Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001063909
Ethics application status
Approved
Date submitted
14/08/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
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
Nil
Universal Trial Number (UTN)
U1111-1241-1817
Trial acronym
HPC3
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2020
Actual
Date of last participant enrolment
Anticipated
1/11/2021
Actual
Date of last data collection
Anticipated
1/11/2022
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303939 0
Government body
Name [1] 303939 0
Medical Research Future Fund, Australian Government Department of Health
Country [1] 303939 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Corner of Edith & Platt Streets
Waratah
New South Wales
2298
Country
Australia
Secondary sponsor category [1] 304090 0
None
Name [1] 304090 0
Address [1] 304090 0
Country [1] 304090 0
Australia
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
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304435 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304435 0
Ethics committee country [1] 304435 0
Australia
Date submitted for ethics approval [1] 304435 0
25/09/2019
Approval date [1] 304435 0
11/03/2020
Ethics approval number [1] 304435 0

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

Contacts
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
Australia
Phone 96946 0
+61 2 49850361
Fax 96946 0
Email 96946 0
[email protected]
Contact person for public queries
Name 96947 0
Jessica Scaife
Address 96947 0
Calvary Mater Newcastle
Corner of Edith & Platt Streets, Waratah NSW 2298
Country 96947 0
Australia
Phone 96947 0
+61 2 49850361
Fax 96947 0
Email 96947 0
[email protected]
Contact person for scientific queries
Name 96948 0
Sarah Moberley
Address 96948 0
Calvary Mater Newcastle
Corner of Edith & Platt Streets, Waratah NSW 2298
Country 96948 0
Australia
Phone 96948 0
+61 2 49850361
Fax 96948 0
Email 96948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy


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.