Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 17, 2026
Open Peer Review Period: Sep 20, 2026 - Nov 15, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A dual-target intervention of patient activation and clinical decision support to improve guideline-recommended pharmacotherapy for chronic obstructive pulmonary disease and cardiovascular disease identified in lung cancer screening: protocol for the Quebec Lung Cancer Screening Plus randomized controlled trial.
ABSTRACT
Background:
Cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) are leading causes of death in lung cancer screening (LCS) populations but remain underdiagnosed and undertreated. Low-dose computed tomography (LDCT) for lung cancer screening can identify untreated COPD and CVD. Treating these comorbidities may increase the value of screening programs.
Objective:
to determine whether a dual-target intervention directed to the participants and their primary care providers (PCP) improves guideline-recommended pharmacotherapy for CVD and COPD.
Methods:
Quebec Lung Cancer Screening Plus (QLC Plus) is a 12-month, open-label, randomized controlled trial with 2 arms (CVD and COPD) embedded within the Quebec LCS program. Adults aged 55–74 years in the Quebec Lung Cancer Screening Program are eligible if they have coronary artery calcification without lipid-lowering therapy and/or symptomatic COPD (radiographic emphysema with modified Medical Research Council dyspnea score ≥1 and/or COPD Assessment Test score ≥10) without long-acting bronchodilator therapy. Patients with suspected lung cancer are excluded. The one-time multimodal intervention combines patient activation materials with clinician decision support delivered electronically and by mail to participants, family doctors, and pharmacists. Controls receive usual care (LDCT report alone). Primary outcomes are initiation and adherence to guideline-recommended pharmacotherapy within 12 months post-intervention: statin for the CVD arm and long-acting inhaler for the COPD arm. A total of 330 participants will be enrolled, 180 participants for the CVD arm and 150 participants for the COPD arm. Randomization will be stratified by access to a family doctor at baseline. Participants are followed up electronically at 3, 6, and 12 months.
Results:
Analyses will follow the intention-to-treat principle. Between-groups difference in primary outcomes will be examined with absolute risk difference (ARD), 95%CI, and number needed to treat (NNT). Generalized linear mixed models (GLMM) will compare the initiation of guideline-recommended pharmacotherapies between intervention and control groups. Subgroup analyses will examine outcomes by arm, sex, access to a family doctor, and baseline COPD treatment. Findings will be disseminated through conference presentations and peer-reviewed publications in 2026-2027. Timeline: Participant recruitment began in April 2023 and ended in December 2024. Prospective follow-up ended in December 2025. Extraction of primary outcomes ended in May 2026 with results expected in 2026.
Conclusions:
QLC plus dual-target intervention by activating patients and cueing clinicians to address untreated CVD and symptomatic COPD may improve guideline-concordant pharmacotherapy and extend the clinical benefit of lung cancer screening beyond nodule detection. Clinical Trial: ClinicalTrials.gov: NCT05444062
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