NCT07249385

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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

Study Progress7%
Feb 2026Mar 2029

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

January 22, 2026

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

November 18, 2025

Last Update Submit

January 21, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    End of intervention (Month 45)

Study Arms (1)

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.

Behavioral: Clinical Decision Support (CDS) tool with Nudges

Interventions

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.

Emergency Department (ED) Providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • \. A provider not present at the specified study sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northwell Health - Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Compact DisksEquipment and Supplies

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Videodisc RecordingOptical Storage DevicesAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Safiya Richardson, MD MPH

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Each emergency department (ED) will function as a control group (usual care) prior to implementation of the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

February 15, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

January 22, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Safiya.richardson@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations