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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family members |
|
| |
| Patients | Patients:
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| |
| healthcare providers | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTSD | Behavioral | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Patients:
Family members:
Healthcare providers:
Exclusion Criteria:
Patients:
Family members:
Healthcare providers:
Failure to obtain the non-opposition
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Family members, Patients hospitalized in ICU for COVID19 infection. Healthcare providers involved in care of patients hospitalized in ICU for COVID19 infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy KENTISH-BARNES, PhD | Contact | 142499995 | +33 | nancy.kentish@aphp.fr |
| Matthieu RESCHE-RIGON, MD PhD | Contact | 142499742 | +33 | matthieu.resche-rigon@u-paris.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elie AZOULAY, MD PhD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin | Recruiting | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35179564 | Derived | 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. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000728151 | Maslach Burnout Inventory |
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|
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| Burnout | Behavioral | Symptoms of burnout as assessed by the Maslash Burnout Inventory |
|
| 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 |
| Pitié Salpetrière | Recruiting | Paris | France |
|
| Saint-Louis Hospital | Not yet recruiting | Paris | Île-de-France Region | 75010 | France |
|
| D007239 |
| Infections |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |