Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation — SDM-LCS-SC  

Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Smoking Cessation

• NCT number: NCT04897568
• Study type: Interventional
• Source: University of Colorado, Denver
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Completion date: November 29, 2023