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

NCT02424409 | Completed

• 2 other identifiers: P130943IDRCB : 2014-A01006-41
• Study Type: interventional
• Target: 1,422
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Asthma; Relapse; Therapeutic counselling; Protocol of care

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of any asthma attacks diagnosed by the GP or the ED doctor, one month after discharge from the ED

  1 month

Secondary Outcomes (9)

• Recurrence rate of asthma attacks at 15 days +/-2 after discharge from the ED

  2 weeks

• Rate of hospitalization within 30 days +/-2 after discharge from the ED

  1 month

• Score to the asthma control test (ACT) 30 days +/-2 after discharge from the ED

  1 month

• Rate of patient's adherence to protocol: we will count the number of GINA (6) discharge recommendations followed in both groups

  1 month

• Percentage of patients having purchased a peak expiratory flow meter at D30 +/-2

  1 month

Study Arms (2)

1: Control

ACTIVE COMPARATOR

Behavioral: 1: Control

2: Intervention

EXPERIMENTAL

Behavioral: 2: Intervention

Interventions

2: Intervention BEHAVIORAL

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.

2: Intervention

1: Control BEHAVIORAL

patients without discharge protocol

1: Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service des Urgences, Hôpital Lariboisière

Paris, 75013, France

Location

MeSH Terms

Conditions

Asthma; Recurrence

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer TRUCHOT, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Patrick PLAISANCE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 23, 2015
• Study Start: August 1, 2015
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-02

Locations

FR (1)