Delirium Clinical Trial
— CADISOfficial title:
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).
Status | Recruiting |
Enrollment | 250 |
Est. completion date | July 2016 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Wyong Hospital | Kanwal | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Central Coast Local Health District |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | Survival | Surivors divided by subjects reaching that milestone | 30, 90, 180 days, 12 and 24 month | Yes |
Primary | 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 | Yes |
Primary | 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 | Yes |
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