Clinical trial NCT04177147: Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care
Official title: Primary Care Clinicians' Responses to a Hypoglycemia Risk Calculator for Diabetes Mellitus in Ambulatory Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Diabetes Mellitus
Keywords: Hypoglycemia
Diabetes mellitus
Clinical decision support
Electronic health records
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 220
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinicians were randomized to see, or not see, a clinical decision-support alert tool when evaluating outpatients with diabetes mellitus
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with hypoglycemia during the study period
timeFrame: Five-month follow-up period
Secondary outcomes:
measure: Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinued
timeFrame: Five-month follow-up period
Other outcomes:
measure: Number of participants with inpatient or outpatient medical encounters
timeFrame: Five-month follow-up period
measure: Number of participants undergoing patient education related to diabetes
timeFrame: Five-month follow-up period
measure: Number of A1c, glucose, and creatinine blood tests
timeFrame: Five-month follow-up period
Locations:
Study officials:
References:
citation: 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.