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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01657279
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : October 30, 2012
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Gustavo Saposnik, St. Michael's Hospital, Toronto

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 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

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].

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 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Practicing and active physicians managing patients with stroke

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01657279

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

Additional Information:
Responsible Party: Gustavo Saposnik, Staff Physician and Clinician Scientist, Associate Professor of medicine, University of Toronto, St. Michael's Hospital, Toronto 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    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases