AsthmaASUR-RNCT02424409
Evaluation of the Relapse Rate One Month After Discharge From Emergency Department for Asthmatic Patients Given a Strict Formalized Follow up Protocol
A study testing 2: Intervention in people with Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- 2: Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,422 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2015to 16 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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) .
- Conditions
- Asthma
- Being tested
- 2: Intervention, 1: Control
- Keywords
- Asthma, Relapse, Therapeutic counselling, Protocol of care
- Medical subject headings
- Asthma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2: InterventionBehavioural
- 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
- A written action plan with formalized recommendations for the patient
- 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
- Recommendations for an early contact with the general practitioner;
- Telephone call of the emergency department to the patient at day 7 +/-1 in order to ensure the link with the general practitioner.
1: ControlBehavioural
patients without discharge protocol
| Study group | Role | What they receive |
|---|---|---|
| 1: Control | Active comparator | Not described Receives: Behavioral: 1: Control |
| 2: Intervention | Experimental | Not described Receives: Behavioral: 2: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of any asthma attacks diagnosed by the GP or the ED doctor, one month after discharge from the ED
Measured: 1 month
Secondary outcomes (9)
Recurrence rate of asthma attacks at 15 days +/-2 after discharge from the ED
Measured: 2 weeks
Rate of hospitalization within 30 days +/-2 after discharge from the ED
Measured: 1 month
Score to the asthma control test (ACT) 30 days +/-2 after discharge from the ED
Measured: 1 month
Rate of patient's adherence to protocol: we will count the number of GINA (6) discharge recommendations followed in both groups
Measured: 1 month
Percentage of patients having purchased a peak expiratory flow meter at D30 +/-2
Measured: 1 month
First day of contact with the general practitioner after leaving the Emergency Department
Measured: 7 days
Percentage of patients' follow-up by the general practitioner at D30 +/-2
Measured: 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.
Measured: 1 month
Percentage of patients self-medicating before calling the doctor
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startAug 2015
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer TRUCHOT, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisPatrick PLAISANCE, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424409
- Sponsor's protocol ID
- P130943
- Other IDs
- IDRCB : 2014-A01006-41
- Acronym
- ASUR-R
- Status last verified
- Feb 2022
- First submitted
- 20 Apr 2015
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02424409
- Acronym / sponsor ID
- ASUR-R / P130943
- Conditions
- Asthma
- Keywords
- Asthma, Relapse, Therapeutic counselling, Protocol of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,422 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Control | Active comparator | Behavioral: 1: Control |
| 2: Intervention | Experimental | Behavioral: 2: Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- Impossibility to a correct follow up (foreigners who do not live in France, language barrier, homeless, no social security).
- Wheezing of other origin:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2: Intervention1. 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. | Behavioural | 2: Intervention |
| 1: Controlpatients without discharge protocol | Behavioural | 1: Control |
Primary outcome
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
9 secondary outcomes
Recurrence rate of asthma attacks at 15 days +/-2 after discharge from the ED
Time frame: 2 weeks
Rate of hospitalization within 30 days +/-2 after discharge from the ED
Time frame: 1 month
Score to the asthma control test (ACT) 30 days +/-2 after discharge from the ED
Time frame: 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
Percentage of patients having purchased a peak expiratory flow meter at D30 +/-2
Time frame: 1 month
First day of contact with the general practitioner after leaving the Emergency Department
Time frame: 7 days
Percentage of patients' follow-up by the general practitioner at D30 +/-2
Time frame: 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
Percentage of patients self-medicating before calling the doctor
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer TRUCHOT, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Patrick PLAISANCE, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2: Intervention in people with Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.