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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL169364-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Decision Support (CDS) tool with Nudges | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
1. A provider not present at the specified study sites.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Henning | Contact | 239-810-1186 | Natalie.henning@nyulangone.org | |
| Lynn Xu | Contact | 646-501-7911 | Lynn.xu@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Safiya Richardson, MD MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health - Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42186073 | Derived | 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. doi: 10.1186/s13012-026-01508-0. Online ahead of print. |
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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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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Each emergency department (ED) will function as a control group (usual care) prior to implementation of the intervention.
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|
| NYU Langone Health |
| New York |
| New York |
| 10016 |
| United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016250 | Compact Disks |
| D004864 | Equipment and Supplies |
| ID | Term |
|---|---|
| D014742 | Videodisc Recording |
| D016249 | Optical Storage Devices |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
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