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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Gustavo Saposnik, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01657279
First received: July 30, 2012
Last updated: October 27, 2012
Last verified: October 2012
  Purpose

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 Intervention
Stroke
Ischemic Stroke
Cerebrovascular Disease
Other: Clinical scenarios

Study Type: Interventional
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:

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 111
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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].

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657279

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

Additional Information:
Publications:
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
Study First Received: July 30, 2012
Last Updated: October 27, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
stroke
risk score
iScore
outcomes
mortality
disability
institutionalization

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014