Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle

Recruiting

• Conditions: COPD

• Registration Number: NCT06646419
• Lead Sponsor: AstraZeneca

Brief Summary

This is a cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital .

Detailed Description

The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.

Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.The control group will maintain the current usual care practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks.

Eligible consented patients will be enrolled consecutively to minimize selection bias. In order to achieve the purpose of continuous enrollment, all patients who visit the outpatient clinic,emergency room, and hospitalized due to exacerbation of COPD will be screened, including newly diagnosed patients or those who have bee n treated.

Study Timeline

• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-17
• Study Start: 2024-11-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1368

Inclusion Criteria

• Diagnosed COPD (post- bronchodilator FEV1/FVC < 0.7)
• 40~80 years
• CAT≥10
• At least two moderate or at least one severe exacerbation history in past 1 year
• Able to sign informed consent

Exclusion Criteria

• Continuous triple inhalation therapy for ≥6 months at baseline (include single inhaler and multiple inhalers)
• Stable COPD (symptom such as cough, sputum and shortness of breath are mild or stable, clinical condition has basically returned to pre-exacerbation)
• Comorbidities require/contraindicate long-term use of glucocorticoid treatment: asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active tuberculosis recurrent aspiration pneumonia ect.
• Serious comorbidities threaten to life expected survival time no more than 1 year: severe heart disease, severe chronic liver, severe kidney disease, cerebrovascular disease with long-term bed rest and malignant tumours ect.
• Not living in the healthcare area
• Patients currently participating in any other interventional studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to CID.	week0-week48	To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).

Secondary Outcome Measures

Name	Time	Method
Proportion of patients received long-acting maintenance inhalation with the percentage of days covered (PDC) ≥70%.	week 12, 24, 36 and 48	To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Inhalation therapy consistency rate with guideline.	week 12, 24, 36 and 48	To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Inhaler device compliance,measured by the score of Test of the adherence to inhalers( TAI ) questionnare.	week 24 and 48	To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Correct operation rate of inhalation device.	week 24 and 48	To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Patient satisfaction rate with treatment.	week 24 and 48	To evaluate the the impact of implementation and audit of transition bundle on treatment satisfaction.
Disease knowledge score of patients.	week 24 and 48	To evaluate the the impact of implementation and audit of transition bundle on disease knowledge.
Proportion of patients received different categories of long-acting maintenance inhalation.	week 12, 24,36 and 48	To evaluate the the impact of implementation and audit of transition bundle on treatment pattern.
Rate of moderate or severe exacerbation.	week 12, 24 and 48	To evaluate the the impact of implementation and audit of transition bundle on exacerbation.
Rate of severe exacerbation.	week 12, 24 and 48	To evaluate the the impact of implementation and audit of transition bundle on exacerbation.
Rate of cardiovascular events.	week 12, 24 and 48	To evaluate the the impact of implementation and audit of transition bundle on cardiovascular events.
Change of CAT score.	week 0 to week 48	To evaluate the the impact of implementation and audit of transition bundle on quality of life.
Percentage change of trough FEV1 and MMEF.	week 0 to week 48	To evaluate the the impact of implementation and audit of transition bundle on PFT.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zaoyang, China