Offering Digital Adherence Support Improves Clinical Outcomes for High-Risk Chronic Obstructive Pulmonary Disease (COPD) Patients With Poor Adherence to Inhaled Therapy

Abstract Rationale: Non-adherence to medication is common in COPD and leads to poor outcomes. Digital interventions have improved inhaler adherence in small short-term studies, but there is minimal evidence of their impact on clinical outcomes. Methods: Our 12-month pragmatic cluster randomised trial (MAGNIFY) evaluated the impact of providing primary care with access to a complex intervention for COPD patients designed to enhance adherence (10.2147/POR.S302809). The intervention included identification of high-risk COPD patients (≥2 moderate/severe exacerbations in last 2 years) using Optimum Patient Care electronic medical record (EMR) driven quality improvement algorithms, a remote COPD review and a digital adherence support package (comprising Ultibro® Breezhaler®, Propeller Health electronic inhaler monitoring device and smartphone app). To minimise contamination, primary care centres were randomised to offer the intervention or continue usual care (control). In practices randomized to the intervention arm, high-risk patients aged ≥40 years and deemed clinically suitable and poorly adherent to inhaled therapy at the review, were offered the digital adherence support package and those that accepted were included in the study. In control practices, we identified high-risk COPD patients aged ≥40 years on the basis of LABA/LAMA prescription date. Primary outcome was time to treatment failure (moderate/severe exacerbation, prescription of ICS or other additional COPD therapy, or death) and secondary outcomes were moderate/severe exacerbation rate and time to exacerbation in 12-month follow-up. Analyses were adjusted for three pre-specified confounders: age, baseline exacerbation rate & baseline adherence. Results: 164 primary care centres (87 intervention, 77 control) were included in the trial. 835 patients were offered the digital adherence support package and 656 (78.6%) accepted. There was a 23% reduced risk of treatment failure over the 12-month trial period (adjusted HR 0.77; 95% CI 0.64, 0.94; p=0.009) in patients provided with the digital intervention compared to controls. The median time to treatment failure was 263 days in the intervention and 361 days in the control arm. Exacerbation rates were 11% lower in the intervention arm (adjusted IRR 0.89; 95% CI 0.79, 0.99; p=0.047). In pre-specified subgroups, the intervention was more effective in patients with FEV1<80% predicted, no previous exacerbations, or a Cambridge Multimorbidity Score ≥3 (Table 1). Conclusions: Offering a digital intervention to optimise adherence reduced risk of treatment failure by almost 25% and reduced exacerbation rate by over 10% in high-risk patients with COPD. This is the first large, year-long trial demonstrating improved clinical outcomes in a real-world primary care setting.

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