User-Centered Design and Implementation of an Interoperable FHIR Application for Pediatric Pneumonia Prognostication in a Randomized Trial

Abstract

Objectives: To support a pragmatic, electronic health record (EHR)-based randomized controlled trial, we applied user-centered design (UCD) principles, evidence-based risk communication strategies, and interoperable software architecture to design, test, and deploy a prognostic tool for children in emergency departments (EDs) with pneumonia.

Methods: Risk for severe in-hospital outcomes was estimated using a validated ordinal logistic regression model to classify pneumonia severity. To render the results usable for ED clinicians, we created an integrated SMART on Fast Healthcare Interoperability Resources (FHIR) web application built for interoperable use in two pediatric EDs using different EHR vendors: Epic and Cerner. We followed a UCD framework, including problem analysis and user research, conceptual design and early prototyping, user interface development, formative evaluation, and postdeployment summative evaluation.

Results: Problem analysis and user research from 39 clinicians and nurses revealed user preferences for risk aversion, accessibility, and timing of risk communication. Early prototyping and iterative design incorporated evidence-based design principles, including numeracy, risk framing, and best-practice visualization techniques. After rigorous unit and end-to-end testing, the application was successfully deployed in both EDs, which facilitated enrollment, randomization, model visualization, data capture, and reporting for trial purposes.

Conclusion: The successful implementation of a custom application for pneumonia prognosis and clinical trial support in two health systems on different EHRs demonstrates the importance of UCD, adherence to modern clinical data standards, and rigorous testing. Key lessons included the need for understanding users' real-world needs, regular knowledge management, application maintenance, and the recognition that FHIR applications require careful configuration for interoperability.

Fig. 1

User-centered design framework. Reproduced with permission of Matthew Weinger MD, Russ Beebe, & Vanderbilt University Medical Center 2014.

Fig. 2

Final software architectural design at VUMC for custom application. VUMC, The Vanderbilt University Medical Center.

Fig. 3

Epic-based enrollment and randomization module via BestPractice Advisory interruptive alert.

Fig. 4

Final application user interface integrated within Epic EHR workflow at VUMC. This is a test patient in a test environment. EHR, electronic health record; VUMC, The Vanderbilt University Medical Center.

Fig. 5

Enrollment dashboard deployed using Tableau Server to monitor ongoing enrollment, randomization, and model views.

Fig. 6

Parallel software architectural design at UPMC describing enrollment and application launch. UPMC, University of Pittsburgh Medical Center.