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

Stroke, Acute Clinical Trial

Official title:

Validation of Clinical Decision Support Tool Information Technology Application for Stroke Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080233
• Other study ID #: 4554-CHS-ERC-16
• Status: Completed
• Phase: N/A
• First received: March 3, 2017
• Last updated: January 9, 2018
• Start date: February 1, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: January 2018
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation Characteristics	Qualitative assessments by focus group discussion will be performed to evaluate the user feedback to further improve the uptake of the tool.	Day 1
Primary	Validation_Primary Outcome Measure_ Sensitivity	Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert	Day 1
Primary	Validation_ Primary Outcome Measure_Specificity	Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert	Day 1
Primary	Validation_Primary Outcome Measure_Positive and Negative Predictive Values	Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert	Day 1
Secondary	Acceptability	Qualitative assessments by focus group discussion will be performed to incorporate user feedback	Day 1