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.Author summary: We developed a computer application to help physicians and other healthcare providers better care for patients with severe liver disease, i.e., cirrhosis, a condition that affects millions worldwide and requires complex, coordinated treatment. Currently, healthcare providers (HCP) must click through many different screens in computer systems to gather all the information they need about a patient, which is time-consuming and can lead to important details being overlooked. Our team created an app that brings together all relevant patient information - laboratory results, medications, symptom reports, and treatment recommendations - into a single, easy-to-use interface. We worked closely with HCPs and nurses to understand their daily challenges and designed the app to fit naturally into their existing workflows. When we tested the app with five healthcare providers, they found it significantly improved their ability to access patient information and follow evidence-based treatment guidelines. The app automatically generates reminders for important medical tasks and helps HCPs track patient progress over time. The current work demonstrates how thoughtfully designed technology can address challenging problems in healthcare delivery. By reducing the burden of navigating complex computer systems, we hope to help HCPs spend more time focusing on patient care and ensure that patients with liver disease receive the comprehensive, guideline-directed treatment they need.