TY - JOUR
T1 - Performance of an Electronic Decision Support System as a Therapeutic Intervention During a Multicenter PICU Clinical Trial
T2 - Heart and Lung Failure-Pediatric Insulin Titration Trial (HALF-PINT)
AU - HALF-PINT Study Investigators
AU - Hirshberg, Eliotte L.
AU - Alexander, Jamin L.
AU - Asaro, Lisa A.
AU - Coughlin-Wells, Kerry
AU - Steil, Garry M.
AU - Spear, Debbie
AU - Stone, Cheryl
AU - Nadkarni, Vinay M.
AU - Agus, Michael S.D.
AU - Agus, Michael
AU - Wypij, David
AU - Asaro, Lisa
AU - Nadkarni, Vinay
AU - Srinivasan, Vijay
AU - Biagas, Katherine
AU - Mourani, Peter M.
AU - Chima, Ranjit
AU - Thomas, Neal J.
AU - Li, Simon
AU - Pinto, Alan
AU - Newth, Christopher
AU - Hassinger, Amanda
AU - Bysani, Kris
AU - Rehder, Kyle J.
AU - Faustino, Edward Vincent
AU - Kandil, Sarah
AU - Hirshberg, Eliotte
AU - Wintergerst, Kupper
AU - Schwarz, Adam
AU - Bagdure, Dayanand
AU - Marsillio, Lauren
AU - Cvijanovich, Natalie
AU - Pham, Nga
AU - Quasney, Michael
AU - Flori, Heidi
AU - Federman, Myke
AU - Nett, Sholeen
AU - Pinto, Neethi
AU - Viteri, Shirley
AU - Schneider, James
AU - Medar, Shivanand
AU - Sapru, Anil
AU - McQuillen, Patrick
AU - Babbitt, Christopher
AU - Lin, John C.
AU - Jouvet, Philippe
AU - Yanay, Ofer
AU - Allen, Christine
AU - Luckett, Peter
AU - Fackler, James
AU - Rozen, Thomas
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2021/9
Y1 - 2021/9
N2 - Background: 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 trial. Research Question: In 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 Methods: 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 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. Results: Over 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. Interpretation: The 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 Registration: ClinicalTrials.gov Identifier: NCT01565941, registered March 29 2012; https://clinicaltrials.gov/ct2/show/NCT01565941?term=HALF-PINT&draw=2&rank=1
AB - Background: 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 trial. Research Question: In 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 Methods: 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 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. Results: Over 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. Interpretation: The 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 Registration: ClinicalTrials.gov Identifier: NCT01565941, registered March 29 2012; https://clinicaltrials.gov/ct2/show/NCT01565941?term=HALF-PINT&draw=2&rank=1
KW - decision support
KW - electronic
KW - glucose
KW - insulin
KW - pediatric
KW - protocol
UR - http://www.scopus.com/inward/record.url?scp=85113465144&partnerID=8YFLogxK
U2 - 10.1016/j.chest.2021.04.049
DO - 10.1016/j.chest.2021.04.049
M3 - Article
C2 - 33932465
AN - SCOPUS:85113465144
SN - 0012-3692
VL - 160
SP - 919
EP - 928
JO - CHEST
JF - CHEST
IS - 3
ER -