Clinical trial NCT05421182: Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19
Official title: Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Stress Disorders, Post-Traumatic
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-Control Study
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

Trusted person of patients admitted to the Adult Intensive Care Unit (ICU) of the "Metropole Savoie"hospital

* during the second wave of COVID-19 in France
* for a serious form of COVID-19
* hospitalized more than 72 hours in ICU

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

Primary outcomes:
measure: 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).
timeFrame: at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after ICU admission for the control group
Secondary outcomes:
measure: Prevalence of anxiety and/or depression symptoms questionnaire in families of patients hospitalized with severe COVID-19.
timeFrame: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
measure: Quality of Life in families of patients with severe COVID-19
timeFrame: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
measure: Satisfaction with the communication between the health care team and the family of the patient hospitalized with severe form of COVID19
timeFrame: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
measure: Qualitative analysis by a psychologist of a semi-structured interview of the testimony and specific experience of families at 8 months.
timeFrame: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Other outcomes:
Locations:
city: Chambéry
country: France
facility: CH Metropole Savoie
Study officials:
affiliation: CH Metropole Savoie
name: Vincent Peigne
role: PRINCIPAL_INVESTIGATOR
References: