Aims
Genomic diagnostics have accelerated therapeutic and preventative breakthroughs in oncology and cancer genetics. However, implementing genomics-based care (a complex clinical intervention) faces serious care fragmentation and scalability issues due to lacking system support. P-OMICs-flow, a novel model of care purposely designed to coordinate precision medicine in oncology, addresses the fundamental issues caused by the widening knowledge-service gap. This model aims to streamline decision support for referring clinicians, enhance quality of care through multifaceted and patient-centred communications, and improve translational capacity by integrating implementation science and clinical informatics.
Methods
Utilising a Type II Hybrid effectiveness-implementation trial design, the P-OMICs-flow service intervention is the model of care – providing centralised multidisciplinary review to support clinicians in the precision oncology care provision. The implementation intervention is design of a platform – applying evidence-based implementation approaches and Learning Health System principles to enhance feasibility and sustainability. All adult patients across Australia referred to P-OMICs-flow (n = est. 100-300/year between 2023-2026), and healthcare professional stakeholders involved in delivery of precision oncology services (n = est. 600), are eligible to participate.
Study phases include: 1) using a mixed-methods approach to inform iterative co-design of an implementation platform for P-OMICs-flow, and a suite of outcome measures to assess clinical, service, implementation, and cost-effectiveness; 2) the delivery of the P-OMICs-flow clinic and implementation platform, and evaluation of the outcome measures designed in Phase 1; and 3) a co-design and feasibility test to enable local adaptations and national roll out of the P-OMICs-flow model.
Conclusion
Simultaneously evaluating the clinical-, service-, implementation-, and cost-effectiveness of this world-first precision medicine model within a routine healthcare setting will provide crucial insights into its potential impact, and inform evidence-based strategies for cost-effective widespread adoption and implementation. Ethics and governance approvals are in place, clinic rollout commenced in June 2023, and Phase 1 data collection is underway.