Systematic Offer of Nurse-Driven Screening for COVID-19 in Emergency Departments in the Paris Metropolitan Area, DEPIST-COVID

NCT04756609 | Completed

• 2 other identifiers: APHP201625IDRCB: 2020-A03532-37
• Study Type: interventional
• Target: 138,352
• Locations: 1 country
• Sites: 1

Brief Summary

European countries faced another wave of the SARS-CoV2 pandemic, which has led to a second lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters. Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population. To the best the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area, one of the most SARS-CoV2 affected regions. The aim is to evaluate the benefit of a systematic offer of SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy) The strategies will be compared during two periods following a cluster-randomized two-period crossover design. During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients using a PCR multiplex for symptomatic patients and a RT-LAMP for asymptomatic patients.

Conditions

SARS-CoV Infection; Nurse's Role

Keywords

SARS-CoV-2; Mass screening; Emergency service; hospital Nurses; Prevention and control

Outcome Measures

Primary Outcomes (1)

• Proportion of patients tested positive for SARS-CoV2 amongst the flow of consulting adults

  At the end of the expected duration of the inclusion period (an average of 3 months in each ED)

Secondary Outcomes (8)

• Proportion of positive patients amongst asymptomatic patients and in the Paris Metropolitan area at the same period (these proportions will be compared amongst each ED geographic area, amongst symptomatic patients and amongst the tested population)

  At the end of the expected duration of the inclusion period (an average of 3 months in each ED)

• Feasibility of screening strategy : proportion of patients having completed the questionnaire, proportion of tests offered , accepted and performed, proportion of patients notified of the result and staff involved

  At the end of the expected duration of the study (2 months and 15±10 days + wash out in each ED)

• Description of patients tested in both periods (proportion of positive tests and of asymptomatic patients)

  At the end of the expected duration of the inclusion period (an average of 3 months in each ED)

• For symptomatic patients: description of the symptomatology

  At the end of the expected duration of the inclusion period (an average of 3 months in each ED)

• Description of patients tested in both periods: patient exposure factors with the DEPIST-COVID questionnaire

  At the end of the expected duration of the inclusion period (an average of 3 months in each ED)

Study Arms (2)

Systematic offer of nurse-driven SARS-CoV-2 screening + usual practice

EXPERIMENTAL

Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice

Procedure: Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice

Control group: Usual emergency department practice

ACTIVE COMPARATOR

Usual emergency department practice with physician-directed diagnostic testing

Other: Usual emergency department practice with physician-directed diagnostic testing

Interventions

Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice PROCEDURE

I- A SARS-CoV2 self-administered questionnaire about SARS-CoV2 symptoms, possibilities of close contacts, risk exposure situations and socio-demographic characteristics will be offered to patients included who are capable of filling it out. * The patient will fill out the questionnaire and hand it in to the nurse caring for him/her. * The nurse, regardless of the answers to the questionnaire, will offer the SARS-CoV2 screening. * A nasopharyngeal swab for SARS-CoV2 will be carried out. * A patient will be considered as symptomatic if he/she presents one or more symptoms listed in the questionnaire. * For symptomatic patients, a SARS-CoV2 for multiplex PCR will be carried out. This analysis takes 75 minutes. * For asymptomatic patients, a RT-LAMP test will be carried out. This analysis takes 5 to 15 minutes.

Systematic offer of nurse-driven SARS-CoV-2 screening + usual practice

Usual emergency department practice with physician-directed diagnostic testing OTHER

The physician offers a SARS-CoV2 test according to current recommendations. The tests are prescribed as a means of diagnosis for patients presenting symptoms suggestive of Covid-19 or as a means of diagnosis for patients requiring hospitalisation for another cause, before their transfer to hospital. Patients will be cared for according to usual procedures of each hospital. Patients tested positive will be asked to fill out the DEPIST-COVID questionnaire. Patients who had not completed it will be contacted by phone to answer the questions over the phone.

Control group: Usual emergency department practice

Eligibility Criteria

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

You may qualify if:

• All consulting adults visiting a participating ED

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

URC-EST, Hôpital saint-Antoine

Paris, 75571, France

Location

Related Publications (1)

• Leblanc J, Dusserre-Telmon L, Chauvin A, Simon T, Sabbatini CE, Hemming K, Colizza V, Berard L, Convert J, Lazazga S, Jegou C, Taibi N, Dautheville S, Zaghia D, Gerlier C, Domergue M, Larrouturou F, Bonnet F, Fontanet A, Salhi S, LeGoff J, Cremieux AC; DEPIST-COVID group; FHU IMPEC (Improving Emergency Care) group. Intensified screening for SARS-CoV-2 in 18 emergency departments in the Paris metropolitan area, France (DEPIST-COVID): A cluster-randomized, two-period, crossover trial. PLoS Med. 2023 Dec 7;20(12):e1004317. doi: 10.1371/journal.pmed.1004317. eCollection 2023 Dec.

  PMID: 38060611 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Judith LEBLANC, RN, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 16, 2021
• Study Start: March 12, 2021
• Primary Completion: May 31, 2021
• Study Completion: June 15, 2021
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)