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

• ClinicalTrials.gov Identifier: NCT01650896
• Recruitment Status: Unknown
• First Posted: July 26, 2012
• Last Update Posted: July 26, 2012
• Sponsor: Central Coast Local Health District
• Information provided by (Responsible Party): Paul Regal MD FRACP FRCP (London), Central Coast Local Health District

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Delirium	Other: Geriatric assessment review	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Randomised Controlled Trial of Delirium Management The Central Coast Australia Delirium Intervention Study (CADIS
• Study Start Date: July 2012
• Estimated Primary Completion Date: July 2014
• Estimated Study Completion Date: July 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Return home rate [ Time Frame: 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 [ Time Frame: 30, 90, 180 days, 12 and 24 month ]
   Surivors divided by subjects reaching that milestone
3. Percentage residing at home [ Time Frame: 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 [ Time Frame: 7-50 days from admission ]
   Absconding from ward, physical violence, pulling out intravenous lines and indwelling catheters, refusing medications, falls and injurious falls

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

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Contacts and Locations

Contacts

Contact: Aileen Carter, BSc; 612 43948000; AECarter@nsccahs.health.nsw.gov.au

Contact: Paul J Regal, MD FRACP; 61 0448 675 93; pregal@nsccahs.health.nsw.gov.au

Locations

Australia, New South Wales

Wyong Hospital; Recruiting

Kanwal, New South Wales, Australia, 2263

Contact: Paul J Regal, MD 0448 675993 pregal@nsccahs.health.nsw.gov.au

Contact: Aileen Carter, BSc 612 43948000

Principal Investigator: Paul J Regal, MD FRACP

Sponsors and Collaborators

Central Coast Local Health District

More Information

• Responsible Party: Paul Regal MD FRACP FRCP (London), Senior Lecturer in Geriatric Medicine, Central Coast Local Health District
• ClinicalTrials.gov Identifier: NCT01650896
• Other Study ID Numbers: CADIS-2012
• First Posted: July 26, 2012
• Last Update Posted: July 26, 2012
• Last Verified: July 2012

Keywords provided by Paul Regal MD FRACP FRCP (London), Central Coast Local Health District:

Delirium; Dementia; Instrumental activities of daily living

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders