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

NCT04181307 | Completed Results DMC

• 2 other identifiers: 19-014645R33AG057382
• Study Type: interventional
• Target: 7,630
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Are CW-Compliant and CW-Noncompliant

  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-noncompliant.

  Month 18

Secondary Outcomes (1)

• Number of Total Prescription Encounters

  Month 18

Study Arms (2)

standard EPIC instantiation

NO INTERVENTION

As per standard procedure at NewYorkUniversity Langone Health

standard EPIC instantiation plus the BE-EHR module.

EXPERIMENTAL

The BE-EHR module includes six components: 1) a tailored advisory for patients over 75 with diabetes, 2) medication refill protocol with information on Choosing Wisely guidelines, 3) pre-population of the medication preference list with metformin, 4) lab result protocol with information on Choosing Wisely guidelines, 5) peer comparisons regarding performance meeting guidelines, and 6) media campaign with information about Choosing Wisely guidelines. The set of nudges is referred to collectively as the BE-EHR module.

Behavioral: BE-EHR module

Interventions

BE-EHR module BEHAVIORAL

The BE-EHR module includes six components: 1) a tailored advisory for patients over 75 with diabetes, 2) medication refill protocol with information on Choosing Wisely guidelines, 3) pre-population of the medication preference list with metformin, 4) lab result protocol with information on Choosing Wisely guidelines, 5) peer comparisons regarding performance meeting guidelines, and 6) media campaign with information about Choosing Wisely guidelines. The set of nudges is referred to collectively as the BE-EHR module.

standard EPIC instantiation plus the BE-EHR module.

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient at NYULH primary care or endocrinology practice
• Practices that have patients aged 75 or older
• Practices that have a diagnosis of diabetes in the EHR chart

You may not qualify if:

• Under age 75

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

• Viswanadham RVN, Belli HM, Martinez TR, Wong C, Blecker S, Troxel AB, Mann DM. When Nudges Don't Budge: A Mixed Methods Study of Why EHR-Based Deprescribing Nudges Failed to Change Provider Behavior. Res Sq [Preprint]. 2025 Sep 23:rs.3.rs-7466262. doi: 10.21203/rs.3.rs-7466262/v1.

  PMID: 41041570 DERIVED

• Belli HM, Troxel AB, Blecker SB, Anderman J, Wong C, Martinez TR, Mann DM. A Behavioral Economics-Electronic Health Record Module to Promote Appropriate Diabetes Management in Older Adults: Protocol for a Pragmatic Cluster Randomized Controlled Trial. JMIR Res Protoc. 2021 Oct 27;10(10):e28723. doi: 10.2196/28723.

  PMID: 34704959 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Andrea B. Troxel, ScD
• Organization: NYU Langone Health

andrea.troxel@nyulangone.org

646-501-3654

Study Officials

• Andrea Troxel, ScD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: December 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 19, 2023
• Results First Posted: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to andrea.troxel@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)