4-question "RACY" Delirium Screening Tool Validation Study

Delirium Clinical Trial

— RACY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01916889
• Other study ID #: UCT 148/2013
• Status: Active, not recruiting
• Phase: N/A
• First received: August 1, 2013
• Last updated: December 2, 2014
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: December 2014
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

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 Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1093
• Est. completion date: March 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• RACY test

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town
South Africa	Victoria Hospital	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No