Corona Virus Infection, Post-traumatic Stress Disorder
Conditions
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).
Interventions
BEHAVIORALPTSD
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
BEHAVIORALBurnout
Symptoms of burnout as assessed by the Maslash Burnout Inventory
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Family members sup 22 | 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Family members | 90 days | Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) |
| PTSD healthcare providers | 2 months after official end of the Covid-19 peak | Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) |
| HADS Family members | 90 days | Among Family members Symptoms of anxiety and depression using the HADS scale |
| HADS Patients | 90 days | Among Patients Symptoms of anxiety and depression using the HADS scale |
| SF36 Patients | 90 days | Among Patients Mental and physical health-related quality of life as assessed by the SF36 |
| PTSD Patients | 90 days | Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) |
| Questionnaire Patients | 90 days | Among Patients Questionnaire describing their experience of the patient's ICU hospitalization |
| Questionnaire healthcare providers | 2 months after official end of the Covid-19 peak | Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization |
| MBI healthcare providers | 2 months after official end of the Covid-19 peak | Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers |
| Karasec instrument healthcare providers | 2 months after official end of the Covid-19 peak | Job Strain as assessed by the Karasec instrument |
| Questionnaire Family members | 90 days | Among Family members Questionnaire describing their experience of the patient's ICU hospitalization |
Countries
France
Contacts
Primary ContactNancy KENTISH-BARNES, PhD
Backup ContactMatthieu RESCHE-RIGON, MD PhD
Outcome results
None listed