Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000637640
Ethics application status
Approved
Date submitted
3/08/2005
Date registered
13/10/2005
Date last updated
13/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
City Views
Scientific title
A randomised controlled trial to compare the effects of a transitional care unit versus usual hospital care for older patients awaiting first-time nursing home placement to decrease hospital length of stay
Universal Trial Number (UTN)
Trial acronym
TOPCAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Need for admission to residential care 765 0
Condition category
Condition code
Other 841 841 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A partnership was developed between the hospitals and a private residential aged care provider to run an off-site 36-bed transitional care facility. The private provider supplied the accommodation, catering, cleaning, nursing and carer staff while the hospitals provided the allied health staff, medical staff, and a transitional care nurse coordinator.
The intervention was based on a medical rehabilitation model which included: goal setting, early multidisciplinary assessment (pharmacist, geriatrician/rehabilitation specialist, physiotherapist, social worker, general practitioner), weekly case conferences, and family meetings to discuss patient and family goals. The transitional care nursing coordinator was responsible for liaison with the family and ensured appropriate transfer of information from hospital to the transitional care facility, including transfer of the hospital medical case notes. The control group (patients randomised to usual care) remained in hospital across a range of medical and surgical wards and discharge was managed as usual by ward social workers and welfare officers.
Intervention code [1] 108 0
Other interventions
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1080 0
Length of stay in hospital for primary acute admission
Timepoint [1] 1080 0
Secondary outcome [1] 1999 0
1.Functional ability (via the Barthel Index and the Nottingham EADL)
Timepoint [1] 1999 0
Collected at baseline, one, four and twelve months.
Secondary outcome [2] 2000 0
2.Number of hospitalisations
Timepoint [2] 2000 0
Collected at baseline, one, four and twelve months.
Secondary outcome [3] 2001 0
3.Attendance at Emergency Department (ED)
Timepoint [3] 2001 0
Collected at baseline, one, four and twelve months.
Secondary outcome [4] 2002 0
4.Home care service usage
Timepoint [4] 2002 0
Collected at baseline, one, four and twelve months.
Secondary outcome [5] 2003 0
5.Care management plan implemented
Timepoint [5] 2003 0
Collected at baseline, one, four and twelve months.
Secondary outcome [6] 2004 0
6.Community services usage (district nursing, therapy, social work, befriending etc)
Timepoint [6] 2004 0
Collected at baseline, one, four and twelve months.
Secondary outcome [7] 2005 0
7.Number of GP visits
Timepoint [7] 2005 0
Collected at baseline, one, four and twelve months.
Secondary outcome [8] 2006 0
8.Health related quality of life (EuroQoL)
Timepoint [8] 2006 0
Collected at baseline, one, four and twelve months.
Secondary outcome [9] 2007 0
9.Social Support (via the Duke Social Support Index)
Timepoint [9] 2007 0
Collected at baseline, one, four and twelve months.
Secondary outcome [10] 2008 0
10.Cognitive Status (via the AMTS questionnaires)
Timepoint [10] 2008 0
Collected at baseline, one, four and twelve months.
Secondary outcome [11] 2009 0
11.Geriatric Depression Scale (GDS-15)
Timepoint [11] 2009 0
Collected at baseline, one, four and twelve months.

Eligibility
Key inclusion criteria
1.Males and females aged 65 or greater years on the day of baseline examination; or aged 55 if of Mäori or Pacific Ethnicity and eligible for NASC/ OPAT services.2.All participants must be eligible for assessment by the three designated MDS-HC assessors.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Those clients with a terminal illness and are currently receiving palliative care services2.Participants directly transferred from hospital to permanent residential care after the initial 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)
Participant identification numbers were marked onto opaque sealed envelopes containing group allocation. The envelopes were opened in sequential order by an external clinical trials pharmacist as participants enrolled in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Zelen randomisation was used. Eligible patients were invited to participate in a four-month follow-up study (phase one). Once baseline assessments were complete, those who consented were randomly allocated to either transfer out of hospital to the transitional care facility or to remain in hospital and receive usual care in a 2:1 ratio. Allocations to the two treatment arms were computer-generated, stratified by referring hospital, and randomised in blocks. Once randomised, only those patients who had been allocated to the intervention group were approached for consent a second time to transfer to the transitional care facility to await residential care (phase two).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
316
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 929 0
Government body
Name [1] 929 0
South Australian Department of Human Services
Country [1] 929 0
Australia
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 788 0
None
Name [1] 788 0
none
Address [1] 788 0
Country [1] 788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2227 0
Repatriation General Hospital
Ethics committee address [1] 2227 0
Ethics committee country [1] 2227 0
Australia
Date submitted for ethics approval [1] 2227 0
Approval date [1] 2227 0
Ethics approval number [1] 2227 0
Ethics committee name [2] 2228 0
Flinders University/ Flinders Medical Centre
Ethics committee address [2] 2228 0
Ethics committee country [2] 2228 0
Australia
Date submitted for ethics approval [2] 2228 0
Approval date [2] 2228 0
Ethics approval number [2] 2228 0
Ethics committee name [3] 2229 0
Noarlunga Health Service
Ethics committee address [3] 2229 0
Ethics committee country [3] 2229 0
Australia
Date submitted for ethics approval [3] 2229 0
Approval date [3] 2229 0
Ethics approval number [3] 2229 0

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

Contacts
Principal investigator
Name 36040 0
Address 36040 0
Country 36040 0
Phone 36040 0
Fax 36040 0
Email 36040 0
Contact person for public queries
Name 9297 0
Prof. Maria Crotty
Address 9297 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9297 0
Australia
Phone 9297 0
+61 8 82751103
Fax 9297 0
+61 8 82751130
Email 9297 0
Maria.Crotty@flinders.edu.au
Contact person for scientific queries
Name 225 0
Prof. Maria Crotty
Address 225 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 225 0
Australia
Phone 225 0
+61 8 82751103
Fax 225 0
+61 8 82751130
Email 225 0
Maria.Crotty@flinders.edu.au

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.