Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services

Post Traumatic Stress Disorder Clinical Trial

— COVER PRO LT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05033223
• Other study ID #: 69HCL21_0311
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: January 16, 2022

Study information

• Verified date: January 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 16, 2022
• Est. primary completion date: January 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Emergencies
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
France	Service d'Accueil des Urgences	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)