Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1107 participants
INTERVENTIONAL
2022-11-25
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
The control group will maintain current practice and follow up every 12 weeks.
DIAGNOSTIC
NONE
Study Groups
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Intervention group
Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease
Intervention group
Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease
control group
Maintain current treatment
control group
Maintain current treatment
Interventions
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Intervention group
Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease
control group
Maintain current treatment
Eligibility Criteria
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Inclusion Criteria
2. Aged 40 years or older
3. CAT≥10
4. With exacerbation history：
1. at least 2 moderate or 1 severe exacerbation in the previous year
2. or 1 moderate exacerbation in the previous year with FEV1 \<50% predicted value at baseline;
5. Must able to sign the informed consent form
Exclusion Criteria
2. 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
3. Patients who are currently involved in any other interventional studies
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Shenzhen People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Rongchang Chen, Professor
Role: PRINCIPAL_INVESTIGATOR
Shenzhen People's Hospital
Locations
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Shenzhen People's Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Dandan Chen
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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ESR-21-21293
Identifier Type: -
Identifier Source: org_study_id