Containment Impact on Primary Care & Adverse Events Unrelated to COVID-19 in Older Patients and/or With Chronic Diseases

NCT04907994 | Unknown

• 1 other identifier: APHP201045
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

In 2017, 10.7 million people affiliated to the general health insurance scheme benefited from the "Long-term condition" scheme, i.e. 17% of insured patients. Most of these patients suffer from chronic diseases requiring regular medical and paramedical follow-up. During the first containment period of the SARS-CoV-2 epidemic, the French government's messages were to call the Urgent Medical Assistance Service (15) and not to go directly to the general practitioner (GP), favouring teleconsultations. Other countries have adopted the same strategy. Mortality rates due to SARS-CoV-2 infection were higher in elderly patients and/or those with co-morbidities, particularly heart failure, hypertension, respiratory failure and diabetes. The elderly and patients with chronic cardiometabolic and respiratory diseases should therefore be particularly protected during the epidemic. However, these populations also need close monitoring to avoid acute decompensation of their chronic diseases or loss of autonomy. However, during the first containment, general practitioners and other medical and paramedical ambulatory health professionals perceived a notable decrease in their daily activity, including for their chronic and/or elderly patients who may not have called for a visit, consultation and/or access to telemedicine. "Public Health France" also reported a decrease in consultations with GPs at the beginning of the lockdown, a decrease in the number of emergency room visits and hospitalizations for cardio and neurovascular diseases. The investigators hypothesise that under-attendance of primary care services during the epidemic is associated with excess mortality and morbidity unrelated to COVID-19. The main objective is to assess non-COVID-19 related overmortality during the containment period and 12 months after the start of containment, in a population of elderly and/or chronically ill patients in France. The overmortality will be assessed globally and according to individual and contextual characteristics such as gender, age, place of residence, pre-existing morbidity and socio-economic level.

Conditions

Covid19

Keywords

Containment; Primary care; Clinical adverse events; Older patients; Chronic diseases patients

Outcome Measures

Primary Outcomes (1)

• Non-COVID-19 related mortality

  Non-COVID-19 related mortality

  - Exhibition to containment (March 17, 2020 to May 10, 2020);- End of containment to end of follow-up (May 11, 2020 to March 17, 2021)

Secondary Outcomes (2)

• Healthcare utilization (Consultation, visits and teleconsultations ; drug delivery ; biological and radiological procedure).

  - Exhibition to containment (March 17, 2020 to May 10, 2020);- End of containment to end of follow-up (May 11, 2020 to March 17, 2021)

• Utilization of hospital services after containment

  - End of containment to end of follow-up (May 11, 2020 to March 17, 2021)

Study Arms (1)

Older patients and/or with chronic diseases

Retrospective cohort study of exposed/unexposed individuals in the national health data system (SNDS). The study population is composed of individuals aged 70 years or older and patients with a chronic disease. Exposure to containment is defined as the period between 17 March 2020 (beginning of week 12, start of containment) and 10 May 2020 (end of week 19, end of containment). The end of monitoring is set at 12 months after the start of the containment, on 17 March 2021. The unexposed group consists of random samples of comparable individuals (aged 70 years or older and/or chronically ill) for the two years prior to the outbreak (2015 and 2016). The second study period (May 10, 2020 to March 17, 2021) may be subdivided depending on the evolution of the health crisis and the governmental measures adopted. Measurement of the outcome measures and comparison between exposed and unexposed will be carried out at the end of each of the two periods.

Other: Cohort

Interventions

Cohort OTHER

Nothing. Only implementation of a cohort with data collection via the SNDS.

Older patients and/or with chronic diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population is made up of people aged 70 or over and / or suffering from chronic pathologies.

You may qualify if:

• Patients aged 70 or older and/or identification of at least one of the chronic pathologies listed in the protocol before the start of confinement (03/17/2020, start of the 12th week of the year)

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Créteil, 94 010, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Florence CANOUI-POITRINE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Emilie FERRAT, MD, PhD

  Inserm - Université Paris Est Créteil

  STUDY DIRECTOR

• Panayotis CONSTANTINOU, MD, PhD

  Caisse nationale de l'assurance maladie, direction de la stratégie, des études et des statistiques

  STUDY DIRECTOR

Central Study Contacts

Florence CANOUI-POITRINE, MD, PhD

CONTACT

+ 33 1 49 81 36 74; florence.canoui-poitrine@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: June 1, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: June 1, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)