Prediction Augmented Screening Initiative

Plain English Summary

Prediction Augmented Screening Initiative is a Not Applicable clinical trial sponsored by VA Office of Research and Development studying Lung Cancer, Lung Cancer Screening. This trial tests new tools to help doctors encourage lung cancer screening for Veterans. It is for Veterans who are at high risk for lung cancer. Participation involves using a new system that helps doctors decide who should get screened. Alternatives include standard lung cancer screening guidelines. The trial aims to enroll 23520 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Veterans who meet current lung cancer screening guidelines (age 50-80, history of smoking) can join. Veterans predicted to have a high benefit from screening, even if they don't fully meet current guidelines, may also be included. Veterans who have already had lung cancer screening or have been diagnosed with lung cancer cannot join. This trial is studying Lung Cancer, Lung Cancer Screening, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see if more Veterans who are likely to benefit get a lung cancer scan when doctors use these new prediction tools. The specific primary outcome measures are: LDCT receipt in high-benefit Veterans (From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because lung cancer is a leading cause of death, especially for Veterans, and this study aims to make screening more effective and accessible. This research targets Lung Cancer, Lung Cancer Screening, where improved treatment options are needed.

Investor Insight

This trial could signal a shift towards personalized, predictive approaches in cancer screening, potentially improving efficiency and reducing disparities in a large market of Veterans. The large enrollment target of 23520 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you are at high risk for lung cancer and if screening is right for you. Your participation might involve using a new system that helps your doctor discuss screening options with you. The study will track whether you receive a lung cancer screening scan. The trial is being conducted at 4 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: FACTORIAL
• Masking: NONE
• Enrollment: 23,520 participants

Interventions

• 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

Primary Outcomes

• LDCT receipt in high-benefit Veterans (From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks)

Secondary Outcomes

• LDCT receipt among all eligible Veterans (From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks)

Full Eligibility Criteria

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

Trial Locations

• VA Bedford HealthCare System, Bedford, MA, Bedford, Massachusetts, United States
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States
• VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States
• Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, United States

Frequently Asked Questions

Related Conditions

• Lung Cancer
• Lung Cancer Screening
• Veterans Health
• Preventive Medicine
• Oncology
• Radiology
• Public Health
• Health Disparities
• Early Detection
• Risk Prediction

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