Evaluation of the Relapse Rate One Month After Discharge From Emergency Department for Asthmatic Patients Given a Strict Formalized Follow up Protocol (ASUR-R)

March 9, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of the Relapse Rate One Month After Discharge From Emergency Department for Asthmatic Patients Given a Strict Formalized Follow up Protocol. Multicenter, Prospective, Cluster-randomized

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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) .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1422

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Service des Urgences, Hôpital Lariboisière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria :

Patients over 18 years, consulting to the Emergency room for an acute asthma attack which, after initial treatment is discharged directly from the ED having given his free and informed consent, and affiliated to the social security.

Exclusion Criteria:

  • Impossibility to a correct follow up (foreigners who do not live in France, language barrier, homeless, no social security).

  • Wheezing of other origin:

    • Infectious pneumonia
    • Acute cardiac failure
    • COPD
  • Immediate resuscitation criteria: respiratory failure or pause, RR < 10/min, and CGS <8
  • PEFR<50% four hours after arrival in the ED
  • Patient under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1: Control
Behavioral: 1: Control
patients without discharge protocol
Experimental: 2: Intervention
Behavioral: 2: Intervention

  1. The corticoid treatment (Prednisolone or Prednisone) given from the ED for the first day if the patient is discharged at nighttime or during the weekend.

    A detailed prescription including 1) A written prescription of the corticosteroid treatment given orally for a total treatment length of 7 days 2) A written prescription describing the adaptation of the inhaled treatment 3) Peak expiratory flowmeter

  2. A written action plan with formalized recommendations for the patient

  3. A formal letter and recommendations to the general practitioner including information about the ED visit, and the necessity to program a follow up with regular consultations as well as to program spirometry evaluation for his patient.

    The ED doctor at discharge will explain all these documents orally

  4. Recommendations for an early contact with the general practitioner;
  5. Telephone call of the emergency department to the patient at day 7 +/-1 in order to ensure the link with the general practitioner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Recurrence rate of any asthma attacks diagnosed by the GP or the ED doctor, one month after discharge from the ED
Time Frame: 1 month
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Recurrence rate of asthma attacks at 15 days +/-2 after discharge from the ED
Time Frame: 2 weeks
2 weeks
Rate of hospitalization within 30 days +/-2 after discharge from the ED
Time Frame: 1 month
1 month
Score to the asthma control test (ACT) 30 days +/-2 after discharge from the ED
Time Frame: 1 month
1 month
Rate of patient's adherence to protocol: we will count the number of GINA (6) discharge recommendations followed in both groups
Time Frame: 1 month
1 month
Percentage of patients having purchased a peak expiratory flow meter at D30 +/-2
Time Frame: 1 month
1 month
First day of contact with the general practitioner after leaving the Emergency Department
Time Frame: 7 days
7 days
Percentage of patients' follow-up by the general practitioner at D30 +/-2
Time Frame: 1 month
1 month
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.
Time Frame: 1 month
1 month
Percentage of patients self-medicating before calling the doctor
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer TRUCHOT, MD, Assistance Publique - Hopitaux de Paris
  • Study Director: Patrick PLAISANCE, MD, PhD, Assistance Publique - Hopitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P130943
  • IDRCB : 2014-A01006-41 (Other Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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