Prediction Augmented Screening Initiative
PASI
2 other identifiers
interventional
23,520
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Jun 2026
Typical duration for not_applicable lung-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2029
Study Completion
Last participant's last visit for all outcomes
September 30, 2029
April 16, 2026
April 1, 2026
2.8 years
July 30, 2024
April 15, 2026
Conditions
Outcome Measures
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)
From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks
Secondary Outcomes (1)
LDCT receipt among all eligible Veterans
From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks
Study Arms (4)
Usual Care
NO INTERVENTIONUsual care
PCP facing tools
EXPERIMENTALSuite of PCP facing tools activated
LCS team population management tools
EXPERIMENTALsite-specific dashboard and proactive outreach toolkit
PCP facing tools plus LCS population management dashboard
EXPERIMENTALboth interventions activated
Interventions
PCP-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
site-specific dashboard and proactive outreach toolkit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Veterans who have previously undergone lung cancer screening, are diagnosed with lung cancer, or who do not meet eligibility criteria outlined above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nichole T Tanner, MD MS BS
Ralph H. Johnson VA Medical Center, Charleston, SC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 6, 2024
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
March 5, 2029
Study Completion (Estimated)
September 30, 2029
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share