Clinical trial NCT03099915: Asthma Attack in the Emergency Department : Reasons Of This Attendance
Official title: Asthma Attack in the Emergency Department : Reasons Of This Attendance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma Attack
Emergency Medicine
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
Collaborators: name: EA 7334, Patient-Centered Outcomes Research
name: Bichat Hospital
name: Beaujon Hospital
First posted: 2017-04-04
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults visiting emergency department for asthma attack

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Poor observance of GINA criteria
timeFrame: 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 outcomes:
measure: GHQ-12 Psychometric tool
timeFrame: 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
Other outcomes:
Locations:
city: Clichy
country: France
facility: Service d'accueil des urgences Hôpital Beaujon
city: Paris
country: France
facility: Service d'acceuil des urgences hôpital Bichat- Claude Bernard
Study officials:
affiliation: EA 7334, University Paris-Diderot, Paris
name: Olivier CHASSANY, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hôpital Bichat-Claude Bernard
name: Prabakar VAITTINADA AYAR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bichat-Claude Bernard
name: Enrique CASALINO, MD
role: STUDY_CHAIR
References: