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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Hypoglycemia
• Interventions: Other: Clinical decision support via alert tool

• Registration Number: NCT04177147
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-01-14
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2019-11
• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-22
• Last Update Submitted: 2019-11-22
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical decision support via alert tool	Clinical decision support via alert tool	Clinicians received access to the electronic alert tool, which automatically displayed patients' risk of hypoglycemia.

Primary Outcome Measures

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

Secondary Outcome Measures

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