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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05203185
Other study ID # 21-01316
Secondary ID 5K23HL145114-02
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date April 30, 2022

Study information

Verified date June 2023
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1612
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary Embolism Risk Kalculator (PERK)
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.

Locations

Country Name City State
United States Huntington Hospital Huntington New York
United States Long Island Jewish Valley Stream Valley Stream New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Patient Visits Where the Provider Adopted the Pulmonary Embolism Risk Kalculator (PERK) Tool 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. Up to Month 6
Secondary Percentage of PE-Designated CTPA Tests That Are Positive for PE 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
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