Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1

Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-insulin) in Adult And Pediatric ICU Patients:Further Refinement and Validation of eProtocol-insulin

The Purpose of this study is to:

1. Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients.
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

This first phase will be a prospective cohort study. We will validate the bedside tool in at least 4 adult and at least 4 pediatric ICUs and if necessary we will modify the bedside tool. The computerized bedside tool will be considered refined if >90% of the generated instructions are accepted and if the percent of glucose values in the 70-110 mg/dl range are equivalent to our pilot experience rate of 55%, and if the rate of glucose values less than or equal to 40 mg/dl is less than 0.5% of glucose measurements.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 05520
      • Completed
      • Yale University
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
      • Principal Investigator: Roy Brower, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Withdrawn
      • Massachusetts General Hospital
    • Springfield, Massachusetts, United States, 01199
      • Active, not recruiting
      • Baystate Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Medical Center
      • Principal Investigator: Robert D Hite, MD
  • Pennsylvania
    • Hersey, Pennsylvania, United States, 17033
      • Completed
      • Pennsylvania State Children's Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Completed
      • Children's Hospital of Philadelphia
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Completed
      • Vanderbilt University
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • Recruiting
      • LDS Hospital
      • Principal Investigator: James Orme, MD
    • Salt Lake City, Utah, United States, 84143
      • Completed
      • Primary Children's Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Active, not recruiting
      • University of Virginia

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 during Phase I will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions: more than 90 % of all instructions accepted by the bedside clinician).	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of glucose determinations within the range of 70-110 mg/dl (3.9-6.1 mMol/l)	3 years
Nursing perception of workload in comparison to ordinary care	3 years

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: February 1, 2006
• 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: January 1, 2008

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-45210-1; HHSN268200425210C