A COPD Quality Improvement Program（QIP） (QIP)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Intervention group; Other: control group

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 Type: Interventional
• Enrollment (Anticipated): 1107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dandan Chen; Phone Number: 13428991007; Email: chendandan81@163.com
• Study Contact Backup: Name: Rongchang Chen; Phone Number: 13902273260; Email: chenrc@vip.163.com

Study Locations

• China
  • Guang Dong
    • Shenzhen, Guang Dong, China
      • Recruiting
      • ShenZhen People's Hospital
      • Contact: Dandan Chen; Phone Number: 13428991007; Email: chendandan81@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosed with COPD
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:

1. Patients on triple therapy at baseline with a LAMA, LABA, and inhaled corticosteroid (ICS) combination (Including open triple and fix-dose triple)
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention group; Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease	Other: Intervention group; Practice standard for clinical diagnosis and treatment of chronic obstructive pulmonary disease
Other: control group; Maintain current treatment	Other: control group; Maintain current treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Rongchang Chen, Professor, ShenZhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ESR-21-21293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No