- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01916889
4-question "RACY" Delirium Screening Tool Validation Study (RACY)
Validation Study of the 4-question "RACY"Delirium Screening Tool in General Medical In-patients From a Developing Country Setting
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 Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cape Town, South Africa, 8001
- Groote Schuur Hospital
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Cape Town, South Africa, 8001
- Victoria Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: RACY test
4-question "RACY" delirium screening tool
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy (Sensitivity, specificity, likelihood ratios) of the "RACY" delirium screening tool
Time Frame: 48 hours
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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.
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48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
12-month cognitive outcomes in patients <50 years
Time Frame: 12-months
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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.
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12-months
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Measurement of IL-6, IL-2, TNF-alpha, IFN-gamma, IGF-1, MCP-1, and hsCRP
Time Frame: 12-months
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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.
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12-months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Peter, University of Cape Town
- Study Director: Peter Raubenheimer, University of Cape Town
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCT 148/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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