Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 12, 2024
Date Accepted: Nov 25, 2024
Evaluation of a Global Initiative for Asthma Education and Implementation Program to Improve Asthma Care Quality: Protocol for a Multi-Center, Single-Arm Study (Care4All)
ABSTRACT
Background:
Poor symptom control and exacerbations of asthma diminish quality of life, and pose a significant burden to patients and society. Implementing evidence-based management as recommended by the Global Initiative for Asthma (GINA), especially introducing inhaled corticosteroid (ICS)-containing treatments, has the potential to vastly reduce exacerbations and the high burden of asthma in China. However, domestic implementation of the GINA recommendations has been unsatisfactory, especially in lower-level hospitals; thus, enhancement to the awareness of and adherence to the GINA recommendations among Chinese physicians is needed to improve patient outcomes.
Objective:
This study aims to bridge the gap between the GINA recommendations and the current clinical practice in China by demonstrating the benefits of an asthma quality improvement program (QIP).
Methods:
A single-arm study will be conducted at around 30 hospitals across China to assess the impact of a specially designed asthma QIP. Approximately 1,500 patients with asthma aged ≥14 years will be enrolled in participating hospitals and followed up for 48 weeks. The QIP targeted at all pulmonologists and specialist nurses will include an initial comprehensive training based on the GINA 2021 recommendations, followed by regular reinforcement learnings, with multiple offline and online approaches (e.g., an online patient management platform) provided as supportive tools. During the study, GINA implementation performance will be continuously monitored to inform necessary adjustments at the hospital level. The primary endpoint is change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at Week 48. Secondary endpoints and exploratory endpoints include changes in clinical practice and patient outcomes such as treatment pattern, asthma control, and hospitalization rate due to exacerbations.
Results:
This study is currently ongoing. As of August 12, 2024, 1,500 patients have been recruited and 1,195 have completed the study. The last visit of the last patient is scheduled on August 30, 2024 (+7 days) and database lock is scheduled on October 8, 2024. Final analysis of data is expected to start in November 2024.
Conclusions:
The Care4All study will help improve asthma management and patient outcomes in China by bridging the gap between evidence-based GINA recommendations and the current clinical practice. Clinical Trial: ClinicalTrials.gov, NCT05440097
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