Clinician JUdgment Versus Risk Score to Predict Stroke outComes: The JURASSIC Clinical Trial (JURASSIC)
Background: Several risk score models are now available to assist clinicians estimate outcomes after an acute ischemic stroke. Limited information is available on the predictive value of these scores compared to real outcomes and clinical judgment.
Objectives: To compare clinician judgment with the use of a validated stroke risk score (iScore) and patients' outcomes.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Clinician JUdgment Versus Risk Score to Predict Stroke outComes:|
- 30 Day Mortality or Disability (mRS >3) at discharge [ Time Frame: Death after 30 days from ischemic stroke onset or Disability following hospital discharge ] [ Designated as safety issue: No ]
- Death at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Death or institutionalization at discharge [ Time Frame: up to 30 days after discharge ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Randomized clinical scenarios
Clinicians are randomized to a sequence of 5 clinical scenarios
Other: Clinical scenarios
Clinicians will be randomized to a sequence of 5 clinical scenarios with a variable range of expected outcome [i.e. from low (<10%) to high (>50%) expected risk death at 30 days].
A convenience sample of 111 practicing clinicians (general and vascular neurologists, internists, and ER physicians) predicted the outcomes of 5 stroke patients based on case summaries. Cases were randomly selected as being representative of the 10 most common clinical scenarios (n=1,415) from a pool of over 12,000 patients admitted to stroke centers in Ontario, Canada. Stroke cases had known clinical presentation, comorbidities, stroke severity, and outcomes.
All participants are active practicing physicians caring for patients with acute stroke. Conditions were standardized to mimic clinical practice.
Main outcomes of interest included 30-day mortality and death or disability at discharge.
Secondary outcome: death or institutionalization at discharge
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657279
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|St Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|McGill University Health Centre|
|Montreal, Quebec, Canada, H3H 2R9|
|Principal Investigator:||Gustavo Saposnik, MD MSc FRCPC||St. Michael's Hospital, Toronto|