QLC+: Quebec Lung Cancer Screening PLUS Trial
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Arm: CVD Patients diagnosed with moderate 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 Patients diagnosed with moderate 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
Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.
|
| No Intervention: Control Arm: COPD Patients with untreated COPD or not on first line guideline recommended therapy. |
|
| Other: Intervention Arm: COPD Patients with untreated COPD or not on first line guideline recommended therapy. |
Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists
Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.
|
| No Intervention: Control Arm: CVD and COPD Patients diagnosed with moderate to severe CAC and not on first line guideline recommended therapy, and with untreated COPD or not on first line guideline recommended therapy. |
|
| Other: Intervention Arm: CVD and COPD Patients diagnosed with moderate to severe CAC and not on first line guideline recommended therapy, and with untreated COPD or not on first line guideline recommended therapy. |
Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists
Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Medication possession ratio (MPR) - Aim 1 [1 year post CT]
Reflects patient adherence. Days of drug supply over 1 year with statin in the previous 1 year from pharmacy dispensation records in the Dossier Santé Québec.
- Medication possession ratio (MPR) - Aim 2 [1 year post CT]
Reflects patient adherence. Days of drug supply over 1 year with LAMA inhaler in the previous 1 year from pharmacy dispensation records in the Dossier Santé Québec.
- 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.
- 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
- 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.
Eligibility Criteria
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.
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Cardiovascular aim: moderate to severe CAC identified on low dose CT, not on guideline recommended statin therapy.
-
COPD aim: diagnosed with COPD, symptomatic (mMRC 2 or greater) and untreated, or not on first line guideline recommended therapy for COPD. (ie. inhaled corticosteroids (ICS) alone or short acting beta agonists alone).
Exclusion Criteria:
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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.
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Cardiovascular aim: Absent or mild CAC, known clinical atherosclerosis, Diabetes Mellitus.
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COPD aim: asymptomatic, or already on appropriate first line COPD therapy (LAMA, long acting beta agonist (LABA), combined LAMA-LABA, combined LAMA-LABA-ICS).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nicole Ezer, MD, FRCPC, MPH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-8641