Clinical trial NCT01657279: Clinician JUdgment Versus Risk Score to Predict Stroke outComes: The JURASSIC Clinical Trial
Official title: Clinician JUdgment Versus Risk Score to Predict Stroke outComes:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Ischemic Stroke
Cerebrovascular Disease
Keywords: stroke
risk score
iScore
outcomes
mortality
disability
institutionalization
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2012-08-06
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Practicing and active physicians managing patients with stroke

Exclusion Criteria:

* retired physicians
* physicians not exposed to care for stroke patients

Primary outcomes:
measure: 30 Day Mortality or Disability (mRS >3) at discharge
timeFrame: Death after 30 days from ischemic stroke onset or Disability following hospital discharge
Secondary outcomes:
measure: Death at 30 days
timeFrame: 30 days
measure: Death or institutionalization at discharge
timeFrame: up to 30 days after discharge
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Unity Health Toronto
name: Gustavo Saposnik, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saposnik G, Fang J, Kapral MK, Tu JV, Mamdani M, Austin P, Johnston SC; Investigators of the Registry of the Canadian Stroke Network (RCSN); Stroke Outcomes Research Canada (SORCan) Working Group. The iScore predicts effectiveness of thrombolytic therapy for acute ischemic stroke. Stroke. 2012 May;43(5):1315-22. doi: 10.1161/STROKEAHA.111.646265. Epub 2012 Feb 3.
citation: Saposnik G, Raptis S, Kapral MK, Liu Y, Tu JV, Mamdani M, Austin PC; Investigators of the Registry of the Canadian Stroke Network and the Stroke Outcome Research Canada Working Group. The iScore predicts poor functional outcomes early after hospitalization for an acute ischemic stroke. Stroke. 2011 Dec;42(12):3421-8. doi: 10.1161/STROKEAHA.111.623116. Epub 2011 Sep 29.
citation: Saposnik G, Kapral MK, Liu Y, Hall R, O'Donnell M, Raptis S, Tu JV, Mamdani M, Austin PC; Investigators of the Registry of the Canadian Stroke Network; Stroke Outcomes Research Canada (SORCan) Working Group. IScore: a risk score to predict death early after hospitalization for an acute ischemic stroke. Circulation. 2011 Feb 22;123(7):739-49. doi: 10.1161/CIRCULATIONAHA.110.983353. Epub 2011 Feb 7.