Clinician JUdgment Versus Risk Score to Predict Stroke outComes: The JURASSIC Clinical Trial

Stroke Clinical Trial

— JURASSIC  

Official title:

Clinician JUdgment Versus Risk Score to Predict Stroke outComes:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657279
• Other study ID #: SMH 09-020
• Secondary ID: 09-020
• Status: Completed
• Phase: N/A
• First received: July 30, 2012
• Last updated: October 27, 2012
• Start date: July 2012
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Practicing and active physicians managing patients with stroke

Exclusion Criteria:

• retired physicians

• physicians not exposed to care for stroke patients

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders
• Ischemic Stroke
• Stroke

Intervention

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].

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Heart and Stroke Foundation of Ontario

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 Day Mortality or Disability (mRS >3) at discharge		Death after 30 days from ischemic stroke onset or Disability following hospital discharge	No
Secondary	Death at 30 days		30 days	No
Secondary	Death or institutionalization at discharge		up to 30 days after discharge	No

External Links

•   Web based tool for estimating outcomes using the iScore to compare clinicians' estimations