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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2022

Interventions

  • Behavioral: BE-EHR module
    • 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.

Arms, Groups and Cohorts

  • No Intervention: standard EPIC instantiation
    • As per standard procedure at NewYorkUniversity Langone Health
  • Experimental: standard EPIC instantiation plus the BE-EHR module.
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Who Are CW-Compliant and CW-Noncompliant
    • Time Frame: 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-noncompliant.

Secondary Measures

  • Number of Total Prescription Encounters
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

• Under age 75

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrea Troxel, ScD, Principal Investigator, NYU Langone

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.