- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03080233
Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)
Validation of Clinical Decision Support Tool Information Technology Application for Stroke Diagnosis
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Karachi, Pakistan, 74800
- Aga Khan University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Validation_Primary Outcome Measure_ Sensitivity
Tidsram: Day 1
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Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
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Day 1
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Validation_ Primary Outcome Measure_Specificity
Tidsram: Day 1
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Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
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Day 1
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Validation_Primary Outcome Measure_Positive and Negative Predictive Values
Tidsram: Day 1
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Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert
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Day 1
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Acceptability
Tidsram: Day 1
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Qualitative assessments by focus group discussion will be performed to incorporate user feedback
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Day 1
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Implementation Characteristics
Tidsram: Day 1
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Qualitative assessments by focus group discussion will be performed to evaluate the user feedback to further improve the uptake of the tool.
|
Day 1
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ayeesha K Kamal, AKUH
- Huvudutredare: Saadia S Choudhry, AKUH
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4554-CHS-ERC-16
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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