Pragmatic Evaluation of an Improvement Program for People Living With Modifiable High-Risk COPD Versus Usual Care: Protocols for the Cluster Randomized PREVAIL Trial.
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Hickman Katherine, Tarabichi Yasir, Dickens Andrew P, Pullen Rachel, Kerr Margee, Couper Amy, Evans Alexander, Gatenby James, Alves Luis, Ariti Cono, Bafadhel Mona, Carter Victoria, Chalmers James, Chen Rongchang, Devereux Graham, Drummond M Bradley, Gibson J Martin, Halpin David M G, Han MeiLan, Hanania Nicola A, Hurst John R, Kaplan Alan, Kostikas Konstantinos, Make Barry, Mapel Douglas, Marshall Jonathan, Martinez Fernando, Meldrum Catherine, van Melle Marije, Miravitlles Marc, Morris Tamsin, Mullerova Hana, Murray Ruth, Muro Shigeo, Nordon Clementine, Ohar Jill, Pace Wilson, Pollack Michael, Quint Jennnifer K, Sharma Anita, Singh Dave, Singh Mukesh, Trudo Frank, Williams Dennis, Wilkinson Tom, Winders Tonya, Price David
Аннотация
METHOD: Two cluster randomized controlled trials (CRTs) in the United Kingdom and United States will assess the impact of a primary care-based quality improvement program (COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care [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 exacerbation(s) 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 or respiratory events, comparing the quality improvement program against routine care.
DISCUSSION: 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.
TRIAL REGISTRATION: UK trial: ISRCTN15819828; US trial: NCT05306743.