Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services (COVER PRO LT)
Primary Purpose
Post Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic
Sponsored by
About this trial
This is an interventional health services research trial for Post Traumatic Stress Disorder focused on measuring post traumatic stress disorder, PTSD, emergency services, COVID-19, burn-out
Eligibility Criteria
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
Sites / Locations
- Service d'Accueil des Urgences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Follow-up
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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.
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.
Work-related stress measured using Karasek questionnaire at 12 months
Work-related stress measured using Karasek questionnaire at 12 months
Work-related stress measured using Karasek questionnaire at 9 months
Work-related stress measured using Karasek questionnaire at 9 months
Consumption of psychoactive substances at 12 months
Change in the consumption of psychoactive substances at 12 months
Percentage of patients with psychological Support at 12 months
Percentage of patients who benefit from a psychological support at 12 months
Mean number of days of sick leave at 12 months
Mean number of days of sick leave at 12 months
Full Information
NCT ID
NCT05033223
First Posted
September 1, 2021
Last Updated
January 26, 2022
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT05033223
Brief Title
Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
January 16, 2022 (Actual)
Study Completion Date
January 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
post traumatic stress disorder, PTSD, emergency services, COVID-19, burn-out
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Follow-up
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic
Intervention Description
PCL-5 autoquestionnaire to make the PTSD diagnosis
Primary Outcome Measure Information:
Title
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale
Description
: 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
Time Frame
12 months after the end of the second Lockdown (December 2020)
Secondary Outcome Measure Information:
Title
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale
Description
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
Time Frame
9months after the end of the second Lockdown (December 2020)
Title
Anxiety evaluation at 12 months using HAD scale
Description
Existence of anxious symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder
Time Frame
12months after the end of the second Lockdown (December 2020)
Title
Anxiety evaluation at 9 months using HAD scale
Description
Existence of anxious symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder
Time Frame
9months after the end of the second Lockdown (December 2020)
Title
Depression evaluation at 12 months using HAD scale
Description
Existence of depression symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder
Time Frame
12months after the end of the second Lockdown (December 2020)
Title
Depression evaluation at 9 months using HAD scale
Description
Existence of depression symptomatology assessed by the HAD scale. 14 items, cut-off score: 8 suspected disorder, 11: proven disorder
Time Frame
9months after the end of the second Lockdown (December 2020)
Title
Presence of a Burn out at 12 months using the Maslach Burnot Inventory (MBI) scale
Description
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.
Time Frame
12months after the end of the second Lockdown (December 2020)
Title
Presence of a Burn out at 9 months using the MBI scale
Description
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.
Time Frame
9months after the end of the second Lockdown (December 2020)
Title
Work-related stress measured using Karasek questionnaire at 12 months
Description
Work-related stress measured using Karasek questionnaire at 12 months
Time Frame
12months after the end of the second Lockdown (December 2020)
Title
Work-related stress measured using Karasek questionnaire at 9 months
Description
Work-related stress measured using Karasek questionnaire at 9 months
Time Frame
9months after the end of the second Lockdown (December 2020)
Title
Consumption of psychoactive substances at 12 months
Description
Change in the consumption of psychoactive substances at 12 months
Time Frame
12months after the end of the second Lockdown (December 2020)
Title
Percentage of patients with psychological Support at 12 months
Description
Percentage of patients who benefit from a psychological support at 12 months
Time Frame
12months after the end of the second Lockdown (December 2020)
Title
Mean number of days of sick leave at 12 months
Description
Mean number of days of sick leave at 12 months
Time Frame
12months after the end of the second Lockdown (December 2020)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service d'Accueil des Urgences
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
12. IPD Sharing Statement
Learn more about this trial
Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services
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