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

Sponsor
NYU Langone Health (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04181307
Collaborator
(none)
5,000
1
2
21
238.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BE-EHR module
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of a BE-EHR Module to Guide the Care of Older Adults With Diabetes
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in Choosing Wisely compliance status [throughout the study, at the end of the 18 months study]

    In order to evaluate Choosing Wisely 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 Outcome Measures

  1. Changes in Tailored Advisory module [throughout the study, at the end of the 18 months study]

    The Tailored Advisory nudge activates in Epic for any patient who is not CW compliant. For each patient seen, clinicians can respond by clicking the "Agree with recommendation. Action taken" button, or by selecting the "Clinically inappropriate. Please explain" option, with space for free text comments. A response is not required.

  2. Changes in Refill Protocol module [throughout the study, at the end of the 18 months study]

    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

  3. Changes in Preference List module [throughout the study, at the end of the 18 months study]

    The Preference List nudge is a system level nudge at the pilot sites. Metformin is listed at the top of the page as the choice for "First-line Type 2 Diabetes," without restricting orders for non-Metformin medications

  4. Changes in Lab Result module [throughout the study, at the end of the 18 months study]

    The Lab Result nudge activates in Epic whenever there is a new A1c lab result for a non-CW compliant patient; the alert remains active in Epic for seven days following the result.

  5. Changes in Peer Comparison module [throughout the study, at the end of the 18 months study]

    The Peer Comparison nudge is sent via a secured Microsoft Outlook account once per month. The subject line of the email is "Message from the desk of Dr. [Insert Practice Director Name]" and the email content includes three graphics: a CW compliance rate for the individual provider, a CW compliance rate for the clinician's practice site, and a CW compliance rate across all NYU Langone practices. Depending on whether the clinician's CW compliance rate was above or below the rate of their respective practice, the provider receives either a "negative" or "positive" version of the email

  6. Changes in Campaign module [throughout the study, at the end of the 18 months study]

    The campaign toolkit for dissemination includes three gameshow-themed animations (Price is Right, Jeopardy, and Who Wants to Be a Millionaire), as well as a flashcard deck that quizzes physicians on CW best practices. The Price is Right campaign includes three unique variations and the Jeopardy campaign includes four unique variations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Andrea Troxel, ScD, NYU Langone

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04181307
Other Study ID Numbers:
  • 19-01464
First Posted:
Nov 29, 2019
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021