CARE FOR ALL：an Evaluation of an Asthma QIP

Study Overview
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Brief Summary
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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.

Official Title
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Change Asthma Clinical Practice Through Guideline Education and Implementation For All Patients With Asthma: an Evaluation of an Asthma Quality Improvement Program

Conditions
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Asthma

Intervention / Treatment
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* Other: QIP intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be 14 years of age or older at the time of signing the informed consent. Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g. from bronchodilator reversibility testing or other test) Participating patients and/or their legally authorised representative must provide signed and dated written informed consent form prior to any study specific procedures. Exclusion Criteria: Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma Any significant disease or disorder (e.g. cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study Disease or condition other than asthma that requires treatment with systemic or oral steroids Participation in another clinical study with an Investigational Product administered in the last 3 months prior to Visit 1.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single-arm<br>GINA guideline education and implementation | Other: QIP intervention<br>* The QIP includes pulmonologist-targeted guideline education and guideline implementation. Guideline education includes the initial comprehensive training and reinforcement learning. The initial comprehensive education will be delivered at each participating hospital by a dedicated national asthma expert team, immediately after last patient enrolled at each site. The PI of respiratory departments from participating hospitals are responsible for arranging the delivery of hospital-level reinforcement learnings and ensuring the quality and success of hospital-level guideline implementation. The pulmonologists' guideline adherence and performance at participating hospitals will be regularly assessed during the study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the change in GINA guideline-recommended treatment after guideline education and implementation | Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 48 | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the asthma control after guideline education and implementation. | Change from baseline in the proportion of participant with well-controlled asthma (ACQ-5 ≤ 0.75) at week 48; Distribution of ACQ-5 average scores [proportion of subjects well-controlled (ACQ-5 ≤ 0.75), partially controlled (0.75 to 1.5) and not well-controlled (ACQ-5 ≥ 1.5)] at week 12, 24, 36 and 48 | 48 weeks | 
| To describe the change in GINA guideline-preferred treatments during guideline education and implementation. | Change from baseline in the proportion of participants on the treatment of ICS-formoterol as reliever at week 12, 24, 36 and 48 | 48 weeks | 
| To describe the change in asthma control during guideline education and implementation. | The Asthma Control Questionnaire-5 (ACQ-5) is a 7-point scale, the minimum average score is 0, the maximum average score is 6 (0=no impairment, 6= maximum impairment for symptoms and rescue use), with higher scores indicating worse asthma control. Change from baseline in ACQ-5 average score at week 12, 24, 36 and 48 Change from baseline in the proportion of participants achieving an improvement in ACQ-5 MCID of 0.5 units or more at week 12, 24, 36 and 48 | 48 weeks | 
| To describe the change in GINA guideline-recommended treatments during guideline education and implementation. | Change from baseline in the proportion of participants with an ICS-based maintenance and/or reliever treatment at week 12, 24 and 36 | 36 weeks | 
| To describe asthma related treatment patterns during the study duration. | Asthma related treatment patterns Asthma treatment distribution at baseline and weeks 12, 24, 36, and 48, e.g., ICS-containing medications, ICS-LABA, ICS-formoterol, oral corticosteroids, leukotriene receptor antagonists, theophylline, Traditional Chinese Medicine | 48 Weeks |