The Purpose of this study is to: 1. Introduce the refined, validated, and safe computerized bedside decision support tool for blood glucose management in critically ill adult and pediatric ICU patients that was studied in Phase 1 into a second group of naïve ICUs, none of which participated in eProtocol-insulin development, refinement or validation 2. Monitor how often low blood sugar levels occur during use of the bedside tool. 3. Determine how the computerized tool effects the workload of the ICU nurses.
In the current second phase of this project (Phase-2), we will introduce the refined, validated, and safe eProtocol-insulin into a second group of naïve ICUs, none of which participated in eProtocol-insulin development, refinement or validation. Our primary goal in this second phase is to determine the feasibility of exporting this tool to naïve ICU environments. In this second phase we will also compare the effects of the eProtocol-insulin and ordinary care approaches to glucose control on the bedside nurse's experience. This second phase will be a prospective cohort study. We will determine the feasibility of distributing eProtocol-insulin and will further validate eProtocol-insulin in \>4 adult and \>4 pediatric ICUs. If necessary we will modify eProtocol-insulin with an iterative refinement process, with Institutional Review Board (IRB) and independent Data and Safety Monitoring Board (DSMB) oversight. eProtocol-insulin will be considered refined if \>90% of the instructions are accepted and if the percent of glucose values between 70 and 110 mg/dl (3.9-6.1 mMol/L) are equivalent to our Phase-1 refinement and validation experience of 46%%, and if the rate of glucose values \< 40 mg/dl (2.2 mMol/l) is less than 0.5% of glucose measurements.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.
Childrens Hospital Centeral California
Madera, California, United States
RECRUITINGChildrens Hospital of Minnesota - St. Paul
Saint Paul, Minnesota, United States
RECRUITINGThe primary outcome variable for feasibility during Phase-2 will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions). Proportion of glucose values < 40 mg/dl.
Time frame: 1 year
Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy)
Time frame: 1 year
Time to reach the 80-110 mg/dl target
Time frame: 1 year
Nursing perception of workload in comparison to ordinary care (efficacy and feasibility)
Time frame: 1 year
Proportion of glucose values 41-60 mg/dl
Time frame: 1 year
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
RECRUITINGCornell University Medical College
New York, New York, United States
RECRUITINGMount Sinai Hospital
New York, New York, United States
RECRUITINGWake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGUniversity of Texas Medical Branch at Galveston
Galveston, Texas, United States
RECRUITINGBen Taub General Hospital
Houston, Texas, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITING