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Preventing Hypoglycemia

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Informatics Alert/Nurse/physician responders
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Prediction Prevention Severe Hypoglycemia RealTime Alert

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 9, 2013
    Last Updated
    June 19, 2014
    Sponsor
    Washington University School of Medicine
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    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
    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
    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
    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
    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
    background
    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
    background
    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
    background
    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
    background
    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
    background
    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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