ABSTRACT
Screening with low-dose CT (LDCT) scans reduces lung cancer mortality. However, the potential harms
associated with screening include false-negative and false-positive results, incidental findings, overdiagnosis,
radiation exposure, and complications from invasive diagnostic procedures and treatments. Given the complexity
of lung cancer screening (LCS) decisions, the United States Preventive Services Task Force strongly
recommends that patients receive counseling about smoking cessation and shared decision-making (SDM) with
a health care provider before being referred for LDCT. The SDM discussion about LCS should address the
benefits and harms of screening, the importance of adhering to annual lung cancer LDCT screening and
recommended diagnostic testing and treatment, and tobacco avoidance. Yet, there is uncertainty about how to
most effectively engage patients in SDM for LCS. Both patients and primary care clinicians perceive important
barriers to LCS decision making and accessing health service. When screening discussions are conducted, they
often fail to meet expectations for SDM. We propose to address these deficiencies by implementing a workflow
aware telemedicine SDM intervention that includes decision coaching and patient navigation that is a potentially
scalable and efficient approach to meeting national screening recommendations. The study’s long-term goal is
to reduce disparities and the burden of lung cancer among heavy smokers by supporting high-quality decision
making about LCS and smoking cessation and abstinence. Our short-term goal is to identify an effective
intervention that can readily be implemented in real-world primary care settings to support high-quality SDM in
racially and ethnically diverse populations. We will conduct an effectiveness-implementation hybrid type I trial
guided by the Practical, Robust Implementation and Sustainability Model (PRISM). A cluster randomized trial
design including 40 primary care practices, 100 providers and 400 patients will evaluate whether a telemedicine
decision coaching and navigation intervention (TELESCOPE) compared to enhanced usual care (EUC) will
improve the quality of decision making, increase adherence with screening and diagnostic testing, and generate
more referrals for smoking cessation. The specific aims are to: 1) Test the effectiveness of a decision coaching
intervention for LCS delivered by nurse navigators vs. EUC on the quality of patient decision making about LCS,
subsequent screening and diagnostic testing, and smoking cessation referrals for current smokers; 2)
Evaluate
the implementation potential of navigator-led decision coaching for LCS; and 3) Determine the resources and
costs required to implement the navigator-led decision coaching intervention for LCS. This highly impactful
research has the potential to greatly advance the field of SDM implementation and improve quality of care by
providing patients with high-quality decision support about LCS, testing feasible strategies for busy PCPs to
support SDM for their high-risk patients, and demonstrating for policy makers and payors new models for
effective delivery of SDM for LCS.