Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a validated diagnostic prediction model in the appropriate diagnosis of Acute Heart Failure (AHF) in patients presenting at the emergency department with undifferentiated dyspnea.

Official Title
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Analysis of the Impact of Using a Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department

Conditions
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Dyspnea, Acute Heart Failure, Shortness of Breath

Intervention / Treatment
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* Other: Treatment as per model probability
* Other: Treatment as per usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Presentation to the ED with undifferentiated shortness of breath Exclusion Criteria: Dyspnea of obvious cause, e.g. chest trauma, obvious clinical exacerbation of known chronic obstructive disease Obvious pulmonary edema in a patient with a known diagnosis of HF and recently admitted to hospital for HF Clinician does not plan to treat for AHF at all, but rather to pursue other causes of dyspnea (i.e., probability of AHF ≤ 20%) Clinician plans to treat for AHF and not to pursue other causes of dyspnea (i.e., probability of AHF ≥ 80%) Acute coronary syndrome within one month Chronic renal failure (serum creatinine ≥ 250 mol/l) Anticipated life expectancy < 6 months due to non-cardiovascular causes Participation in another interventional outcome trial Inability to obtain informed consent, including inability of patient to understand English

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinician exposed to Model result<br> | Other: Treatment as per model probability<br>* Patients randomized to the arm where the clinician is exposed to the model results should be treated as per the model probability (i.e. if the model probability suggests AHF the clinician should treat for AHF).<br>|
| Experimental: Clinician blinded to Model result<br> | Other: Treatment as per usual care<br>* Patients randomized to the arm where the clinician is blinded to the model results will undergo diagnostic tests and receive treatment as per the clinician's judgment and usual care standards.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients |  | 60 days after patient presentation to the emergency department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if use of the diagnostic prediction model leads to cost savings and better health outcomes |  | From randomization until 60 days after patient presentation to the emergency department |