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

Primary Purpose

Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Geriatric assessment review
Sponsored by
Central Coast Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Delirium, Dementia, Instrumental activities of daily living

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Wyong HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

General Medicine

Geriatric Medicine

Arm Description

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

Outcomes

Primary Outcome Measures

Return home rate
The percentage of subjects returning home divided by the number living at home prior to admission and surviving until discharge
Survival
Surivors divided by subjects reaching that milestone
Percentage residing at home
Number of subjects at home divided by number surviving to that milesone
Hospital complications of delirium
Absconding from ward, physical violence, pulling out intravenous lines and indwelling catheters, refusing medications, falls and injurious falls

Secondary Outcome Measures

Full Information

First Posted
July 10, 2012
Last Updated
July 24, 2012
Sponsor
Central Coast Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT01650896
Brief Title
Prospective Randomised Controlled Trial of Delirium Management by Geriatric Medicine Versus General Medicine
Acronym
CADIS
Official Title
Prospective Randomised Controlled Trial of Delirium Management The Central Coast Australia Delirium Intervention Study (CADIS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Coast Local Health District

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Dementia, Instrumental activities of daily living

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General Medicine
Arm Type
No Intervention
Arm Title
Geriatric Medicine
Arm Type
Active Comparator
Arm Description
Daily medical review, adjust medications, treat infection, occupational therapy
Intervention Type
Other
Intervention Name(s)
Geriatric assessment review
Intervention Description
Adjust medications, treat precipitants of delirium, one-on-one supervision of agitated violent patients
Primary Outcome Measure Information:
Title
Return home rate
Description
The percentage of subjects returning home divided by the number living at home prior to admission and surviving until discharge
Time Frame
10-50 days
Title
Survival
Description
Surivors divided by subjects reaching that milestone
Time Frame
30, 90, 180 days, 12 and 24 month
Title
Percentage residing at home
Description
Number of subjects at home divided by number surviving to that milesone
Time Frame
30, 90 and 180 days, 12 and 24 months
Title
Hospital complications of delirium
Description
Absconding from ward, physical violence, pulling out intravenous lines and indwelling catheters, refusing medications, falls and injurious falls
Time Frame
7-50 days from admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aileen Carter, BSc
Phone
612 43948000
Email
AECarter@nsccahs.health.nsw.gov.au
First Name & Middle Initial & Last Name or Official Title & Degree
Paul J Regal, MD FRACP
Phone
61 0448 675 93
Email
pregal@nsccahs.health.nsw.gov.au
Facility Information:
Facility Name
Wyong Hospital
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2263
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul J Regal, MD
Phone
0448 675993
Email
pregal@nsccahs.health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Aileen Carter, BSc
Phone
612 43948000
First Name & Middle Initial & Last Name & Degree
Paul J Regal, MD FRACP

12. IPD Sharing Statement

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

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