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临床试验/NCT02424409
NCT02424409已完成不适用

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

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 1,422 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,422
试验地点
2
主要终点
Recurrence rate of any asthma attacks diagnosed by the GP or the ED doctor, one month after discharge from the ED

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • 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

结局指标

主要结局

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

时间窗: 1 month

次要结局

  • Recurrence rate of asthma attacks at 15 days +/-2 after discharge from the ED(2 weeks)
  • Score to the asthma control test (ACT) 30 days +/-2 after discharge from the ED(1 month)
  • Percentage of patients' follow-up by the general practitioner at D30 +/-2(1 month)
  • Percentage of patients having purchased a peak expiratory flow meter at D30 +/-2(1 month)
  • First day of contact with the general practitioner after leaving the Emergency Department(7 days)
  • 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.(1 month)
  • Percentage of patients self-medicating before calling the doctor(1 month)
  • Rate of hospitalization within 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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