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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL145114-02 | 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Embolism Risk Kalculator (PERK) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Safiya Richardson, MD, MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Hospital | Huntington | New York | 11743 | United States | ||
| Long Island Jewish Valley Stream |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39091509 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Site - Providers | Providers at the site assigned to the intervention: 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 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. |
| FG001 | No Intervention Site - Providers | Providers at the site assigned to 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). |
| FG002 | Intervention Site - Patients | Patients at the site assigned to the intervention: 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 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. |
| FG003 | No Intervention Site - Patients | Patients at the site assigned to 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Sex, ethnicity and race data were not collected from Provider participants. Sex data were not collected from Patient participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Site - Providers | Providers at the site assigned to the intervention: 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Percentage of Patient Visits | Up to Month 6 | Patient Visits | Patient Visits |
|
6 months.
PI reviewed EHR reporting data every two weeks during the study. Adverse events, serious adverse events, and all-cause mortality data were not collected from Provider participants; Provider participant arms are not included below.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Site - Patients | Patients at the site assigned to the intervention: 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Safiya Richardson, MD, MPH | NYU Langone Health | 212-263-8313 | Safiya.Richardson@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2021 | May 2, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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|
| Valley Stream |
| New York |
| 11580 |
| United States |
| BG001 | No Intervention Site - Providers | Providers at the site assigned to 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). |
| BG002 | Intervention Site - Patients | Patients at the site assigned to the intervention: 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 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. |
| BG003 | No Intervention Site - Patients | Patients at the site assigned to 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). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Sex data were not collected from study participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity data were not collected from Provider participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race data were not collected from Provider participants. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | No Intervention Site - Patients and Providers | Patients and Providers at the site assigned to 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). |
|
|
| 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. | Posted | Number | Percentage of PE-Designated CTPA Tests | Up to Month 6 | PE-Designated CTPA Tests | PE-Designated CTPA Tests |
|
|
|
| 0 |
| 793 |
| 0 |
| 793 |
| 0 |
| 793 |
| EG001 | No Intervention Site - Patients | Patients at the site assigned to 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). | 0 | 735 | 0 | 735 | 0 | 735 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|