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Completed

NCT Number: NCT03080233

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aga Khan University

Karachi, 74800, Pakistan

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Validation_Primary Outcome Measure_ Sensitivity

    Time frame: Day 1

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

  2. Validation_ Primary Outcome Measure_Specificity

    Time frame: Day 1

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

  3. Validation_Primary Outcome Measure_Positive and Negative Predictive Values

    Time frame: Day 1

    Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert

Secondary outcomes

  1. Acceptability

    Time frame: Day 1

    Qualitative assessments by focus group discussion will be performed to incorporate user feedback

Other outcomes

  1. Implementation Characteristics

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 15, 2017
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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