CARE FOR ALL：an Evaluation of an Asthma QIP (CARE FOR ALL)

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

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.

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.

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

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

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

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

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

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

The proportion of patients whose pulmonologists develop or review the written asthma action plan at weeks 0, 12, 24, 36 and 48 The proportion of patients whose pulmonologists watch the patient using their inhaler, educate their technique at weeks 0, 12, 24, 36 and 48

To explore health-related quality of life in patients with asthma after guideline education and implementation.

The Asthma Quality of Life Questionnaire (+12)( AQLQ(S)+12) is a 7-point scale, The minimum average score of is 1,the maximum average score is 7, (7 = not impaired at all,1 = severely impaired), with higher scores indicating better quality of life. Change from baseline in health-related quality of life evaluated by Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12) average score at week 0, 12, 24, 36 and 48

To evaluate the actual treatment change in GINA guideline-recommended treatments after guideline education and implementation

Change from baseline in the proportion of patients with an ICS-based maintenance and/or reliever actual treatment at week 48

To explore adherence change in GINA guideline-recommended treatments after guideline education and implementation.

Medication Adherence Report Scale for Asthma(MARS-A) is a 5-point scale, The minimum average score of is 1,the maximum average score is 5 .The higher the score, the better the adherence. Change from baseline in MARS-A average score at week 12, 24, and 48

Use Inhaler skill score assessment checklist to evaluate inhaler skill. (Minimum to maximum average score 0-7). The higher the score, the better the skill. Change from baseline by inhaler skills score of investigators at week 12, 24 and 48; Change from baseline by inhaler skills score of subjects at week 12, 24 and 48

Describe consistency of patient self-assessment and GINA-evaluated asthma severity level. Patient self assessment used one question for respondents to classify asthma severity by 3 choices: mild, moderate, severity.

The asthma control level is assessed by Asthma Control Questionnaire-5 (ACQ-5), and the control level is divided based on average scores, e.g. well-controlled (ACQ-5 ≤ 0.75), partially controlled (0.75 to 1.5) and not well-controlled (ACQ-5 ≥ 1.5)], baseline characteristic include demographics characters, education level, Hospital level, medication regime etc. Asthma control level of baseline, week 0, 12, 24, 36 and 48

To explore relationship between subject characteristics and the related symptoms after COVID-19 infection

Use the COVID-19 Infection Cough Characteristics and Prognosis Survey Version 1.0" (released in January 2023) to collect the patients' covid-19 related symptoms, etc.And compare it with ACQ-5 etc. to see whether there is a relationship.

Use Disease Knowledge Questionnaire for Asthma Patients to evaluate asthma education, (Minimum to maximum average score 0-25). The higher the score, the better the education. Change from baseline by asthma knowledge questionnaire score of subjects at week 12, 24 and 48 Change from baseline by asthma knowledge questionnaire score of investigators at week 12, 24 and 48

To explore change in patient expectation of asthma treatment after guideline education and implementation.

Patient's expectation for asthma treatment Questionnaire has 14 items, (Minimum to maximum average score 0-10). The higher the score, the more important the item is. Change from baseline by patient expectation of asthma treatment of subjects at week 12, 24, and 48

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.

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When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.