Electronic Support for Pulmonary Embolism Emergency Disposition

Study Overview
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Brief Summary
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To evaluate the impact of an integrated electronic clinical decision support system to facilitate risk stratification and site-of-care decision-making for patients with acute pulmonary embolism.

Detailed Description
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Many low-risk emergency department patients with acute pulmonary embolism are routinely hospitalized despite being eligible for outpatient care. One impediment to home discharge is the difficulty of identifying which patients can safely forego hospitalization. This pragmatic clinical trial intends to evaluate the effect on emergency department disposition of a multicomponent intervention, including electronic clinical decision support system access, physician education, and physician-specific audit and feedback. The hypothesis for this study is that intervention sites, when compared with concurrent control sites, will see an increase in home discharges without an increase in 5-day pulmonary embolism-related return visits or 30-day all-cause mortality.

Official Title
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Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Other: Integration of electronic clinical decision support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute objectively-confirmed pulmonary embolism, diagnosed in the emergency department Exclusion Criteria: Comfort-care only Left the ED against medical advice Current PE radiologically diagnosed >12 hrs prior to arrival Recent DVT or PE diagnosed within 30 days Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic clinical trial of a multidimensional technology and educational intervention undertaken over 16 months with an 8-month pre-intervention and an 8-month post-intervention period, conducted across 21 emergency departments with 10 serving as intervention and 11 as control sites.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br> | Other: Integration of electronic clinical decision support<br>* Integration of an electronic clinical decision support system into the emergency department patient care workflow to assist with site-of-care decision-making for emergency department patients with acute pulmonary embolism.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of home discharge from the emergency department following treatment for pulmonary embolism |  | 8 months post-implementation compared to 8 months pre-implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality |  | 30 days | 
| Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions |  | 5 days |