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

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
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring Glucose, Insulin, computer, critical care

Eligibility Criteria

1 Month - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Yale University
  • Johns Hopkins UniversityRecruiting
  • Massachusetts General Hospital
  • Baystate Medical Center
  • Wake Forest Medical CenterRecruiting
  • Pennsylvania State Children's Hospital
  • Children's Hospital of Philadelphia
  • Vanderbilt University
  • LDS HospitalRecruiting
  • Primary Children's Hospital
  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

eProtocol

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2008
Last Updated
February 24, 2015
Sponsor
Intermountain Health Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00655460
Brief Title
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (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: Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients. 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
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.

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

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 H 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
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
05520
Country
United States
Individual Site Status
Completed
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Brower, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Withdrawn
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wake Forest Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert D Hite, MD
Facility Name
Pennsylvania State Children's Hospital
City
Hersey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Completed
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Orme, MD
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Individual Site Status
Completed
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

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

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