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

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

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).

Study Overview

• Status: Unknown
• Conditions: Delirium
• Intervention / Treatment: Other: Geriatric assessment review

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aileen Carter, BSc; Phone Number: 612 43948000; Email: AECarter@nsccahs.health.nsw.gov.au
• Study Contact Backup: Name: Paul J Regal, MD FRACP; Phone Number: 61 0448 675 93; Email: pregal@nsccahs.health.nsw.gov.au

Study Locations

• Australia
  • New South Wales
    • Kanwal, New South Wales, Australia, 2263
      • Recruiting
      • Wyong Hospital
      • Contact: Paul J Regal, MD; Phone Number: 0448 675993; Email: pregal@nsccahs.health.nsw.gov.au
      • Contact: Aileen Carter, BSc; Phone Number: 612 43948000
      • Principal Investigator: Paul J Regal, MD FRACP

Participation Criteria

Eligibility Criteria

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

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return home rate	The percentage of subjects returning home divided by the number living at home prior to admission and surviving until discharge	10-50 days
Survival	Surivors divided by subjects reaching that milestone	30, 90, 180 days, 12 and 24 month
Percentage residing at home	Number of subjects at home divided by number surviving to that milesone	30, 90 and 180 days, 12 and 24 months
Hospital complications of delirium	Absconding from ward, physical violence, pulling out intravenous lines and indwelling catheters, refusing medications, falls and injurious falls	7-50 days from admission

Collaborators and Investigators

• Sponsor: Central Coast Local Health District

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): July 26, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Dementia; Delirium; Instrumental activities of daily living
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: CADIS-2012