NCT04181307

A Randomized Trial of a BE-EHR Module to Guide the Care of Older Adults With Diabetes

Completed NA Results posted Last updated 19 July 2023

What this trial tests

NA trial testing BE-EHR module in Diabetes in 7,630 participants. Completed in 1 July 2022.

Timeline

1 December 2020

Primary endpoint
1 July 2022

1 July 2022

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7,630
Start date	1 December 2020
Primary completion	1 July 2022
Estimated completion	1 July 2022
Sites	1 location across United States

Drugs / interventions tested

• BE-EHR module

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

NYU Langone Health — full company profile →

Who can join

75 and older, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Are CW-Compliant and CW-Noncompliant Primary · Month 18

In order to evaluate Choosing Wisely (CW) compliance status, the BE-EHR algorithm will capture information on demographics, diagnoses in the patient's problem list, prescription history, and relevant lab results (i.e. allergies and blood glucose (HbA1c)) The study team members will not collect this information directly; data will be collected in NYULH's EHR system, EPIC, and an EPIC Reporting analyst will extract the relevant parameters from the EHR into a report. The study team members only receive the ultimate determination from the algorithm that the patient is either CW-compliant or CW-non

Group	Value	95% CI
Standard EPIC Instantiation	412
Standard EPIC Instantiation Plus the BE-EHR Module.	704
Standard EPIC Instantiation	1232
Standard EPIC Instantiation Plus the BE-EHR Module.	1854

Number of Total Prescription Encounters Secondary · Month 18

The Refill Protocol nudge activates in Epic any time a medication refill for either Metformin or a non-Metformin diabetes medication is generated for a patient over 75

Group	Value	95% CI
Standard EPIC Instantiation	0
Standard EPIC Instantiation Plus the BE-EHR Module.	2056

Sponsor's own description

This RCT will test a new electronic health record module to improve guideline-compliant care of older adults with diabetes. The module incorporates effective behavioral economics (BE) principles to improve the degree to which care of older adults is compliant with Choosing Wisely (CW) guidelines; this generally involves less aggressive targets for HbA1c, and reductions of medications other than metformin. The implementation of the module is triggered by patient scheduling and medication prescribing in EPIC. The BE principles include suggesting alternatives to medications, requiring justification, setting of appropriate default order sets, and incorporation of anchoring and checklists to guide behavior.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.