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

NCT ID: NCT04181307

Last Updated: 2023-07-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard EPIC instantiation

As per standard procedure at NewYorkUniversity Langone Health

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

BE-EHR module

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Troxel, ScD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41041570 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34704959 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R33AG057382

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-01464

Identifier Type: -

Identifier Source: org_study_id

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