Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in the number of correctly reported diagnoses before and after intervention
研究概览
简要总结
Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.
详细描述
Patients aged 6 to 17 years presenting to the emergency department with an acute asthma exacerbation were included. Clinical outcomes were compared between a pre-intervention period (October 2024-May 2025) and a post-intervention period (October 2025-May 2026).
Between the two study periods, a structured educational intervention targeting medical and nursing staff was implemented. The intervention consisted of didactic lectures, clinical simulation sessions, case-based discussions, and the dissemination of updated diagnostic and therapeutic flowcharts based on the 2025 Global Initiative for Asthma (GINA) guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 17 years
- •Presentation to the emergency department with a diagnosis of acute asthma exacerbation
- •Evaluation in the emergency department of one of the participating centers during the study periods
排除标准
- •Age < 6 years or > 17 years
- •Diagnosis other than acute asthma exacerbation
- •Incomplete or missing clinical data
- •Patients transferred from other hospitals already treated for the same episode
- •history of allergy to any drugs used in the protocol
研究组 & 干预措施
Pre-intervention cohort
Pediatric patients aged 6-17 years presenting to the emergency department with an acute asthma exacerbation during the pre-intervention period (October 2024-May 2025). Patients received standard care according to local clinical practice prior to the implementation of the structured educational intervention.
Intervention:
No intervention (standard of care)
Post-intervention cohort
Pediatric patients aged 6-17 years presenting to the emergency department with an acute asthma exacerbation during the post-intervention period (October 2025-May 2026), after the implementation of a structured educational intervention for emergency department staff.
Intervention:
Educational intervention (health care provider-directed)
结局指标
主要结局
Change in the number of correctly reported diagnoses before and after intervention
时间窗: Pre-intervention and through study completion, an average of 9 months
Assessment of adherence to guideline-based diagnostic and therapeutic management of pediatric patients presenting with acute asthma exacerbations in the emergency department.
Percentage of patients with correct timing, dosage, and method of drug administration before and after intervention
时间窗: Pre-intervention and through study completion, an average of 9 months
Percentage of patients with correct follow-up at discharge
时间窗: Pre-intervention and through study completion, an average of 9 months
Percentage of patients in whom additional drugs are used in refractory cases
时间窗: Pre-intervention and through study completion, an average of 9 months
Percentage of patients with correct therapy at discharge
时间窗: Pre-intervention and through study completion, an average of 9 months
次要结局
- Incidence of acute asthma exacerbations(Pre-intervention and through study completion, an average of 9 months)
研究者
Grazia Fenu
Principal Investigator
Meyer Children's Hospital IRCCS