Covid19COPINGNCT04908007
COvid Pandemic Institutional maNaGement
An observational study of Covid19, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Qualitative analysis for professionals, Quantitative analysis for Professionals and Quantitative analysis for Patients
- How many people
- 20,000 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Sep 2020to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Professionals and members of the institutions' bodies in the 4 university hospitals: Lyon, St Etienne, Clermont Ferrand, Grenoble * Adult patients hospitalized for at least 48 hours during the first wave of the pandemic COVID-19 in the 4 university hospitals: Lyon, St Etienne, Clermont Ferrand, Grenoble
Who may be able to join
- 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)
Show all 11Show fewer
- 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).
Who cannot join
- none
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHU Clermont-Ferrand , Pôle de Santé Publique, unité d'Epidémiologie, Economie de la Santé et Prévention
Clermont-Ferrand, 63003
Laurent GERBAUD, MD, lgerbaud@chu-clermontferrand.fr
- Recruiting
CHU Grenoble, Pôle Santé Publique, service de veille sanitaire
Grenoble, 38700
Patrice FRANCOIS, MD, PFrancois@chu-grenoble.fr
- Recruiting
Hospices Civils de Lyon, DOQ-RU
Lyon, 69002
Philippe MICHEL, MD, 4 72 40 71 03 ext. +33, philippe.michel@chu-lyon.fr
- Recruiting
CHU Saint-Etienne , Unité de gestion du risque infectieux
Saint-Etienne, 42055
Philippe BERTHELOT, MD, Philippe.berthelot@chu-st-Etienne.fr
About this study
Official title: Institutional Management and Professional Experience During the Pandemic COVID-19 by Health Care Institutions in the Auvergne-Rhône-Alpes Region: Assessment and Lessons Learned
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:
Read more
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.
- Conditions
- Covid19
- Being tested
- Qualitative analysis for professionals, Quantitative analysis for Professionals, Quantitative analysis for Patients, Tools development
- Keywords
- Covid-19, Institutional management process, Professional experience, Crisis management
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative analysis for professionalsOther
3 individual interviews with the different categories of professionals most involved during the crisis in each university hospital. In the first phase, the points of improvement identified will be analyzed In the second phase, good practices and innovations will be analyzed. For these first two phases, the duration of one hour was chosen because it is difficult to mobilize the professionals for longer. Individual interviews are preferred, but group interviews are possible with no more than three people so that everyone can express himself or herself. Finally, individual interviews of 15 to 30 minutes will be conducted with some of the people interviewed previously in order to identify the costs of the dysfunctions or problems encountered during the crisis.
Questionnaires with establishments associated with the crisis management, the ARS AuRA and France Assos Santé AuRA.
Analysis of evidence documents in the university hospitals
Quantitative analysis for ProfessionalsOther
A self-assessment of the three phases of the crisis management process (preparation, crisis management, crisis recovery) will be carried out in the participating establishments using the WHO grid with the target persons identified within the establishments.
This step will use the crisis response assessment tool developed by the WHO following the H1N1 pandemic in 2011. This grid will be adapted beforehand to the COVID-19 situation and to the local organization by the study's scientific committee. The dimensions investigated will be : Command and control, Communication, Safety and security, Triage, Surge capacity, Continuity of essential services; Human resources, Logistics and supply management, Post-disaster recovery.
The grids will be sent to the 4 university hospitals to be filled in with the target audience recommended by the WHO methodological guide.
The results of this self-assessment will be linked to and interpreted with the results of the interviews in phase 1.
Quantitative analysis for PatientsOther
A questionnaire of patients' perceptions on the same perimeter (crisis and post-crisis management, from the point of view of points of improvement and good practices) will be constructed and sent by the management of the establishments to all patients hospitalized for 48 hours or more during the first wave and who have left their email address (methods similar to the e-satis survey). The online questionnaire survey is preferred in order to get away from the emotion and for feasibility reasons. This patient experience questionnaire adapted to COVID will be co-constructed with expert/partner patients and user associations.
Four dimensions will be investigated : The perception of the quality of the information received by the patient, The nature of the information on the specific health protection protocol from which the patient benefited, The patient's consideration of the overall context, during and after, The effects of the health context on the overall management of the patient
Tools developmentOther
Development of tools to prepare for situations of uncertainty : In the third phase of the project, design thinking workshops will be organized (within the HCL) to develop training (in the form of simulation) in order to appropriate virtuous practices in situations of uncertainty. The purpose of these training sessions will be to improve the institution's ability to learn in a situation of uncertainty and thus to develop its reliability.
The aim of these workshops is to provide tools for raising awareness of situations of uncertainty to all hospital staff.
| Study group | Role | What they receive |
|---|---|---|
| Professional qualitative group | Qualitative analysis of crisis management by interviewing professionals most involved during the crisis in each university hospital. Receives: Other: Qualitative analysis for professionals | |
| Professional quantitative group | Quantitative analysis of crisis management using the WHO grid adapted sent to the target persons identified within the establishments Receives: Other: Quantitative analysis for Professionals | |
| Patient quantitative group | 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. Receives: Other: Quantitative analysis for Patients | |
| Tools development | Development of tools to prepare for situations of uncertainty Receives: Other: Tools development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crisis management process based on a qualitative approach
The qualitative evaluation (interviews, document review) will make it possible to identify the points of improvement and virtuous practices implemented in the establishments.
