Education Intervention for Lung Cancer Screening Compliance

(QLC+ Trial)

Overseen By Nicole Ezer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nicole Ezer, MD, FRCPC, MPH

Disqualifiers: Lung cancer suspicion, Atherosclerosis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educational materials can help individuals with untreated COPD (a lung condition that makes breathing difficult) or cardiovascular disease (heart-related issues) adhere to their medication plans more effectively over a year. Participants will be divided into groups based on whether they have COPD or cardiovascular disease. Eligible participants have been screened for lung cancer and either have untreated COPD or specific heart concerns identified through a CT scan. This trial suits those diagnosed with COPD who are not currently on the recommended treatment or those with a heart condition identified through lung cancer screening. As an unphased trial, it offers a unique opportunity to contribute to understanding how educational support can improve medication adherence.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it seems to focus on people who are not on certain recommended therapies, so you might not need to stop any current treatments.

What prior data suggests that this educational intervention is safe for patients with COPD and cardiovascular disease?

Research has shown that educational programs, like those in this trial, are generally safe. Studies have found that these programs help people manage chronic diseases such as COPD (a lung condition) and CVD (heart disease) without causing harm. Participants in past studies did not report any serious side effects from receiving educational materials and treatment advice.

Additionally, self-management programs, which often include educational components, have demonstrated positive results. These programs help people better manage their conditions, leading to fewer hospital visits. This suggests that the educational approach is safe and well-received by participants.

In this trial, the educational programs aim to assist patients and their healthcare providers in better managing conditions that often occur with lung cancer. While specific side effects or risks are not detailed, past experiences with similar programs support their safety and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how educational interventions can boost compliance with lung cancer screening recommendations. Unlike traditional approaches that might focus solely on medical interventions, this trial emphasizes the power of informed decision-making by providing tailored educational materials and treatment recommendations to patients, general practitioners, and pharmacists. The unique aspect of this method is its holistic approach, aiming to bridge knowledge gaps and promote collaborative healthcare. By enhancing understanding and communication among all parties, this trial could lead to more proactive and effective lung cancer screenings, potentially catching conditions earlier and improving outcomes.

What evidence suggests that this educational intervention is effective for improving medication adherence in COPD and cardiovascular disease patients?

Research has shown that educational programs can help people better adhere to treatment plans for diseases like COPD (a lung disease) and CVD (heart disease). Studies have found that well-trained and informed healthcare providers can enhance their knowledge and practices, leading to improved patient health. Specifically, one study discovered that these educational efforts increased understanding of the disease and treatment adherence within just one year. Patients may be more likely to take their medications as prescribed when both they and their doctors are well-informed. In this trial, some participants will receive educational materials as part of the intervention arms for COPD and CVD. Additionally, incorporating these educational materials into existing programs, like lung cancer screenings, can amplify these benefits. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals who have been screened for lung cancer and found to have mild to severe coronary artery calcification (CAC) without being on recommended lipid-lowering therapy, or diagnosed with symptomatic COPD not treated with first-line therapies. It's not suitable for those already on appropriate COPD treatment, without CAC, with known heart issues, diabetes, or a high suspicion of lung cancer.

Inclusion Criteria

I have COPD, experience symptoms, and am not on first-line treatment.

You have been screened for lung cancer using a low-dose CT scan of the chest as part of a specific project in Quebec.

I have mild to severe artery plaque and am not on cholesterol-lowering medication.

Exclusion Criteria

I don't have heart calcification, known heart disease, past heart surgery, or diabetes.

I am suspected to have lung cancer with a high-risk rating.

My COPD is either symptom-free or I am on the first line of treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Educational intervention for untreated COPD and cardiovascular disease integrated in an existing lung cancer screening program

12 months

Regular visits as per intervention protocol

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 months

Follow-up assessments at 6 and 12 months post intervention

What Are the Treatments Tested in This Trial?

Interventions

• Educational material and treatment recommendations for patients, general practitioners and pharmacists

Trial Overview

The study tests if providing educational materials and treatment recommendations can improve adherence to medication guidelines at 12 months in patients with untreated COPD and cardiovascular disease within a lung cancer screening program.

How Is the Trial Designed?

Group I: Intervention Arm: CVD Experimental Treatment 1 Intervention

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

Group II: Intervention Arm: COPD Experimental Treatment 1 Intervention

Patients with untreated COPD or not on first line guideline recommended therapy.

Group III: Control Arm: CVD Active Control 1 Intervention

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

Group IV: Control Arm: COPD Active Control 1 Intervention

Patients with untreated COPD or not on first line guideline recommended therapy.

Who Is Running the Clinical Trial?

Nicole Ezer, MD, FRCPC, MPH

Lead Sponsor

Trials

2

Recruited

430+

Published Research Related to This Trial

In a study of 1,078 COPD patients, only 40.4% had self-management plans, highlighting a significant gap in the implementation of recommended self-management support as per UK guidelines.

Patients with self-management plans were more likely to adhere to their medication, attend support groups, and have better knowledge about COPD, indicating that these plans are crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management behaviour and support among primary care COPD patients: cross-sectional analysis of data from the Birmingham Chronic Obstructive Pulmonary Disease Cohort. Khan, A., Dickens, AP., Adab, P., et al.[2022]

The Global Initiative for Chronic Obstructive Lung Disease Report emphasizes the importance of proper management and prevention strategies for COPD, particularly in older adults who are most affected by this condition.

