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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00654797
First received: April 7, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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.

Condition Intervention Phase
Critically Ill
Hyperglycemia
Procedure: glucose control with computer generated recommendations
Phase 2

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

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Time to reach the 80-110 mg/dl target [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Nursing perception of workload in comparison to ordinary care (efficacy and feasibility) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of glucose values 41-60 mg/dl [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654797

Contacts
Contact: Alan Morris, MD 801-408-1610 Alan.Morris@intermountainmail.org

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

No publications provided

Responsible Party: Alan H. Morris, Intermountain Medical Center
ClinicalTrials.gov Identifier: NCT00654797     History of Changes
Other Study ID Numbers: N01-HC-45210-2, HHSN268200425210C
Study First Received: April 7, 2008
Last Updated: April 7, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Center for Research Resources (NCRR):
Glucose
Insulin
computer
critical care

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014