DiabetesNCT04181307
A Randomized Trial of a BE-EHR Module to Guide the Care of Older Adults With Diabetes
A study testing BE-EHR module in people with Diabetes, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- BE-EHR module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,630 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Under age 75
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- BE-EHR module
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BE-EHR moduleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BE-EHR module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 18
Secondary outcomes (1)
Number of Total Prescription Encounters
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
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Dec 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Andrea Troxel, ScD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181307
- Sponsor's protocol ID
- 19-01464
- Other IDs
- 5R33AG057382
- Status last verified
- Jul 2023
- First submitted
- 26 Nov 2019
- Last updated
- 19 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Viswanadham RVN, Belli HM, Martinez TR, Wong C, Blecker SB, Troxel AB, Mann DM. Provider comments reveal barriers to EHR nudge effectiveness: process evaluation of a null deprescribing trial. Implement Sci Commun. 2026 Jun 6. doi: 10.1186/s43058-026-00983-2. Online ahead of print.
PubMed 42251456Viswanadham 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.
PubMed 41041570Belli 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.
PubMed 34704959
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a BE-EHR Module to Guide the Care of Older Adults With Diabetes
- ClinicalTrials.gov ID
- NCT04181307
- Acronym / sponsor ID
- 19-01464
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,630 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Posted 19 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard EPIC instantiation | No intervention | –As per standard procedure at NewYorkUniversity Langone Health |
| standard EPIC instantiation plus the BE-EHR module. | Experimental | Behavioral: BE-EHR moduleThe 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Under age 75
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BE-EHR moduleThe 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. | Behavioural | standard EPIC instantiation plus the BE-EHR module. |
Primary outcome
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.
1 secondary outcome
Number of Total Prescription Encounters
Time frame: Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42251456Viswanadham RVN, Belli HM, Martinez TR, Wong C, Blecker SB, Troxel AB, Mann DM. Provider comments reveal barriers to EHR nudge effectiveness: process evaluation of a null deprescribing trial. Implement Sci Commun. 2026 Jun 6. doi: 10.1186/s43058-026-00983-2. Online ahead of print.
- Derived from this study: PubMed 41041570Viswanadham 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.
- Derived from this study: PubMed 34704959Belli 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Troxel, ScD principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BE-EHR module in people with Diabetes, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Are CW-Compliant and CW-Noncompliant (time frame: Month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04181307, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.