跳至主要内容
临床试验/NCT01916889
NCT01916889已完成不适用

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

University of Cape Town2 个研究点 分布在 1 个国家目标入组 1,093 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,093
试验地点
2
主要终点
Diagnostic accuracy (Sensitivity, specificity, likelihood ratios) of the "RACY" delirium screening tool

研究概览

简要总结

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 Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

RACY test

Experimental

4-question "RACY" delirium screening tool

干预措施: RACY test (Other)

结局指标

主要结局

Diagnostic accuracy (Sensitivity, specificity, likelihood ratios) of the "RACY" delirium screening tool

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Peter

Honorary Consultant, Department of Medicine

University of Cape Town

研究点 (2)

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