Pharmacists play a crucial role in improving COPD management by providing counseling on medication selection, educating patients about the disease, ensuring adherence to treatment, and teaching proper inhaler techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Obstructive Pulmonary Disease, Part 2: A Review of Pharmacotherapy Options. Naberhaus, T.[2023]

A study involving 18 general practices in Poland will evaluate a tailored implementation strategy aimed at improving general practitioners' adherence to COPD management guidelines, focusing on four key recommendations.

The trial will compare the effectiveness of these tailored interventions against usual care over a nine-month period, with the primary outcome being adherence to recommendations such as smoking cessation advice and proper inhaler use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial. Godycki-Cwirko, M., Zakowska, I., Kosiek, K., et al.[2021]

A pharmacist-led intervention for patients with chronic obstructive pulmonary disease (COPD) aims to improve medication adherence and inhaler technique, potentially enhancing health-related quality of life and reducing healthcare resource use.

This study, involving community pharmacies in Newfoundland and Labrador, will measure the effectiveness of the intervention over 6 months, focusing on changes in medication adherence and quality of life, indicating a promising approach to managing COPD in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a pharmacist-driven intervention in COPD (EPIC): study protocol for a randomized controlled trial. Davis, E., Marra, C., Gamble, JM., et al.[2023]

A 1-month study involving 181 COPD patients showed that pharmacist-led educational interventions significantly improved medication adherence rates from 66.3% to 90.1% (p < 0.001).

In addition to enhancing adherence, the intervention also led to improvements in patients' knowledge about their disease and medication, as well as better dyspnea scores and inhalation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of clinical pharmacist intervention on medication adherence in patients with chronic obstructive pulmonary disease - A randomized controlled study. Nguyen, T., Truong, MTX., Lam, DN., et al.[2023]

A study involving 293 COPD patients showed that despite improved skills of general practitioners in COPD management, patients' self-management skills did not significantly improve over time, indicating a need for ongoing education.

Patients' information needs about COPD remained high, particularly regarding diet, exercise, and self-management, with 57% reporting unchanged or increased needs after 18 months, suggesting that tailored patient education is crucial for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care patients with mild or stable chronic obstructive pulmonary disease need more support in disease management: a secondary analysis of a cluster randomized controlled trial. Sandelowsky, H., Krakau, I., Modin, S., et al.[2023]

A randomized controlled trial involving 3,376 patients showed that outreach contact combined with decision counseling significantly increased lung cancer screening rates to 5.5% compared to 1.8% in usual care, indicating effective strategies to boost screening participation.

While the combination of outreach and decision counseling led to higher screening rates than outreach alone (7% vs. 4%), the difference was not statistically significant, suggesting that further research is needed to fully understand the impact of shared decision-making on screening uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outreach to primary care patients in lung cancer screening: A randomized controlled trial. DiCarlo, M., Myers, P., Daskalakis, C., et al.[2022]

A multicenter study involving 390 COPD patients showed that a simple educational intervention significantly improved adherence to management recommendations for COPD and general health, with 53% of cases showing progress after 6 months.

While the intervention was effective in enhancing overall management, it had limited impact on specific cardiovascular comorbidities, particularly ischemic heart disease and coronary artery disease, indicating a need for more targeted strategies in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a simple intervention on management of acute exacerbations of chronic obstructive pulmonary disease and its cardiovascular comorbidities: COREPOC study. Díez-Manglano, J., Recio Iglesias, J., Varela Aguilar, JM., et al.[2018]

An educational program for general practitioners (GPs) in Denmark significantly improved adherence to COPD guidelines, with the registration of key patient metrics like FEV1 increasing from 45% to 69% and FEV1 % of predicted from 30% to 56%.

The program also enhanced the management of COPD, including better recording of smoking status and dyspnea severity, and reduced inappropriate use of inhaled corticosteroids in mild COPD patients, demonstrating that targeted education can lead to better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of COPD in general practice in Denmark--participating in an educational program substantially improves adherence to guidelines. Ulrik, CS., Hansen, EF., Jensen, MS., et al.[2021]

In a study of 156 patients, only 30% were compliant with their prescribed pulmonary medication, indicating a significant issue with adherence in general practice settings.

Patients who understood their prescription as requiring regular medication were more likely to comply, suggesting that improving patient education about medication regimens could enhance compliance rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with pulmonary medication in general practice. Dekker, FW., Dieleman, FE., Kaptein, AA., et al.[2013]

An educational program for general practitioners in Sicily improved the management of COPD, as evidenced by an increase in spirometry registrations from 59.7% to 73.0% over two years, compared to a national average of 64.8%.

The program also led to a decrease in COPD-related hospitalizations from 6.9% to 4.0% and all-cause hospitalizations from 23.0% to 18.9%, indicating enhanced patient care despite some quality indicators remaining unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in the management of chronic obstructive pulmonary disease following a clinical educational program: results from a prospective cohort study in the Sicilian general practice setting. Ferrara, R., Ientile, V., Piccinni, C., et al.[2019]

A study of 941 and 927 COPD patient records over two audits in Denmark showed that the quality of care was initially suboptimal but improved significantly after staff participated in an educational program, with referrals to rehabilitation increasing from 56.3% to 62.7%.

Key assessments such as BMI and dyspnoea evaluation also saw dramatic improvements, with BMI assessment rising from 7.8% to 56.1% and dyspnoea assessment from 7.2% to 47.2%, indicating that systematic staff education can enhance adherence to COPD care guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of COPD care in hospital outpatient clinics in Denmark: The KOLIBRI study. Lange, P., Andersen, KK., Munch, E., et al.[2009]

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Systematic reviews have provided evidence that self-management interventions improve outcomes in COPD. A 2022. Cochrane review reported that ...