Atherosclerotic Cardiovascular DiseaseNCT07914777
EHR Nudges: Optimizing a Clinical Decision Support System for Evidence-Based Statin Medication Prescribing to Reduce the Risk of Cardiovascular Disease
A study testing EHR Nudge in people with Atherosclerotic Cardiovascular Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
The overall objective of this proposal is to develop and optimize a CDSS, including several nudges, to increase guideline-concordant statin prescribing for CVD risk (Nudge-CVD-CDSS). Potential nudges will be developed, usability tested and refined and then evaluated in a factorial trial. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- EHR Nudge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,501 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Providers:
- 1. Medical doctor, nurse practitioner, and physician assistants practicing at any NYULH Internal or Family Medicine practice.
- Patients:
- Age 40-75 years old
- Had a previous visit in the past 12 months with a provider at any NYULH Internal or Family Medicine practice.
- Had blood pressure documented in the last 12 months
- Had LDL results completed in the last 12 months
- Has either a diagnosis of cardiovascular disease, LDL > 190, or ASCVD risk score ≥ 20%
Who cannot join
- Providers - N/A
- Patients:
- Pregnant
- Has allergy or contraindication to statin
- Already taking a high-intensity statin
- Has diagnosis of dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The overall objective of this proposal is to develop and optimize a CDSS, including several nudges, to increase guideline-concordant statin prescribing for CVD risk (Nudge-CVD-CDSS). Potential nudges will be developed, usability tested and refined and then evaluated in a factorial trial. The aim of this trial is to develop, based on a conceptual model of the prescribing process, a set of potential intervention components (EHR-nudges) to promote and support AHA/ACC guideline-concordant statin prescribing. A user-centered design process will be employed. EHR audit log data will be used to identify technical workflows of current provider prescribing patterns. Provider- and patient-directed default, peer comparison, and salient messaging nudges will be developed (5 total). Patient-directed nudges will encourage patients to prompt their providers to prescribe guideline-concordant statins.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- EHR Nudge
- Keywords
- Atherosclerotic Cardiovascular Disease, CVD
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR NudgeOther
A clinical decision support system (CDSS) inside of the electronic health record (EHR) to support and encourage providers to prescribe statins for at risk patients, in concordance with guidelines. EHR Nudges consist of 5 different nudges (A, B, C, D, E).
| Study group | Role | What they receive |
|---|---|---|
| Provider | Experimental | Providers will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. Receives: Other: EHR Nudge |
| Control | No intervention | Providers randomized to this arm will receive no EHR nudges. |
| Patient | Experimental | Patients will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. Receives: Other: EHR Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients indicated for statin therapy who were prescribed a guideline-approved statin at the correct dose during the study period
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 posted4 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized factorial trial. Randomization will be by practice to minimize contamination effects.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 7,501 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Safiya Richardson, MD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914777
- Sponsor's protocol ID
- 23-01349
- Other IDs
- 1R01HL171292-01
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Nicole.Redfern@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHR Nudges: Optimizing a Clinical Decision Support System for Evidence-Based Statin Medication Prescribing to Reduce the Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT07914777
- Acronym / sponsor ID
- 23-01349
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- Atherosclerotic Cardiovascular Disease, CVD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,501 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this proposal is to develop and optimize a CDSS, including several nudges, to increase guideline-concordant statin prescribing for CVD risk (Nudge-CVD-CDSS). Potential nudges will be developed, usability tested and refined and then evaluated in a factorial trial. The aim of this trial is to develop, based on a conceptual model of the prescribing process, a set of potential intervention components (EHR-nudges) to promote and support AHA/ACC guideline-concordant statin prescribing. A user-centered design process will be employed. EHR audit log data will be used to identify technical workflows of current provider prescribing patterns. Provider- and patient-directed default, peer comparison, and salient messaging nudges will be developed (5 total). Patient-directed nudges will encourage patients to prompt their providers to prescribe guideline-concordant statins.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Randomized factorial trial. Randomization will be by practice to minimize contamination effects.
| Arm | Type | Receives |
|---|---|---|
| Provider | Experimental | Other: EHR NudgeProviders will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. |
| Control | No intervention | –Providers randomized to this arm will receive no EHR nudges. |
| Patient | Experimental | Other: EHR NudgePatients will be randomly assigned into 1 of 31 conditions. Each condition will have a unique combination of nudges A-E. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Medical doctor, nurse practitioner, and physician assistants practicing at any NYULH Internal or Family Medicine practice.
- Age 40-75 years old
- Had a previous visit in the past 12 months with a provider at any NYULH Internal or Family Medicine practice.
- Had blood pressure documented in the last 12 months
- Had LDL results completed in the last 12 months
Key exclusion criteria (6 listed)
- Providers - N/A
- Pregnant
- Has allergy or contraindication to statin
- Already taking a high-intensity statin
- Has diagnosis of dementia
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 |
|---|---|---|
| EHR NudgeA clinical decision support system (CDSS) inside of the electronic health record (EHR) to support and encourage providers to prescribe statins for at risk patients, in concordance with guidelines. EHR Nudges consist of 5 different nudges (A, B, C, D, E). | Other | Patient, Provider |
Primary outcome
Percentage of patients indicated for statin therapy who were prescribed a guideline-approved statin at the correct dose during the study period
Time frame: Month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Nicole.Redfern@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Safiya Richardson, MD, MPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR Nudge in people with Atherosclerotic Cardiovascular Disease, 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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Redfern (646-501-2501, Nicole.Redfern@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients indicated for statin therapy who were prescribed a guideline-approved statin at the correct dose during the study period (time frame: Month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.