Pulmonary EmbolismNCT07249385
Nudging Provider Adoption of Clinical Decision Support: Implementation of an EHR-Agnostic Pulmonary Embolism Risk Prediction Tool
A study testing Clinical Decision Support (CDS) tool with Nudges in people with Pulmonary Embolism, run by NYU Langone Health at 3 sites in United States.
Trial summary
The purpose of this study is to examine the impact of the nudge implementation strategy (CDS tool + Nudge) on adoption of guideline-concordant CT ordering for pulmonary embolism (PE) in 10 EDs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Clinical Decision Support (CDS) tool with Nudges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Feb 2026to 31 Mar 2029
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of older
- A provider (MD, NP, PA) ordering CTs for evaluation of PE in adult patients present at study site Emergency Department (i.e., Northwell Health - Feinstein Institute for Medical Research, Baylor College of Medicine and NYU Langone Health).
Who cannot join
- 1. A provider not present at the specified study sites.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Baylor College of Medicine
Houston, Texas, 77030
Northwell Health - Feinstein Institute for Medical Research
Manhasset, New York, 11030
NYU Langone Health
New York, New York, 10016
About this study
The purpose of this study is to examine the impact of the nudge implementation strategy (CDS tool + Nudge) on adoption of guideline-concordant CT ordering for pulmonary embolism (PE) in 10 EDs. The study will be a 33-month, rigorous, pragmatic, cluster-randomized, stepped wedge trial across 3 health systems and 10 EDs after collecting pre-implementation baseline data. The aim is to to demonstrate technological feasibility as well as examine efficacy of the nudges on adoption. The secondary objective is to decrease CT-ordering when it is not indicated.
Read the detailed description
Part 1 of the study included the collection of data. During the pre-implementation period each sites electronic health record (EHR) and baseline data was collected for 12 months. In Part 2, the study will examine the impact of the nudge implementation strategy (CDS tool + Nudge) on adoption of guideline-concordant CT ordering for PE in 10 EDs. Adoption outcomes data will be collected through EHR reporting systems.
- Conditions
- Pulmonary Embolism
- Being tested
- Clinical Decision Support (CDS) tool with Nudges
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support (CDS) tool with NudgesBehavioural
The CDS tool with nudges provide information to providers to practice medicine in accordance with CT (computed tomography) ordering guidelines. The tool will only deploy when the provider is going against clinical guidelines and therefore provides a chance for the provider to reconsider their actions.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department (ED) Providers | Experimental | Each ED will serve as its own control. Baseline data will be collected for 12 months prior to the implementation of the CDS system with nudges. The CDS tool with nudges will then be implemented for 33 months. Receives: Behavioral: Clinical Decision Support (CDS) tool with Nudges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of CT scan orders that are guideline-concordant
Guideline-concordant is defined as CT scan orders with Wells' Score >4 ["PE Likely"] and/or d-dimer above upper limit of normal.
Measured: Baseline (Month 12)
Percentage of CT scan orders that are guideline-concordant
Guideline-concordant is defined as CT scan orders with Wells' Score >4 ["PE Likely"] and/or d-dimer above upper limit of normal.
Measured: End of intervention (Month 45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Feb 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each emergency department (ED) will function as a control group (usual care) prior to implementation of the intervention.
- Masking
- None (open label)
- Enrolment
- 440 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
- NCT07249385
- Sponsor's protocol ID
- 23-01528
- Other IDs
- 5R01HL169364-02
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Safiya.richardson@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Publications
Khan S, Thomas Y, Garg N, Genes N, Simon GW, Cleland CM, Mir U, Dauber-Decker KL, Solomon JN, Shunk A, Xu L, Mastrianni A, Cui Y, Henning N, Diefenbach MA, McGinn T, Richardson S. Nudging provider adoption of clinical decision support: study protocol for a stepped-wedge cluster randomized, hybrid type III trial of an electronic health record-agnostic pulmonary embolism risk tool. Implement Sci. 2026 May 25;21(1):43. doi: 10.1186/s13012-026-01508-0.
