NCT06825715

Multilevel Intervention for Precision Oncology

Multilevel Veteran-centric Intervention to Improve Precision Oncology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,653 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The investigators are rolling out a 3 level intervention designed to improve the use of Precision Oncology at 8 VA medical centers. The 3 components of the intervention are 1: a short educational video for patients, 2: audit and feedback to providers on their Precision Oncology practice patterns, and 3: a change in the electronic medical record to make it easier to order and review results of Precision Oncology tests.

Detailed description

Background: Precision oncology (PO), the use of molecular testing to identify tumor specific abnormalities which facilitate targeted therapy, is proven to extend lives and improve quality of life for patients with cancer. Extensive study, however, documents that up to 50% of patients in the VA, especially those with adverse social determinants of health (older age, rural), do not receive guideline recommended PO. Methodology: Building on the investigators' previous analyses, and the Theoretical Domains Framework, the investigators designed a mixed-methods type I hybrid effectiveness-implementation study of a multilevel intervention (MLI) to improve the use of PO. The MLI will be instituted for veterans with advanced cancers of the colon, lung, and prostate, as well as providers at 8 sites, chosen to represent diversity at the level of rurality, geographic region, cancer volume, and mode of delivery (virtual/in-person). The patient intervention is a 5-minute educational module accessible by QR code. The provider intervention is a 45-minute academic detailing session, as well as individualized audit and feedback on practice patterns. The facility level intervention is a previously piloted integration of PO ordering, interdepartmental communication, and results return into the primary electronic medical record via a consult function. The primary efficacy outcome is the rate of molecular testing/eligible veterans. Validated survey measures will be used for stakeholder engagement. The process evaluation employs a mixed methods approach based in the RE-AIM framework, which includes quantitative analyses of collected data, and interviews of patients and providers. The statistical design is a randomized stepped-wedge trial over 3 years which retains control data from across all sites.

Conditions

• Advanced Cancers of the Prostate
• Cancers of the Lung

Interventions

Type	Name	Description
OTHER	Multilevel intervention	3 components: patient education video, provider audit/feedback, and EMR ordering change

Timeline

• Start date: 2025-07-02
• Primary completion: 2029-02-28
• Completion: 2030-02-28
• First posted: 2025-02-13
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States