Assessing Outcomes in ED Patients With RV Failure

Study Overview
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Brief Summary
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Millions of Americans seek emergency care for acute shortness of breath, and many undergo computerized tomographic pulmonary angiography (CTPA) testing that is negative for acute disease. Management of patients with persistent shortness of breath despite normal testing continues to pose a challenge for clinicians. Right ventricular (RV) failure is a common cause of dyspnea that brings patients to the emergency department (ED), however, it is often not considered in the differential diagnosis, remains unrecognized, or patients are not properly followed up once diagnosed. Delays in diagnosis and management of RV failure are associated with poor outcomes. The investigators propose a novel clinical pathway, which entails identifying and enrolling patients with RV failure in the ED, then referring them to a specialized cardiovascular clinic where they will receive a standardized evaluation and management plan. Our hypothesis is that management of RV failure, through this pathway, will improve patient outcomes when compared to standard care. The primary outcome will assess 1-year unscheduled healthcare visits.

Official Title
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Implementation of a Clinical Pathway to Improve Outcomes in Emergency Department Patients With Right Ventricular Failure

Conditions
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Right Heart Failure

Intervention / Treatment
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* Diagnostic Test: Clinical Pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients > 18 years old, with a non-significant CTPA scan (i.e. no acute disease), dyspnea PLUS an emergency physician performed echocardiogram with isolated RV failure OR CTPA scan with evidence of pulmonary hypertension OR comprehensive echocardiogram within 3 months of index hospital visit showing isolated RV dysfunction Exclusion Criteria: Currently being evaluated and/or treated for RV failure or PH, those unable to have a comprehensive echocardiography performed, those with indeterminate RV function OR LV dysfunction on comprehensive echocardiography, and those patients with circumstances where they may be lost to follow-up (homeless, prisoner, severe psychiatric disorder, no reliable contact information).

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinical Pathway Cohort<br>Patients with isolated RV failure will be evaluated and managed in a specialized cardiovascular clinic. | Diagnostic Test: Clinical Pathway<br>* Patients will be evaluated and managed in a specialized cardiovascular clinic to determine the etiology of right heart failure and begin treatment.<br>|
| No Intervention: Standard Care<br>Patients with isolated RV failure will receive standard care and follow up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unscheduled healthcare visits |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 year | 
| Hospital re-admissions |  | 1 year | 
| Change in quality of life via the SF-36 |  | 1 year |