Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03080233
Enrollment
210
Registered
2017-03-15
Start date
2017-02-01
Completion date
2017-06-30
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Acute

Keywords

stroke, Validation, Clinical decision support tool

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.

Interventions

None listed

Sponsors

Aga Khan University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Validation_Primary Outcome Measure_ SensitivityDay 1Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Validation_ Primary Outcome Measure_SpecificityDay 1Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
Validation_Primary Outcome Measure_Positive and Negative Predictive ValuesDay 1Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert

Secondary

MeasureTime frameDescription
AcceptabilityDay 1Qualitative assessments by focus group discussion will be performed to incorporate user feedback

Other

MeasureTime frameDescription
Implementation CharacteristicsDay 1Qualitative assessments by focus group discussion will be performed to evaluate the user feedback to further improve the uptake of the tool.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026