Asthma Attack in the Emergency Department : Reasons Of This Attendance (AERO)

Objective: Identify modifiable factors that may affect asthma control and the use of emergency room to define customized interventions for the management of asthma prior to emergency room.

Emergency department attendance is always a sign of poor balance or control of asthma. In spite of a decrease in the number of deaths that has been halved in 20 years and hospitalization due to asthmatic disease, the use of emergency center for this disease has not decreased. We now know that the passage through emergencies and hospitalization for aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor balance or control of asthma is essential to further reduce the mortality and morbidity of asthma.

Study Overview

• Status: Completed
• Conditions: Emergency Medicine; Asthma Attack
• Intervention / Treatment: Other: completion of self-reported questionnaires

Detailed Description

There is two parts in this study:

Part 1 - Qualitative study by individual interviews until data saturation (although about ten patients should be enough to capture the concepts of interest) on the factors that induce an imbalance of asthma (based on the GINA (Global Initiative for Asthma) report whose criteria are validated).

An interview guide will be written to systematically address all aspects related to asthma control.

In agreement with the patient the interview will be recorded, and the verbatim will be transcribed and coded using a software (Nvivo version 10).

Preparation of a questionnaire

A questionnaire will be developed from:

• analysis of patient verbatim
• other data: GINA criteria, psychological criteria (psychological distress is assessed by the 12-item general health questionnaire (GHQ-12) which is valid psychometric tools in French) and social criteria.

Part 2-Observational cohort qualitative study. The questionnaire thus prepared will be placed in the patient file upon admission. As soon as possible it will be filled by the patient after improvement of his condition and collected by the doctor or nurse who took care of the patient.

To obtain sufficient power to demonstrate significant associations, and assuming that 15 variables are taken into account in a multivariate model and based on the recommendations of 10 subjects per variable, 150 patients are required.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• France
  • Clichy, France, 92110
    • Service d'accueil des urgences Hôpital Beaujon
  • Paris, France, 75018
    • Service d'acceuil des urgences hôpital Bichat- Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults visiting emergency department for asthma attack

Description

Inclusion Criteria:

• Age> 18 years
• Ambulatory patient, visiting one of these centers
• Diagnosis of asthma already evolving for more than 6 months
• Prescription of treatment for more than 3 months
• Patient who can read and write French
• Agreement for an individual interview (Part 1) or fill up a self-questionnaire (Part 2)
• Health insurance coverage

Exclusion Criteria:

• Patients with other etiology that may explain their dyspnea: heart failure, chronic obstructive pulmonary disease , pneumopathy
• Patients with a social background that is not compatible with the study: a patient who does not speak French, is homeless or does not have a telephone number
• Inpatients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poor observance of GINA criteria	Explanation of Asthma imbalance by poor observance and knowledge of GINA global strategy for asthma management and prevention criteria.	Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GHQ-12 Psychometric tool	Psychological distress caused by asthma will be measured by general health questionnaire	Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital

Collaborators and Investigators

• Sponsor: Olivier CHASSANY
• Collaborators: Beaujon Hospital; Bichat Hospital; EA 7334, Patient-Centered Outcomes Research
• Investigators: Study Director: Olivier CHASSANY, MD, PhD, EA 7334, University Paris-Diderot, Paris; Principal Investigator: Prabakar VAITTINADA AYAR, MD, Hopital Bichat-Claude Bernard; Study Chair: Enrique CASALINO, MD, Hopital Bichat-Claude Bernard

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Emergencies; Asthma
• Other Study ID Numbers: AERO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No