Stroke, AcuteNCT03080233
Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)
An observational study of Stroke, Acute, run by Aga Khan University at 1 site in Pakistan.
Trial summary
This is a observational validation study. The Stroke Clinical Decision Support Tool ( InstaDx) , an information technology application will be adapted and developed in accordance to evidence based clinical practice guidelines ( Level IA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 210 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2017to 30 Jun 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All men and women greater than or equal to 18 years of age presenting in emergency department with neurological deficit consistent with stroke, fulfilling our eligibility criteria and willing to give voluntary informed consent to participate in the study.
Who may be able to join
- Adult men and women, >18 years of age.
- Patients admitted with neurological deficit consistent with stroke.
- Confirmation of stroke by objective modality of CT scan and MRI.
- Consenting to participate in the study.
Who cannot join
- Patients presenting with any type of Haemorrhagic stroke such as Sub-Arachnoid Haemorrhage, Intracerebral Haemorrhage and others.
- Stroke due to any iatrogenic causes such as post-surgeries, trauma, or any rare or non atherosclerotic causes eg carotid dissection.
- Patients signing LAMA (left against Medical Advice) and leaving undiagnosed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Clinical Decision Support Tool Information Technology Application for Stroke Diagnosis
This is a observational validation study. The Stroke Clinical Decision Support Tool ( InstaDx) , an information technology application will be adapted and developed in accordance to evidence based clinical practice guidelines ( Level IA). Neurology Residents will be using the InstaDx CDST to improve their diagnostic accuracy and the findings will be validated against the review of a stroke subject expert. The study hypothesis is that Clinical Decision Support Tool used by neurology residents will have an agreement of >0.77 when compared to Stroke Expert (gold standard) in diagnosing type of ischemic stroke.
Read the detailed description
Overall Objective: To adapt, develop and validate the clinical decision support tool, an information technology application to assist acute stroke diagnosis for use among neurology graduate trainees compared to stroke expert (gold standard).
Specific Aims:
- To validate the adapted clinical decision support tool, an information technology application to assist acute ischemic stroke diagnosis for use among neurology residents compared to stroke expert (Gold standard) in the adult population presenting at a tertiary care hospital in Pakistan.
The study will be conducted in Emergency department and the Neurology ward at Aga Khan University Hospital. The data collector will enroll the patients meeting the eligibility criteria and providing informed consent. Neurology residents will use the Clinical Decision Support Tool application to assist in acute stroke diagnosis. In the second part, the Stroke Expert will independently assess all diagnosis. The purpose of this would be to validate the Clinical Decision Support Tool application to assist in acute stroke diagnosis.
- Conditions
- Stroke, Acute
- Keywords
- stroke, Validation, Clinical decision support tool
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pakistani adult | Men and women aged 18 years or above,presenting with neurological deficit consistent with stroke in the Emergency Department at Aga Khan University Hospital Consenting to participate in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation_Primary Outcome Measure_ Sensitivity
Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Measured: Day 1
Validation_ Primary Outcome Measure_Specificity
Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Measured: Day 1
Validation_Primary Outcome Measure_Positive and Negative Predictive Values
Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Measured: Day 1
Secondary outcomes (1)
Acceptability
Qualitative assessments by focus group discussion will be performed to incorporate user feedback
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start1 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ayeesha Kamran Kamal, Aga Khan University
- Investigators
- Ayeesha K Kamal, Principal investigator, AKUHSaadia S Choudhry, Principal investigator, AKUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080233
- Sponsor's protocol ID
- 4554-CHS-ERC-16
- Status last verified
- Jan 2018
- First submitted
- 3 Mar 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This may be shared on request only.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinical Decision Support Tool Information Technology Application for Stroke Diagnosis
- ClinicalTrials.gov ID
- NCT03080233
- Acronym / sponsor ID
- 4554-CHS-ERC-16
- Conditions
- Stroke, Acute
- Keywords
- stroke, Validation, Clinical decision support tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 15 Mar 2017 (actual)
- 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.
This is a observational validation study. The Stroke Clinical Decision Support Tool ( InstaDx) , an information technology application will be adapted and developed in accordance to evidence based clinical practice guidelines ( Level IA). Neurology Residents will be using the InstaDx CDST to improve their diagnostic accuracy and the findings will be validated against the review of a stroke subject expert. The study hypothesis is that Clinical Decision Support Tool used by neurology residents will have an agreement of >0.77 when compared to Stroke Expert (gold standard) in diagnosing type of ischemic stroke.
Detailed description
Overall Objective: To adapt, develop and validate the clinical decision support tool, an information technology application to assist acute stroke diagnosis for use among neurology graduate trainees compared to stroke expert (gold standard).
Specific Aims:
- To validate the adapted clinical decision support tool, an information technology application to assist acute ischemic stroke diagnosis for use among neurology residents compared to stroke expert (Gold standard) in the adult population presenting at a tertiary care hospital in Pakistan.
The study will be conducted in Emergency department and the Neurology ward at Aga Khan University Hospital. The data collector will enroll the patients meeting the eligibility criteria and providing informed consent. Neurology residents will use the Clinical Decision Support Tool application to assist in acute stroke diagnosis. In the second part, the Stroke Expert will independently assess all diagnosis. The purpose of this would be to validate the Clinical Decision Support Tool application to assist in acute stroke diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pakistani adult | – | –Men and women aged 18 years or above,presenting with neurological deficit consistent with stroke in the Emergency Department at Aga Khan University Hospital Consenting to participate in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men and women greater than or equal to 18 years of age presenting in emergency department with neurological deficit consistent with stroke, fulfilling our eligibility criteria and willing to give voluntary informed consent to participate in the study.
Key inclusion criteria (4 listed)
- Adult men and women, >18 years of age.
- Patients admitted with neurological deficit consistent with stroke.
- Confirmation of stroke by objective modality of CT scan and MRI.
- Consenting to participate in the study.
Key exclusion criteria (3 listed)
- Patients presenting with any type of Haemorrhagic stroke such as Sub-Arachnoid Haemorrhage, Intracerebral Haemorrhage and others.
- Stroke due to any iatrogenic causes such as post-surgeries, trauma, or any rare or non atherosclerotic causes eg carotid dissection.
- Patients signing LAMA (left against Medical Advice) and leaving undiagnosed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation_Primary Outcome Measure_ Sensitivity
Time frame: Day 1
Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Validation_ Primary Outcome Measure_Specificity
Time frame: Day 1
Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Validation_Primary Outcome Measure_Positive and Negative Predictive Values
Time frame: Day 1
Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
1 secondary outcome
Acceptability
Time frame: Day 1
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 10 Jan 2018.
- Individual participant dataSharing planned: No. This may be shared on request only.
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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.
Ayeesha K Kamal principal investigator
AKUH
Saadia S Choudhry principal investigator
AKUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Aga Khan University at 1 site in Pakistan.
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 4 inclusion and 3 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
Validation_Primary Outcome Measure_ Sensitivity (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2018.