NCT05203185

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,612

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 26, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

January 10, 2022

Results QC Date

May 3, 2023

Last Update Submit

June 1, 2023

Conditions

Keywords

Clinical Decision SupportPulmonary EmbolismBehavioral DesignHealth Informatics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of PE-Designated CTPA Tests That Are Positive for PE

    Up to Month 6

Study Arms (2)

Intervention Site

EXPERIMENTAL

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

Other: Pulmonary Embolism Risk Kalculator (PERK)

No Intervention Site

NO INTERVENTION

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).

Interventions

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.

Intervention Site

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical doctors, nurse practitioners and physician assistants working full time at Huntington Hospital and Long Island Jewish Valley Stream

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Huntington Hospital

Huntington, New York, 11743, United States

Location

Long Island Jewish Valley Stream

Valley Stream, New York, 11580, United States

Location

Related Publications (1)

  • Richardson S, Dauber-Decker KL, Solomon J, Seelamneni P, Khan S, Barnaby DP, Chelico J, Qiu M, Liu Y, Sanghani S, Izard SM, Chiuzan C, Mann D, Pekmezaris R, McGinn T, Diefenbach MA. Effect of a behavioral nudge on adoption of an electronic health record-agnostic pulmonary embolism risk prediction tool: a pilot cluster nonrandomized controlled trial. JAMIA Open. 2024 Aug 1;7(3):ooae064. doi: 10.1093/jamiaopen/ooae064. eCollection 2024 Oct.

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Safiya Richardson, MD, MPH
Organization
NYU Langone Health

Study Officials

  • Safiya Richardson, MD, MPH

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

July 1, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 26, 2023

Results First Posted

June 26, 2023

Record last verified: 2023-06

Locations