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4-question "RACY" Delirium Screening Tool Validation Study (RACY)

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
RACY test
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium focused on measuring Delirium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groote Schuur Hospital
  • Victoria Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RACY test

Arm Description

4-question "RACY" delirium screening tool

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 1, 2013
Last Updated
May 10, 2016
Sponsor
University of Cape Town
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1. Study Identification

Unique Protocol Identification Number
NCT01916889
Brief Title
4-question "RACY" Delirium Screening Tool Validation Study
Acronym
RACY
Official Title
Validation Study of the 4-question "RACY"Delirium Screening Tool in General Medical In-patients From a Developing Country Setting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1093 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RACY test
Arm Type
Experimental
Arm Description
4-question "RACY" delirium screening tool
Intervention Type
Other
Intervention Name(s)
RACY test
Primary Outcome Measure Information:
Title
Diagnostic accuracy (Sensitivity, specificity, likelihood ratios) of the "RACY" delirium screening tool
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
12-month cognitive outcomes in patients <50 years
Description
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.
Time Frame
12-months
Title
Measurement of IL-6, IL-2, TNF-alpha, IFN-gamma, IGF-1, MCP-1, and hsCRP
Description
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.
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Peter
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Raubenheimer
Organizational Affiliation
University of Cape Town
Official's Role
Study Director
Facility Information:
Facility Name
Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Victoria Hospital
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
22668961
Citation
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.
Results Reference
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4-question "RACY" Delirium Screening Tool Validation Study

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