NCT03409523

Brief Summary

This study will develop a new electronic health record module to improve guideline-compliant care of older adults with diabetes. The module will incorporate effective behavioral economics (BE) principles to improve the degree to which care of older adults is compliant with Choosing Wisely guidelines; this generally involves less aggressive targets for HbA1c, and reductions of medications other than metformin. The implementation of the module will ultimately be triggered by 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. The study will involve provider workflow analysis based on observation, module user testing, and live usability testing with direct observation and semi-structure interviews.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

December 26, 2017

Last Update Submit

July 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compliance with Choosing Wisely guidelines measured by number of reductions of medications

    The implementation of the module will ultimately be triggered by medication prescribing in EPIC.

    60 Months

Secondary Outcomes (1)

  • Usability measured by module user testing with direct observation and semi structured interviews

    60 Months

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Providers in NYU outpatient primary care, geriatrics, or endocrine clinics at NYU who care for older adults with diabetes

You may qualify if:

  • Providers in NYU outpatient primary care, geriatrics, or endocrine clinics at NYU who care for older adults with diabetes

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • Belli HM, Chokshi SK, Hegde R, Troxel AB, Blecker S, Testa PA, Anderman J, Wong C, Mann DM. Implementation of a Behavioral Economics Electronic Health Record (BE-EHR) Module to Reduce Overtreatment of Diabetes in Older Adults. J Gen Intern Med. 2020 Nov;35(11):3254-3261. doi: 10.1007/s11606-020-06119-z. Epub 2020 Sep 3.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andrea Troxel, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 24, 2018

Study Start

January 8, 2018

Primary Completion

July 3, 2019

Study Completion

July 3, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations