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
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
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
NCT ID
NCT04177147
First Posted
November 21, 2019
Last Updated
November 22, 2019
Sponsor
Indiana University
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
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Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care
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