Impact of the COVID-19 Pandemic on the Organization of Healthcare in France

COVID-19 Clinical Trial

— IRIS  

Official title:

Impact of the Covid19 Pandemic on the Organization of Healthcare in France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05013047
• Other study ID #: 2021-13
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Laurent BOYER
• Phone: 04 91 38 75 83
• Email: laurent.boyer[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The 2020 COVID-19 pandemic, which began spreading on January 24, 2020 in France, has required a profound and rapid reorganization of the health system, based in particular on internal hospital reorganizations of front-line establishments, deprogramming of non-urgent activities, and transfers of non-covid19 patients to 2nd line facilities. Beyond the immediate impact on the management of patients infected with COVID-19, this reorganization may have reduced the capacity of management for patients requiring urgent or semi-urgent intervention, or may have postponed some necessary care. The isolation of patients at home may also have resulted in lower compliance to therapy and medical treatments and may have contributed to decompensation.

At the end of this crisis, the different organizational responses in France should be evaluated to identify the consequences and the areas for improvement in order to be prepared for future exceptional health situations. This investigation on healthcare systems confronted to an exceptional health situation thus seeks to determine if the profound reorganizations implemented during this health crisis have indirect effects on the performance of care, in particular if there is a destabilization of the care systems (emergency, semi-emergency and chronic), a loss of chance for the patients and if innovative care paths have emerged.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with one of these three types of chronic diseases (Prevention Quality Indicators of the Agency for Healthcare Research and Quality): heart failure, diabetes, chronic obstructive pulmonary disease.

• All French adult patients suffering from the studied chronic diseases, covered by the Health Insurance and living in metropolitan France are included.

Exclusion Criteria:

• Patients under 18 years of age or with incomplete or inconsistent data on the "Système National des Données de Santé", or with a symptomatic COVID-19 diagnosis.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the effect of pandemic COVID-19 on medication compliance in patients with chronic disease	Combined chronic drug coverage rate calculated on a three-monthly basis (average of the coverage rates for each drug)	Measured by trimesters (from March 2019 to February 2021)
Secondary	Evaluate the effects of pandemic and lock-down on the risk of decompensation in patients with chronic disease.	Occurrence of at least one hospitalization for acute decompensation during each of the 6-month periods studied (exposed or not to pandemic and lock-down).	6 months period