B94-03 Quality Improvement Program Delays Composite Clinical Deterioration in High-risk COPD: A Cluster-randomized Trial in China

Abstract Background Chronic obstructive pulmonary disease (COPD) patients with prior exacerbations face a markedly increased risk of future clinically deterioration. Whether a standardized, hospital-level quality-improvement intervention can modify this risk remains unclear. Methods The Quality Improvement Program (QIP) study was a pragmatic, cluster-randomized, controlled trial conducted in 41 Chinese hospitals from 2022 to 2025. Hospitals were allocated (1:1) to implement a COPD Quality Standard (QS) bundle or to continue usual care. Eligible COPD patients had post-bronchodilator FEV1/FVC 0.7, FEV1 ≥25 %predicted, CAT ≥10 and either (1) ≥2 moderate or ≥ 1 severe exacerbation in the previous year, or (2) 1 moderate exacerbation plus FEV1 50 %predicted. The primary endpoint was time to first clinically important deterioration (CID), defined as any of trough FEV1 decline ≥100 mL, COPD Assessment Test (CAT) Score increase ≥2 points, or moderate/severe exacerbation. Patients were followed for 48 weeks. Cluster-adjusted log-rank test was used for between-group comparison of time-to-event. Cox models adjusted for clustering and baseline data were used to evaluate the risk of CID and each of its individual components. Results Among 1,055 enrolled patients (mean age 66.2 ± 7.5 years, 14.4 % female, 1.5 ± 0.8 moderate-to-severe exacerbations in the prior year), baseline characteristics were balanced between groups. Implementation of the QS bundle significantly prolonged median time to CID (25.1 95 % CI 23.9-34.6 vs 21.1 15.3-23.7 weeks; p0.0001) (Figure 1) and reduced the 48-week CID incidence from 80.8 % to 63.5 % (hazard ratio HR 0.64 0.48-0.85; p=0.002). The risk of CAT worsening ≥2 points (19.2 % vs 36.3 %; HR 0.43 0.26-0.73; p=0.002) and moderate/severe exacerbations (27.4 % vs 44.1 %; HR 0.51 0.35-0.74; p0.001) were reduced in intervention group. The incidence of a ≥ 100 mL trough FEV1decline was 44.3 % with intervention versus 50.2 % with control (median time-to-event 56.4 vs 49.6 weeks; p = 0.29), and multivariable Cox regression showed no significant between-group difference in risk (HR 0.88, 95 % CI 0.65-1.20; p = 0.43). Conclusion The hospital-level quality-improvement bundle delayed time to clinical deterioration and reduced its incidence, nearly halving symptom worsening and exacerbations in high-risk COPD patients. These results indicate meaningful clinical impact, supporting structured quality-improvement programs to improve patient-centered outcomes. This abstract is funded by: AstraZeneca China