Molecular Services and EMR-Laboratory Integration Application (ELIA) for Reducing Leakage and Improving Healthcare Disparities in Cancer Patients
Bien-Willner Physicians Group PA
Summary
The goal of this observational study is to measure and try to reduce leakage in precision medicine care in the community cancer clinic. The goal of precision medicine is to identify the best possible therapy the the patient based on the biology of the tumor. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). It has been observed that there are healthcare disparities in the community setting compared to academic medical centers, particularly in the use of precision medicine. The main questions the study aims to answer are: * How much leakage occurs in the use of precision medicine in the community setting? * Can we reduce leakage by providing access to better tools and services typically found in the academic medical centers? Participants will not be directly impacted and will receive standard of care. Measurements will be made of how often physicians select the appropriate test for patients, and how often they select the most appropriate therapy for their patients before and after the implementation of tools created to reduce leakage. We hope to reduce leakage in with the use of advanced tools and services, and use this study as a model to improve healthcare in the community cancer setting.
Description
Precision Medicine in oncology requires the application of molecular diagnostic reporting to inform clinical decision making. However, its implementation has been slow and inefficient. Recent studies have demonstrated that contrary to new established standards of care and guidelines, eligible patients are often not getting the appropriate testing and test results are not being used appropriately to identify optimal therapies. This is especially true in the community oncology setting, resulting in healthcare disparities. The investigators believe that the lack of efficiency and adoption of pre…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * newly diagnosed or change in status Advanced Cancer patient (recurrent, refractory, metastatic, or high grade) * Cancer patient for whom genomic testing (comprehensive genomic profile (CGP)) is recommended by relevant guidelines Exclusion Criteria: * Patient does not seek additional treatment * Patient younger than 18 years * Treatment provided at a tertiary medical center * CGP testing already performed and there is no change in patient cancer status
Interventions
- Combination ProductComprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultation
TSO500; detect single nucleotide variants (SNV), INDELs, copy number alterations (CNAs), microsatellite instability (MSI), and tumor mutation burden (TMB) in eligible patients; ELIA software to interface clinic EMR to lab; Consultations and molecular tumor boards by molecular genetic pathologist (MGP)
- Diagnostic Testlimited genetic testing or no testing
Minimal genetic testing for eligible patients or treatment without testing
Location
- Carolina Blood and Cancer Care AssociatesRock Hill, South Carolina