Delirium | 4-question "RACY" Delirium Screening Tool Validation Study
Delirium research study
What is the primary objective of this 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 Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RACY test4-question "RACY" delirium screening tool
Start Date: September 2013
Completed Date: April 2015
Primary Outcome: Diagnostic accuracy (Sensitivity, specificity, likelihood ratios) of the "RACY" delirium screening tool
Secondary Outcome: 12-month cognitive outcomes in patients <50 years
Study sponsors, principal investigator, and references
Principal Investigator: Jonathan Peter
Lead Sponsor: University of Cape Town
Stuart-Clark H, Vorajee N, Zuma S, Van Niekerk L, Burch V, Raubenheimer P, Peter JG. Twelve-month outcomes of patients admitted to the acute general medical service at Groote Schuur Hospital. S Afr Med J. 2012 May 23;102(6):549-53.