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At the "Métropole Savoie" hospital, to deal with the daily influx of severe patients during the second wave of COVID-19, 23 patients had to be transferred away from their home city and far from their families as part of a medical evacuation (EVASAN).
The purpose of the study is to investigate whether there is an association between medical evacuations and the occurrence of psychological disorders such as post-traumatic stress, anxiety or depression occurring within 6 to 10 months in families of evacuated patients.
The investigators want to compare the prevalence of psychological disorders in the families of patients evacuated for a serious form of COVID-19 (cases) compared to that of families of patients not evacuated (controls) hospitalized for a serious form of COVID-19.
The case group is trusted person of evacuated patient. The control group is trusted person of not evacuated patient.
The trusted person of the group control will be matched to trusted patient of the case group on :
their relationship with the patient (spouse/ascendant/descendant/other) and on criteria specific to the patient: sex, age range ( <75 years or ≥ 75 years), invasive ventilation and becoming at 3 months post COVID-19 (survivor / non survivor)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interview of the trusted person of evacuated patient | Other | The interview of the trusted person of evacuated patient will be done 8 months (+/-2 months) after the medical evacuation. The interview will be carried out by a psychologist or by a doctor from the ICU |
|
| Interview of the trusted person of the not evacuated patient | Other | The interview of the trusted person of the not evacuated patient will be done 8 months (+/-2months) after the ICU admission The interview will be carried out by a psychologist or by a doctor from the ICU. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revised Impact of Event Scale | Other | to measure the affect of routine life stress,everyday traumas and acute stress |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the prevalence of post-traumatic stress disorder, among families of patients with severe COVID-19 evacuated to another region (case) compared to families of matched patients with severe COVID-19 not evacuated to another region (controls). | the post-traumatic stress disorder of the trusted person is assessed by the Impact of Event Scale - Revised (IES-R), at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after Intensive Care Unit (ICU) admission for the control group | at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after ICU admission for the control group |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of anxiety and/or depression symptoms questionnaire in families of patients hospitalized with severe COVID-19. | Association between medical evacuations and the occurrence of symptoms of anxiety and/or depression at 8 months in families of patients hospitalized in intensive care for a serious form of COVID19. anxiety and/or depression symptoms assessed by the Hospital Anxiety and Depresion Scale (HADS) |
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Inclusion Criteria:
Trusted person of patients admitted to the Adult Intensive Care Unit (ICU) of the "Metropole Savoie"hospital
the case group is trusted person of evacuated patient. the control group is trusted person of not evacuated patient.
Non -inclusion criteria :
Trusted Person Refusing patient Medical Evacuation
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Peigne | CH Metropole Savoie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Metropole Savoie | Chambéry | 73000 | France |
The individual participant data (IPD) collected in this study, will not be available to other researchers
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Case-Control Study
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|
| Hospital Anxiety and Depression scale | Other | to measure anxiety and depression |
|
|
| 36-Item Short Form Survey | Other | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. |
|
|
| satisfaction survey | Other | satisfaction survey of the trusted person about the communication with ICU personal |
|
| semi-directed interview with trusted person on the general experience of the patient's medical evacuation | Other | interview of the trusted person about the medical evacuation : evacuation announcement;organization of the medical evacuation,; concerns related to evacuations;reception and information by the center admitting the evacuated patient; arrangements of visit, patient repatriated |
|
| semi-directed interview with trusted person on the general experience of hospitalization in intensive care | Other | interview of the trusted person about ICU hospitalization: reception in ICU; ICU organization; concerns related to ICU hospitalization, information and communication with ICU staff, arrangements of visit, context of ICU discharge |
|
| at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19. |
| Quality of Life in families of patients with severe COVID-19 | Quality of Life assessed by Medical Outcomes Study Short Form 36 (SF-36) | at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19. |
| Satisfaction with the communication between the health care team and the family of the patient hospitalized with severe form of COVID19 | satisfaction is measured using a simple digital scale, | at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19. |
| Qualitative analysis by a psychologist of a semi-structured interview of the testimony and specific experience of families at 8 months. | semi-structured interview | at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C018209 | 4-amino-4'-hydroxylaminodiphenylsulfone |
| D003422 | Critical Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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