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

NCT ID: NCT01650896

Last Updated: 2012-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-07-31

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).

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

General Medicine

Group Type: NO_INTERVENTION

No interventions assigned to this group

Geriatric Medicine

Daily medical review, adjust medications, treat infection, occupational therapy

Group Type: ACTIVE_COMPARATOR

Geriatric assessment review

Intervention Type: OTHER

Adjust medications, treat precipitants of delirium, one-on-one supervision of agitated violent patients

Interventions

Geriatric assessment review

Adjust medications, treat precipitants of delirium, one-on-one supervision of agitated violent patients

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Coast Local Health District

OTHER

Sponsor Role: lead

Responsible Party

Paul Regal MD FRACP FRCP (London)

Senior Lecturer in Geriatric Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wyong Hospital

Kanwal, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Aileen Carter, BSc

Role: CONTACT

AECarter@nsccahs.health.nsw.gov.au

612 43948000

Paul J Regal, MD FRACP

Role: CONTACT

pregal@nsccahs.health.nsw.gov.au

61 0448 675 93

Facility Contacts

Paul J Regal, MD

Role: primary

pregal@nsccahs.health.nsw.gov.au

0448 675993

Aileen Carter, BSc

Role: backup

612 43948000

Other Identifiers

CADIS-2012

Identifier Type: -

Identifier Source: org_study_id