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Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care (HG_Tool)

Primary Purpose

Hypoglycemia, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical decision support via alert tool
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring Hypoglycemia, Diabetes mellitus, Clinical decision support, Electronic health records

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The study included clinicians who were scheduled to provide primary care during the four-month intervention period.

Inclusion Criteria for patients:

  • Being at least 21 years of age
  • Have been prescribed or dispensed a drug for diabetes mellitus

Exclusion Criteria for patients:

N/A

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Clinical decision support via alert tool

    Usual care

    Arm Description

    Clinicians received access to the electronic alert tool, which automatically displayed patients' risk of hypoglycemia.

    Clinicians did not receive access to the electronic alert tool.

    Outcomes

    Primary Outcome Measures

    Number of participants with hypoglycemia during the study period
    Participants with hypoglycemia had blood glucose level less than 70 mg/dL

    Secondary Outcome Measures

    Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinued
    Prescriptions for insulin and sulfonylurea drugs are assessed

    Full Information

    First Posted
    November 21, 2019
    Last Updated
    November 22, 2019
    Sponsor
    Indiana University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04177147
    Brief Title
    Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care
    Acronym
    HG_Tool
    Official Title
    Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 14, 2016 (Actual)
    Primary Completion Date
    September 30, 2016 (Actual)
    Study Completion Date
    September 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indiana University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Hypoglycemia (HG) is common and can be dangerous in diabetes mellitus, so identifying patients at risk may lead to useful preventive strategies and improved quality of care and health outcomes. This study will test the implementation of a computerized alert tool for clinicians.
    Detailed Description
    Diabetes mellitus is one of the most common non-communicable diseases worldwide and is a major cause of morbidity and mortality. An estimated 346 million people had diabetes in 2011, and diabetes is predicted to become the seventh leading cause of death in the world by the year 2030. In the United States, the incidence of diabetes nearly tripled between 1990 and 2010, with 1.9 million new cases diagnosed in 2010. Hypoglycemia (HG) is recognized as a limiting factor in optimal glycemic management of patients with diabetes. This potentially costly condition, occurring in approximately 20% to 60% of patients who receive oral medications for diabetes, threatens patient safety, quality of life, and potentially, cardiovascular health. Investigators have identified risk factors for HG, built a risk calculator for use by clinicians, integrated the calculator into the G3 electronic medical record system, and demonstrated our ability to collect data about outcomes. In this project, investigators studied the outcomes of implementing the risk calculator tool into clinical practice in ambulatory primary care. The findings and tools developed from this project will promote improved patient safety and medical care for diabetes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoglycemia, Diabetes Mellitus
    Keywords
    Hypoglycemia, Diabetes mellitus, Clinical decision support, Electronic health records

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Clinicians were randomized to see, or not see, a clinical decision-support alert tool when evaluating outpatients with diabetes mellitus
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    220 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinical decision support via alert tool
    Arm Type
    Experimental
    Arm Description
    Clinicians received access to the electronic alert tool, which automatically displayed patients' risk of hypoglycemia.
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Clinicians did not receive access to the electronic alert tool.
    Intervention Type
    Other
    Intervention Name(s)
    Clinical decision support via alert tool
    Intervention Description
    The alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus.
    Primary Outcome Measure Information:
    Title
    Number of participants with hypoglycemia during the study period
    Description
    Participants with hypoglycemia had blood glucose level less than 70 mg/dL
    Time Frame
    Five-month follow-up period
    Secondary Outcome Measure Information:
    Title
    Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinued
    Description
    Prescriptions for insulin and sulfonylurea drugs are assessed
    Time Frame
    Five-month follow-up period
    Other Pre-specified Outcome Measures:
    Title
    Number of participants with inpatient or outpatient medical encounters
    Description
    Includes emergency encounters
    Time Frame
    Five-month follow-up period
    Title
    Number of participants undergoing patient education related to diabetes
    Description
    Text analysis of medical encounter notes
    Time Frame
    Five-month follow-up period
    Title
    Number of A1c, glucose, and creatinine blood tests
    Description
    Mean and SD
    Time Frame
    Five-month follow-up period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    The study included clinicians who were scheduled to provide primary care during the four-month intervention period. Inclusion Criteria for patients: Being at least 21 years of age Have been prescribed or dispensed a drug for diabetes mellitus Exclusion Criteria for patients: N/A

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31951747
    Citation
    Weiner M, Cummins J, Raji A, Ofner S, Iglay K, Teal E, Li X, Engel SS, Knapp K, Rajpathak S, Baker J, Chatterjee AK, Radican L. A randomized study on the usefulness of an electronic outpatient hypoglycemia risk calculator for clinicians of patients with diabetes in a safety-net institution. Curr Med Res Opin. 2020 Apr;36(4):583-593. doi: 10.1080/03007995.2020.1717451. Epub 2020 Feb 6.
    Results Reference
    derived

    Learn more about this trial

    Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care

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