Using Connected Health to Increase Lung Cancer Screening
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This study will consist of two primary aims designed to help advance quality and utilization
      of lung cancer screening (LCS) within an academic and community-based medical system. The
      objective of Aim 1 is to pilot test the effect and feasibility of using direct outreach and
      telemedicine to increase LCS counseling and LDCT uptake among screening-eligible patients.
      Patients who confirm eligibility and agree to participate will be randomized into two study
      arms: 1) usual care or 2) telemedicine LCS counseling referral. For Aim 2, each arm will
      first complete a baseline survey to explore how individual beliefs and knowledge impact
      screening intention and uptake. Patients in both arms will also receive brief information on
      lung cancer screening guidelines and be asked to report LCS-related preferences after
      exposure to the information. All interventions will be administered using a secure, web-based
      platform.
    

Detailed description: 
      In 2013, the United States Preventive Services Task Force (USPSTF) provided a Grade "B"
      recommendation for annual lung cancer screening (LCS) for asymptomatic adults aged 55-80 who
      are or have been heavy smokers (≥30 pack-years of smoking and quit-date < 15 years ago), and
      are able to undergo surgery. In 2015, The Centers for Medicare and Medicaid Services (CMS)
      issued national coverage for LCS requiring that LCS counseling, which must include shared
      decision-making and tobacco cessation counseling, occur prior to LCS. CMS also provides
      reimbursement for LCS counseling to further support providers to engage in meaningful,
      collaborative conversations about LCS with patients. Despite widespread support, uptake and
      implementation of LCS across the United States has been low (estimated 3-5%
      screening-eligible population screened). Locally, since the onset of the Penn Medicine LCS
      Program in 2014, over 3,500 individual patients have received LCS; however, documentation and
      reimbursement of LCS counseling are limited.

      Challenges of implementing LCS include substantial barriers to identifying screening-eligible
      patients, supporting high-quality decision-making, and remaining uncertainties regarding
      risks and benefits. For other types of cancer screening, insights from behavioral science
      have been applied to understand how cognitive biases and beliefs impact screening uptake. Yet
      for LCS, there is limited evidence on how these beliefs may affect screening behaviors in
      routine practice. Given the complexities of LCS, in which the benefits do not clearly
      outweigh the harms, understanding how these biases impact screening can help inform
      development of intervention strategies that both support informed decision-making and
      increase uptake among eligible patients. Leveraging an existing EMR-based data warehouse,
      this study will combine insights from behavioral economics and connected health strategies to
      pilot test connected health approaches including direct patient outreach and telemedicine
      visits to improve LCS counseling, and to explore individual-level moderators of LCS screening
      intention and uptake. The long-term goal is to decrease lung cancer burden by increasing
      utilization of LCS and providing clinicians and patients with effective strategies to deliver
      high-quality, patient-centered care. This study will also advance scientific understanding of
      the mechanisms that drive or hinder health behavior in the context of cancer prevention.
    

Intervention name(s): Referral to Telemedicine LCS Counseling Visit; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients in the intervention arm will be invited to complete a telemedicine LCS counseling visit, and asked for permission to be referred directly to the LCS navigator to help schedule an appointment. They will also be given the option to directly contact the LCS navigator. Telemedicine counseling visits will be conducted using established clinical procedures for virtual or telephone visits at Penn Medicine. In accordance with reimbursement policies for lung cancer screening, these visits will be conducted by a physician or nurse practitioner within the Lung Cancer Screening Program at Penn Medicine. Counseling visits are covered without co-pay as standalone visits according to USPSTF guidelines and costs will not be covered by the study. LCS is an evidence-based practice and considered standard of care for those who are eligible and desire to be screened. Clinicians retain full control on how to conduct LCS counseling or LDCT in this trial.; Patients in the usual care arm will be provided with contact information for the Penn LCS Program and encouraged to discuss LCS with their providers.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized (1:1) intervention or usual care
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: telemedicine; behavioral economics; connected health strategies; lung cancer screening; patient outreach