An interventional study of Pulmonary Embolism Risk Kalculator (PERK) in Pulmonary Embolism, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research
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.
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.
753 studies on the registry are indexed under Pulmonary Embolism; 157 are open to participants now.
This study's enrollment of 1,612 is above the median of 150 across 387 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
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).
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.
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.
Time frame: Up to Month 6
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.
Time frame: Up to Month 6
| Milestone | Intervention Site - Providers | No Intervention Site - Providers | Intervention Site - Patients | No Intervention Site - Patients |
|---|---|---|---|---|
| Started | 49 | 35 | 793 | 735 |
| Completed | 49 | 35 | 793 | 735 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Percentage of Patient Visits | Intervention Site - Patients and Providers | No Intervention Site - Patients and Providers |
|---|---|---|
| Percentage of Patient Visits Where the Provider Adopted the Pulmonary Embolism Risk Kalculator (PERK) Tool | 39.11 | 20.66 |
Monitored using EHR reporting data. Calculated as the percentage of CTPA tests ordered to evaluate for PE that are positive for PE.
| Percentage of PE-Designated CTPA Tests | Intervention Site - Patients and Providers | No Intervention Site - Patients and Providers |
|---|---|---|
| Percentage of PE-Designated CTPA Tests That Are Positive for PE | 26.45 | 10.76 |
Collected over 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Site - Patients | 0/793 (0%) | 0/793 (0%) | 0/793 (0%) |
| No Intervention Site - Patients | 0/735 (0%) | 0/735 (0%) | 0/735 (0%) |
Sex, ethnicity and race data were not collected from Provider participants. Sex data were not collected from Patient participants.
| Age, Continuous(years) | Intervention Site - Providers | No Intervention Site - Providers | Intervention Site - Patients | No Intervention Site - Patients | Total |
|---|---|---|---|---|---|
| Median | 38 (33 to 44) | 35 (33 to 38) | 65 (53 to 79) | 64 (49 to 77) | 51 (38 to 65) |
| Sex: Female, Male(Participants) | Intervention Site - Providers | No Intervention Site - Providers | Intervention Site - Patients | No Intervention Site - Patients | Total |
|---|---|---|---|---|---|
| Female | — | — | — | — | 0 |
| Male | — | — | — | — | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Site - Providers | No Intervention Site - Providers | Intervention Site - Patients | No Intervention Site - Patients | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | — | — | 69 | 32 | 101 |
| Not Hispanic or Latino | — | — | 673 | 617 | 1290 |
| Unknown or Not Reported | — | — | 51 | 86 | 137 |
| Race (NIH/OMB)(Participants) | Intervention Site - Providers | No Intervention Site - Providers | Intervention Site - Patients | No Intervention Site - Patients | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | — | — | 0 | 0 | 0 |
| Asian | — | — | 14 | 32 | 46 |
| Native Hawaiian or Other Pacific Islander | — | — | 0 | 0 | 0 |
| Black or African American | — | — | 42 | 435 | 477 |
| White | — | — | 618 | 146 | 764 |
| More than one race | — | — | 0 | 0 | 0 |
| Unknown or Not Reported | — | — | 119 | 122 | 241 |
| Region of Enrollment(Participants) | Intervention Site - Providers | No Intervention Site - Providers | Intervention Site - Patients | No Intervention Site - Patients | Total |
|---|---|---|---|---|---|
| United States | 49 | 35 | 793 | 735 | 1612 |
Documents are hosted by the registry — open the source record to download them.
Ran from Jul 2021 to primary completion in Apr 2022, 9 months.
Results were first posted in Jun 2023, 1 year 1 month after primary completion.
Of 114 non-industry interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 9 months is below that.
Counting every sponsor, half of 139 studies reached it within 26 months; a quarter within 15 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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