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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoglycemia, Diabetes Mellitus

Intervention / Treatment
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* Other: Clinical decision support via alert tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoglycemia, Diabetes mellitus, Clinical decision support, Electronic health records