PubMed 42186073
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Provider Adoption of Clinical Decision Support: Implementation of an EHR-Agnostic Pulmonary Embolism Risk Prediction Tool
- ClinicalTrials.gov ID
- NCT07249385
- Acronym / sponsor ID
- 23-01528
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 25 Nov 2025 (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 purpose of this study is to examine the impact of the nudge implementation strategy (CDS tool + Nudge) on adoption of guideline-concordant CT ordering for pulmonary embolism (PE) in 10 EDs. The study will be a 33-month, rigorous, pragmatic, cluster-randomized, stepped wedge trial across 3 health systems and 10 EDs after collecting pre-implementation baseline data. The aim is to to demonstrate technological feasibility as well as examine efficacy of the nudges on adoption. The secondary objective is to decrease CT-ordering when it is not indicated.
Detailed description
Part 1 of the study included the collection of data. During the pre-implementation period each sites electronic health record (EHR) and baseline data was collected for 12 months. In Part 2, the study will examine the impact of the nudge implementation strategy (CDS tool + Nudge) on adoption of guideline-concordant CT ordering for PE in 10 EDs. Adoption outcomes data will be collected through EHR reporting systems.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each emergency department (ED) will function as a control group (usual care) prior to implementation of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Emergency Department (ED) Providers | Experimental | Behavioral: Clinical Decision Support (CDS) tool with NudgesEach ED will serve as its own control. Baseline data will be collected for 12 months prior to the implementation of the CDS system with nudges. The CDS tool with nudges will then be implemented for 33 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of older
- A provider (MD, NP, PA) ordering CTs for evaluation of PE in adult patients present at study site Emergency Department (i.e., Northwell Health - Feinstein Institute for Medical Research, Baylor College of Medicine and NYU Langone Health).
Key exclusion criteria (1 listed)
- 1. A provider not present at the specified study sites.
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 |
|---|---|---|
| Clinical Decision Support (CDS) tool with NudgesThe CDS tool with nudges provide information to providers to practice medicine in accordance with CT (computed tomography) ordering guidelines. The tool will only deploy when the provider is going against clinical guidelines and therefore provides a chance for the provider to reconsider their actions. | Behavioural | Emergency Department (ED) Providers |
Primary outcome
Percentage of CT scan orders that are guideline-concordant
Time frame: Baseline (Month 12)
Guideline-concordant is defined as CT scan orders with Wells' Score >4 ["PE Likely"] and/or d-dimer above upper limit of normal.
Percentage of CT scan orders that are guideline-concordant
Time frame: End of intervention (Month 45)
Guideline-concordant is defined as CT scan orders with Wells' Score >4 ["PE Likely"] and/or d-dimer above upper limit of normal.
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 22 Jan 2026.
- Derived from this study: PubMed 42186073Khan S, Thomas Y, Garg N, Genes N, Simon GW, Cleland CM, Mir U, Dauber-Decker KL, Solomon JN, Shunk A, Xu L, Mastrianni A, Cui Y, Henning N, Diefenbach MA, McGinn T, Richardson S. Nudging provider adoption of clinical decision support: study protocol for a stepped-wedge cluster randomized, hybrid type III trial of an electronic health record-agnostic pulmonary embolism risk tool. Implement Sci. 2026 May 25;21(1):43. doi: 10.1186/s13012-026-01508-0.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Safiya.richardson@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support (CDS) tool with Nudges in people with Pulmonary Embolism, run by NYU Langone Health at 3 sites 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 2 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Natalie Henning (239-810-1186, Natalie.henning@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of CT scan orders that are guideline-concordant (time frame: Baseline (Month 12)). The study lists 2 primary outcomes in all. 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 NCT07249385, which also lists 1 linked publication.
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 22 Jan 2026.