• Chest · Sep 2021

    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).

    • Eliotte L Hirshberg, Jamin L Alexander, Lisa A Asaro, Kerry Coughlin-Wells, Garry M Steil, Debbie Spear, Cheryl Stone, Vinay M Nadkarni, AgusMichael S DMSDDepartment of Pediatrics, Division of Medical Critical Care, Boston Children's Hospital, Boston, MA; Department of Pediatrics, Harvard Medical School, Boston, MA., and HALF-PINT Study Investigators.
    • Pulmonary Division, Intermountain Medical Center, Salt Lake City, UT; Center for Humanizing Critical Care, Intermountain Healthcare, Salt Lake City, UT; Pulmonary and Critical Care Medicine, University of Utah School of Medicine, Salt Lake City, UT; Pediatric Critical Care, University of Utah School of Medicine, Salt Lake City, UT. Electronic address: ellie.hirshberg@imail.org.
    • Chest. 2021 Sep 1; 160 (3): 919-928.

    BackgroundThe 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 trial.Research QuestionIn critically ill pediatric patients who were treated with CHECKS, how was user compliance associated with outcomes; and what patient and clinician factors might account for the observed differences in CHECKS compliance?Study Design And MethodsDuring 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 use a computer interface analysis framework (the user, function, representation, and task analysis framework) to categorize user interactions. We discuss implications for future randomized controlled trials.ResultsOver a 4.5-year period, 658 of 698 children were treated 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 of 32 sites, younger (P = .02), and less likely to be on inotropic support (P = .04). They were more likely to be have been assigned randomly to the lower blood glucose target (80% vs 48%; P < .001) and to have spent a shorter time (53% vs 75%; P < .001) at the blood glucose target. Overrides (classified by the user, function, representation, and task analysis framework), were largely (89%) due to the user with patient factors contributing 29% of the time.InterpretationThe use of CHECKS for the Heart And Lung Failure-Pediatric Insulin Titration 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.Clinical Trial RegistrationClinicalTrials.gov Identifier: NCT01565941, registered March 29 2012; https://clinicaltrials.gov/ct2/show/NCT01565941?term=HALF-PINT&draw=2&rank=1.Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

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