A pilot feasibility study of human-centered design for cirrhosis care: Development and pilot testing of SMARTLiver prototype, a FHIR-based clinical decision support system for hepatology

Management of cirrhosis suffers from poor guideline adherence due to fragmented electronic health record (EHR) systems that scatter critical patient data across multiple modules, creating cognitive burden for clinicians and impeding evidence-based care delivery. We developed SMARTLiver, a Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART-on-FHIR) clinical decision support application employing human-centered design principles to consolidate patient data, incorporate evidence-based guidelines, and enhance cirrhosis care workflows. Following literature reviews of cirrhosis management guidelines and clinical workflow analysis within our health system, we created a FHIR-based application integrating automated task management, prognostic scoring, patient-reported outcomes, and real-time clinical decision support features. Usability evaluation with five clinical staff members using Think-Aloud protocols and the validated Health-ITUES survey revealed high satisfaction scores for Clinical Utility (4.4-4.6/5.0) and User Interface design (4.2/5.0), with moderate scores for workflow integration (4.0/5.0) and decision support (3.8-4.0/5.0). Qualitative feedback aligned with quantitative results, identifying enhancement opportunities in customization controls and notification management. The SMARTLiver prototype demonstrated technical feasibility in aggregating fragmented clinical data into a unified interface, automating evidence-based task generation, and maintaining interoperability across healthcare systems. This pilot study provides initial evidence for the potential of SMART-on-FHIR technology to address EHR fragmentation in cirrhosis care, though clinical effectiveness remains to be demonstrated.