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

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

History of Changes

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:	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 Gustavo Saposnik, 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 ]

Secondary Outcome Measures:

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


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 (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

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
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

Additional Information:

Web based tool for estimating outcomes using the iScore to compare clinicians' estimations This link exits the ClinicalTrials.gov site

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 )
Study First Received:	July 30, 2012
Last Updated:	October 27, 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

ClinicalTrials.gov processed this record on July 21, 2017

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