Lung Cancer Clinical Trial

Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation

Summary

The intervention is aimed to improve adherence to the lung cancer screening (LCS) guidelines and Centers for Medicare and Medicaid Services (CMS) coverage criteria to conduct shared decision-making (SDM) and provide smoking cessation services in rural primary care practices.

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Full Description

The pilot intervention will engage no more than 300 patients using a pragmatic, pre-post design guided by an enhanced RE-AIM/PRISM framework. The primary goal of this intervention is to improve LCS practice by offering a formal SDM process and smoking cessation support aligned with the CMS coverage criteria. The investigators will conduct a type II effectiveness implementation hybrid trial using a stepped wedge design to evaluate the effectiveness (co-primary outcomes of LCS and decision quality) and implementation at four rural clinics. Space precludes discussion of pragmatic design features, but this study was designed to be pragmatic using the PRECIS-2 criteria and it scores highly on almost all PRECIS-2 dimensions.

Each clinic will recruit the minimum of 9 patients eligible to LCS (based on CMS guidelines) every 2 months for the total of 8 months. The first period of 2 months is for baseline data, the second period of 2 months is for step 1 of the stepped wedge design, the third period of 2 months is for step 2 and finally the last 4th period of 2 months is for step 3 of the stepped wedge design. Each participating patient will receive 2 surveys (one immediately after the doctor's visit and a second one a month later). The intervention will be in the form of patient decision aid (information flyer) the participant receives during a healthcare provider visit.

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Eligibility Criteria

Inclusion Criteria:

Asymptomatic to lung cancer symptoms
Tobacco smoking history of 20+ pack-years
Current smoker or quit within last 15 years

Exclusion Criteria:

- A patient that does not meet inclusion criteria

Study is for people with:

Lung Cancer

Estimated Enrollment:

118

Study ID:

NCT04897568

Recruitment Status:

Completed

Sponsor:

University of Colorado, Denver

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There is 1 Location for this study

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University of Colorado Hospital
Aurora Colorado, 80045, United States

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Study is for people with:

Lung Cancer

Estimated Enrollment:

118

Study ID:

NCT04897568

Recruitment Status:

Completed

Sponsor:


University of Colorado, Denver

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