Post-stroke Delirium Screening

Study Overview
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Brief Summary
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For a long time, delirium was considered a merely temporary dysfunction of the brain. Today, it is established that it is a brain disease associated with network dysfunction, neuroinflammation and impaired transmitter homeostasis in a multicausal model. Following an episode of delirium, many patients do not return to their prior level of cognitive and functional performance. In particular, failed or delayed diagnosis with consecutive inadequate therapy contribute to the development of long-term cognitive decline that may ultimately lead to long-term care. Stroke patients are a particularly common delirium-affected population (10-46% depending on severity). Despite the frequency and clinical relevance of delirium in stroke patients, diagnostic characteristics of common screening methods are unknown. Similarly, the clinical phenotype and risk factors of patients who develop delirium have not been adequately described. This study primarily aims to evaluate the diagnostic properties of established screening tools for delirium in a prospective cohort of well-characterised patients following ischemic cerebral events (either transient or manifest stroke). Secondary outcome criteria include predictors of post-stroke delirium (PSD) such as stroke location and size, pre-stroke cognitive functioning, ability to participate in daily routine activities and medical conditions.

Official Title
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Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium

Conditions
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Delirium, Ischemic Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Diagnostic Test: Stroke screening tools


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stroke unit admission for a high-risk transient ischemic attack (ABCD2 score >= 6) or stroke within the last 24 hours Exclusion Criteria: hemorrhagic stroke
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSD<br>Patients fulfilling DSM-5 criteria of PSD within 7 days of admission. | Diagnostic Test: Stroke screening tools<br>* Patients are evaluated for the presence of PSD using DSM-5 criteria (gold standard). Established delirium detection tools are evaluated for their diagnostic accuracy compared to the gold standard.<br>|
| No PSD<br>Patients NOT fulfilling DSM-5 criteria of PSD within 7 days of admission. | Diagnostic Test: Stroke screening tools<br>* Patients are evaluated for the presence of PSD using DSM-5 criteria (gold standard). Established delirium detection tools are evaluated for their diagnostic accuracy compared to the gold standard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria | Binary outcomes of delirium screening tests will be compared, i.e. if they characterize an individual patient as delirious at any of two time points during the 7 day observation period. Instruments include: Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM), rapid assessment test for delirium (4-AT). Binary outcomes (yes or no according to each of the scales) are then aggregated in one test that compares the observed frequency of delirious patients (according the above mentioned tests) with the actual number of delirious patients as assessed by the DSM-5 standard. | two times daily for 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSD prevalence | DSM-5 criteria and chart review are used to assess the occurence of PSD among included patients over the complete study period | three times daily for 7 days | 
| pre-stroke modified Rankin Scale | functional status before stroke | once on admission | 
| pre-stroke Barthel Index | ability to take care of personal daily routine before stroke | once on admission | 
| pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) | cognitive impairment before stroke | once on admission | 
| pre-stroke Groningen Frailty Index (GFI) | presence of a frailty syndrome before stroke | once on admission | 
| National Institutes of Health Stroke Scale (NIHSS) | estimate of clinical stroke severity | three times daily for three days starting on the day of admission | 
| Critical Care Pain Observation Tool (CPOT) | pain during stroke unit treatment | once daily for three days starting on the day of admission | 
| Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP)) | clinical characterisation based on phenotype as either total anterior, partial anterior, partial posterior or lacunar stroke | once on admission | 
| Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4)) | in patients with imaging of the definite stroke location, differences of mean locations between groups will be calculated | once on admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, delirium, screening tool