Preventing Hypoglycemia
Primary Purpose
Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Informatics Alert/Nurse/physician responders
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes focused on measuring Prediction Prevention Severe Hypoglycemia RealTime Alert
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria for participating charge nurses and physicians is the insulin management educational classes and the pre/post quiz. No exclusion criteria.
Exclusion Criteria:
- No exclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Informatics Real-Time Alert
control-no intervention
Arm Description
Alert/Nurse and Physician Intervention
Outcomes
Primary Outcome Measures
Incidence of Severe Hypoglycemia
The incidence of Severe Hypoglycemia (<40mg/dl) in patients after receiving a PES Hypoglycemia Risk Alert until discharge from the hospital in both intervention and control groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT01923688
First Posted
August 9, 2013
Last Updated
June 19, 2014
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01923688
Brief Title
Preventing Hypoglycemia
Official Title
Prevention of Hypoglycemia and Insulin Errors in Barnes-Jewish Hospital Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the project is to improve in-patient safety by lowering the risk of severe hypoglycemia (low blood sugar) for patients with diabetes on insulin therapy and to improve communication between healthcare providers.
The procedures of the study are:
the hospital patient information system [Pharmacy Event System,(PES)] will generate for healthcare providers a real-time risk alert of severe hypoglycemia (low blood sugar)
the real-time PES risk alert will be sent via a beeper to the patient's charge nurse
the charge nurse will follow the specific guidelines in the alert for assessment of the patient's care and insulin regimen
the charge nurse will then notify the physician of the patient's assessment and of the recommendation for change/no change in insulin regimen and/or clinical care
the alerted charge nurse and physician will complete a collaboration scale
Detailed Description
This prospective nonrandomized intervention study involved inpatients admitted to 6 designated intervention and 8 designated control acute medicine divisions at Barnes-Jewish Hospital in St Louis, the academic teaching hospital of Washington University School of Medicine, from August 2011 through December 2011. The study population consisted of patients cared for on either the control or intervention floors who were receiving anti-diabetic medications during their hospital stay. The study was approved by the Washington University Medical Center institutional review board, and included a waiver of consent for all patients.
The pharmacy informatics system was programmed with the previously-developed hypoglycemia alert parameters to identify those patients at high risk of hypoglycemia based on real-time patient information (7). Patients were identified as high risk on intervention floors if insulin or an oral anti-hyperglycemic agent was prescribed, if their hypoglycemia informatics-generated risk score was greater than 35, and if they had a capillary or venous blood glucose level of ≤90 mg/dL. The risk score of 35 was the value that corresponded to 50% sensitivity for a subsequent blood glucose < 60 mg/ dl and a 75% sensitivity for a blood glucose < 40 mg/ dL. Patients were assigned to categories based on the division that they were admitted to and risk score algorithm.
The electronic alert was sent to division-specific charge nurses via a pager. Fourteen charge nurses on intervention divisions were trained to assess the alert, interview the patient, identify an alternate dosing strategy and collaborate with the patient's physicians. These trained nurses were available on intervention divisions Monday through Friday from 0700 to 1700. Control patients (HR-) were identified as high risk on control divisions based on the same criteria as intervention patients. The control patients' charts were reviewed upon discharge of the patient by a certified diabetes nurse educator on the research team who evaluated the number of hypoglycemic episodes in these patients as well as physician recognition of increased risk and whether appropriate changes were made to the patient orders in response to a low or down-trending blood glucose levels.
Nurses and physicians caring for patients on study divisions provided informed consent to participate in the study. Nurses' satisfaction with the alert process and physician interaction was assessed with a collaboration scale that was completed after each alert as well as a post study satisfaction scale (9). Nurses and physicians provided informed consent to participate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Prediction Prevention Severe Hypoglycemia RealTime Alert
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Informatics Real-Time Alert
Arm Type
Experimental
Arm Description
Alert/Nurse and Physician Intervention
Arm Title
control-no intervention
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Informatics Alert/Nurse/physician responders
Primary Outcome Measure Information:
Title
Incidence of Severe Hypoglycemia
Description
The incidence of Severe Hypoglycemia (<40mg/dl) in patients after receiving a PES Hypoglycemia Risk Alert until discharge from the hospital in both intervention and control groups.
Time Frame
from time of the Pharmacy Expert System (PES) alert until discharge of the patient from the hospital, an average of 3-5 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for participating charge nurses and physicians is the insulin management educational classes and the pre/post quiz. No exclusion criteria.
Exclusion Criteria:
No exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garry Tobin, MD
Organizational Affiliation
Washington University School of Medicine St. Louis, Missouri
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22937877
Citation
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Results Reference
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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
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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
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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
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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
22042479
Citation
Deal EN, Liu A, Wise LL, Honick KA, Tobin GS. Inpatient insulin orders: are patients getting what is prescribed? J Hosp Med. 2011 Nov;6(9):526-9. doi: 10.1002/jhm.938. Epub 2011 Oct 31.
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
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PubMed Identifier
16873812
Citation
ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association Consensus statement on inpatient diabetes and glycemic control. Diabetes Care. 2006 Aug;29(8):1955-62. doi: 10.2337/dc06-9913. No abstract available.
Results Reference
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PubMed Identifier
17037970
Citation
Goldberg PA, Bozzo JE, Thomas PG, Mesmer MM, Sakharova OV, Radford MJ, Inzucchi SE. "Glucometrics"--assessing the quality of inpatient glucose management. Diabetes Technol Ther. 2006 Oct;8(5):560-9. doi: 10.1089/dia.2006.8.560.
Results Reference
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PubMed Identifier
21210611
Citation
Kesten KS. Role-play using SBAR technique to improve observed communication skills in senior nursing students. J Nurs Educ. 2011 Feb;50(2):79-87. doi: 10.3928/01484834-20101230-02. Epub 2010 Dec 30.
Results Reference
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PubMed Identifier
23100037
Citation
Hawkins K, Donihi AC, Korytkowski MT. Glycemic management in medical and surgical patients in the non-ICU setting. Curr Diab Rep. 2013 Feb;13(1):96-106. doi: 10.1007/s11892-012-0340-1.
Results Reference
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PubMed Identifier
8366922
Citation
Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
Results Reference
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Links:
URL
http://www.hospitalmedicine.org
Description
Society of Hospital Medicine
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Preventing Hypoglycemia
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