Cardiovascular disease risk and Lung cancer screening for Early Assessment of Risk (project CLEAR) in Missouri: A protocol for a mixed methods study

Abstract

Background Lung cancer and atherosclerotic cardiovascular disease (ASCVD) are leading causes of mortality in the United States, sharing common risk factors like smoking and age. Preventive care for these conditions is often siloed, leading to missed opportunities to prevent ASCVD-related mortality in lung cancer screening (LCS) patients. In various trial settings, patients undergoing LCS were more likely to die from ASCVD than from cancer; however, less than half of eligible patients got statin prescription. This study aims to understand the degree to which ASCVD risk assessment and prevention is done in routine real-world clinical settings providing LCS in Missouri. Our objectives are to determine the prevalence of statin eligibility, statin prescription and explore factors, disparities and barriers to statin therapy in people undergoing LCS. Methods A parallel convergent mixed-methods design will be used. Quantitative data from people undergoing LCS at Barnes-Jewish Healthcare System will be extracted from Epic electronic medical records (EMR) from January 2022-December 2023, capturing demographics, socioeconomic factors, and clinical data including ASCVD risk factors and statin use. We anticipate gathering about records for approximately 8,000 patients. Qualitative data will be gathered from in-depth interviews with up to 15 healthcare providers to identify barriers, facilitators and recommendations for enhancing statin therapy in people undergoing LCS. Discussion The risk of mortality is drastically heightened in people undergoing LCS who are not receiving statin therapy, and thus there is an urgent need to identify those who are eligible but not receiving ASCVD prevention. Promoting ASCVD risk assessment and prevention in LCS programs has the potential to mitigate the dual burden of ASCVD and lung cancer in high-risk populations who smoke cigarettes. This study will demonstrate the extent of the gap in statin therapy among LCS and provide insights into disparities, barriers and recommendations for integrating ASCVD risk assessment and prevention with LCS. Conclusion This study will provide real-world baseline data on statin therapy among people undergoing LCS in Missouri, and will highlight disparities, barriers and recommendations for integrating ASCVD prevention in LCS.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee/IRB of Washington University in St.Louis- Barnes-Jewish Healthcare gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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