Quebec Lung Cancer Screening PLUS Trial - a Randomized Controlled Trial of an Educational Intervention for Untreated Chronic Obstructive Pulmonary Disease (COPD) and/or Cardiovascular Disease (CVD) Identified During Lung Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Guideline concordant inhaler therapy 1 year following the first low dose CT scan
研究概览
简要总结
Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient screened for lung cancer as part of the Quebec Lung Cancer Demonstration project by low dose CT scan of the chest.
- •Cardiovascular aim: mild to severe CAC identified on low dose CT, not on guideline recommended lipid-lowering therapy.
- •COPD aim: diagnosed with COPD, symptomatic (mMRC >=1 or CAT>= 10) and untreated, or not on first line guideline recommended therapy for COPD.
排除标准
- •Any participant with a high suspicion of lung cancer, defined as Lung-RADS (Lung Imaging Reporting and Data System) 3 or 4, as this is an inopportune time to initiate new medical therapies.
- •Cardiovascular aim: Absent CAC, known clinical atherosclerosis, known former heart surgery, Diabetes Mellitus.
- •COPD aim: asymptomatic, or already on appropriate first line COPD therapy.
研究组 & 干预措施
Control Arm: CVD
Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy.
Coronary artery Calcification (CAC) score obtained from lung cancer screening CT Scan images
Intervention Arm: CVD
Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy.
CAC score obtained from lung cancer screening CT Scan images
干预措施: Educational material and treatment recommendations for patients, general practitioners and pharmacists (Behavioral)
Control Arm: COPD
Patients with untreated COPD or not on first line guideline recommended therapy.
Intervention Arm: COPD
Patients with untreated COPD or not on first line guideline recommended therapy.
干预措施: Educational material and treatment recommendations for patients, general practitioners and pharmacists (Behavioral)
结局指标
主要结局
Guideline concordant inhaler therapy 1 year following the first low dose CT scan
时间窗: 1 year post CT
Among patients who have untreated or inappropriately treated COPD at baseline, any long acting muscarinic antagonist inhaler prescribed at least once in the 1 year following the first low dose CT scan (aim 2)
Guideline concordant statin therapy 1 year following the first low dose CT scan.
时间窗: 1 year post CT
Among patients with moderate to severe coronary artery calcifications (CAC) not on a statin at baseline, any statin prescribed for primary prevention at least once in the 1 year following the first low dose CT scan. (aim 1)
次要结局
- COPD Symptoms(Baseline, 6 months post intervention, 12 months post intervention)
- Health Care Utilisation(1 year post intervention)
- Medication possession ratio (MPR) - Aim 1(1 year post CT)
- Medication possession ratio (MPR) - Aim 2(1 year post CT)
- Quality of life using SF-36 questionnaire(Baseline, 12 months post intervention)
- Absenteeism and presenteeism(baseline)
- Patient satisfaction with communication and decision making(3 months post intervention)
- Health literacy(baseline)
研究者
Nicole Ezer, MD, FRCPC, MPH
Assistant professor of medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre