Hypoglycemia Prediction Model
Primary Purpose
Hypoglycemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypoglycemia prediction alert
Sponsored by
About this trial
This is an interventional prevention trial for Hypoglycemia focused on measuring inpatient diabetes, hypoglycemia
Eligibility Criteria
Inclusion Criteria:
- All adult inpatients having glucoses measured (point of care)
Exclusion Criteria:
- adults admitted to obstetrics
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Alert
No alert
Arm Description
If glucose <90 mg/dl and hypoglycemia prediction score >35, then alert with suggestion for intervention sent to treating team
Routine standard care. If glucose <90 mg/dl and hypoglycemia prediction score >35, then report for investigators will be collected, but no active alert will be sent to teams.
Outcomes
Primary Outcome Measures
The proportion of patients (in each group) who ultimately have a hypoglycemic event
Secondary Outcome Measures
Full Information
NCT ID
NCT03006510
First Posted
December 28, 2016
Last Updated
October 1, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03006510
Brief Title
Hypoglycemia Prediction Model
Official Title
Leveraging the Power of the EMR: Using a Real Time Prediction Model to Decrease Inpatient Hypoglycemic Events
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our goal for this Learning Healthcare System Demonstration Project is to reduce the rate of inpatient hypoglycemia. Hypoglycemia can result in longer lengths of stay and increased morbidity and mortality (ie falls and cardiovascular or cerebral events).
The group at Washington University (WSL) developed a predictive hypoglycemia risk score. Using current glucose, body weight, creatinine clearance, insulin type and dosing, and oral diabetic therapy, they identified patients at high risk for hypoglycemia and then provided in-person education to the providers of these patients. This resulted in a 68% reduction in severe hypoglycemia (blood glucose < 40 mg/dL). This approach required significant personnel hours and is difficult to replicate in other systems.
The investigators will implement an EHR-based intervention at UCSF to predict which patients are at high risk of inpatient hypoglycemia and take action to prevent the hypoglycemic event. In real time, all adult (non OB) patients with a glucose < 90, and a high risk of future hypoglycemia (based on the WSL formula) will be identified. Patients will be randomly assigned to intervention or no intervention (current standard care). The intervention will consist of an automated provider alert with recommendations on what adjustments could be made to avoid a potentially serious hypoglycemic event.
The outcomes that will be measured include: 1) reductions in serious hypoglycemic events, 2) monitor the changes made by providers as a result of alerts in order to study provider behavior and identify future areas of intervention, and 3) provider satisfaction with the alert system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
inpatient diabetes, hypoglycemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
498 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alert
Arm Type
Active Comparator
Arm Description
If glucose <90 mg/dl and hypoglycemia prediction score >35, then alert with suggestion for intervention sent to treating team
Arm Title
No alert
Arm Type
No Intervention
Arm Description
Routine standard care. If glucose <90 mg/dl and hypoglycemia prediction score >35, then report for investigators will be collected, but no active alert will be sent to teams.
Intervention Type
Other
Intervention Name(s)
Hypoglycemia prediction alert
Intervention Description
In real time, for a patient with a glucose <90 mg/d, using a hypoglycemia prediction model that takes into account patient weight, renal function, eating and insulin dosing a risk score is produced.
If the Risk score is >35, then the patient is determined to be at risk for hypoglycemia in the next 72 hours.
If a patient is determined to be at risk for hypoglycemia, the following will occur:
Alert will be generated and sent via "careweb" a pager alert system that sends the alert specifically to the current oncall provider The "alert" also points the provider to the EMR order section where a formal more detailed alert gives recommendationsd for changes in insulin dosing to potentially prevent hypoglycemia.
Primary Outcome Measure Information:
Title
The proportion of patients (in each group) who ultimately have a hypoglycemic event
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adult inpatients having glucoses measured (point of care)
Exclusion Criteria:
adults admitted to obstetrics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Rushakoff, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19564471
Citation
Turchin A, Matheny ME, Shubina M, Scanlon JV, Greenwood B, Pendergrass ML. Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general ward. Diabetes Care. 2009 Jul;32(7):1153-7. doi: 10.2337/dc08-2127.
Results Reference
background
PubMed Identifier
22937877
Citation
Nirantharakumar K, Marshall T, Kennedy A, Narendran P, Hemming K, Coleman JJ. Hypoglycaemia is associated with increased length of stay and mortality in people with diabetes who are hospitalized. Diabet Med. 2012 Dec;29(12):e445-8. doi: 10.1111/dme.12002.
Results Reference
background
PubMed Identifier
12912719
Citation
Kagansky N, Levy S, Rimon E, Cojocaru L, Fridman A, Ozer Z, Knobler H. Hypoglycemia as a predictor of mortality in hospitalized elderly patients. Arch Intern Med. 2003 Aug 11-25;163(15):1825-9. doi: 10.1001/archinte.163.15.1825.
Results Reference
background
PubMed Identifier
23065370
Citation
Carey M, Boucai L, Zonszein J. Impact of hypoglycemia in hospitalized patients. Curr Diab Rep. 2013 Feb;13(1):107-13. doi: 10.1007/s11892-012-0336-x.
Results Reference
background
PubMed Identifier
23248192
Citation
Garg R, Hurwitz S, Turchin A, Trivedi A. Hypoglycemia, with or without insulin therapy, is associated with increased mortality among hospitalized patients. Diabetes Care. 2013 May;36(5):1107-10. doi: 10.2337/dc12-1296. Epub 2012 Dec 17.
Results Reference
background
PubMed Identifier
12716809
Citation
Desouza C, Salazar H, Cheong B, Murgo J, Fonseca V. Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care. 2003 May;26(5):1485-9. doi: 10.2337/diacare.26.5.1485.
Results Reference
background
PubMed Identifier
18056893
Citation
Schwartz AV, Vittinghoff E, Sellmeyer DE, Feingold KR, de Rekeneire N, Strotmeyer ES, Shorr RI, Vinik AI, Odden MC, Park SW, Faulkner KA, Harris TB; Health, Aging, and Body Composition Study. Diabetes-related complications, glycemic control, and falls in older adults. Diabetes Care. 2008 Mar;31(3):391-6. doi: 10.2337/dc07-1152. Epub 2007 Dec 4. Erratum In: Diabetes Care. 2008 May;31(5):1089.
Results Reference
background
PubMed Identifier
24936545
Citation
Dendy JA, Chockalingam V, Tirumalasetty NN, Dornelles A, Blonde L, Bolton PM, Meadows RY, Andrews SS. Identifying risk factors for severe hypoglycemia in hospitalized patients with diabetes. Endocr Pract. 2014 Oct;20(10):1051-6. doi: 10.4158/EP13467.OR.
Results Reference
background
PubMed Identifier
25667368
Citation
Ulmer BJ, Kara A, Mariash CN. Temporal occurrences and recurrence patterns of hypoglycemia during hospitalization. Endocr Pract. 2015 May;21(5):501-7. doi: 10.4158/EP14355.OR. Epub 2015 Feb 9.
Results Reference
background
PubMed Identifier
22538139
Citation
Elliott MB, Schafers SJ, McGill JB, Tobin GS. Prediction and prevention of treatment-related inpatient hypoglycemia. J Diabetes Sci Technol. 2012 Mar 1;6(2):302-9. doi: 10.1177/193229681200600213.
Results Reference
background
PubMed Identifier
24898687
Citation
Kilpatrick CR, Elliott MB, Pratt E, Schafers SJ, Blackburn MC, Heard K, McGill JB, Thoelke M, Tobin GS. Prevention of inpatient hypoglycemia with a real-time informatics alert. J Hosp Med. 2014 Oct;9(10):621-6. doi: 10.1002/jhm.2221. Epub 2014 Jun 5.
Results Reference
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Hypoglycemia Prediction Model
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