Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000798864
Ethics application status
Approved
Date submitted
18/07/2012
Date registered
30/07/2012
Date last updated
27/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of patient centred intervention to reduce re-presentations of older people at risk after discharge from the emergency department
Scientific title
In older people at risk after discharge from the emergency department (ED), is a patient centred intervention post discharge more effective than standard care in reducing re-presentation to the ED within 28 days?
Secondary ID [1] 280766 0
Nil
Universal Trial Number (UTN)
U1111-1132-2577
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geriatric syndromes 286822 0
Depression 286823 0
Polypharmacy 286824 0
Cognitive impairment 286825 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287134 287134 0 0
Other physical medicine / rehabilitation
Public Health 287283 287283 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Care coordination commenced by a research team member within 72 hours of ED discharge.
We will conduct a home assessment to supplement assessments done prior to discharge, and in conjunction with the patient formulate specific plans based around identifiable risks. Initial contact will involve establishment of rapport and commencement of assessment including assisting the patient (+/- family/carer as appropriate) to express their understanding of their risk for early re-presentation and potentially modifiable contributing factors.
Further information will then be provided to the patient regarding their identifiable risks found on risk assessment, and what services may be available so that the patient can make an informed choice regarding their options.
Research staff will have a coordinating and advisory role assisting the patient/carer in invoking these plans. These will be directed towards addressing where possible risks found from our risk algorithm which was used to identify the patient at high risk of re-presentation.
It is estimated that the duration of initial home assessment will be 1.5 hours, and on average this will be followed by 2x1 hour further face to face sessions and 20 minute weekly telephone contact for a minimum of 4 weeks
Intervention code [1] 285192 0
Early detection / Screening
Intervention code [2] 285193 0
Behaviour
Intervention code [3] 285194 0
Rehabilitation
Comparator / control treatment
Unspecified post discharge instruction and care at the discretion of the ED team.
Control group
Active

Outcomes
Primary outcome [1] 287556 0
28 day reattendance rate to ED assessed by patient contact triangulated with hospital electronic ED attendance data
Timepoint [1] 287556 0
28 days post enrolment
Secondary outcome [1] 298381 0
Time to 1st ED presentation post discharge assessed by patient contact triangulated with hospital electronic ED attendance data
Timepoint [1] 298381 0
Number of days after enrolment
Secondary outcome [2] 298382 0
Count of ED presentations in 12 months post enrolment assessed by patient contact triangulated with hospital electronic ED attendance data
Timepoint [2] 298382 0
One year after enrolment
Secondary outcome [3] 298383 0
Time to 1st hospital admission assessed by patient contact triangulated with hospital electronic admission data
Timepoint [3] 298383 0
Number of days after enrolment
Secondary outcome [4] 298384 0
Count of admissions in 12 months post enrolment assessed by patient contact triangulated with hospital electronic admission data
Timepoint [4] 298384 0
One year after enrolment
Secondary outcome [5] 298385 0
12 month mortality rate assessed by mortality registry data
Timepoint [5] 298385 0
One year after enrolment
Secondary outcome [6] 298386 0
12 month rate of admission to residential aged care facility assessed by patient contact
Timepoint [6] 298386 0
One year after enrolment

Eligibility
Key inclusion criteria
1. Age at least 65 years old
2. Live in geographical area of Perth Western Australia covered by post discharge community services
3. Identified as high risk (approximately 35% or higher probability) for re-presentation based on our risk algorithm
4. Informed consent
5. Meet occupational health and safety policy on safe home and community visiting
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Resident of high level aged care facility
2. No fixed residential address
3. Currently under palliative care services, or deemed not likely to survive longer than 90 days
4. Discharged without ED care coordination team assessment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients aged 65 years and over where discharge from ED is planned will be assessed by a care coordination team. Part of this assessment will be to use a risk algorithm to determine their probability of ED reattendance post discharge. The algorithm is based on previous research done by our group that has found certain risk factors such as depression, polypharmacy and cognitive impairment are most influential in detrmining reattendance risk. Those who meet all inclusion criteria will be randomised to either post discharge care coordination follow up, or standard care. Randomisation and allocation concealment will be done by computer using a remote secure web based program. It will not be possible to know which group the patient is randomised to until after consent and enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Web based random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
12/11/2012
Date of last participant enrolment
Anticipated
Actual
10/12/2014
Date of last data collection
Anticipated
Actual
10/12/2015
Sample size
Target
300
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285657 0
Government body
Name [1] 285657 0
State Health Research Advisory Council
Country [1] 285657 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Stirling Hwy
Crawley
WA 6009
Country
Australia
Secondary sponsor category [1] 284494 0
None
Name [1] 284494 0
Address [1] 284494 0
Country [1] 284494 0
Other collaborator category [1] 276950 0
Hospital
Name [1] 276950 0
Royal Perth Hospital
Address [1] 276950 0
Wellington St
Perth
WA 6000
Country [1] 276950 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287654 0
Royal Perth Hospital HREC
Ethics committee address [1] 287654 0
Ethics committee country [1] 287654 0
Date submitted for ethics approval [1] 287654 0
25/07/2012
Approval date [1] 287654 0
28/08/2012
Ethics approval number [1] 287654 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34384 0
A/Prof Glenn Arendts
Address 34384 0
Emergency Medicine School of Primary, Aboriginal and Rural Health Care Faculty of Medicine, Dentistry and Health Services University of Western Australia 2nd Floor, R Block, QE11 Medical Centre NEDLANDS WA 6009
Country 34384 0
Australia
Phone 34384 0
61 8 64574354
Fax 34384 0
Email 34384 0
[email protected]
Contact person for public queries
Name 17631 0
Roz Jaworski
Address 17631 0
Emergency Medicine

School of Primary, Aboriginal and Rural Health Care

Faculty of Medicine, Dentistry and Health Services

University of Western Australia

2nd Floor, R Block, QE11 Medical Centre

NEDLANDS WA 6009
Country 17631 0
Australia
Phone 17631 0
61 8 64574354
Fax 17631 0
Email 17631 0
[email protected]
Contact person for scientific queries
Name 8559 0
Glenn Arendts
Address 8559 0
Emergency Medicine

School of Primary, Aboriginal and Rural Health Care

Faculty of Medicine, Dentistry and Health Services

University of Western Australia

2nd Floor, R Block, QE11 Medical Centre

NEDLANDS WA 6009
Country 8559 0
Australia
Phone 8559 0
61 8 64574354
Fax 8559 0
Email 8559 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.