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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00654797
• Other study ID #: N01-HC-45210-2
• Secondary ID: HHSN268200425210
• Status: Recruiting
• Phase: Phase 2
• First received: April 7, 2008
• Last updated: February 24, 2015
• Start date: September 2007
• Est. completion date: December 2018

Study information

• Verified date: February 2015
• Source: Intermountain Health Care, Inc.
• Contact: Alan Morris, MD
• Phone: 801-408-1610
• Email: Alan.Morris[@]intermountainmail.org
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Ben Taub General Hospital	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Childrens Hospital Centeral California	Madera	California
United States	Cornell University Medical College	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Childrens Hospital of Minnesota - St. Paul	St. Paul	Minnesota
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy)		1 year	Yes
Secondary	Time to reach the 80-110 mg/dl target		1 year	Yes
Secondary	Nursing perception of workload in comparison to ordinary care (efficacy and feasibility)		1 year	No
Secondary	Proportion of glucose values 41-60 mg/dl		1 year	No