Multilevel Intervention for Precision Oncology (MIPO)

VA Office of Research and Development

Status: Enrolling

Conditions: Cancers of the Lung; Advanced Cancers of the Prostate

Treatments: Other: Multilevel intervention

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT06825715

IIR 22-169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,653 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in the VA with cancer of the lung or prostate who are seen in the oncology clinic

Exclusion criteria

• Cancer that did not originate in the prostate or the lung

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,653 participants in 1 patient group

During intervention period

Experimental group

Description:

All sites will receive the 3 level intervention of patient education, provider audit/feedback, and EMR order change.

Treatment:

Other: Multilevel intervention