Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)

Completed

• Conditions: Stroke, Acute

• Registration Number: NCT03080233
• Lead Sponsor: Aga Khan University

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Adult men and women, >18 years of age.
2. Patients admitted with neurological deficit consistent with stroke.
3. Confirmation of stroke by objective modality of CT scan and MRI.
4. Consenting to participate in the study.

Exclusion Criteria

1. Patients presenting with any type of Haemorrhagic stroke such as Sub-Arachnoid Haemorrhage, Intracerebral Haemorrhage and others.
2. Stroke due to any iatrogenic causes such as post-surgeries, trauma, or any rare or non atherosclerotic causes eg carotid dissection.
3. Patients signing LAMA (left against Medical Advice) and leaving undiagnosed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation_Primary Outcome Measure_ Sensitivity	Day 1	Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Validation_ Primary Outcome Measure_Specificity	Day 1	Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Validation_Primary Outcome Measure_Positive and Negative Predictive Values	Day 1	Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert

Secondary Outcome Measures

Name	Time	Method
Acceptability	Day 1	Qualitative assessments by focus group discussion will be performed to incorporate user feedback

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Pakistan