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Clinical Trials/NCT01657279
NCT01657279CompletedNot Applicable

Clinician JUdgment Versus Risk Score to Predict Stroke outComes:

Unity Health Toronto8 sites in 2 countries111 target enrollmentStarted: July 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
111
Locations
8
Primary Endpoint
30 Day Mortality or Disability (mRS >3) at discharge

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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 Outcomes

  • Death at 30 days(30 days)
  • Death or institutionalization at discharge(up to 30 days after discharge)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gustavo Saposnik

Staff Physician and Clinician Scientist, Associate Professor of medicine, University of Toronto

Unity Health Toronto

Study Sites (8)

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