Discovery | Use case identification | Focus on prospective collection of key outcome data in the EHR in a low-burden, structured way that can support clinical care and research | |
Planning | Plan out high level project plan, deliverables, success measures, high level timeline, key stakeholders, etc |
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Phase 1 | Validate ability to prospectively collect high-quality data in the EHR | Successfully partnered with 2 clinical trials and 5 health systems to show agreement between EHR data collection and traditional clinical trials data collection when disease is absent: 96% concordance with 95% probability. Motivated further study in ICAREdata Study Phase 2 | |
Phase 2 | Continue the expansion of mCODE adoption at health systems with ICAREdata use case. Support the collection of high-quality EHR data, based on mCODE, to enable clinical oncology research. Expand on Phase 1 validation. | Onboarding ICAREdata health system and clinical trial partners to scale ICAREdata collection. 10 health systems with contracts. 7 health systems currently sharing data to the ICAREdata infrastructure. Data analysis in progress. | |
Adverse Event Reporting | Test an mCODE-compatible data model for adverse events that is embedded within the EHR. Focuses on usability, burden, and acceptance by providers, and secondarily considers comparison to similar items collected via traditional clinical trials data collection mechanisms. | Initial data model completed June 2021 Initial ICAREdata AE collection workflow documentation completed June 2021 Developed IT implementation tracker. Extended project period into 2023. 2 health systems currently sharing adverse events data to the ICAREdata infrastructure. ICAREdata AE project team agreed to leverage Vulcan clinical research AE implementation guide for ICAREdata AE project. There is much overlap with initial draft CTCAE IG. Vulcan CR AE IG will be balloted in Sept 2023 to become an HL7 FHIR standard.
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