Education Intervention for Lung Cancer Screening Compliance
(QLC+ Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nicole Ezer, MD, FRCPC, MPH
Disqualifiers: Lung cancer suspicion, Atherosclerosis, Diabetes, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
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
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 data supports the effectiveness of this treatment for improving lung cancer screening compliance?
Is the educational intervention for lung cancer screening compliance safe for humans?
The educational interventions, including those involving pharmacists and outreach for lung cancer screening, have been studied in various contexts like COPD and cardiovascular disease management. These studies focus on improving patient adherence and decision-making without reporting any safety concerns, suggesting that such educational interventions are generally safe for humans.678910
How does the education intervention for lung cancer screening compliance differ from other treatments?
This treatment is unique because it focuses on educating patients to improve their compliance with lung cancer screening, rather than using medication or traditional therapies. It involves outreach and decision counseling to encourage patients to follow screening guidelines, which is different from standard medical treatments that typically involve drugs or procedures.1391112
Eligibility Criteria
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.
Trial Timeline
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
Treatment Details
Interventions
- Educational material and treatment recommendations for patients, general practitioners and pharmacists (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm: CVDExperimental Treatment1 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: COPDExperimental Treatment1 Intervention
Patients with untreated COPD or not on first line guideline recommended therapy.
Group III: Control Arm: CVDActive Control1 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: COPDActive Control1 Intervention
Patients with untreated COPD or not on first line guideline recommended therapy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
McGill University Health CenterMontreal, Canada
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Who Is Running the Clinical Trial?
Nicole Ezer, MD, FRCPC, MPHLead Sponsor
References
Management of COPD in general practice in Denmark--participating in an educational program substantially improves adherence to guidelines. [2021]The general practitioner (GP) is the first contact with the health care system for most patients with COPD in Denmark. We studied, if participating in an educational program could improve adherence to guidelines, not least for diagnosis, staging, and treatment of the disease.
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. [2019]Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disorder of the lungs associated with progressive disability. Although general practitioners (GPs) should play an important role in the COPD management, critical issues have been documented in the primary care setting. The aim of this study was to evaluate the effectiveness of an educational program for the improvement of the COPD management in a Sicilian general practice setting. The effectiveness of the program, was evaluated by comparing 15 quality-of-care indicators developed from data extracted by 33 GPs, at baseline vs. 12 and 24 months, and compared with data from a national primary care database (HSD). Moreover, data on COPD-related and all-cause hospitalizations over time of COPD patients, was measured. Overall, 1,465 patients (3.2%) had a registered diagnosis of COPD at baseline vs. 1,395 (3.0%) and 1,388 (3.0%) over time (vs. 3.0% in HSD). COPD patients with one spirometry registered increased from 59.7% at baseline to 73.0% after 2 years (vs. 64.8% in HSD). Instead, some quality of care indicators where not modified such as proportion of COPD patients treated with ICS in monotherapy that was almost stable during the study period: 9.6% (baseline) vs. 9.9% (after 2 years), vs. 7.7% in HSD. COPD-related and all-cause hospitalizations of patients affected by COPD decreased during the two observation years (from 6.9% vs. 4.0%; from 23.0% vs. 18.9%, respectively). Our study showed that educational program involving specialists, clinical pharmacologists and GPs based on training events and clinical audit may contribute to partly improve both diagnostic and therapeutic management of COPD in primary care setting, despite this effect may vary across GPs and indicators of COPD quality of care.
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. [2023]Patient education based on the patient's individual needs and circumstances is known to be associated with positive changes in clinical outcomes in chronic obstructive pulmonary disease (COPD). We aimed to assess the levels of patients' subjective needs for information about COPD before and after their general practitioners had taken part in a COPD education.
Quality of COPD care in hospital outpatient clinics in Denmark: The KOLIBRI study. [2009]We studied the quality of care for COPD patients in 22 hospital-based outpatient clinics in Denmark and evaluated if participation by the staff in an educational programme could improve the quality of care and adherence to the COPD guidelines.
Self-management behaviour and support among primary care COPD patients: cross-sectional analysis of data from the Birmingham Chronic Obstructive Pulmonary Disease Cohort. [2022]Self-management support for chronic obstructive pulmonary disease (COPD) patients is recommended by UK national guidelines, but extent of implementation is unknown. We aimed to describe self-management behaviour and support among COPD patients and explore behaviour associated with having a self-management plan. We undertook cross-sectional analysis of self-reported data from diagnosed COPD patients in the Birmingham COPD Cohort study. Questionnaire items relevant to self-management behaviour, knowledge of COPD, receipt of self-management plans and advice from healthcare professionals were examined. Multiple regression models were used to identify behaviour associated with having a self-management plan. One-thousand seventy-eight participants (676 males, 62.7%, mean age 69.8 (standard deviation 9.0) years) were included. The majority reported taking medications as instructed (940, 94.0%) and receiving annual influenza vaccinations (962, 89.2%). Only 400 (40.4%) participants had self-management plans, 538 (49.9%) reported never having received advice on diet/exercise and 110 (42.7%) current smokers had been offered practical help to stop smoking in the previous year. General knowledge about COPD was moderate (mean total Bristol COPD Knowledge Questionnaire score: 31.5 (standard deviation 10.7); max score 65), corresponding to 48.5% of questions answered correctly. Having a self-management plan was positively associated with self-reported adherence to medication (odds ratio 3.10, 95% confidence interval 1.43 to 6.72), attendance at a training course (odds ratio 2.72, 95% confidence interval 1.81 to 4.12), attendance at a support group (odds ratio 6.28, 95% confidence interval 2.96 to 13.35) and better disease knowledge (mean difference 4.87, 95% confidence interval 3.16 to 6.58). Primary care healthcare professionals should ensure more widespread implementation of individualised self-management plans for all patients and improve the lifestyle advice provided.
