Pragmatic Evaluation of an Improvement Program for People Living With Modifiable High-Risk COPD Versus Usual Care: Protocols for the Cluster Randomized PREVAIL Trial.

The burden of COPD is well established, but opportunities for earlier diagnosis and improved management are still missed. Compared to the general COPD population, patients with a history of exacerbations and sub-optimal treatment ('modifiable high-risk') are at greater risk of future exacerbations and adverse health outcomes. To date there is no systematic approach for identifying and treating this patient group. Two cluster randomized controlled trials (CRTs) in the UK and US will assess the impact of a primary care-based quality improvement program (CONQUEST), compared to routine care. In each trial, 126 primary care clusters will be randomized 1:1 to intervention or control arms. Three groups of modifiable high-risk patients will be identified using electronic medical records: undiagnosed with potential COPD, newly diagnosed COPD and already diagnosed COPD. Eligible patients will be aged ≥40 years, have experienced ≥2 moderate/≥1 severe exacerbations in the prior 24 months, including ≥1 in the last 12 months, and not be prescribed inhaled triple therapy. Patients in the undiagnosed group will also be required to have a positive smoking history. Primary trial outcomes will be the annual rate of exacerbations and the annual rate of major adverse cardiac and respiratory events, comparing the quality improvement program against routine care. These will be the first CRTs assessing such a comprehensive primary care-based COPD quality improvement program. Intention to treat analysis of trial outcomes after 24 months will inform its effectiveness in targeting the identification, assessment, treatment and follow-up of patients with modifiable high-risk COPD. UK trial: ISRCTN15819828; US trial: NCT05306743.