Multilevel Intervention for Precision Oncology (MIPO)
Multilevel Veteran-centric Intervention to Improve Precision Oncology
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Antoinette Vo, BA MA
- Phone Number: 3922 (212) 686-7500
- Email: antoinette.vo@va.gov
Study Contact Backup
- Name: Daniel J Becker, MD
- Phone Number: 3303 (212) 686-7500
- Email: Daniel.Becker2@va.gov
Study Locations
-
-
New York
-
New York, New York, United States, 10010-5011
- Recruiting
- VA NY Harbor Healthcare System, New York, NY
-
Contact:
- Daniel J Becker, MD
- Phone Number: 3303 (212) 686-7500
- Email: Daniel.Becker2@va.gov
-
Contact:
- Antoinette Vo, BA MA
- Phone Number: 3922 212-686-7500
- Email: antoinette.vo@va.gov
-
Principal Investigator:
- Daniel J Becker, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: During intervention period
All sites will receive the 3 level intervention of patient education, provider audit/feedback, and EMR order change.
|
3 components: patient education video, provider audit/feedback, and EMR ordering change
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of molecular testing
Time Frame: 3 years
|
Proportion of eligible patients with lung and prostate cancer who have next generation sequencing molecular testing
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of targeted therapy
Time Frame: 3 years
|
Proportion of patients with actionable molecular alterations who have targeted therapy.
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Daniel J Becker, MD, VA NY Harbor Healthcare System, New York, NY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 22-169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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