Evaluation of a Global Initiative for Asthma Education and Implementation Program to Improve Asthma Care Quality (CARE4ALL): Protocol for a Multicenter, Single-Arm Study.

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-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, an 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 1500 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 (including a pretraining questionnaire and posttraining quizzes) provided by a dedicated, qualified training team based on the GINA 2021 recommendations, followed by regular reinforcement learnings (integrated into the regular department lectures delivered by department directors), with multiple offline and online approaches (eg, an online patient management platform) provided as supportive tools. During this study, GINA implementation performance will be continuously monitored to inform necessary adjustments at the hospital level. The primary end point is change from baseline in the proportion of participants with an inhaled corticosteroid-based maintenance or reliever treatment at week 48. Secondary end points and exploratory end points include changes in clinical practice and patient outcomes such as treatment patterns, asthma control, and hospitalization rates due to exacerbations.

RESULTS

This study has been completed, with 1500 patients enrolled and 1271 patients completing the study. The last visit of the last patient was on September 3, 2024, and the database lock was on September 28, 2024. Final analysis of data has started in October 2024.

CONCLUSIONS

The Change Asthma Clinical Practice through GINA Education and Implementation for All Patients With Asthma (CARE4ALL) study will hopefully help improve asthma management and patient outcomes in China by bridging the gap between evidence-based GINA recommendations and the current clinical practice.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05440097; https://clinicaltrials.gov/study/NCT05440097.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65197.