A replicable method for blood glucose control in critically Ill patients.
BACKGROUND
To ensure interpretability and replicability of clinical experiments, methods must be adequately explicit and should elicit the same decision from different clinicians who comply with the study protocol.


OBJECTIVE
The objective of this study was to determine whether clinician compliance with protocol recommendations exceeds 90%.


METHODS
We developed an adequately explicit computerized protocol (eProtocol-insulin) for managing critically ill adult patient blood glucose. We monitored clinician compliance with eProtocol-insulin recommendations in four intensive care units in four hospitals and compared blood glucose distributions with those of a simple clinical guideline at one hospital and a paper-based protocol at another. All protocols and the guideline used intravenous insulin and 80 to 110 mg/dL (4.4-6.1 mmol/L) blood glucose targets.


METHODS
The setting for this study was four academic hospital intensive care units.


METHODS
This study included critically ill adults requiring intravenous insulin.


METHODS
Intervention used in this study was a bedside computerized protocol for managing blood glucose.


METHODS
The main outcome measure was clinician compliance with eProtocol-insulin recommendations.


RESULTS
The number of patients was 31 to 458 and the number of blood glucose measurements was 2,226 to 19,925 among the four intensive care units. Clinician compliance with eProtocol-insulin recommendations was 91% to 98%. Blood glucose distributions were similar in the four hospitals (generalized linear model p = .18). Compared with the simple guideline, eProtocol-insulin glucose measurements within target increased from 21% to 39%, and mean blood glucose decreased from 142 to 115 mg/dL (generalized linear model p < .001). Compared with the paper-based protocol, eProtocol-insulin glucose measurements within target increased from 28% to 42%, and mean blood glucose decreased from 134 to 116 mg/dL (generalized linear model p = .001).


CONCLUSIONS
The 91% to 98% clinician compliance indicates eProtocol-insulin is an exportable instrument that can establish a replicable experimental method for clinical trials of blood glucose management in critically ill adults. Control of blood glucose was better with eProtocol-insulin than with a simple clinical guideline or a paper-based protocol.
Morris
Alan H
AH
Pulmonary Division, Department of Medicine, LDS Hospital and the University of Utah School of Medicine, Salt Lake City, UT, USA. ldamorri@ihc.com
Orme
James
J
Truwit
Jonathon D
JD
Steingrub
Jay
J
Grissom
Colin
C
Lee
Kang H
KH
Li
Guoliang L
GL
Thompson
B Taylor
BT
Brower
Roy
R
Tidswell
Mark
M
Bernard
Gordon R
GR
Sorenson
Dean
D
Sward
Katherine
K
Zheng
Hui
H
Schoenfeld
David
D
Warner
Homer
H
D018806:APACHE; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000378:metabolism*; D002986:Clinical Trials as Topic; D003422:Critical Care / Q000379:methods*; D003661:Decision Support Techniques; D004360:Drug Therapy, Computer-Assisted; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D017052:Hospital Mortality; D006801:Humans; D007262:Infusions, Intravenous; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D016347:Medical Records Systems, Computerized; D008875:Middle Aged; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D012984:Software; D014481:United States
D001786:Blood Glucose; D007328:Insulin