Prediction Augmented Screening Initiative
NCT Number: NCT06538636
Acronym: PASI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer|Lung Cancer Screening
Interventions: OTHER: PCP-Facing Tools|OTHER: LCS team population management tools
Sponsor: VA Office of Research and Development
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 23520
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2025-06-02
Completion Date: 2029-09-30
Locations: VA Bedford HealthCare System, Bedford, MA, Bedford, Massachusetts, 01730-1114, United States|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, 02130-4817, United States|VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, 48105-2303, United States|Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, 29401-5703, United States

Summary:
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.

Primary Outcome Measures: LDCT receipt, the probability of receiving an initial LDCT LCS scan at a given site 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, From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks
Secondary Outcome Measures: High-benefit Veteran Uptake, LCS orders and uptake among high-benefit Veterans, Every quarterly through study completion, an average of 3 years|Black Veteran Uptake, LCS orders and uptake among high-benefit Black Veterans, Every quarterly through study completion, an average of 3 years|non-high-benefit uptake, LCS orders and uptake among eligible but non-high-benefit Veterans and among those with high comorbidity, Every quarterly through study completion, an average of 3 years|Lung cancer detection, lung cancer detection rates, Every quarterly through study completion, an average of 3 years|Invasive procedures, invasive procedures resulting from lung cancer screening exam findings, Every quarterly through study completion, an average of 3 years|Complications from invasive procedures, Complications following invasive procedures done as a result of LCS, quarterly through study completion, an average of 3 years|lung cancer deaths avoided, this will be calculated among additional people screened due to study interventions, through study completion, an average of 3 years