- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05203185
Nudging Provider Adoption of Clinical Decision Support
June 1, 2023 updated by: NYU Langone Health
The central hypothesis of this proposal is that the addition of a theory-informed "nudge" to a clinical decision support (CDS) tool will address identified behavioral barriers to use and significantly improve adoption by providers.
Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making.
This study will use a behavioral theory-informed process to develop a new CDS tool that includes a nudge that addresses barriers to adoption.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research team developed and pilot tested two CDS tools for pulmonary embolism (PE) risk stratification in the Emergency Department (ED).
One of the tools incorporated two behavioral theory-informed nudges in the user interface.
The research team's objective was to pilot test the tools to demonstrate feasibility as well as examine preliminary efficacy of the nudges on provider adoption of the tool.
This cluster non-randomized controlled trial took place between September 20th, 2021 and March 3rd, 2022 in two EDs that are a part of a large academic health system in the New York City metropolitan area.
All ED providers (physicians, physician assistants and nurse practitioners) seeing patients for the evaluation of PE during this time were included in the trial.
The EDs were chosen based on their comparable size and acuity levels.
Study Type
Interventional
Enrollment (Actual)
1612
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Huntington, New York, United States, 11743
- Huntington Hospital
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Valley Stream, New York, United States, 11580
- Long Island Jewish Valley Stream
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Medical doctors, nurse practitioners and physician assistants working full time at Huntington Hospital and Long Island Jewish Valley Stream
Exclusion Criteria:
- Does not meet the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Site
Full time employed Emergency Department providers will use the new CDS tool, Pulmonary Embolism Risk Kalculator (PERK), which includes nudges to improve use and will be integrated into the electronic medical record and will be accessible for 6 months
|
Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making.
Nudges will be to the PE CALC CDS tool to develop the new CDS tool, PERK.
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No Intervention: No Intervention Site
Full time employed Emergency Department providers used a CDS tool, Pulmonary Embolism Calculator (PE CALC), without nudges to improve use, to reduce unnecessary imaging in the diagnosis of pulmonary embolism (PE) in the emergency department (ED).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patient Visits Where the Provider Adopted the Pulmonary Embolism Risk Kalculator (PERK) Tool
Time Frame: Up to Month 6
|
The tool is considered adopted during a patient visit if the provider accepted the recommendation given by the PERK tool (i.e., a D-dimer was recommended and ordered or a CT pulmonary angiogram (CTPA) was recommended and ordered).
This outcome measure is assessed using electronic health record (EHR) data from the patient visit.
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Up to Month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of PE-Designated CTPA Tests That Are Positive for PE
Time Frame: Up to Month 6
|
Monitored using EHR reporting data.
Calculated as the percentage of CTPA tests ordered to evaluate for PE that are positive for PE.
|
Up to Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Safiya Richardson, MD, MPH, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
January 10, 2022
First Posted (Actual)
January 24, 2022
Study Record Updates
Last Update Posted (Actual)
June 26, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-01316
- 5K23HL145114-02 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Embolism
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Boston Scientific CorporationEKOS CorporationCompletedPulmonary Embolism | Acute Pulmonary Embolism | Pulmonary Thromboembolism | Massive Pulmonary Embolism | Sub-massive Pulmonary EmbolismUnited States
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University of California, Los AngelesEnrolling by invitationPulmonary Disease | Pulmonary Embolism | Pulmonary Embolus/Emboli | Pulmonary Embolism and Thrombosis | Pulmonary Embolism Subacute Massive | Pulmonary Embolism Acute MassiveUnited States
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Clinical Trials on Pulmonary Embolism Risk Kalculator (PERK)
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University Hospital, Basel, SwitzerlandCompletedMissed Pulmonary Embolism at the Emergency Department
-
Intermountain Health Care, Inc.Completed
-
Mark W. DodsonUnknownChronic Thromboembolic Pulmonary HypertensionUnited States
-
University Hospital, Strasbourg, FranceRecruitingPulmonary EmbolismFrance
-
University Hospital, GrenobleSanofi; Ministry of Health, France; SFMV (Société Française de Médecine Vasculaire)CompletedVascular Diseases | Embolism and Thrombosis | Venous Insufficiency | Phlebitis | Pulmonary EmbolismFrance, Belgium, Guadeloupe
-
Società Italiana di Medicina di Emergenza-UrgenzaCompletedPulmonary Embolism | HemoptysisItaly
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingPulmonary EmbolismUnited States
-
University of CalgaryCompletedPulmonary Embolism | Clinical Reasoning | Diagnostic Uncertainty | Evidence Based Medicine | Visualization of UncertaintyCanada
-
Aysel SünnetçioğluYuzuncu Yıl UniversityCompleted