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Multilevel Intervention for Precision Oncology

Multilevel Veteran-centric Intervention to Improve Precision Oncology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06825715
Acronym
MIPO
Enrollment
2653
Registered
2025-02-13
Start date
2025-07-02
Completion date
2030-02-28
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancers of the Prostate, Cancers of the Lung

Brief 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.

Interventions

3 components: patient education video, provider audit/feedback, and EMR ordering change

Sponsors

VA Office of Research and Development
Lead SponsorFED
VA Madison Health Care
CollaboratorUNKNOWN
VA Pittsburgh Healthcare System
CollaboratorFED
Martinsburg VA Medical Center
CollaboratorUNKNOWN
VA Eastern Oklahoma Health Care
CollaboratorUNKNOWN
New Orleans VA Medical Center
CollaboratorUNKNOWN
Northport VA Medical Center
CollaboratorUNKNOWN
Fargo VA Medical Center
CollaboratorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Multilevel intervention with components of patient education, provider audit/feedback, and change in electronic medical record test order and results return.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Use of molecular testing3 yearsProportion of eligible patients with lung and prostate cancer who have next generation sequencing molecular testing

Secondary

MeasureTime frameDescription
Use of targeted therapy3 yearsProportion of patients with actionable molecular alterations who have targeted therapy.

Countries

United States

Contacts

CONTACTAntoinette Vo, BA MA
antoinette.vo@va.gov(212) 686-7500
CONTACTDaniel J Becker, MD
Daniel.Becker2@va.gov(212) 686-7500
PRINCIPAL_INVESTIGATORDaniel J Becker, MD

VA NY Harbor Healthcare System, New York, NY

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026