Prediction Augmented Screening Initiative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorVA Office of Research and Development
About this trial
Lung cancer is responsible for more deaths in the United States than breast, prostate and colon cancer combined and is the number one cancer killer of Veterans. This is because lung cancer is usually diagnosed when the disease has spread, and cure is less likely. Lung cancer screening (LCS) finds cancer at an earlier stage when it is curable, yet only 20% of eligible Veterans have been screened. Uptake is even lower among Black Veterans despite higher lung cancer risk. Using prediction models to identify high-benefit people for whom LCS should be encouraged improves efficiency and reduces disparities. Moreover, it is more patient-centered as shared decision-making conversations can be tailored with personalized information. The US Preventive Services Task Force has called for research to demonstrate that prediction-augmented LCS can be feasibly implemented at the point-of-care. The investigators propose for VA to lead this effort with a large-scale pragmatic clinical trial to show that prediction-augmented LCS is both feasible and improves LCS uptake.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
meeting USPSTF eligibility criteria for LCS, as currently encoded in the background logic of LCS clinical reminders maintained by the VA National Center for Lung Cancer Screening (i.e., age 50-80 years; smoked 20 pack-years; current smoking or quit <15 years ago) OR
predicted benefit calculated using LYFS-CTVA model exceeds a stringent high-benefit threshold of life-year gains with annual LCS, as recommended in the 2021 CHEST LCS guidelines
Disqualifiers
Veterans who have previously undergone lung cancer screening, are diagnosed with lung cancer, or who do not meet eligibility criteria outlined above
Trial design
Design model
Factorial
Treatments tested in this trial
PCP-Facing Tools
Other interventionPCP-facing tools will be turned on as a package: a) enhanced LCS clinical reminder including DP+ generated smart message; b) Integrated one-click DP+ full decision tool for automating personalized information about the net benefit of LCS based on patient characteristics; c) the TurboHM tool: automated Health maintenance app for tracking all preventive care, including a dedicated LCS section with personalized information
LCS team population management tools
Other interventionsite-specific dashboard and proactive outreach toolkit
Treatment groups
23,520 Participants
are divided into 4 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: PCP facing toolsExperimental treatment 2 interventions
Group C: LCS team population management toolsExperimental treatment 2 interventions
Group D: PCP facing tools plus LCS population management dashboardExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
LDCT receipt in high-benefit Veterans
The probability of completion of an initial LDCT scan among eligible subjects defined as high-benefit during each quarter of the study (quarter assigned by date of the LDCT order as this event is most proximal to the LCS decision; passage of time between order and scan completion could lead to erroneous attribution of primary outcome to the wrong study phase if scan date is used)
Time frame
From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeksSecondary outcomes
1
LDCT receipt among all eligible Veterans
The probability of completion of an initial LDCT scan among eligible subjects during each quarter of the study (quarter assigned by date of the LDCT order as this event is most proximal to the LCS decision; passage of time between order and scan completion could lead to erroneous attribution of primary outcome to the wrong study phase if scan date is used)
Time frame
From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeksSponsors and contacts
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Source ClinicalTrials.gov