Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19

COVID-19 Clinical Trial

— IPES-CoV  

Official title:

Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421182
• Other study ID #: CHMS21004
• Status: Completed
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: February 14, 2022

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Metropole Savoie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Stress Disorders, Post-Traumatic

Intervention

Other:
• Revised Impact of Event Scale
to measure the affect of routine life stress,everyday traumas and acute stress
• Hospital Anxiety and Depression scale
to measure anxiety and depression
• 36-Item Short Form Survey
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
• satisfaction survey
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
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
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

Locations

Country	Name	City	State
France	CH Metropole Savoie	Chambéry

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Metropole Savoie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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)	at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Secondary	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.
Secondary	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.
Secondary	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.