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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Ischemic Stroke; Cerebrovascular Disease	Other: Clinical scenarios	Not Applicable

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	111 participants
Intervention Model:	Single Group Assignment
Masking:	Double (Investigator, Outcomes Assessor)
Primary Purpose:	Diagnostic
Official Title:	Clinician JUdgment Versus Risk Score to Predict Stroke outComes:
Study Start Date :	July 2012
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	August 2012

Arms and Interventions

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Arm	Intervention/treatment
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].

Outcome Measures

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Primary Outcome Measures :

1. 30 Day Mortality or Disability (mRS >3) at discharge [ Time Frame: Death after 30 days from ischemic stroke onset or Disability following hospital discharge ]

Secondary Outcome Measures :

1. Death at 30 days [ Time Frame: 30 days ]
2. Death or institutionalization at discharge [ Time Frame: up to 30 days after discharge ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Practicing and active physicians managing patients with stroke

Exclusion Criteria:

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

Contacts and Locations

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Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3H 2R9

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator:	Gustavo Saposnik, MD MSc FRCPC	St. Michael's Hospital, Toronto

More Information

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Additional Information:

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

Publications:

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.

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.

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.

Responsible Party:	Gustavo Saposnik, Staff Physician and Clinician Scientist, Associate Professor of medicine, University of Toronto, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01657279 History of Changes
Other Study ID Numbers:	SMH 09-020; 09-020 ( Other Identifier: St Michael's Hospital, University of Toronto )
First Posted:	August 6, 2012
Last Update Posted:	October 30, 2012
Last Verified:	October 2012

Keywords provided by Gustavo Saposnik, St. Michael's Hospital, Toronto:

stroke; risk score; iScore; outcomes	mortality; disability; institutionalization

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases