Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2
Primary Purpose
Critically Ill, Hyperglycemia
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
glucose control with computer generated recommendations
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill focused on measuring Glucose, Insulin, computer, critical care
Eligibility Criteria
Inclusion Criteria:
- 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).
- 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:
- Pregnancy (negative pregnancy test required for females of child-bearing age)
- Age less than one month
- Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis
- 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
- 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)
- Severe chronic liver disease (Child-Pugh score >10)
Sites / Locations
- Childrens Hospital Centeral CaliforniaRecruiting
- Childrens Hospital of Minnesota - St. PaulRecruiting
- Dartmouth Hitchcock Medical CenterRecruiting
- Cornell University Medical CollegeRecruiting
- Mount Sinai HospitalRecruiting
- Wake Forest University Baptist Medical CenterRecruiting
- Ohio State UniversityRecruiting
- University of Texas Medical Branch at GalvestonRecruiting
- Ben Taub General HospitalRecruiting
- MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eProtocol
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy)
Time to reach the 80-110 mg/dl target
Nursing perception of workload in comparison to ordinary care (efficacy and feasibility)
Proportion of glucose values 41-60 mg/dl
Full Information
NCT ID
NCT00654797
First Posted
April 7, 2008
Last Updated
February 24, 2015
Sponsor
Intermountain Health Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00654797
Brief Title
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Purpose of this study is to:
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
Monitor how often low blood sugar levels occur during use of the bedside tool.
Determine how the computerized tool effects the workload of the ICU nurses.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Hyperglycemia
Keywords
Glucose, Insulin, computer, critical care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
eProtocol
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
glucose control with computer generated recommendations
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy)
Time Frame
1 year
Title
Time to reach the 80-110 mg/dl target
Time Frame
1 year
Title
Nursing perception of workload in comparison to ordinary care (efficacy and feasibility)
Time Frame
1 year
Title
Proportion of glucose values 41-60 mg/dl
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
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:
Pregnancy (negative pregnancy test required for females of child-bearing age)
Age less than one month
Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis
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
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)
Severe chronic liver disease (Child-Pugh score >10)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Morris, MD
Phone
801-408-1610
Email
Alan.Morris@intermountainmail.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan H Morris, MD
Organizational Affiliation
Intermountain Medical Center, Murray, Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Centeral California
City
Madera
State/Province
California
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Graciano, MD
Facility Name
Childrens Hospital of Minnesota - St. Paul
City
St. Paul
State/Province
Minnesota
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Kurachek, MD
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Levin, MD
Facility Name
Cornell University Medical College
City
New York
State/Province
New York
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Greenwald, MD
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Gong, MD
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Bowton, MD
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Naeem, MD
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Cardenas, MD
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalpalatha Guntupalli, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Nates, MD
12. IPD Sharing Statement
Learn more about this trial
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2
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