Study identifier:D589BC00027
ClinicalTrials.gov identifier:NCT05440097
EudraCT identifier:N/A
CTIS identifier:N/A
Change Asthma Clinical Practice through Guideline Education and Implementation For All Patients with Asthma: an Evaluation of an Asthma Quality Improvement Program
asthma
Phase 4
No
-
All
1500
Interventional
n/a - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
This is an evaluation on an asthma Quality Improvement Program (QIP, including GINA guideline education/training and implementation) to understand the change of physician behaviours, which leads to the change of patient outcomes. Primary endpoint is "Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 48 ". A total of around 30 eligible Tier 3 and Tier 2 hospitals will be selected across China. Approximately 1500 eligible asthmatic patients fulfilling the following inclusion and exclusion criteria will be enrolled consecutively from participating hospitals,. The QIP (including GINA guideline education/training and implementation) will be delivered at the hospital level, targeting all pulmonologists and specialist nurses at participating hospitals, including initial comprehensive education, reinforcement learning, and performance assessment and feedback of pulmonologists’ guideline implementation, along with multiple online and offline approaches serving as reminders and supportive tools to ensure consistent education and to facilitate the asthma management in routine clinical practice in accordance with GINA recommendation. After the initiation of the intervention program participating patients will return to the study hospital every 12 weeks for on-site follow-up visits (V1 to V5), in accordance with guideline recommendations. Meanwhile, investigators are mandatory requested to join in reinforce education at regular time. Guideline implementation performance will be assessed against with multi-approach indicators for each participant’s offline or online visit. The objective of the CARE FOR ALL study is to bridge the gap that exists between the recommendations from GINA 2021 and current clinical practice by demonstrating the benefits of an asthma quality improvement program (QIP), i.e. a standardized pulmonologist-targeted GINA guideline education and practice implementation.
Location
Location
Beijing, China, 100020
Location
Wuyishan, China, 354300
Location
Foshan, China, 528315
Location
Hebi, China, 458000
Location
Changzhi, China, 046000
Location
Shanghai, China, 200030
Location
Tianjin, China, 300450
Location
shiyan, China, 442005
Arms | Assigned Interventions |
---|---|
Other: single-arm GINA guideline education and implementation | - |
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