COPD, Coronary Artery Calcification
Conditions
Keywords
COPD, Coronary Artery Calcification, Lung cancer screening, Undiagnosed disease, Educational intervention, Medication adherence, Untreated disease, Statins, Inhalers
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
Interventions
BEHAVIORALEducational material and treatment recommendations for patients, general practitioners and pharmacists
Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.
Sponsors
Nicole Ezer, MD, FRCPC, MPH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Guideline concordant statin therapy 1 year following the first low dose CT scan. | 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) |
| Guideline concordant inhaler therapy 1 year following the first low dose CT scan | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COPD Symptoms | Baseline, 6 months post intervention, 12 months post intervention | 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 |
| Quality of life using SF-36 questionnaire | Baseline, 12 months post intervention | SF-36 questionnaire will be filled at baseline and 12 months post intervention |
| Patient satisfaction with communication and decision making | 3 months post intervention | 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. |
| Medication possession ratio (MPR) - Aim 1 | 1 year post CT | Reflects patient adherence. Days of drug supply over 1 year with cholesterol lowering medication in the previous 1 year from pharmacy dispensation records. |
| Absenteeism and presenteeism | baseline | Work productivity and activity impairment (WPAI) questionnaire |
| Health literacy | baseline | Health literacy will be assessed at study entry using the Brief Health Literacy Screen. |
| Health Care Utilisation | 1 year post intervention | Number of unplanned clinic visits, hospitalizations for respiratory or cardiac disease, consultations with specialists (cardiology and respirology), invasive/non-invasive cardiac or respiratory investigations |
| Medication possession ratio (MPR) - Aim 2 | 1 year post CT | 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. |
Countries
Canada
Outcome results
None listed