Clinical trial NCT04612946: Using Connected Health to Increase Lung Cancer Screening
Official title: Using Connected Health to Increase Lung Cancer Screening: Single Center Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: telemedicine
behavioral economics
connected health strategies
lung cancer screening
patient outreach
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Abramson Cancer Center at Penn Medicine
First posted: 2020-11-03
Enrollment: 137
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized (1:1) intervention or usual care
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 55-77
2. Had a primary care visit at the healthcare system within the last 24 months
3. No history of lung cancer
4. Heavy smokers (30+ pack year and current smoker or quit within 15 years)
5. Access to phone and internet
6. English-speaking
7. Have an assigned primary care provider at recruiting practices
8. Never received LCS within the healthcare system

Exclusion Criteria:

1. Aged \<55 or \>77 years
2. Did not have a primary care visit at the healthcare system within the last 24 months
3. History of lung cancer
4. Smoking history of \<30 pack years
5. No access to phone and internet
6. Inability to speak English
7. Does not have an assigned primary care provider at recruiting practices
8. History of LCS within the healthcare system

Primary outcomes:
measure: Completion of LCS counseling
timeFrame: Initial measurement will occur within 8 weeks of baseline survey
Secondary outcomes:
measure: Completion of LDCT scan for LCS
timeFrame: Within 6 months following baseline survey
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katharine A Rendle, PhD,MSW,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Anil Vachani, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: