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

NCT03080233 | Completed DMC

• 1 other identifier: 4554-CHS-ERC-16
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

stroke; Validation; Clinical decision support tool

Outcome Measures

Primary Outcomes (3)

• Validation_Primary Outcome Measure_ Sensitivity

  Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert

  Day 1

• Validation_ Primary Outcome Measure_Specificity

  Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert

  Day 1

• 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 Outcomes (1)

• Acceptability

  Day 1

Other Outcomes (1)

• Implementation Characteristics

  Day 1

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, 74800, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ayeesha K Kamal

  AKUH

  PRINCIPAL INVESTIGATOR

• Saadia S Choudhry

  AKUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 15, 2017
• Study Start: February 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)