Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2

Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-insulin) in Adult And Pediatric Intensive Care Unit Patients-Second Phase (Phase-2): Distribution and Implementation of Validated eProtocol-insulin in Naïve ICUs

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.

Study Overview

• Status: Unknown
• Conditions: Hyperglycemia; Critically Ill
• Intervention / Treatment: Procedure: glucose control with computer generated recommendations

Detailed Description

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
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alan Morris, MD; Phone Number: 801-408-1610; Email: Alan.Morris@intermountainmail.org

Study Locations

• United States
  • California
    • Madera, California, United States
      • Recruiting
      • Childrens Hospital Centeral California
      • Principal Investigator: Ana Graciano, MD
  • Minnesota
    • St. Paul, Minnesota, United States
      • Recruiting
      • Childrens Hospital of Minnesota - St. Paul
      • Principal Investigator: Stephen Kurachek, MD
  • New Hampshire
    • Lebanon, New Hampshire, United States
      • Recruiting
      • Dartmouth Hitchcock Medical Center
      • Principal Investigator: Dan Levin, MD
  • New York
    • New York, New York, United States
      • Recruiting
      • Cornell University Medical College
      • Principal Investigator: Bruce Greenwald, MD
    • New York, New York, United States
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Michelle Gong, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States
      • Recruiting
      • Wake Forest University Baptist Medical Center
      • Principal Investigator: David Bowton, MD
  • Ohio
    • Columbus, Ohio, United States
      • Recruiting
      • Ohio State University
      • Principal Investigator: Ali Naeem, MD
  • Texas
    • Galveston, Texas, United States
      • Recruiting
      • University of Texas Medical Branch at Galveston
      • Principal Investigator: Victor Cardenas, MD
    • Houston, Texas, United States
      • Recruiting
      • Ben Taub General Hospital
      • Principal Investigator: Kalpalatha Guntupalli, MD
    • Houston, Texas, United States
      • Recruiting
      • MD Anderson Cancer Center
      • Principal Investigator: Joseph Nates, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Pediatric ICU: Proposed indications by pediatric clinicians at participating ICUs for glucose control in their ICUs would include patients who require mechanical ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g. dopamine >3 mg/kg/min, dobutamine, epinephrine, or vasopressin).
2. Adult ICUs: Proposed indications by clinicians in participating ICUs for glucose control in participating adult ICUs include critically ill patients with an anticipated ICU length of stay of 3 or more days.

Exclusion Criteria:

1. Pregnancy (negative pregnancy test required for females of child-bearing age)
2. Age less than one month
3. Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis
4. Acute or chronic liver disease with any documented episode of blood or plasma glucose <60 mg/dl within the 24 hours prior to study entry
5. Diabetic Ketoacidosis (critically ill patients with insulin dependent diabetes not in ketoacidosis will be eligible if attending physicians intend to use intravenous insulin as part of ordinary care)
6. Severe chronic liver disease (Child-Pugh score >10)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eProtocol	Procedure: glucose control with computer generated recommendations; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The 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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy)	1 year
Time to reach the 80-110 mg/dl target	1 year
Nursing perception of workload in comparison to ordinary care (efficacy and feasibility)	1 year
Proportion of glucose values 41-60 mg/dl	1 year

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Alan H Morris, MD, Intermountain Medical Center, Murray, Utah

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 7, 2008
• First Submitted That Met QC Criteria: April 7, 2008
• First Posted (Estimate): April 9, 2008

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Insulin; critical care; computer; Glucose
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Hyperglycemia; Critical Illness
• Other Study ID Numbers: N01-HC-45210-2; HHSN268200425210C