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

NCT05421182 | Completed

• 1 other identifier: CHMS21004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Prevalence of anxiety and/or depression symptoms questionnaire in families of patients hospitalized with severe COVID-19.

  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

  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

  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.

  at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.

Study Arms (2)

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

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

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.

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 hospitalization in intensive care

Interventions

Revised Impact of Event Scale OTHER

to measure the affect of routine life stress,everyday traumas and acute stress

Also known as: IES-R

Interview of the trusted person of evacuated patient; Interview of the trusted person of the not evacuated patient

Hospital Anxiety and Depression scale OTHER

to measure anxiety and depression

Also known as: HADS

Interview of the trusted person of evacuated patient; Interview of the trusted person of the not evacuated patient

36-Item Short Form Survey OTHER

SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.

Also known as: SF-36

Interview of the trusted person of evacuated patient; Interview of the trusted person of the not evacuated patient

satisfaction survey OTHER

satisfaction survey of the trusted person about the communication with ICU personal

Interview of the trusted person of evacuated patient; Interview of the trusted person of the not evacuated patient

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

Interview of the trusted person of evacuated patient

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

Interview of the trusted person of the not evacuated patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Trusted Person Refusing patient Medical Evacuation

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

CH Metropole Savoie

Chambéry, 73000, France

Location

MeSH Terms

Conditions

COVID-19; Stress Disorders, Post-Traumatic

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone; Critical Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Vincent Peigne

  CH Metropole Savoie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-Control Study

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: June 30, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 28, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)