Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services (COVER PRO LT)

Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services and SAMU: Multicenter Cohort Study (COVid in EmeRgency PROfessionnals Long Term)

The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO. In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products. This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic. It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD. These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Other: PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Service d'Accueil des Urgences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults
• Administrative and technical medical staff of the Hospices Civils de Lyon
• Contractual or holder
• Having participated in the COVER PRO study
• Working in one of the HCL phase 3 departments of the COVID-19 pandemic.
• Affiliated with a social security system
• Having signed an informed consent

Exclusion Criteria:

• Refusal to participate
• Major under legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Follow-up	Other: PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic; PCL-5 autoquestionnaire to make the PTSD diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale	: Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening. The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life	12 months after the end of the second Lockdown (December 2020)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale	Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening. The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life	9months after the end of the second Lockdown (December 2020)
Anxiety evaluation at 12 months using HAD scale	Existence of anxious symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder	12months after the end of the second Lockdown (December 2020)
Anxiety evaluation at 9 months using HAD scale	Existence of anxious symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder	9months after the end of the second Lockdown (December 2020)
Depression evaluation at 12 months using HAD scale	Existence of depression symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder	12months after the end of the second Lockdown (December 2020)
Depression evaluation at 9 months using HAD scale	Existence of depression symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder	9months after the end of the second Lockdown (December 2020)
Presence of a Burn out at 12 months using the Maslach Burnot Inventory (MBI) scale	Burnout characterized by the Maslach burnout inventory scale. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout.	12months after the end of the second Lockdown (December 2020)
Presence of a Burn out at 9 months using the MBI scale	Burnout characterized by the Maslach burnout inventory scale. All MBI items are scored using a 7 level frequency ratings from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout.	9months after the end of the second Lockdown (December 2020)
Work-related stress measured using Karasek questionnaire at 12 months	Work-related stress measured using Karasek questionnaire at 12 months	12months after the end of the second Lockdown (December 2020)
Work-related stress measured using Karasek questionnaire at 9 months	Work-related stress measured using Karasek questionnaire at 9 months	9months after the end of the second Lockdown (December 2020)
Consumption of psychoactive substances at 12 months	Change in the consumption of psychoactive substances at 12 months	12months after the end of the second Lockdown (December 2020)
Percentage of patients with psychological Support at 12 months	Percentage of patients who benefit from a psychological support at 12 months	12months after the end of the second Lockdown (December 2020)
Mean number of days of sick leave at 12 months	Mean number of days of sick leave at 12 months	12months after the end of the second Lockdown (December 2020)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): January 16, 2022
• Study Completion (Actual): January 16, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: PTSD; COVID-19; post traumatic stress disorder; burn-out; emergency services
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Trauma and Stressor Related Disorders; COVID-19; Emergencies; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 69HCL21_0311

Drug and device information, study documents

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