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

NCT ID: NCT04177147

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-14
• Study Completion Date: 2016-09-30

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.

Conditions

Hypoglycemia; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical decision support via alert tool

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

Group Type: EXPERIMENTAL

Clinical decision support via alert tool

Intervention Type: OTHER

The alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus.

Usual care

Clinicians did not receive access to the electronic alert tool.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical decision support via alert tool

The alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being at least 21 years of age
• Have been prescribed or dispensed a drug for diabetes mellitus

Exclusion Criteria

N/A

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Michael Weiner

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31951747 (View on PubMed)

Other Identifiers

Merck RI 22

Identifier Type: -

Identifier Source: org_study_id