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

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT01657279
• Collaborator: Heart and Stroke Foundation of Ontario (Other)
• Enrollment: 111
• Locations: 4
• Arm: 1
• Duration (Months): 1
• Patients Per Site: 27.8
• Patients Per Site Per Month: 27.2

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: N/A
• 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: Jul 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

1. Death at 30 days [30 days]

2. Death or institutionalization at discharge [up to 30 days after discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Unity Health Toronto
• Heart and Stroke Foundation of Ontario

Investigators

• Principal Investigator: Gustavo Saposnik, MD MSc FRCPC, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

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, 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.
• 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.

• Responsible Party: Gustavo Saposnik, Staff Physician and Clinician Scientist, Associate Professor of medicine, University of Toronto, Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT01657279
• Other Study ID Numbers: SMH 09-020; 09-020
• First Posted: Aug 6, 2012
• Last Update Posted: Oct 30, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Gustavo Saposnik, Staff Physician and Clinician Scientist, Associate Professor of medicine, University of Toronto, Unity Health Toronto: stroke; risk score; iScore; outcomes; mortality; disability; institutionalization
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebrovascular Disorders

Study Results

No Results Posted as of Oct 30, 2012