Prediction Augmented Screening Initiative (PASI)

April 15, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Despite large-randomized trials demonstrating the mortality benefit from lung cancer screening (LCS) and a recommendation from the US Preventive Services Task Force (USPSTF) and VHA since 2013, only 20% of eligible Veterans have received LCS. Uptake is even lower among Black Veterans despite higher lung cancer risk. Current USPSTF eligibility criteria of age and smoking history are simple, but do not incorporate the heterogeneity in lung cancer risk and life expectancy across people and leads to exclusion of some persons, especially Blacks, with potential for high benefit from LCS. While the USPSTF acknowledged that using prediction models to augment simple eligibility criteria is more efficient and equitable, they stopped short of recommending prediction-augmented LCS, noting that a pragmatic trial was needed to demonstrate that prediction-augmented LCS can be feasibly implemented in real-world settings and assess its impact on LCS uptake. Significance: By demonstrating the real-world feasibility of prediction-augmented LCS, and its ability to improve LCS uptake especially in those of high-benefit, the VA as a learning healthcare system will influence national LCS guidelines and improve LCS outcomes both inside and outside the VA. Innovation & Impact: Prediction-augmented LCS is based on strong evidence, yet implementing this approach would represent paradigm shift from typical preventive cancer screening. The proposed work is a unique opportunity for the VA to advance implementation of more equitable, personalized LCS by improving on the status quo of making broad 'one-size-fits-all' recommendations. The innovation is the advancement of primary care-facing and population management informatics tools that present individualized information on how strongly to encourage LCS, with the potential to be expanded to other cancer screenings. Specific Aims: 1. Conduct a pragmatic stepped wedge (site-level) factorial trial comparing usual care (USPSTF criteria) versus prediction-augmented LCS (supported by primary care-facing informatics tools, LCS team population management tools, external facilitation) on effectiveness at increasing LCS uptake. 2. Determine what drives implementation success of prediction-augmented LCS in various contexts, using mixed methods. Methodology: The investigators will utilize a factorial stepped wedge design in the Lung Precision Oncology Program network to establish the effectiveness and evaluate the implementation of precision-augmented LCS. Veterans assigned a PCP at a participating site and who meet inclusion criteria based on Clinical Data Warehouse data will be passively enrolled in the study: 1) patients meeting USPSTF criteria for LCS; OR 2) patients whose predicted LCS benefit exceeds a stringent high-benefit threshold of life gained with annual LCS (to capture high-benefit Veterans currently excluded by USPSTF criteria). The primary outcome is 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). The factorial design allows us to discern the effect on LCS uptake of primary care-facing vs LCS team population management tools. Secondary outcomes include 1) LDCT orders and completion among all eligible Veterans; 2) LCS orders and completion among high-benefit Black Veterans and among all eligible Black Veterans; 3) LDCT orders and completion among eligible but non-high-benefit Veterans and among those with high comorbidity; 4) Effects on lung cancer detection rates; 5) LCS outcomes (invasive procedures and complications) and projected cancer outcomes (e.g., lung cancer deaths avoided) among additional people screened due to the interventions, and care gaps in which LCS was ordered but not completed. Implementation evaluation will be guided by the i-PARIHS framework using mixed methods. This approach combines data drawn from across all trial sites (tool usage data, clinician surveys, facilitation data, patient interviews) to gain a broad view of implementation, with in-depth ethnographic assessments from 6 selected sites that will provide deeper insights into how and why implementation succeeded (or faced challenges) in different contexts. Our findings will inform creation of an implementation playbook to support enterprise-wide spread of prediction-augmented LCS. Next Steps / Implementation: The investigators will work with our operational partners to spread implementation of prediction-augmented LCS across the VA enterprise.

Study Type

Interventional

Enrollment (Estimated)

23520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730-1114
      • Boston, Massachusetts, United States, 02130-4817
    • Michigan
      • Ann Arbor, Michigan, United States, 48105-2303
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5703
        • Ralph H. Johnson VA Medical Center, Charleston, SC
        • Contact:
        • Principal Investigator:
          • Nichole T Tanner, MD MS BS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Veterans assigned a PCP at a participating site and who meet inclusion criteria at any point during the study timeframe will be enrolled into the trial. There will be two paths to patient inclusion:

  • 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

Exclusion Criteria:

  • Veterans who have previously undergone lung cancer screening, are diagnosed with lung cancer, or who do not meet eligibility criteria outlined above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Usual care
Experimental: PCP facing tools
Suite of PCP facing tools activated
Other: PCP-Facing Tools
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
Other: LCS team population management tools
site-specific dashboard and proactive outreach toolkit
Experimental: LCS team population management tools
site-specific dashboard and proactive outreach toolkit
Other: PCP-Facing Tools
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
Other: LCS team population management tools
site-specific dashboard and proactive outreach toolkit
Experimental: PCP facing tools plus LCS population management dashboard
both interventions activated
Other: PCP-Facing Tools
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
Other: LCS team population management tools
site-specific dashboard and proactive outreach toolkit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDCT receipt in high-benefit Veterans
Time Frame: From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDCT receipt among all eligible Veterans
Time Frame: From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks
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)
From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Nichole T Tanner, MD MS BS, Ralph H. Johnson VA Medical Center, Charleston, SC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 5, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLP-001-24S
  • CX002850 (Other Grant/Funding Number: Veterans Affairs Office of Research & Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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