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

OBJECTIVE: 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 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 post-deployment 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 facilitatd enrollment, randomization, model visualization, data capture, and reporting for trial purposes. CONCLUSIONS: 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.

Rebuilding the Standing Prescription Renewal Orders.

BACKGROUND: Managing prescription renewal requests is a labor-intensive challenge in ambulatory care. In 2009, Vanderbilt University Medical Center developed clinic-specific standing prescription renewal orders that allowed nurses, under specific conditions, to authorize renewal requests. Formulary and authorization changes made maintaining these documents very challenging. OBJECTIVE: This article aims to review, standardize, and restructure legacy standing prescription renewal orders into a modular, scalable, and easier to manage format for conversion and use in a new electronic health record (EHR). METHODS: We created an enterprise-wide renewal domain model using modular subgroups within the main institutional standing renewal order policy by extracting metadata, medication group names, medication ingredient names, and renewal criteria from approved legacy standing renewal orders. Instance-based matching compared medication groups in a pairwise manner to calculate a similarity score between medication groups. We grouped and standardized medication groups with high similarity by mapping them to medication classes from a medication terminology vendor and filtering them by intended route (e.g., oral, subcutaneous, inhalation). After standardizing the renewal criteria to a short list of reusable criteria, the Pharmacy and Therapeutics (P&T) committee reviewed and approved candidate medication groups and corresponding renewal criteria. RESULTS: Seventy-eight legacy standing prescription renewal orders covered 135 clinics (some applied to multiple clinics). Several standing orders were perfectly congruent, listing identical medications for renewal. We consolidated 870 distinct medication classes to 164 subgroups and assigned renewal criteria. We consolidated 379 distinct legacy renewal criteria to 21 criteria. After approval by the P&T committee, we built subgroups in a structured and consistent format in the new EHR, where they facilitated chart review and standing order adherence by nurses. Additionally, clinicians could search an autogenerated document of the standing order content from the EHR data warehouse. CONCLUSION: We describe a methodology for standardizing and scaling standing prescription renewal orders at an enterprise level while transitioning to a new EHR.

Use of a computerized C-reactive protein (CRP) based sepsis evaluation in very low birth weight (VLBW) infants: a five-year experience.

BACKGROUND: Serial C-reactive protein (CRP) values may be useful for decision-making regarding duration of antibiotics in neonates. However, established standard of practice for its use in preterm very low birth weight (<1500 g, VLBW) infants are lacking. OBJECTIVE: Evaluate compliance with a CRP-guided computerized decision support (CDS) algorithm and compare characteristics and outcomes of compliant versus non-compliant cases. Measure correlation between CRPs and white blood count (WBC) indices. METHODS: We examined 3 populations: 1) all preterm VLBW infants born at Vanderbilt 2006-2011 - we assessed provider compliance with CDS algorithm and measured relevant outcomes; 2) all patients with positive blood culture results admitted to the Vanderbilt NICU 2006-2012 - we tested the correlation between CRP and WBC results within 7 days of blood culture phlebotomy; 3) 1,000 randomly selected patients out of the 7,062 patients admitted to the NICU 2006-2012 - we correlated time-associated CRP values and absolute neutrophil counts. RESULTS: Of 636 VLBW infants in cohort 1), 569 (89%) received empiric antibiotics for suspected early-onset sepsis. In 409 infants (72%) the CDS algorithm was followed; antibiotics were discontinued ≤48 hours in 311 (55%) with normal serial CRPs and continued in 98 (17%) with positive CRPs, resulting in significant reduction in antibiotic exposure (p<0.001) without increase in complications or subsequent infections. One hundred sixty (28%) were considered non-compliant because antibiotics were continued beyond 48 hours despite negative serial CRPs and blood cultures. Serial CRPs remained negative in 38 (12%) of 308 blood culture-positive infants from cohort 2, but only 4 patients had clinically probable sepsis with single organisms and no immunodeficiency besides extreme prematurity. Leukopenia of any cell type was not linked with CRPs in cohorts 2 and 3. CONCLUSIONS: CDS/CRP-guided antibiotic use is safe and effective in culture-negative VLBW infants. CRP results are not affected by low WBC indices.