Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000210673
Ethics application status
Approved
Date submitted
30/01/2014
Date registered
27/02/2014
Date last updated
27/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Emergency Department Delirium Identification (EDDI) trial: a study to improve the diagnosis and management of older people with delirium.
Scientific title
In older people hospitalised via emergency departments, does a brief screening process and warning card system compared to standard care improve the diagnosis and management of delirium?
Secondary ID [1] 283965 0
None
Universal Trial Number (UTN)
Trial acronym
EDDI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 290993 0
Condition category
Condition code
Neurological 291338 291338 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A risk assessment score based on nursing assessment, prompting a standardised diagnostic and management pathway. This is a locally developed and tested delirium screening score to be applied by based on clinical findings at the initial nurse assessment in ED. It takes approximately 5 minutes to complete. If the patient screens positive on this score, it triggers medical staff to perform a diagnostic Confusion Assessment Method and follow a set of action plans for diagnostic workup and prevention/management of delirium e.g. medication review. These action plans will be prompted by the visual cue of placing an end of bed warning card with the patient, which will stay with them throughout their admission. The intervention period will last for six months.
Intervention code [1] 288651 0
Early detection / Screening
Intervention code [2] 288864 0
Diagnosis / Prognosis
Comparator / control treatment
Standard (unspecified) diagnosis and management. In the six months prior to the intervention period, we will collect identical outcome data on patients before the introduction of the intervention. Hence the control group is the group in the baseline six month period. We have chosen historical, though these patients will be prospectively followed up.
Control group
Historical

Outcomes
Primary outcome [1] 291387 0
Hospital length of stay in bed days
Timepoint [1] 291387 0
Hospital discharge
Secondary outcome [1] 306649 0
Percentage of patients receiving a diagnosis of delirium during their admission
Timepoint [1] 306649 0
Hospital discharge
Secondary outcome [2] 306650 0
Percentage of patients receiving a formal delirium assessment
Timepoint [2] 306650 0
Hospital discharge
Secondary outcome [3] 306651 0
Inpatient morbidity including falls, fractures, pressure sores, requirement for pharmacological sedation and complications of sedation such as aspiration pneumonia, as determined by ICD10 coding performed for that admission augmented by medical chart review.
Timepoint [3] 306651 0
Hospital discharge
Secondary outcome [4] 306652 0
Discharge destination from the hospital, based on electronic discharge records.
Timepoint [4] 306652 0
Hospital discharge
Secondary outcome [5] 306653 0
Death
Timepoint [5] 306653 0
Hospital discharge

Eligibility
Key inclusion criteria
All patients aged 65 years or more who are to be admitted to any inpatient unit via the ED
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with critical illness requiring acute resuscitation
Patients who are unable to speak English with no professional interpreter present

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A locally developed delirium screening assessment will be performed by ED nursing staff on all patients not meeting exclusion criteria. In the initial six months of the study, we will conduct the screening only to define a comparator population for the intervention. The results of screening assessments will NOT be brought to the attention of medical staff and no visual identification of delirium risk for these patients will be made.

During the next six months intervention period, patients will undergo screening identical to that described above but those patients with positive screening test will receive intervention: placement of end-of-bed cards and a formal diagnostic process using the recognised gold standard Confusion Assessment Method (CAM) to confirm the diagnosis of delirium.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised consecutive enrolments
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Nonrandom allocation (before - after study) to control and intervention groups
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on a mean length of hospital stay for patients with a diagnosis of delirium of 14 days with a standard deviation of 13 days (local data 2012), a reduction of length of stay by 25% (4 days) in the intervention group will require 223 patients in each study arm if alpha = 0.05 and 1-beta= 0.9. We estimate from our preliminary study that 30 patients aged 65 and over per day will present to our ED, and conservatively 3 will have or develop delirium. Therefore, a 6 month period for both the comparator (baseline) and intervention populations should be ample to obtain 223 patients in each period, as it is estimated that 500 or more older people will have delirium in each period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
7/10/2014
Date of last participant enrolment
Anticipated
Actual
10/01/2016
Date of last data collection
Anticipated
Actual
2/05/2016
Sample size
Target
446
Accrual to date
Final
3905
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2027 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 3642 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 288640 0
Government body
Name [1] 288640 0
Research Development Unit, WA Health
Country [1] 288640 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
PO Box 480
Fremantle 6959
WA
Country
Australia
Secondary sponsor category [1] 287352 0
None
Name [1] 287352 0
Address [1] 287352 0
Country [1] 287352 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290495 0
South Metropolitan Humann Research Ethics Committee
Ethics committee address [1] 290495 0
Ethics committee country [1] 290495 0
Australia
Date submitted for ethics approval [1] 290495 0
Approval date [1] 290495 0
22/08/2013
Ethics approval number [1] 290495 0
13/66

Summary
Brief summary
Delirium occurs commonly in hospitalised older patients and is frequently under-diagnosed and mistreated.
There are two major shortfalls in Emergency Department (ED) care related to delirium: failure to diagnose and treat already established delirium, and failure to prevent the development of delirium.
This study will test whether a screening process we have developed to identify delirium risk, coupled with the use of diagnostic and preventative measures in the ED and during hospital admission, will address these shortfalls.
Trial website
Trial related presentations / publications
PMID 28675451
Public notes

Contacts
Principal investigator
Name 45802 0
Dr Ian Dey
Address 45802 0
Emergency Department, Fremantle Hospital
Alma St
Fremantle
WA 6160
Country 45802 0
Australia
Phone 45802 0
61 8 94312798
Fax 45802 0
Email 45802 0
[email protected]
Contact person for public queries
Name 45803 0
Holly Criddle
Address 45803 0
Emergency Department, Fremantle Hospital
Alma St
Fremantle
WA 6160
Country 45803 0
Australia
Phone 45803 0
61 8 94312798
Fax 45803 0
Email 45803 0
[email protected]
Contact person for scientific queries
Name 45804 0
Glenn Arendts
Address 45804 0
Emergency Medicine, University of Western Australia
Level 2 R Block
QEII Medical Centre
Nedlands WA 6009
Country 45804 0
Australia
Phone 45804 0
61 8 93464354
Fax 45804 0
Email 45804 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.