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临床试验/NCT01650896
NCT01650896Unknown不适用

Prospective Randomised Controlled Trial of Delirium Management The Central Coast Australia Delirium Intervention Study (CADIS

Central Coast Local Health District2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
2
主要终点
Return home rate

研究概览

简要总结

The typical delirium study between 1989 and 2005 compared delirium management in a specialty unit such as geriatric medicine with delirium management in general medicine (in most cases the research diagnosis of delirium was not communicated to the general medicine group). This study will provide open diagnosis of delirium by the CAM to both the geriatric medicine and general medicine groups (medical staff, patients, families) plus daily monitoring of delirium using digit span and delirium index which is reported to both patient groups. It will also compare confusion assessment method (CAM)to a novel diagnostic system of Paul Regal with respect to hard endpoints (survival and return home). Hypotheses: 1) General medicine can manage delirium as well as geriatric medicine when delirium is openly diagnosed and monitored daily (even in speciality units it is rare to find daily measurement of tools such as delirium index); 2) The Regal diagnostic system will be superior to the CAM in predicting hard endpoints (survival and return home rate for patients living in the community).

详细描述

Delirium research has been stuck in 1990 with the CAM. Articles appearing in 2012 could have been written in 1990. The CAM is riddled with logical fallacies such as 1) Circular reasoning about hearing loss causing delirium - hearing loss causes incorrect answers to questions on orientation and attention, leading to false positive diagnosis of delirium; 2) Circular reasoning on dementia causing delirium - dementia often does cause delirium but behavioral and psychological symptoms of delirium (BPSD) are the most common false positive diagnosis of delirium. CADIS (Central Coast Australia Delirium Intervention Study) will compare CAM+ to CAM- age 65+ in emergency department (prevalent delirium). Paul Regal has already shown that the 8% of 630 elderly he admitted from January 2011 to June 2012 who were CAM+ had the same survival (hospital, 90 day, 180 day and 12 month) and return home rate (65%) as 580 CAM negative elderly. The Regal criteria for delirium are completely novel. For every error in questions, the Regal system forces the examiner to determine if the error is due to poor hearing or cognitive impairment. A portable amplifier with headphones is used. The Regal methods uses recent records as the baseline for attention, memory and orientation questions. For example, an 83 year-old woman was assessed in memory clinic and had digit span forward 5/5 and 5/6; 5-word recall at 5 minutes in MoCA was 4/5; orientation was 10/10. Two months later she is admitted for RLL pneumonia and confusion. Digit span declined by 40% to 3/5, 5-word recall at 5 minutes declined by 100% to 0/5 and orientation declined by 40% to 6/10. There was no event during the two months such as stroke to explain this decline.

Another novel feature of CADIS is follow-up by a blinded clinical nurse consultant at 30 and 90 days, 12 and 24 months for MoCA, Addenbrooke Cognitve Assessment and four tests from CANTABeclipse (Cambridge Cognition) touchscreen laptop. The hypothesis is that "persistent delirium" is due primarily to irreverible brain events such as ischemic stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • age 65+ medical admissions from emergency department with CAM positive delirium who have an informant / caregiver -

排除标准

  • Aphasia; 2) Unable to speak English; 3) End stage dementia; 4) Terminal care; 5) No close informant; 6) Unable to hear questions with or without portable amplifier with headphones; 7) Intensive care; 8) Surgical admissions

结局指标

主要结局

Return home rate

时间窗: 10-50 days

The percentage of subjects returning home divided by the number living at home prior to admission and surviving until discharge

Survival

时间窗: 30, 90, 180 days, 12 and 24 month

Surivors divided by subjects reaching that milestone

Percentage residing at home

时间窗: 30, 90 and 180 days, 12 and 24 months

Number of subjects at home divided by number surviving to that milesone

Hospital complications of delirium

时间窗: 7-50 days from admission

Absconding from ward, physical violence, pulling out intravenous lines and indwelling catheters, refusing medications, falls and injurious falls

次要结局

未报告次要终点

研究者

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

Paul Regal MD FRACP FRCP (London)

Senior Lecturer in Geriatric Medicine

Central Coast Local Health District

研究点 (2)

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