Effectiveness of a simple intervention on management of acute exacerbations of chronic obstructive pulmonary disease and its cardiovascular comorbidities: COREPOC study. [2018]To determine the effectiveness of a simple educational intervention to improve the management of cardiovascular comorbidities in patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (COPD).
Effectiveness of a pharmacist-driven intervention in COPD (EPIC): study protocol for a randomized controlled trial. [2023]Patients with chronic obstructive pulmonary disease (COPD) are often nonadherent with medications and have poor inhaler technique. Community pharmacists can help to improve health-related quality of life and overall outcomes in patients with COPD. We aim to measure the effectiveness of a systematic, pharmacist-driven intervention on patients with diagnosed COPD.
Effectiveness of clinical pharmacist intervention on medication adherence in patients with chronic obstructive pulmonary disease - A randomized controlled study. [2023]In patients with chronic obstructive pulmonary disease (COPD), non-adherence remains challenging to achieve optimal disease control. Our study aimed to determine the impact of pharmacist-led educational interventions on COPD management, focusing mainly on medication adherence.
Outreach to primary care patients in lung cancer screening: A randomized controlled trial. [2022]Current guidelines recommend annual lung cancer screening (LCS), but rates are low. The current study evaluated strategies to increase LCS. This study was a randomized controlled trial designed to evaluate the effects of patient outreach and shared decision making (SDM) about LCS among patients in four primary care practices. Patients 50 to 80 years of age and at high risk for lung cancer were randomized to Outreach Contact plus Decision Counseling (OC-DC, n = 314), Outreach Contact alone (OC, n = 314), or usual care (UC, n = 1748). LCS was significantly higher in the combined OC/OC-DC group versus UC controls (5.5% vs. 1.8%; hazard ratio, HR = 3.28; 95% confidence interval, CI: 1.98 to 5.41; p = 0.001). LCS was higher in the OC-DC group than in the OC group, although not significantly so (7% vs. 4%, respectively; HR = 1.75; 95% CI: 0.86 to 3.55; p = 0.123). LCS referral/scheduling was also significantly higher in the OC/OC-DC group compared to controls (11% v. 5%; odds ratio, OR = 2.02; p = 0.001). We observed a similar trend for appointment keeping, but the effect was not statistically significant (86% v. 76%; OR = 1.93; p = 0.351). Outreach contacts significantly increased LCS among primary care patients. Research is needed to assess the additional value of SDM on screening uptake.
Chronic Obstructive Pulmonary Disease, Part 2: A Review of Pharmacotherapy Options. [2023]The Global Initiative for Chronic Obstructive Lung Disease Report provides guidance on prevention and management of chronic obstructive pulmonary disease (COPD), a pulmonary syndrome largely impacting older adults. Management of COPD in this patient population is often further complicated because of medication and disease state interactions. Pharmacists are in a unique position to impact patients with COPD through counseling on proper medication selection, disease state education, adherence, and proper inhaler technique.
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. [2021]Chronic obstructive pulmonary disease (COPD) remains a major health problem, strongly related to smoking. Despite the publication of practice guidelines on prevention and treatment, not all patients with the disease receive the recommended healthcare, particularly with regard to smoking cessation advice where applicable. We have developed a tailored implementation strategy for enhancing general practitioners' adherence to the disease management guidelines. The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners' adherence to guidelines.
Compliance with pulmonary medication in general practice. [2013]We wanted to assess compliance with regular pulmonary medication, in 156 patients in a general practice setting. Patients completed a questionnaire on their reported daily intake, the perceived prescription, and their self-assessed perceived compliance with pulmonary medication. Compliance was defined as a reported daily intake > or = 50% of the prescribed amount. Using this definition, 30% of patients were considered to be compliant. Compliant patients had daily symptoms more often, were more often prescribed two or more different medications, and a greater proportion of them had at some time consulted a chest physician. When patients correctly perceived the prescription to refer to medication which had to be taken on a regular basis, they were more likely to be compliant. We conclude that, since less than one third of patients was compliant with medication, more efforts are needed to improve compliance in general practice. Non-compliance with medication may well provide an alternative explanation for the discrepancy between prescribed medication and medical outcome, which has been labelled in the literature as "undertreatment".