Performance of an Electronic Decision Support System as a Therapeutic Intervention During a Multicenter PICU Clinical Trial: Heart and Lung Failure-Pediatric Insulin Titration trial (HALF-PINT).

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The use of electronic clinical decision support (CDS) systems for pediatric critical care trials is rare. We sought to describe in detail the use of a CDS tool (Children's Hospital Euglycemia for Kids Spreadsheet- CHECKS), for the management of hyperglycemia during the 32 multicenter Heart And Lung Failure-Pediatric INsulin Titration (HALF-PINT) trial.In critically ill pediatric patients managed with CHECKS, how was user compliance associated with outcomes; and what patient and clinician factors might account for the observed differences in CHECKS compliance.During an observational retrospective study of compliance with a CDS tool used during a prospective randomized controlled trial, we compared patients with high and low CHECKS compliance. We investigated the association between compliance and blood glucose metrics. We describe CHECKS, and utilize a computer interface analysis framework, the UFuRT, to categorize user interactions. We discuss implications for future randomized controlled trials.Over a 4.5-year period, 658/698 children were managed with the CHECKS protocol for ≥24 hours with a median of 119 recommendations per patient. Compliance per patient was high (median 99.5%), with only 30 patients having low compliance (<90%). Patients with low compliance were from 16/32 sites, younger (P=0.02), and less likely to be on inotropic support (P=0.04). They were more likely to be randomized to the lower blood glucose (BG) target (80% vs 48%, P<0.001) and spent a shorter time (53% vs 75%, P<0.001) at BG target. Overrides (classified by UFuRT), were largely (89%) due to the user with patient factors contributing 29% of the time.The use of CHECKS for the HALF-PINT trial resulted in a highly reproducible and explicit method for the management of hyperglycemia in critically ill children across varied environments. CDS systems represent an important mechanism for conducting explicit complex pediatric critical care trials.


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Authors: Eliotte L Hirshberg, Jamin L Alexander, Lisa A Asaro, Kerry Coughlin-Wells, Garry M Steil, Debbie Spear, Cheryl Stone, Vinay M Nadkarni, Michael S D Agus, HALF-PINT Study Investigators*

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