Clinician JUdgment Versus Risk Score to Predict Stroke outComes: The JURASSIC Clinical Trial (JURASSIC)
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| ClinicalTrials.gov Identifier: NCT01657279 |
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Recruitment Status :
Completed
First Posted : August 6, 2012
Last Update Posted : October 30, 2012
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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 | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 111 participants |
| 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 : | July 2012 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | August 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Randomized clinical scenarios
Clinicians are randomized to a sequence of 5 clinical scenarios
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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]. |
- 30 Day Mortality or Disability (mRS >3) at discharge [ Time Frame: Death after 30 days from ischemic stroke onset or Disability following hospital discharge ]
- Death at 30 days [ Time Frame: 30 days ]
- Death or institutionalization at discharge [ Time Frame: up to 30 days after discharge ]
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| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657279
| 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 | |
| Principal Investigator: | Gustavo Saposnik, MD MSc FRCPC | St. Michael's Hospital, Toronto |
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 ( Other Identifier: St Michael's Hospital, University of Toronto ) |
| First Posted: | August 6, 2012 Key Record Dates |
| Last Update Posted: | October 30, 2012 |
| Last Verified: | October 2012 |
Keywords provided by Gustavo Saposnik, St. Michael's Hospital, Toronto:
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stroke risk score iScore outcomes |
mortality disability institutionalization |
Additional relevant MeSH terms:
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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |