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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Stress Disorders, Post-Traumatic
• Intervention / Treatment: Other: Revised Impact of Event Scale; Other: Hospital Anxiety and Depression scale; Other: 36-Item Short Form Survey; Other: satisfaction survey; Other: semi-directed interview with trusted person on the general experience of the patient's medical evacuation; Other: semi-directed interview with trusted person on the general experience of hospitalization in intensive care

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)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Chambéry, France, 73000
    • CH Métropole Savoie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interview of the trusted person of evacuated patient; 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	Other: Revised Impact of Event Scale; to measure the affect of routine life stress,everyday traumas and acute stress; Other Names: IES-R; Other: Hospital Anxiety and Depression scale; to measure anxiety and depression; Other Names: HADS; Other: 36-Item Short Form Survey; SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.; Other Names: SF-36; Other: satisfaction survey; satisfaction survey of the trusted person about the communication with ICU personal; Other: 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
Other: Interview of the trusted person of the not evacuated patient; 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.	Other: Revised Impact of Event Scale; to measure the affect of routine life stress,everyday traumas and acute stress; Other Names: IES-R; Other: Hospital Anxiety and Depression scale; to measure anxiety and depression; Other Names: HADS; Other: 36-Item Short Form Survey; SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.; Other Names: SF-36; Other: satisfaction survey; satisfaction survey of the trusted person about the communication with ICU personal; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Metropole Savoie
• Investigators: Principal Investigator: Vincent Peigne, CH Métropole Savoie

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; COVID-19; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: CHMS21004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) collected in this study, will not be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No