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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Central Coast Local Health District
Sponsor:
Information provided by (Responsible Party):
Paul Regal MD FRACP FRCP (London), Central Coast Local Health District
ClinicalTrials.gov Identifier:
NCT01650896
First received: July 10, 2012
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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 Intervention
Delirium
Other: Geriatric assessment review

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Controlled Trial of Delirium Management The Central Coast Australia Delirium Intervention Study (CADIS

Resource links provided by NLM:


Further study details as provided by Central Coast Local Health District:

Primary Outcome Measures:
  • Return home rate [ Time Frame: 10-50 days ] [ Designated as safety issue: Yes ]
    The percentage of subjects returning home divided by the number living at home prior to admission and surviving until discharge

  • Survival [ Time Frame: 30, 90, 180 days, 12 and 24 month ] [ Designated as safety issue: Yes ]
    Surivors divided by subjects reaching that milestone

  • Percentage residing at home [ Time Frame: 30, 90 and 180 days, 12 and 24 months ] [ Designated as safety issue: Yes ]
    Number of subjects at home divided by number surviving to that milesone

  • Hospital complications of delirium [ Time Frame: 7-50 days from admission ] [ Designated as safety issue: Yes ]
    Absconding from ward, physical violence, pulling out intravenous lines and indwelling catheters, refusing medications, falls and injurious falls


Estimated Enrollment: 250
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650896

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

No publications provided

Responsible Party: Paul Regal MD FRACP FRCP (London), Senior Lecturer in Geriatric Medicine, Central Coast Local Health District
ClinicalTrials.gov Identifier: NCT01650896     History of Changes
Other Study ID Numbers: CADIS-2012
Study First Received: July 10, 2012
Last Updated: July 24, 2012
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Central Coast Local Health District:
Delirium
Dementia
Instrumental activities of daily living

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014