COvid Pandemic Institutional maNaGement

• Conditions: Covid19
• Interventions: Other: Quantitative analysis for Patients; Other: Qualitative analysis for professionals; Other: Quantitative analysis for Professionals; Other: Tools development

• Registration Number: NCT04908007
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Covid-19 has increased organizational tensions within health services (lack of resources, difficulties in recruiting healthcare professionals , elderly and polypathological patients, etc.) and tested the reliability of health facilities. This project aims to draw lessons so that hospitals can transform themselves while improving their reliability to face future crises and other exceptional situations.

Research hypothesis:

Crisis management arrangements lack sensitivity to uncertainty, which manifests itself in lower quality of care and efficiency losses for the entire institution.

The virtuous practices implemented during the crisis spontaneously incorporated principles of the highly reliable organization.

The integration of principles from complexity theory into the management of institutions promotes high reliability organization.

Sustaining these virtuous practices in order to anticipate and cope with crises requires the activation of two interconnected levers: a shared vision (by patients, healthcare professionals, ARS, HAS, and the Ministry in the first place) of the meaning of the action taken by hospitals, and the development of a policy enabling hospitals to become both learning and highly reliable.

Main objective:

To evaluate the management process of the Covid-19 epidemic by the university hospitals of the Auvergne-Rhône-Alpes region, and the structures linked to them (establishments in their territory, ARS, user associations), in terms of points of improvement and good practices. This evaluation concerns the preparation, management and exit phases of the crisis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-04
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-06-01
• Last Update Posted: 2021-06-01
• Primary Completion: 2021-12
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Establishments :

  • 4 university hospitals: Lyon, St Etienne, Clermont Ferrand, Grenoble
  • Establishments in the same territories, public and private

• Professionals and members of the institutions' bodies:

  • Governance: management and chair of the CME
  • Management (care, communication, medical, technical, logistics, IT, personnel)
  • Clinical and public health cluster governance
  • Medical, paramedical and non-medical staff in the departments most concerned (emergency and EMS reception, intensive care, infectiology, hygiene, virology, imaging, occupational medicine in particular)
  • Organizations representing the personnel
  • Members of the users' representatives committee

• Adult patients hospitalized for at least 48 hours during the study period (quantitative study by questionnaires).

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient quantitative group	Quantitative analysis for Patients	Quantitative analysis of crisis management using a questionnaire sent to patients hospitalized in the first wave asking them about their perception of crisis and post-crisis management.
Professional qualitative group	Qualitative analysis for professionals	Qualitative analysis of crisis management by interviewing professionals most involved during the crisis in each university hospital.
Professional quantitative group	Quantitative analysis for Professionals	Quantitative analysis of crisis management using the WHO grid adapted sent to the target persons identified within the establishments
Tools development	Tools development	Development of tools to prepare for situations of uncertainty

Primary Outcome Measures

Name	Time	Method
Crisis management process based on a qualitative approach	The Qualitative analysis (intervention 1) will take place from September, 2020 to December, 2021	The qualitative evaluation (interviews, document review) will make it possible to identify the points of improvement and virtuous practices implemented in the establishments.
Crisis management process based on a quantitative approach with the patients (hospitalized in the first wave)	The Quantitative analysis for patients (intervention 3) will be conducted from March, 2021 to June 2021. The tool development phase (intervention 4) will be carried out from January, 2022 to June, 2022	The second quantitative evaluation will be based on patients' perceptions with a constructed questionnaire on theses perimeters: crisis and post-crisis management, from the point of view of points of improvement and good practices.; This patient experience questionnaire will be adapted to COVID with expert/partner patients and user associations.
Crisis management process based on a quantitative approach with the professionals (identified within the establishments)	The Quantitative analysis for professionals (intervention 2) will be conducted from March, 2021 to June 2021.	The quantitative evaluation will be based on the WHO checklist. This first part will report, for each hospital, the proportion of items validated in each dimension of the WHO checklist (https://www.who.int/publications/i/item/hospital-emergency-response-checklist):

Trial Locations

Locations (4)

CHU Clermont-Ferrand , Pôle de Santé Publique, unité d'Epidémiologie, Economie de la Santé et Prévention; 🇫🇷 Clermont-Ferrand, France

CHU Grenoble, Pôle Santé Publique, service de veille sanitaire; 🇫🇷 Grenoble, France

CHU Saint-Etienne , Unité de gestion du risque infectieux; 🇫🇷 Saint-Étienne, France

Hospices Civils de Lyon, DOQ-RU; 🇫🇷 Lyon, France