Design and Usability of an Electronic Health Record—Integrated, Point-of-Care, Clinical Decision Support Tool for Modeling and Simulation of Antihemophilic Factors

Abstract

Background With the consequences of inadequate dosing ranging from increased bleeding risk to excessive drug costs and undesirable administration regimens, the antihemophilic factors are uniquely suited to dose individualization. However, existing options for individualization are limited and exist outside the flow of care. We developed clinical decision support (CDS) software that is integrated with our electronic health record (EHR) and designed to streamline the process for our hematology providers.

Objectives The aim of this study is to develop and examine the usability of a CDS tool for antihemophilic factor dose individualization.

Methods Our development strategy was based on the features associated with successful CDS tools and driven by a formal requirements analysis. The back-end code was based on algorithms developed for manual individualization and unit tested with 23,000 simulated patient profiles created from the range of patient-derived pharmacokinetic parameter estimates defined in children and adults. A 296-item heuristic checklist was used to guide design of the front-end user interface. Content experts and end-users were recruited to participate in traditional usability testing under an institutional review board approved protocol.

Results CDS software was developed to systematically walk the point-of-care clinician through dose individualization after seamlessly importing the requisite patient data from the EHR. Classical and population pharmacokinetic approaches were incorporated with clearly displayed estimates of reliability and uncertainty. Users can perform simulations for prophylaxis and acute bleeds by providing two of four therapeutic targets. Testers were highly satisfied with our CDS and quickly became proficient with the tool.

Conclusion With early and broad stakeholder engagement, we developed a CDS tool for hematology provider that affords seamless transition from patient assessment, to pharmacokinetic modeling and simulation, and subsequent dose selection.

Keywords

software design - therapeutic drug monitoring - usability testing - factor VII - factor VIII - factor IX

Authors' Contributions

S.M.A.R. conceived of the application, developed the initial algorithm around which the software was based, led the development of the decision support tool, and conducted the usability testing. S.L.C. and B.W. coordinated the requirements analysis for the clinical aspects of this tool. H.G., P.G., and A.K. were involved in coding of the back-end analytics. S.M.A.R., H.G., and P.G. undertook unit testing and validation. M.B. and A.G. were responsible for the design and coding of the UI. H.G. was responsible for integration of the software with the electronic health record. A.K. was responsible for supervising all informatics activities. All authors reviewed and approved the manuscript.

Protection of Human and Animal Subjects

The study was performed in compliance with the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects. All participants were enrolled with informed consent under a protocol that was reviewed and approved by the Institutional Review Board at Children's Mercy Hospital (IRB# 00000285).

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