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

Indiana University

Status: Completed

Conditions: Hypoglycemia; Diabetes Mellitus

Treatments: Other: Clinical decision support via alert tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04177147

Merck RI 22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Clinical decision support via alert tool

Experimental group

Description:

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

Treatment:

Other: Clinical decision support via alert tool

Usual care

No Intervention group

Description:

Clinicians did not receive access to the electronic alert tool.