R01HL158850

Telehealth Shared Decision-Making Coaching for Lung Cancer Screening in Primary Care (TELESCOPE) - 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 healthcare 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 services. 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. This 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.
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 primary care providers to support SDM for their high-risk patients, and demonstrating for policymakers and payors new models for effective delivery of SDM for LCS.

Rutgers The State University Of New Jersey

NOT APPLICABLE

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Newark, New Jersey 071073001 United States

Single Zip Code

Implementation of shared decision making for HLBS diseases and conditions (R01 Clinical Trial Optional) (PA-19-166)

Amendment Since initial award the total obligations have increased 370% from $736,380 to $3,463,249.