Effectiveness of delivering integrated COPD care at public healthcare facilities: A cluster randomised trial in Pakistan

Background: In Pakistan chronic obstructive pulmonary disease (COPD) prevalence is 2.1% in adults aged > 40 years. Despite being a health policy focus, integrated COPD care has remained neglected, with wide variation in practice. Aim: To assess whether enhanced care at public health facilities resulted in better control of COPD, treatment adherence, and smoking cessation. Design & setting: A two-arm cluster randomised controlled trial was undertaken in 30 public health facilities (23 primary and 7 secondary), across three districts of Punjab, between October 2014- December 2016. Both arms had enhanced diagnosis and patient recording processes. Intervention facilities also had clinical care guides; drugs for COPD; patient education flipcharts; associated staff training; and mobile phone follow-up. Method: Facilities were randomised in a 1:1 ratio (sealed envelope independent lottery method), and 159 intervention and 154 control patients were recruited. The eligibility criteria were as follows: diagnosed with COPD, aged ≤18 years, and living in the catchment area. The primary outcome was change in BODE (Body mass index, airway Obstruction, Dyspnoea, Exercise capacity) index score from baseline to final follow-up visit. Staff and patients were not blinded. Results: Six-month primary outcomes were available for 147/159 (92.5%) intervention and 141/154 (91.6%) control participants (all clusters). The primary outcome results cluster-level analysis were as follows: mean intervention outcome = -1.67 (95% confidence intervals [CI] = -2.18 to -1.16); mean control outcome = -0.66 (95% CI = -1.09 to -0.22); and covariate-adjusted mean intervention- control difference = -0.96 (95% CI = -1.49 to -0.44; P = 0.001). Conclusion: The findings of this trial and a separate process evaluation study support the scaling of this integrated COPD care package at primary and secondary level public health facilities in Pakistan and similar settings.