4-question RACY Delirium Screening Tool Validation Study

Study Overview
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Brief Summary
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Delirium is a serious medical condition associated with increased mortality, longer hospital stay, increased rates of institutionalisation, and declines in post-admission functionality. Despite the prognostic utility of diagnosing delirium and its utility as an important indicator of health quality in elderly patients in developed countries, it is not routinely screened for in many busy general medical in-patient settings, especially in developing countries. Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week period received any formal cognitive testing or had documentation of the presence/absence of delirium in routine clinical notes. This under-recognition is largely the result of the length and complexity of available delirium diagnostic tools e.g. Mini-mental state exam (MMSE), although the perceived lack of clinical importance and conflicting results about specific treatment modalities also contribute. The investigators recently developed the simple 4-question RACY delirium screening tool for use in general medical in-patients. Preliminary data show the test to be simple and effective with a sensitivity and specificity of 78% and 85% respectively using a ROC-selected cut-point of RACY≤2. The investigators hypothesis that the RACY screening tool has the potential to be a simple and effective bedside delirium diagnostic instrument for use in non-geriatric, busy general medical in-patient settings. This study is a two-centre validation study to evaluate the diagnostic accuracy of this tool.

Official Title
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Validation Study of the 4-question RACYDelirium Screening Tool in General Medical In-patients From a Developing Country Setting

Conditions
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Delirium

Intervention / Treatment
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* Other: RACY test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge) >18 years and willing to give informed consent Exclusion Criteria: Patient admitted directly to intensive care unit Patient refusing consent or <18 years old Patients unable to undergo delirium testing due to: i) Glasgow coma scale ≤ 12/15, ii) Aphasia

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RACY test<br>4-question RACY delirium screening tool | Other: RACY test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy (Sensitivity, specificity, likelihood ratios) of the RACY delirium screening tool | The 4-question RACY delirium screening tool and reference delirium testing will be performed within 24 hours of hospital admission to the general medical wards. RACY delirium screening and reference delirium testing will be performed within 4 hours of each other by two independent testers. Testers performing the RACY delirium screening will be blinded to the results of the reference testing. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month cognitive outcomes in patients <50 years | A subset of cohort patients <50 years diagnosed with delirium during acute general medical admission will undergo full neurocognitive assessment at 12-month post-enrolment. | 12-months | 
| Measurement of IL-6, IL-2, TNF-alpha, IFN-gamma, IGF-1, MCP-1, and hsCRP | Using samples stored at the time of delirium diagnosis, biomarker levels will be compared between delirium and non-delirium in-patients less than 50 years old. | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium