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

NCT04177147 | Completed DMC

• 1 other identifier: Merck RI 22
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoglycemia; Diabetes Mellitus

Keywords

Hypoglycemia; Diabetes mellitus; Clinical decision support; Electronic health records

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with changes to prescriptions for diabetes or antibiotics: new, refilled, changed, or discontinued

  Five-month follow-up period

Other Outcomes (3)

• Number of participants with inpatient or outpatient medical encounters

  Five-month follow-up period

• Number of participants undergoing patient education related to diabetes

  Five-month follow-up period

• Number of A1c, glucose, and creatinine blood tests

  Five-month follow-up period

Study Arms (2)

Clinical decision support via alert tool

EXPERIMENTAL

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

Other: Clinical decision support via alert tool

Usual care

NO INTERVENTION

Clinicians did not receive access to the electronic alert tool.

Interventions

Clinical decision support via alert tool OTHER

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

Clinical decision support via alert tool

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Indiana University: lead

Related Publications (1)

• 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.

  PMID: 31951747 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Clinicians were randomized to see, or not see, a clinical decision-support alert tool when evaluating outpatients with diabetes mellitus

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 26, 2019
• Study Start: January 14, 2016
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: November 26, 2019

Record last verified: 2019-11