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

Primary Purpose

Stroke, Ischemic Stroke, Cerebrovascular Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clinical scenarios
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring stroke, risk score, iScore, outcomes, mortality, disability, institutionalization

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Practicing and active physicians managing patients with stroke

Exclusion Criteria:

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

Sites / Locations

  • Duke University Medical Center
  • Sunnybrook Health Sciences Centre
  • St Michael's Hospital
  • McGill University Health Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Randomized clinical scenarios

Arm Description

Clinicians are randomized to a sequence of 5 clinical scenarios

Outcomes

Primary Outcome Measures

30 Day Mortality or Disability (mRS >3) at discharge

Secondary Outcome Measures

Death at 30 days
Death or institutionalization at discharge

Full Information

First Posted
July 30, 2012
Last Updated
October 27, 2012
Sponsor
Unity Health Toronto
Collaborators
Heart and Stroke Foundation of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT01657279
Brief Title
Clinician JUdgment Versus Risk Score to Predict Stroke outComes: The JURASSIC Clinical Trial
Acronym
JURASSIC
Official Title
Clinician JUdgment Versus Risk Score to Predict Stroke outComes:
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
Collaborators
Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Stroke, Cerebrovascular Disease
Keywords
stroke, risk score, iScore, outcomes, mortality, disability, institutionalization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized clinical scenarios
Arm Type
Experimental
Arm Description
Clinicians are randomized to a sequence of 5 clinical scenarios
Intervention Type
Other
Intervention Name(s)
Clinical scenarios
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Death at 30 days
Time Frame
30 days
Title
Death or institutionalization at discharge
Time Frame
up to 30 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Practicing and active physicians managing patients with stroke Exclusion Criteria: retired physicians physicians not exposed to care for stroke patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Saposnik, MD MSc FRCPC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 2R9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22308252
Citation
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.
Results Reference
background
PubMed Identifier
21960583
Citation
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.
Results Reference
background
PubMed Identifier
21300951
Citation
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.
Results Reference
background
Links:
URL
http://www.sorcan.ca/iscore/
Description
Web based tool for estimating outcomes using the iScore to compare clinicians' estimations

Learn more about this trial

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

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