Measured: The Qualitative analysis (intervention 1) will take place from September, 2020 to December, 2021
Crisis management process based on a quantitative approach with the professionals (identified within the establishments)
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):
Measured: The Quantitative analysis for professionals (intervention 2) will be conducted from March, 2021 to June 2021.
Crisis management process based on a quantitative approach with the patients (hospitalized in the first wave)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Sep 2020
- Primary completionDec 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908007
- Sponsor's protocol ID
- 69HCL20_0466
- Acronym
- COPING
- Status last verified
- Apr 2021
- First submitted
- 17 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Management and Professional Experience During the Pandemic COVID-19 by Health Care Institutions in the Auvergne-Rhône-Alpes Region: Assessment and Lessons Learned
- ClinicalTrials.gov ID
- NCT04908007
- Acronym / sponsor ID
- COPING / 69HCL20_0466
- Conditions
- Covid19
- Keywords
- Covid-19, Institutional management process, Professional experience, Crisis management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Professional qualitative group | – | Other: Qualitative analysis for professionalsQualitative analysis of crisis management by interviewing professionals most involved during the crisis in each university hospital. |
| Professional quantitative group | – | Other: Quantitative analysis for ProfessionalsQuantitative analysis of crisis management using the WHO grid adapted sent to the target persons identified within the establishments |
| Patient quantitative group | – | Other: Quantitative analysis for PatientsQuantitative 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. |
| Tools development | – | Other: Tools developmentDevelopment of tools to prepare for situations of uncertainty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Professionals and members of the institutions' bodies in the 4 university hospitals: Lyon, St Etienne, Clermont Ferrand, Grenoble * Adult patients hospitalized for at least 48 hours during the first wave of the pandemic COVID-19 in the 4 university hospitals: Lyon, St Etienne, Clermont Ferrand, Grenoble
Key inclusion criteria (11 listed)
- Establishments :
- Professionals and members of the institutions' bodies:
- Adult patients hospitalized for at least 48 hours during the study period (quantitative study by questionnaires).
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative analysis for professionals3 individual interviews with the different categories of professionals most involved during the crisis in each university hospital. In the first phase, the points of improvement identified will be analyzed In the second phase, good practices and innovations will be analyzed. For these first two phases, the duration of one hour was chosen because it is difficult to mobilize the professionals for longer. Individual interviews are preferred, but group interviews are possible with no more than three people so that everyone can express himself or herself. Finally, individual interviews of 15 to 30 minutes will be conducted with some of the people interviewed previously in order to identify the costs of the dysfunctions or problems encountered during the crisis. Questionnaires with establishments associated with the crisis management, the ARS AuRA and France Assos Santé AuRA. Analysis of evidence documents in the university hospitals | Other | Professional qualitative group |
| Quantitative analysis for ProfessionalsA self-assessment of the three phases of the crisis management process (preparation, crisis management, crisis recovery) will be carried out in the participating establishments using the WHO grid with the target persons identified within the establishments. This step will use the crisis response assessment tool developed by the WHO following the H1N1 pandemic in 2011. This grid will be adapted beforehand to the COVID-19 situation and to the local organization by the study's scientific committee. The dimensions investigated will be : Command and control, Communication, Safety and security, Triage, Surge capacity, Continuity of essential services; Human resources, Logistics and supply management, Post-disaster recovery. The grids will be sent to the 4 university hospitals to be filled in with the target audience recommended by the WHO methodological guide. The results of this self-assessment will be linked to and interpreted with the results of the interviews in phase 1. | Other | Professional quantitative group |
| Quantitative analysis for PatientsA questionnaire of patients' perceptions on the same perimeter (crisis and post-crisis management, from the point of view of points of improvement and good practices) will be constructed and sent by the management of the establishments to all patients hospitalized for 48 hours or more during the first wave and who have left their email address (methods similar to the e-satis survey). The online questionnaire survey is preferred in order to get away from the emotion and for feasibility reasons. This patient experience questionnaire adapted to COVID will be co-constructed with expert/partner patients and user associations. Four dimensions will be investigated : The perception of the quality of the information received by the patient, The nature of the information on the specific health protection protocol from which the patient benefited, The patient's consideration of the overall context, during and after, The effects of the health context on the overall management of the patient | Other | Patient quantitative group |
| Tools developmentDevelopment of tools to prepare for situations of uncertainty : In the third phase of the project, design thinking workshops will be organized (within the HCL) to develop training (in the form of simulation) in order to appropriate virtuous practices in situations of uncertainty. The purpose of these training sessions will be to improve the institution's ability to learn in a situation of uncertainty and thus to develop its reliability. The aim of these workshops is to provide tools for raising awareness of situations of uncertainty to all hospital staff. | Other | Tools development |
Primary outcome
Crisis management process based on a qualitative approach
Time frame: 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 professionals (identified within the establishments)
Time frame: 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):
Crisis management process based on a quantitative approach with the patients (hospitalized in the first wave)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe MICHEL, MD (4 72 40 71 03 ext. +33, philippe.michel@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crisis management process based on a qualitative approach (time frame: The Qualitative analysis (intervention 1) will take place from September, 2020 to December, 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.