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Trial registered on ANZCTR


Registration number
ACTRN12612000111875
Ethics application status
Approved
Date submitted
19/01/2012
Date registered
24/01/2012
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Date results provided
29/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an initial assessment palliative care clinic for new clients referred to palliative care by retrospective case note audit.
Scientific title
Evaluation of an initial assessment palliative care clinic for new clients referred to palliative care by retrospective case note audit.
Secondary ID [1] 279766 0
None
Universal Trial Number (UTN)
U1111-1127-3797
Trial acronym
No accronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
It is a new model of care that is being studied with a focus on initial assessment, education and health promotion. 285635 0
Initial assessment is conducted for all new patients referred to palliative care to determine the extent of their illness and the likely disease trajectory. Palliative care demands an holistic approach so assessment occurs across the physical, social and psychological, and spiritual domains 285636 0
Education is provided to ensure patients and their caregivers can make choices that are congruent with their beliefs and values. often by the time patients reach palliative care they are overwhelmed with the health care system and this clinic aims to address information needs 285637 0
Health promotion is addressed by focusing on a strengths based approach. Hosting the clinic in a community center which is attached to a major shopping center places the emphasis back on living and not on dying. 285638 0
Condition category
Condition code
Public Health 285824 285824 0 0
Health promotion/education
Public Health 285838 285838 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is attendance at an interdisciplinary team
The intervention is an invitation to attend an interdisicplinary clinic by way of early intoroduction to the palliative care service. Participants are asked to allow 90 minutes in which time they will spend 30 minutes with each health care provider.The intervention includes assessment of both the patient and caregiver by the nurse practitioner for physical assessment, the social worker for assistance with finances, housing and advanced care documents. The patient and caregiver are then separated from each other and the patient is seen by the psycho-oncology nurse who conducts a mental health screen for coping and adjustment to illness and the caregiver is assessed by the Caregiver Network Facilitator who focuses on the role of carer and identifies supports within the family network and those from agencies. The outcome measure is to determine the value of separating patient and caregiver for assessment of coping and managing with the illness and the role of caregiving. At completion of the clinic an assessment is made to determine the involvement from the palliative care service. In some cases the patient may have no pressing needs and this will be communicated back to the referrer who will resume management of the patient. Some patients will enage in a shared care arrangement where palliative care provides support for a defined period with the referrer reamaining responsible for their ongoing management. In this situation the patient will be referred to the medical assessment clinic which is the current usual care utilised for ongoing follow up. Those patients that are assessed to require the full support of the specialist palliative care team wil be followed up in an ongoing manner either through the medical assessment clinic or via the home visiting program. The frequency of follow up will depend on the assessed level of need and this will be communicated back to the referrer.
Intervention code [1] 284087 0
Other interventions
Comparator / control treatment
This is a retrospective case note audit, looking at files that date back to the commencement of this clinic which was September 2011. Patient files from February 2012 to september 2011 will be reviewed.
Control group
Historical

Outcomes
Primary outcome [1] 286337 0
The primary outcome of this study is to determine whether this new model of care is effective in delivering an holistic approach to assessment, and whether patients and their caregivers value it.
Timepoint [1] 286337 0
This is a retrospective case note audit which will commence with approval from ANZCTR and be supported by questionnaires to clients who attended the weekly clinic which commenced on 1/9/11.
Secondary outcome [1] 295631 0
The secondary outcome will be to assess if a bigger study is required which would then include using a comparator such as a palliative medicine clinic as the control. A health economics perspective would be included to determine cost benefit to the health system.
Timepoint [1] 295631 0
To be determined following completion of audit.

Eligibility
Key inclusion criteria
Patient is triaged on referral as well enough to attend an outpatient clinic appointment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the patient does not wish to attend the clinic this will be the exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2012
Actual
7/12/2011
Date of last participant enrolment
Anticipated
Actual
22/02/2012
Date of last data collection
Anticipated
Actual
22/02/2012
Sample size
Target
40
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 4866 0
5034

Funding & Sponsors
Funding source category [1] 284548 0
Self funded/Unfunded
Name [1] 284548 0
Country [1] 284548 0
Australia
Primary sponsor type
Individual
Name
Kate Swetenham
Address
700 Goodwood Road
Daw park
South Australia, 5041
Country
Australia
Secondary sponsor category [1] 283474 0
None
Name [1] 283474 0
Address [1] 283474 0
Country [1] 283474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286532 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286532 0
Ethics committee country [1] 286532 0
Australia
Date submitted for ethics approval [1] 286532 0
Approval date [1] 286532 0
06/12/2011
Ethics approval number [1] 286532 0
1/11/0462

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

Contacts
Principal investigator
Name 33661 0
Ms Kate swetenham
Address 33661 0
Ms Kate Swetenham
Clinical Director
Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park
SA, 5041
Country 33661 0
Australia
Phone 33661 0
+61 8 82751732
Fax 33661 0
Email 33661 0
[email protected]
Contact person for public queries
Name 16908 0
Kate Swetenham
Address 16908 0
700 Goodwood Road
Daw Park
South Australia, 5041
Country 16908 0
Australia
Phone 16908 0
+61 8 82751732
Fax 16908 0
+61 8 82774957
Email 16908 0
[email protected]
Contact person for scientific queries
Name 7836 0
Kate swetenham
Address 7836 0
700 Goodwood road
Daw Park
SA 5041
Country 7836 0
Australia
Phone 7836 0
+61 8 82751732
Fax 7836 0
+61 8 82774957
Email 7836 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


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.