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

Aga Khan University

Status: Completed

Conditions: Stroke, Acute

Study type: Observational

Funder types: Other

Identifiers

NCT03080233

4554-CHS-ERC-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

210 participants in 1 patient group

Pakistani adult

Description:

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