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

TY - JOUR

T1 - Pragmatic Evaluation of an Improvement Program for People Living With Modifiable High-Risk COPD Versus Usual Care

T2 - Protocol for the Cluster Randomized PREVAIL Trial

AU - Hickman, Katherine

AU - Tarabichi, Yasir

AU - Dickens, Andrew P

AU - Pullen, Rachel

AU - Kerr, Margee

AU - Couper, Amy

AU - Evans, Alexander

AU - Gatenby, James

AU - Alves, Luis

AU - Ariti, Cono

AU - Bafadhel, Mona

AU - Carter, Victoria

AU - Chalmers, James

AU - Chen, Rongchang

AU - Devereux, Graham

AU - Drummond, M Bradley

AU - Gibson, J Martin

AU - Halpin, David M G

AU - Han, MeiLan

AU - Hanania, Nicola A

AU - Hurst, John R

AU - Kaplan, Alan

AU - Kostikas, Konstantinos

AU - Make, Barry

AU - Mapel, Douglas

AU - Marshall, Jonathan

AU - Martinez, Fernando

AU - Meldrum, Catherine

AU - van Melle, Marije

AU - Miravitlles, Marc

AU - Morris, Tamsin

AU - Mullerova, Hana

AU - Murray, Ruth

AU - Muro, Shigeo

AU - Nordon, Clementine

AU - Ohar, Jill

AU - Pace, Wilson

AU - Pollack, Michael

AU - Quint, Jennnifer K

AU - Sharma, Anita

AU - Singh, Dave

AU - Singh, Mukesh

AU - Trudo, Frank

AU - Williams, Dennis

AU - Wilkinson, Tom

AU - Winders, Tonya

AU - Price, David

N1 - Publisher Copyright: © 2025 COPD Foundation. All rights reserved.

PY - 2025/4/25

Y1 - 2025/4/25

N2 - Background: The burden of chronic obstructive pulmonary disease (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 suboptimal 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. Methods: 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.

AB - Background: The burden of chronic obstructive pulmonary disease (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 suboptimal 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. Methods: 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.

UR - http://www.scopus.com/inward/record.url?scp=105007524980&partnerID=8YFLogxK

U2 - 10.15326/jcopdf.2024.0564

DO - 10.15326/jcopdf.2024.0564

M3 - Article

C2 - 40300198

SN - 2372-952X

VL - 12

SP - 223

EP - 239

JO - Chronic obstructive pulmonary diseases (Miami, Fla.)

JF - Chronic obstructive pulmonary diseases (Miami, Fla.)

IS - 3

ER -