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

Diabetes Mellitus Clinical Trial

— HG_Tool  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177147
• Other study ID #: Merck RI 22
• Status: Completed
• Phase: N/A
• Start date: January 14, 2016
• Est. completion date: September 30, 2016

Study information

• Verified date: November 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypoglycemia

Intervention

Other:
• Clinical decision support via alert tool
The alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Outcome

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