Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02424409 |
Other study ID # |
P130943 |
Secondary ID |
IDRCB : 2014-A01 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 2015 |
Est. completion date |
February 16, 2022 |
Study information
Verified date |
February 2022 |
Source |
Assistance Publique - Hôpitaux de Paris |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
For over ten years, the French group ASUR (ASthme aux URgences) has studied the asthmatic
disease. The first epidemiological study enrolling 3.772 patients, in 39 emergency services,
showed that the treatment protocols during the acute asthma attacks were not homogeneous and
that oral corticosteroids were prescribed in only 50% of the cases. The second major French
study in the emergency department by the same group enrolled 3.049 patients. The results
showed that 38% of patients have a new acute asthma relapse in the month following their
consultation in the emergency department. In the same study, a multivariate analysis of
predictors of relapse showed that there are controllable factors (absence of written
recommendations at discharge, only 50% of prescriptions for oral corticosteroids at discharge
from the emergency department, limited follow-up by a general practitioner (GP) or
pneumologist ...).
The emergency physician has a responsibility in educating the patient during the period
between an acute asthma attack and return to the stability of long term therapy. To date, the
impact of patient education on the rate of further consultations in the emergency department
has not been proven, although it seems to be a positive trend on its effect. In France, half
of the patients coming to the emergency department for asthma attack will not be
hospitalized. More than a third will return to the ED within the first 30 days for a new
attack. The impact of post-interventional education on relapse should be explored. A first
major study on a strict formalized protocol designed to reduce the relapse rate is essential
and could allow a major improvement.
Our main objective is to assess the impact of a strict formalized protocol of care of
asthmatic patients discharged from the Emergency Department on the recurrence rate of asthma
attacks, one month after an asthma attack.
The expected benefit for the patient is the short-term reduction of relapse after asthma
exacerbations, thus avoiding the problems of readmission. The strict formalized discharge
protocol would also improve education in terms of self-medication in this gray zone of
post-therapeutic monitoring. The benefit is even more important in terms of public health due
to the important prevalence of asthma in the world and in our country. The advantage of this
protocol is to strengthen the links between the hospital and the GPs. Education of asthmatic
patients is essential in reducing morbidity. Thus, the potential benefits of this protocol
are: reducing the cost of health and re-hospitalization, improved education of asthma
patients, strengthening their link with the required GP, decreased absenteeism usually
frequent in this type of disease in the workplace.
Description:
Main objective
To assess the impact of a strict formalized protocol of care of asthmatic patients discharged
from the Emergency Department on the recurrence rate of asthma attacks, one month after an
asthma attack.
Secondary objectives
Assess the impact of a strict formalized protocol on the rate of hospitalization one month
after discharge from the ED.
Assess the rate of early recurrence of asthma attacks within the first 15 days after
discharge from the ED.
Assess the control of the asthmatic disease at one month after discharge from the ED, by
using a recognized tool, the Asthma Control Test (ACT).
Assess the compliance rate of the patients to the recommended therapeutic strategy.
Primary end point:
Recurrence rate of any asthma attacks diagnosed by the GP or the ED doctor, one month after
discharge from the ED.
Secondary end points:
Recurrence rate of asthma attacks at 15 days +/-2 after discharge from the ED. Rate of
hospitalization within 30 days +/-2 after discharge from the ED Score to the asthma control
test (ACT) 30 days +/-2 after discharge from the ED.
Rate of patient's adherence to protocol: we will count the number of GINA (6) discharge
recommendations followed in both groups Percentage of patients having purchased a peak
expiratory flow meter at D30 +/-2 First day of contact with the general practitioner after
leaving the Emergency Department.
Percentage of patients' follow-up by the general practitioner at D30 +/-2 Percentage of
patients using their peak expiratory flow meter at D30 +/-2. We will classify four categories
of use of PEF: daily, weekly, less than once a week, never.
Percentage of patients self-medicating before calling the doctor Experimental plan
Multicenter, prospective, cluster-randomized, open study, enrolling a cohort of patients who
were managed in the emergency department for an acute asthma attack and who have no admission
criteria at the end of treatment. Forty-six Emergency Departments will be selected on the
national territory, randomized by cluster (centers A [control=standard group], centers B
[treatment group= strict formalized protocol] and stratified by size (number of patients per
year) and types [CHU, CHG, CHR]).
The two groups of patients will be contacted by telephone at Day 15 +/-2, and Day 30 +/-2 of
discharge in order to identify a possible relapse, to collect the various elements of the
evolution of their disease as well as a to answer a formalized questionnaire.
Relapse is defined as a respiratory discomfort due to asthma and requiring medical assistance
(in the emergency department or with the GP).
Number of patients needed: A sample size of N= 466 patients/group allow 80% power to detect a
30% relative difference in recurrences (i.e. from 25% to 17.5%) with a chi-square test and a
two-sided 5% significance level. Considering an attrition rate around 5% and that the study
is a cluster- randomized design, we applied a variance inflation factor equal to 1.5 (based
on previous studies) .