Quebec Lung Cancer Screening PLUS Trial

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
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

Conditions
-----------------
COPD, Coronary Artery Calcification

Intervention / Treatment
-----------------
* Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm: CVD<br>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 | |
| Other: Intervention Arm: CVD<br>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 | Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists<br>* Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.<br>|
| No Intervention: Control Arm: COPD<br>Patients with untreated COPD or not on first line guideline recommended therapy. | |
| Other: Intervention Arm: COPD<br>Patients with untreated COPD or not on first line guideline recommended therapy. | Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists<br>* Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guideline concordant statin therapy 1 year following the first low dose CT scan. | 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) | 1 year post CT | 
| Guideline concordant inhaler therapy 1 year following the first low dose CT scan | 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) | 1 year post CT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication possession ratio (MPR) - Aim 1 | Reflects patient adherence. Days of drug supply over 1 year with cholesterol lowering medication in the previous 1 year from pharmacy dispensation records. | 1 year post CT | 
| Medication possession ratio (MPR) - Aim 2 | Reflects patient adherence. Days of drug supply over 1 year with guideline concordant inhaler therapy for COPD in the previous 1 year from pharmacy dispensation records. | 1 year post CT | 
| COPD Symptoms | COPD Assessment Test is a validated patient-reported outcome. It measures 8 symptoms of COPD on a 0-5 point scale at baseline, 6 and 12 months post intervention | Baseline, 6 months post intervention, 12 months post intervention | 
| Quality of life using SF-36 questionnaire | SF-36 questionnaire will be filled at baseline and 12 months post intervention | Baseline, 12 months post intervention | 
| Patient satisfaction with communication and decision making | COMRADE is a 20-item self-reported measure for use in primary care to assess risk communication and confidence in treatment decision making. It assesses patient satisfaction with information provided about risks/benefits of treatment, perception of participation in treatment decisions, and satisfaction with that decision. COMRADE questionnaire will be sent to patients after their first meeting with their general practitioner up to 3 months after intervention. | 3 months post intervention | 
| Health Care Utilisation | Number of unplanned clinic visits, hospitalizations for respiratory or cardiac disease, consultations with specialists (cardiology and respirology), invasive/non-invasive cardiac or respiratory investigations | 1 year post intervention | 
| Absenteeism and presenteeism | Work productivity and activity impairment (WPAI) questionnaire | baseline | 
| Health literacy | Health literacy will be assessed at study entry using the Brief Health Literacy Screen. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Coronary Artery Calcification, Lung cancer screening, Undiagnosed disease, Educational intervention, Medication adherence, Untreated disease, Statins, Inhalers