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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN268200425210C |
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The Purpose of this study is to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eProtocol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucose control with computer generated recommendations | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy) | 1 year | |
| Time to reach the 80-110 mg/dl target | 1 year | |
| Nursing perception of workload in comparison to ordinary care (efficacy and feasibility) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alan Morris, MD | Contact | 801-408-1610 | Alan.Morris@intermountainmail.org |
| Name | Affiliation | Role |
|---|---|---|
| Alan H Morris, MD | Intermountain Medical Center, Murray, Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Centeral California | Recruiting | Madera | California | United States |
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| 1 year |
| Proportion of glucose values 41-60 mg/dl | 1 year |
| Childrens Hospital of Minnesota - St. Paul | Recruiting | Saint Paul | Minnesota | United States |
|
| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | United States |
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| Cornell University Medical College | Recruiting | New York | New York | United States |
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| Mount Sinai Hospital | Recruiting | New York | New York | United States |
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| Wake Forest University Baptist Medical Center | Recruiting | Winston-Salem | North Carolina | United States |
|
| Ohio State University | Recruiting | Columbus | Ohio | United States |
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| University of Texas Medical Branch at Galveston | Recruiting | Galveston | Texas | United States |
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| Ben Taub General Hospital | Recruiting | Houston | Texas | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | United States |
|
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D006943 | Hyperglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
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