A COPD Quality Improvement Program（QIP）

Study Overview
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Brief Summary
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QIP(Quality Improvement Programme) is a COPD quality improvement program in China. The initial step of this program is to set up the Quality Standards(QS) of COPD management in clinical practice, then embed Quality Standards into routine care and uses Quality Control Indicators (QCI)to check the QS implementation. The aim of the QIP program is to standardize COPD management in clinical practice in China, including the standardization of diagnosis, assessment, pharmacological and non-pharmacological intervention, and follow-up. COPD patients can benefit from standardization clinical behaviours, to be identified early, be accessed comprehensively, and be treated correctly according to guidelines, and with an appropriate follow-up to improve adherence.

Detailed Description
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Background and Rationale Chronic obstructive pulmonary disease (COPD) is currently the most common chronic respiratory disease in China which causes a huge economic and social burden. Acute Exacerbation is a crucial issue that cannot be ignored in the management of COPD. Patients with frequent exacerbations have been found to have greater airflow limitation, a greater symptom burden, increased mortality, and worsen the quality of life (QoL). However, The COPD management of those patients in clinical practice is poor in China. Patients with a low standard of care, lack of regularly pharmacological and non-pharmacological intervention, and insufficient follow-up and disease education in clinical practice. Objectives and Outcomes QIP(Quality Improvement Programme) is a COPD quality improvement program in China. The initial step of this program is to set up the Quality Standards(QS) of COPD management in clinical practice, then embed Quality Standards into routine care and uses Quality Control Indicators (QCI)to check the QS implementation. The aim of the QIP program is to standardize COPD management in clinical practice in China, including the standardization of diagnosis, assessment, pharmacological and non-pharmacological intervention, and follow-up. COPD patients can benefit from standardization clinical behaviours, to be identified early, be accessed comprehensively, and be treated correctly according to guidelines, and with an appropriate follow-up to improve adherence. The objective of QIP study is to address key gaps in management of patients with high-risk through a targeted quality improvement programme in a healthcare system or practice. The aim is to evaluate the impact of QS implementation on target population compared to usual care in a real-world setting, including but not limited to COPD exacerbation, lung function, quality of life, and treatment pattern. Study design This is a interventional, cluster-randomized, pragmatic clinical study. A total of 41 hospitals will be selected. Among them, 40 eligible hospitals will be selected across China and randomized (stratified by tier and geographic region) to the intervention group or control group at the ratio of 1:1. In addition, the leading site will be assigned to the intervention group without following the randomization procedure. In the intervention group, QS implementation will be performed. The control group will maintain the current practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks.

Official Title
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A Prospective, Multicentre, Cluster Randomised Controlled Trial to Evaluate the Impact of the Implementation of COPD Quality Standards in High Exacerbation Risk Patients------- A COPD Quality Improvement Program（QIP）

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Intervention group
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with COPD Aged 40 years or older CAT≥10 With exacerbation history： at least 2 moderate or 1 severe exacerbation in the previous year or 1 moderate exacerbation in the previous year with FEV1 <50% predicted value at baseline; Must able to sign the informed consent form Exclusion Criteria: Patients on triple therapy at baseline with a LAMA, LABA, and inhaled corticosteroid (ICS) combination (Including open triple and fix-dose triple) Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study Patients who are currently involved in any other interventional studies

Ages Eligible for Study
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Minimum Age: 40 Years

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention was delivered at the hospital level. The intervention group will receive QS implementation, including QS training for physicians of respiratory department every 12 weeks; QS implementation check every 12 weeks, and follow-up every 12 weeks, QS-related written COPD clinical procedures will be also suggested to established key QS training requirements are:1) COPD diagnosis and assessment; 2)Therapy prescribed in accordance with national guideline 3)Non-pharmacological interventions; 4)An appropriate follow-up according to QS. The control group will maintain current practice and follow up every 12 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group<br>Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease | Other: Intervention group<br>* Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease<br>|
| Other: control group<br>Maintain current treatment | Other: control group<br>* Maintain current treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinically important deterioration (CID) | Time to CID, which is defined as the time from the date of enrolment until the date of the first CID.CID defined as any of the following events:1) Trough FEV1 decline ≥100ml;2) CAT increasing ≥ 2 unit;3) one moderate or severe exacerbation. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual rate of moderate or severe COPD exacerbation | Annual rate of moderate or severe COPD exacerbation | 1 year | 
| Annual rate of severe COPD exacerbation | Annual rate of severe COPD exacerbation | 1 year | 
| Change from baseline in trough FEV1 over 48 weeks | Change from baseline in trough FEV1 over 48 weeks | 48 weeks | 
| Change from baseline in CAT over 48 weeks | Change from baseline in CAT over 48 weeks | 48 weeks | 
| Proportion of patients received inhalation technique review at least once during follow-up period | Proportion of patients received inhalation technique review at least once during follow-up period | 48 weeks | 
| Proportion of patients received long-acting inhaled medicine with percentage of days covered (PDC)≥ 80% over 48 weeks | Proportion of patients received long-acting inhaled medicine with percentage of days covered (PDC)≥ 80% over 48 weeks | 48 weeks | 
| Proportion of prescription of inhaled maintenance medicine at 12 weeks | Proportion of prescription of inhaled maintenance medicine at 12 weeks | 12 weeks | 
| Proportion of prescription of inhaled maintenance medicine at 24 weeks | Proportion of prescription of inhaled maintenance medicine at 24 weeks | 24 weeks | 
| Proportion of prescription of inhaled maintenance medicine at 36 weeks | Proportion of prescription of inhaled maintenance medicine at 36 weeks | 36 weeks | 
| Proportion of prescription of inhaled maintenance medicine at 48 weeks | Proportion of prescription of inhaled maintenance medicine at 48 weeks | 48 weeks | 
| Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 12 weeks | Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 12 weeks | 12 weeks | 
| Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 24 weeks | Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 24 weeks | 24 weeks | 
| Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 36 weeks | Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 36 weeks | 36 weeks | 
| Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 48 week | Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 48 week | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD