Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-27 @ 11:20 AM
Study NCT ID:
NCT03080233
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2017-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)
Sponsor:
Aga Khan University
Organization:
Study Overview
Official Title:
Validation of Clinical Decision Support Tool Information Technology Application for Stroke Diagnosis
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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). 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:
1\. 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.
Specific Aims:
1\. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: