Clinical Trial: 4-question "RACY" Delirium Screening Tool Validation Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week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


Detailed Summary:
Sponsor: University of Cape Town

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: University of Cape Town

Dates:
Date Received: August 1, 2013
Date Started: September 2013
Date Completion:
Last Updated: May 10, 2016
Last Verified: May 2016