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

26 janvier 2022 mis à jour par: Elisa Letellier, Hospices Civils de Lyon

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

71

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Follow-up
Autre: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale
Délai: 12 months after the end of the second Lockdown (December 2020)
: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale
Délai: 9months after the end of the second Lockdown (December 2020)
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
Délai: 12months after the end of the second Lockdown (December 2020)
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
Délai: 9months after the end of the second Lockdown (December 2020)
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
Délai: 12months after the end of the second Lockdown (December 2020)
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
Délai: 9months after the end of the second Lockdown (December 2020)
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
Délai: 12months after the end of the second Lockdown (December 2020)
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
Délai: 9months after the end of the second Lockdown (December 2020)
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
Délai: 12months after the end of the second Lockdown (December 2020)
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
Délai: 9months after the end of the second Lockdown (December 2020)
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
Délai: 12months after the end of the second Lockdown (December 2020)
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
Délai: 12months after the end of the second Lockdown (December 2020)
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
Délai: 12months after the end of the second Lockdown (December 2020)
Mean number of days of sick leave at 12 months
12months after the end of the second Lockdown (December 2020)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospices Civils de Lyon

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 octobre 2021

Achèvement primaire (Réel)

16 janvier 2022

Achèvement de l'étude (Réel)

16 janvier 2022

Dates d'inscription aux études

Première soumission

1 septembre 2021

Première soumission répondant aux critères de contrôle qualité

1 septembre 2021

Première publication (Réel)

2 septembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 69HCL21_0311

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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