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NCT Number: NCT01916889

4-question "RACY" Delirium Screening Tool Validation Study

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 Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groote Schuur Hospital, Cape Town, South Africa

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

RACY test

Other

Primary outcomes

  1. Diagnostic accuracy (Sensitivity, specificity, likelihood ratios) of the "RACY" delirium screening tool

    Time frame: 48 hours

    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.

Secondary outcomes

  1. 12-month cognitive outcomes in patients <50 years

    Time frame: 12-months

    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.

  2. Measurement of IL-6, IL-2, TNF-alpha, IFN-gamma, IGF-1, MCP-1, and hsCRP

    Time frame: 12-months

    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.

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Official study title

Validation Study of the 4-question "RACY"Delirium Screening Tool in General Medical In-patients From a Developing Country Setting

Acronym: RACY

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 6, 2013
Registry last updated
May 12, 2016

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

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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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