionnaire describing their experience of the patient's ICU hospitalization

Time frame: 90 days

Questionnaire Patients

Among Patients Questionnaire describing their experience of the patient's ICU hospitalization

Time frame: 90 days

Questionnaire healthcare providers

Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization

Time frame: 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

Time frame: 2 months after official end of the Covid-19 peak

Karasec instrument healthcare providers

Job Strain as assessed by the Karasec instrument

Time frame: 2 months after official end of the Covid-19 peak

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts