StrokeJURASSICNCT01657279
Clinician JUdgment Versus Risk Score to Predict Stroke outComes: The JURASSIC Clinical Trial
A study testing Clinical scenarios in people with Stroke and Ischemic Stroke, run by Unity Health Toronto at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke, Ischemic Stroke, Cerebrovascular Disease
- What is being tested?
- Clinical scenarios
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Practicing and active physicians managing patients with stroke
Who cannot join
- retired physicians
- physicians not exposed to care for stroke patients
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites
McGill University Health Centre
Montreal, Quebec, H3H 2R9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St Michael's Hospital
Toronto, Ontario, M5B 1W8
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Clinician JUdgment Versus Risk Score to Predict Stroke outComes:
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.
Read the 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
- Conditions
- Stroke, Ischemic Stroke, Cerebrovascular Disease
- Being tested
- Clinical scenarios
- Keywords
- stroke, risk score, iScore, outcomes, mortality, disability, institutionalization
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical scenariosOther
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].
| Study group | Role | What they receive |
|---|---|---|
| Randomized clinical scenarios | Experimental | Clinicians are randomized to a sequence of 5 clinical scenarios Receives: Other: Clinical scenarios |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 Day Mortality or Disability (mRS >3) at discharge
Measured: Death after 30 days from ischemic stroke onset or Disability following hospital discharge
Secondary outcomes (2)
Death at 30 days
Measured: 30 days
Death or institutionalization at discharge
Measured: up to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Principal investigator, Gustavo Saposnik, Unity Health Toronto
- Investigators
- Gustavo Saposnik, MD MSc FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657279
- Sponsor's protocol ID
- SMH 09-020
- Other IDs
- 09-020
- Acronym
- JURASSIC
- Status last verified
- Oct 2012
- First submitted
- 30 Jul 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22308252Saposnik 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.
PubMed 21960583Saposnik 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.
PubMed 21300951
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician JUdgment Versus Risk Score to Predict Stroke outComes:
- ClinicalTrials.gov ID
- NCT01657279
- Acronym / sponsor ID
- JURASSIC / SMH 09-020
- Conditions
- Stroke, Ischemic Stroke, Cerebrovascular Disease
- Keywords
- stroke, risk score, iScore, outcomes, mortality, disability, institutionalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Randomized clinical scenarios | Experimental | Other: Clinical scenariosClinicians are randomized to a sequence of 5 clinical scenarios |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Practicing and active physicians managing patients with stroke
Key exclusion criteria (2 listed)
- retired physicians
- physicians not exposed to care for stroke patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical scenariosClinicians 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]. | Other | Randomized clinical scenarios |
Primary outcome
30 Day Mortality or Disability (mRS >3) at discharge
Time frame: Death after 30 days from ischemic stroke onset or Disability following hospital discharge
2 secondary outcomes
Death at 30 days
Time frame: 30 days
Death or institutionalization at discharge
Time frame: up to 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
- Background: PubMed 22308252Saposnik 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.
- Background: PubMed 21960583Saposnik 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.
- Background: PubMed 21300951Saposnik 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.
- Web based tool for estimating outcomes using the iScore to compare clinicians' estimationsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Saposnik, MD MSc FRCPC principal investigator
Unity Health Toronto
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical scenarios in people with Stroke and Ischemic Stroke, run by Unity Health Toronto at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 Day Mortality or Disability (mRS >3) at discharge (time frame: Death after 30 days from ischemic stroke onset or Disability following hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01657279, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.