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A Direct-to-Patient Digital Health Program for Lung Cancer Screening: A Randomized Clinical Trial
David P Miller1,2, Anna C Snavely3, Ajay Dharod1,2
1Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina.
Importance:
Screening chest computed tomography (CT) scans reduce lung cancer mortality in high-risk individuals, but less than 20% of eligible individuals are screened in the US.
Objective:
To determine whether a direct-to-patient digital health program increases lung cancer screening.
Design, Setting, And Participants:
Randomized clinical trial enrolling individuals aged 50 to 77 years who met Centers for Medicare & Medicaid Services criteria for lung cancer screening between April 18, 2022, and May 30, 2023, at 2 academic health systems in the southeastern US. The date of last follow-up was September 30, 2024.
Interventions:
Participants were randomized 1:1 to the mPATH-Lung program, a digital health program delivered outside a clinical visit that included a brief decision aid and option to request a screening appointment (n = 669) or enhanced usual care, in which patients were notified of their lung cancer screening eligibility and advised to speak with their primary care clinician (n = 664).
Main Outcomes And Measures:
The primary outcome was completion of any chest CT within 16 weeks. Secondary outcomes included screening decisions, process measures (screening visits, CT scans ordered), clinical outcomes (lung cancer screening results, lung cancers diagnosed), screening harms, and implementation outcomes.
Results:
Electronic invitations were sent to 26 909 individuals with a smoking history in their electronic health record; 3267 completed website eligibility questions and 1333 were deemed eligible and enrolled. The mean age was 60.7 years (SD, 6.8 years); 864 (65%) were female; 232 (17%) were Black and 1054 (79%) were non-Hispanic White; and 621 (47%) had commercial insurance and 595 (45%) had public insurance. Chest CT completion was higher in the mPATH-Lung group than in controls (24.5% [164/669] vs 17.0% [113/664]; odds ratio, 1.6; 95% CI, 1.2-2.1). Among patients who completed screening CT, false-positive results occurred in 12.7% (19/150) of mPATH-Lung participants and 8.4% (8/95) of controls. Invasive procedures were performed in 2.0% (3/150) in the intervention group and 1.1% (1/95) in the control group, with no complications.
Conclusions And Relevance:
Compared with enhanced usual care, a direct-to-patient digital health intervention increased rates of lung cancer screening. Future research should assess the reach and effectiveness of digital lung cancer screening interventions across diverse populations and health care settings.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04083859.
