Chronic Obstructive Pulmonary DiseaseQIPNCT05638646
A COPD Quality Improvement Program（QIP）
A study testing Intervention group in people with Chronic Obstructive Pulmonary Disease, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,107 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Dandan Chen, 13428991007, chendandan81@163.com
About this study
Official title: 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）
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.
Read the detailed description
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Intervention group, control group
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease
control groupOther
Maintain current treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease Receives: Other: Intervention group |
| control group | Other | Maintain current treatment Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (14)
Annual rate of moderate or severe COPD exacerbation
Annual rate of moderate or severe COPD exacerbation
Measured: 1 year
Annual rate of severe COPD exacerbation
Annual rate of severe COPD exacerbation
Measured: 1 year
Change from baseline in trough FEV1 over 48 weeks
Change from baseline in trough FEV1 over 48 weeks
Measured: 48 weeks
Change from baseline in CAT over 48 weeks
Change from baseline in CAT over 48 weeks
Measured: 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
Measured: 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
Measured: 48 weeks
Proportion of prescription of inhaled maintenance medicine at 12 weeks
Proportion of prescription of inhaled maintenance medicine at 12 weeks
Measured: 12 weeks
Proportion of prescription of inhaled maintenance medicine at 24 weeks
Proportion of prescription of inhaled maintenance medicine at 24 weeks
Measured: 24 weeks
Proportion of prescription of inhaled maintenance medicine at 36 weeks
Proportion of prescription of inhaled maintenance medicine at 36 weeks
Measured: 36 weeks
Proportion of prescription of inhaled maintenance medicine at 48 weeks
Proportion of prescription of inhaled maintenance medicine at 48 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start25 Nov 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Rongchang Chen, Professor, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638646
- Sponsor's protocol ID
- ESR-21-21293
- Acronym
- QIP
- Status last verified
- Oct 2022
- First submitted
- 11 Nov 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang K, Chen D, Wang Y, Wang F, Wang L, Wang J, Yu T, Hou H, Liu W, Huang P, Yang H, Chen R. COPD Patients with a High Exacerbation Risk: Baseline Data Analysis of a National Chinese Prospective Multi-Center Study of Quality Improvement Project. Int J Chron Obstruct Pulmon Dis. 2026 Jun 3;21:597295. doi: 10.2147/COPD.S597295. eCollection 2026.
PubMed 42266895
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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）
- ClinicalTrials.gov ID
- NCT05638646
- Acronym / sponsor ID
- QIP / ESR-21-21293
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,107 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Intervention groupPractice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease |
| control group | Other | Other: control groupMaintain current treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with COPD
- Aged 40 years or older
- CAT≥10
- With exacerbation history：
- Must able to sign the informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupPractice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease | Other | Intervention group |
| control groupMaintain current treatment | Other | control group |
Primary outcome
Time to clinically important deterioration (CID)
Time frame: 48 weeks
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.
14 secondary outcomes
Annual rate of moderate or severe COPD exacerbation
Time frame: 1 year
Annual rate of severe COPD exacerbation
Time frame: 1 year
Change from baseline in trough FEV1 over 48 weeks
Time frame: 48 weeks
Change from baseline in CAT over 48 weeks
Time frame: 48 weeks
Proportion of patients received inhalation technique review at least once during follow-up period
Time frame: 48 weeks
Proportion of patients received long-acting inhaled medicine with percentage of days covered (PDC)≥ 80% over 48 weeks
Time frame: 48 weeks
Proportion of prescription of inhaled maintenance medicine at 12 weeks
Time frame: 12 weeks
Proportion of prescription of inhaled maintenance medicine at 24 weeks
Time frame: 24 weeks
Proportion of prescription of inhaled maintenance medicine at 36 weeks
Time frame: 36 weeks
Proportion of prescription of inhaled maintenance medicine at 48 weeks
Time frame: 48 weeks
Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 12 weeks
Time frame: 12 weeks
Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 24 weeks
Time frame: 24 weeks
Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 36 weeks
Time frame: 36 weeks
Proportion of patients prescribed ICS-containing inhaled maintenance medicine at 48 week
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Derived from this study: PubMed 42266895Yang K, Chen D, Wang Y, Wang F, Wang L, Wang J, Yu T, Hou H, Liu W, Huang P, Yang H, Chen R. COPD Patients with a High Exacerbation Risk: Baseline Data Analysis of a National Chinese Prospective Multi-Center Study of Quality Improvement Project. Int J Chron Obstruct Pulmon Dis. 2026 Jun 3;21:597295. doi: 10.2147/COPD.S597295. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongchang Chen, Professor principal investigator
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Chronic Obstructive Pulmonary Disease, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dandan Chen (13428991007, chendandan81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinically important deterioration (CID) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022; AzTrials last refreshed its copy on 31 Oct 2026.