4-question "RACY" Delirium Screening Tool Validation Study

NCT01916889 | Completed

• 1 other identifier: UCT 148/2013
• Study Type: interventional
• Target: 1,093
• Locations: 1 country
• Sites: 2

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 Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week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

Conditions

Delirium

Keywords

Delirium

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 12-month cognitive outcomes in patients <50 years

  12-months

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

  12-months

Study Arms (1)

RACY test

EXPERIMENTAL

4-question "RACY" delirium screening tool

Other: RACY test

Interventions

RACY test OTHER

RACY test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge)
• \>18 years and willing to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (2)

Groote Schuur Hospital

Cape Town, 8001, South Africa

Location

Victoria Hospital

Cape Town, 8001, South Africa

Location

Related 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. doi: 10.7196/samj.5615.

  PMID: 22668961 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jonathan Peter

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Peter Raubenheimer

  University of Cape Town

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Consultant, Department of Medicine

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 6, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

ZA (2)