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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new model of community based palliative care
Scientific title
A randomised controlled trial on effect of a multidisciplinary model of community palliative care on patient-centred care in preferred place
Secondary ID [1] 299429 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Terminal illness 314635 0
End of life 314636 0
Community based care 314637 0
Palliative Care 318629 0
End of life care 318630 0
Condition category
Condition code
Public Health 312974 312974 0 0
Health service research

Study type
Description of intervention(s) / exposure
Community based palliative care patients randomised to the intervention arm will have their care managed by a care coordinator (clinical nurse specialist). Once stable they will receive weekly contact to identify any new symptoms or needs and they will be addressed as necessary. If required, patients can access assistant in nursing support in their home during unstable periods.
The duration and frequency of the intervention will be based on needs identified.
All interventions will be based in the patient's residence in person.
The total duration of the study will be 12 months or until end of life.
Intervention code [1] 318340 0
Treatment: Other
Comparator / control treatment
Community based palliative care patients randomised to the control arm will receive standard care. Standard community-based multidisciplinary palliative care is an as-needed model of responsive care, based on patient or carer identified reporting of unmet need through a 24 hour phone support or re-referral by GP. Patients requiring personal care are referred for assessment and packages through NDIS or Aged Care.
Control group

Primary outcome [1] 324768 0
Number of days spent in preferred location using routine data collection from the department of palliative care.
Timepoint [1] 324768 0
At end of life or end of the study period
Secondary outcome [1] 385710 0
Quality of life assessed using Euro Quality of Life (EQ5D-5L) score
Timepoint [1] 385710 0
Quarterly post-intervention commencement for 12 months or until end of life
Secondary outcome [2] 386993 0
Place of death
Timepoint [2] 386993 0
End of life
Secondary outcome [3] 386994 0
Emergency department presentations, hospital or hospice admission
Timepoint [3] 386994 0
At any time during the study period, as collected by medical record review.
Secondary outcome [4] 386995 0
Patient reported experience measure
Timepoint [4] 386995 0
Quarterly or until end of life
Secondary outcome [5] 386996 0
Staff professional quality of life and experience as collected by ProQOL and qualitative interview
Timepoint [5] 386996 0
ProQOL will be conducted at baseline and study end. Qualitative interviews will be conducted at study end.

Key inclusion criteria
New referral to palliative care, based in the community and intending to receive their care at home and consent to participate in research
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation (computer generated)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The urban setting will recruit ~67 patients per month, while the regional sector will recruit ~17 per month; providing a total sample size of 400 urban and 100 rural patients respectively

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 303939 0
Government body
Name [1] 303939 0
Medical Research Future Fund, Australian Government Department of Health
Address [1] 303939 0
Sirius Building, 23 Furzer Street, Canberra ACT 2606
Country [1] 303939 0
Primary sponsor type
Calvary Mater Newcastle
Corner of Edith & Platt Streets
New South Wales
Secondary sponsor category [1] 304090 0
Name [1] 304090 0
Address [1] 304090 0
Country [1] 304090 0
Other collaborator category [1] 281425 0
Other Collaborative groups
Name [1] 281425 0
Hunter Medical Research Institute
Address [1] 281425 0
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country [1] 281425 0

Ethics approval
Ethics application status
Ethics committee name [1] 304435 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304435 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 304435 0
Date submitted for ethics approval [1] 304435 0
Approval date [1] 304435 0
Ethics approval number [1] 304435 0

Brief summary
We will pilot a community palliative care coordination package in an urban and rural setting within Hunter New England Local Health District. We hypothesise that earlier identification of distress through routine surveillance in our community based patient together with the availability of a pool of Assistants in Nursing will improve the number of days spent in the place of preference (home).
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 96946 0
Ms Jessica Scaife
Address 96946 0
Calvary Mater Newcastle
Corner of Edith & Platt Streets, Waratah NSW 2298
Country 96946 0
Phone 96946 0
+61 2 49850361
Fax 96946 0
Email 96946 0
Contact person for public queries
Name 96947 0
Ms Jessica Scaife
Address 96947 0
Calvary Mater Newcastle
Corner of Edith & Platt Streets, Waratah NSW 2298
Country 96947 0
Phone 96947 0
+61 2 49850361
Fax 96947 0
Email 96947 0
Contact person for scientific queries
Name 96948 0
Dr Sarah Moberley
Address 96948 0
Calvary Mater Newcastle
Corner of Edith & Platt Streets, Waratah NSW 2298
Country 96948 0
Phone 96948 0
+61 2 49850361
Fax 96948 0
Email 96948 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results