Clinical trial NCT04979208: 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)
Official title: 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 the Aquitaine Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019
Stroke
Acute Myocardial Infarction
Keywords: Stroke
Acute Myocardial Infarction
Coronavirus Disease 2019
Health Organization
Health Inequalities
Healthcare pathway
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 9218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for an AMI or a recent stroke

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years, domiciled in metropolitan France
* Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for AMI
* Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for recent stroke

Exclusion Criteria:

AMI cohort :

* Patient with pacemaker;
* Patients in cardiac arrest before performing the first qualifying ECG.

Stroke cohort :

- Patients treated for sequelae rehabilitation, complications of a recent stroke, transient ischemic accident or any other neurological pathology

Both :

Patients who refused to participate

Primary outcomes:
measure: Delay for AMI patient
timeFrame: At inclusion in the cohort during the acute episode
measure: Delay for stroke patient
timeFrame: At inclusion in the cohort during the acute episode
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References:
citation: Lesaine E, Francis-Oliviero F, Domecq S, Bijon M, Cetran L, Coste P, Lhuaire Q, Miganeh-Hadi S, Pradeau C, Rouanet F, Sevin F, Sibon I, Saillour-Glenisson F; AVICOVID group. Effects of healthcare system transformations spurred by the COVID-19 pandemic on management of stroke and STEMI: a registry-based cohort study in France. BMJ Open. 2022 Sep 21;12(9):e061025. doi: 10.1136/bmjopen-2022-061025.