NCT04979208: AVICOVID

Impact of Changes in the Use of Care and Reorganization of the Healthcare System Linked to the Covid-19 Outbreak on the Quality of Care Pathways of Patients Suffering From Acute Myocardial Infarction and Stroke in Aquitaine (AVICOVID)

Completed Last updated 11 August 2021

What this trial tests

trial in Coronavirus Disease 2019 in 9,218 participants. Completed in 9 July 2021.

Timeline

15 July 2020

Primary endpoint
9 July 2021

9 July 2021

Quick facts

Lead sponsor	University Hospital, Bordeaux
Status	Completed
Study type	OBSERVATIONAL
Enrollment	9,218
Start date	15 July 2020
Primary completion	9 July 2021
Estimated completion	9 July 2021
Sites	1 location across France

Conditions studied

• Coronavirus Disease 2019 — all drugs for Coronavirus Disease 2019 →
• Stroke — all drugs for Stroke →
• Acute Myocardial Infarction — all drugs for Acute Myocardial Infarction →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Coronavirus Disease 2019 or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Covid-19 pandemic and its health and societal consequences raise fears of a deterioration in the management of non-Covid-19 pathologies, particularly those requiring rapid treatment. These fears relate in particular to strokes and acute myocardial infarctions (AMI), the two most frequent diseases, for which emergency treatment is a major factor in the vital and functional prognosis of patients. They are based on activity data from the emergency services, which have shown a sharp drop in admissions for AMI and strokes at the start of the pandemic. This drop is interpreted as being partly linked to a tendency for patients to delay or even give up care, which may be explained by fear of contamination, the desire not to solicit already overworked healthcare professionals and overload in emergency structures. In addition, studies have shown that the time required to treat AMI during the pandemic phase in China has been extended due to the new organizations set up in healthcare institutions in connection with this major health event. In addition, certain inequalities in access to care, already identified during the non- pandemic period among AMI and stroke patients, are likely to be accentuated by the new healthcare organizations set up during the pandemic period.

The investigators are interested in the impact of changes in healthcare utilization and reorganization within hospitals, related to the Covid-19 pandemic, on the quality of the care pathway for stroke and AMI patients in the Aquitaine region. The investigators also study the role of the socio-demographic, socio-economic and geographical characteristics of these patients as factors of inequality of access to care during this period.

The project is based on data collected within the Aquitaine Cardio-Neuro-Vascular Registries (CNV), an exhaustive cohort of stroke and AMI patients treated by a health care institution in Aquitaine. They are an excellent tool for describing the care pathway and outcomes of these patients, from the onset of symptoms to the end of the acute episode. An additional collection is planned to collect all the organizations and activities set up within the hospitals in Aquitaine. The study period, from January 2019 to August 2020, provides sufficient time before lockdown and after the date of the end of lockdown, to analyze trends in the quality of pathways, according to the various reorganizations of the health system and changes in the use of care linked to the management of the Covid-19 pandemic.

The project identifies the reorganizations with the most striking consequences on the quality of care for patients suffering from non Covid-19 pathologies. It analyzes the changes in the behaviour of patients and their family and caregivers in their use of care during the Covid-19 pandemic and their impact on the care pathways and results. It contributes to the policy of reducing inequalities in access to care and to the definition of a health strategy in the event of a major health crisis.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of healthcare system transformations spurred by the COVID-19 pandemic on management of stroke and STEMI: a registry-based cohort study in France.
   Lesaine E, Francis-Oliviero F, Domecq S, Bijon M, et al · · 2022 · cited 9× · PMID 36130741 · DOI 10.1136/bmjopen-2022-061025
2. Social and clinical vulnerability in stroke and STEMI management during the COVID-19 pandemic: a registry-based study.
   Lesaine E, Francis F, Domecq S, Miganeh-Hadi S, et al · · 2024 · cited 3× · PMID 38171619 · DOI 10.1136/bmjopen-2023-073933
3. The Impact of the Healthcare System Transformations Spurred by the COVID-19 Pandemic on Stroke and STEMI Management: Cohorts of Patients Included in a French Regional Cardio-Neuro-Vascular Registry
   Lesaine E, Francis F, Domecq S, Bijon M, et al · · 2021 · DOI 10.2139/ssrn.3922670