NCT01193998CompletedNot Applicable
Analysis of the Impact of Using a Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
Unity Health Toronto3 sites in 3 countries186 target enrollmentStarted: September 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Unity Health Toronto
- Enrollment
- 186
- Locations
- 3
- Primary Endpoint
- Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Clinician exposed to Model result
Active Comparator
Intervention: Treatment as per model probability (Other)
Clinician blinded to Model result
Experimental
Intervention: Treatment as per usual care (Other)
Outcomes
Primary Outcomes
Comparison of diagnostic model versus clinical judgment in appropriate diagnosis of Acute Heart Failure in dyspneic emergency department patients
Time Frame: 60 days after patient presentation to the emergency department
Secondary Outcomes
- 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)
Investigators
Brian Steinhart
Physician
Unity Health Toronto
Study Sites (3)
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