Protocol for a pragmatic trial to enhance quality safety, and patient experience in chronic obstructive pulmonary...

Chronic obstructive pulmonary disease (COPD) affects nearly 26 million Americans, causes functional impairment and reduced quality of life, and is the fifth leading cause of death. Evidence-based therapies can reduce morbidity and improve symptoms, but too few patients receive them. Moreover, many patients receive unnecessary treatments that increase risks of harm. Systematic and population-based approaches are needed to address the widespread gaps in care. Among these, high-quality evidence shows that proactive electronic consultations to primary care providers can improve COPD care quality and clinical outcomes. While effective, these strategies rely on pulmonary specialists who are a scarce and costly resource nationwide. Given their relevant expertise, there is increasing interest around clinical pharmacist-led population management of COPD, but the effectiveness of this approach is unclear. We designed the cluster-randomized EQuiP-COPD trial to test the non-inferiority of clinical pharmacist relative to pulmonary specialist-led population health management of COPD. The primary outcome is the composite endpoint of COPD exacerbation, pneumonia, all-cause hospitalization, or death. Secondary outcomes will compare disease-related quality of life, quality of care, costs incurred by patients and caregivers, and heterogeneity of treatment effect. We will also conduct qualitative interviews among patients and staff to elicit experiences with the intervention.