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Prospective Randomised Controlled Trial of Delirium Management by Geriatric Medicine Versus General Medicine

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Estado
Patrocinadores
Central Coast Local Health District

Palabras clave

Abstracto

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).

Descripción

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.

fechas

Verificado por última vez: 06/30/2012
Primero enviado: 07/09/2012
Inscripción estimada enviada: 07/23/2012
Publicado por primera vez: 07/25/2012
Última actualización enviada: 07/23/2012
Última actualización publicada: 07/25/2012
Fecha de inicio real del estudio: 06/30/2012
Fecha estimada de finalización primaria: 06/30/2014
Fecha estimada de finalización del estudio: 06/30/2016

Condición o enfermedad

Delirium

Intervención / tratamiento

Other: Geriatric Medicine

Fase

-

Grupos de brazos

BrazoIntervención / tratamiento
No Intervention: General Medicine
Active Comparator: Geriatric Medicine
Daily medical review, adjust medications, treat infection, occupational therapy
Other: Geriatric Medicine
Adjust medications, treat precipitants of delirium, one-on-one supervision of agitated violent patients

Criterio de elegibilidad

Edades elegibles para estudiar 65 Years A 65 Years
Sexos elegibles para estudiarAll
Acepta voluntarios saludablessi
Criterios

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

Exclusion Criteria: 1)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

-

Salir

Medidas de resultado primarias

1. Return home rate [10-50 days]

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

2. Survival [30, 90, 180 days, 12 and 24 month]

Surivors divided by subjects reaching that milestone

3. Percentage residing at home [30, 90 and 180 days, 12 and 24 months]

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

4. Hospital complications of delirium [7-50 days from admission]

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

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