Clinical trial NCT03080233: Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)
Official title: Validation of Clinical Decision Support Tool Information Technology Application for Stroke Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Keywords: stroke
Validation
Clinical decision support tool
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation_Primary Outcome Measure_ Sensitivity
timeFrame: Day 1
measure: Validation_ Primary Outcome Measure_Specificity
timeFrame: Day 1
measure: Validation_Primary Outcome Measure_Positive and Negative Predictive Values
timeFrame: Day 1
Secondary outcomes:
measure: Acceptability
timeFrame: Day 1
Other outcomes:
measure: Implementation Characteristics
timeFrame: Day 1
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: AKUH
name: Ayeesha K Kamal
role: PRINCIPAL_INVESTIGATOR
affiliation: AKUH
name: Saadia S Choudhry
role: PRINCIPAL_INVESTIGATOR
References: