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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Hypoglycemia
• Intervention / Treatment: Other: Clinical decision support via alert tool

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinical decision support via alert tool; Clinicians received access to the electronic alert tool, which automatically displayed patients' risk of hypoglycemia.	Other: Clinical decision support via alert tool; The alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus.
No Intervention: Usual care; Clinicians did not receive access to the electronic alert tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with hypoglycemia during the study period	Participants with hypoglycemia had blood glucose level less than 70 mg/dL	Five-month follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinued	Prescriptions for insulin and sulfonylurea drugs are assessed	Five-month follow-up period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with inpatient or outpatient medical encounters	Includes emergency encounters	Five-month follow-up period
Number of participants undergoing patient education related to diabetes	Text analysis of medical encounter notes	Five-month follow-up period
Number of A1c, glucose, and creatinine blood tests	Mean and SD	Five-month follow-up period

Collaborators and Investigators

• Sponsor: Indiana University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2016
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): September 30, 2016

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Hypoglycemia; Diabetes mellitus; Clinical decision support; Electronic health records
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemia
• Other Study ID Numbers: Merck RI 22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No