Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001032044
Ethics application status
Approved
Date submitted
14/01/2010
Date registered
24/11/2010
Date last updated
13/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of palliative care extended packages at home
Scientific title
Randomised control trial of effect of palliative care extended care packages at home, for palliative care patients with complex needs or terminal care on time out of hospital
Secondary ID [1] 253144 0
none
Universal Trial Number (UTN)
Trial acronym
PEACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Care 256535 0
advanced cancer and other non cancer life limiting illness in advanced stage 258696 0
Condition category
Condition code
Public Health 256709 256709 0 0
Health service research
Other 258847 258847 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group (PEACH) involves rapidity in response (where services can be put in place within 24 hours), and higher intensity of hands on nursing hours above what is provided in usual care. This may include nursing services (utilising agency nursing staff) overnight and for longer duration including 24 hour nursing for duration of the package (maximum 3 - 5 days). It also coordinates allied health input (occupational therapy, physiotherapy, pastoral care) if equipment or other services are needed. The intervention will be differ on a case by case basis and is for a maximum of up to 24 hours/ day for 7 days duration. The study duration is 4 weeks which includes a followup phase.
Intervention code [1] 255813 0
Treatment: Other
Comparator / control treatment
usual community or hospital based care. This will include referral to primary care nurses, specialist palliative care medical/nursing services and community allied health and equipment services. The provision of these services will be based on individual assessment and current waiting times for access. The patient may need to remain in hospital until services are available.
Control group
Active

Outcomes
Primary outcome [1] 257595 0
number of days out of institutional care (determined from medical records of admissions to hospital and patient/caregiver report of date of admission to residential care)
Timepoint [1] 257595 0
28 days from baseline
Secondary outcome [1] 262856 0
Change in symptom score (from baseline) at end of package and at 28 days (Questionnaire)
Timepoint [1] 262856 0
28 days from baseline
Secondary outcome [2] 262857 0
survival
Timepoint [2] 262857 0
28 days from baseline
Secondary outcome [3] 262860 0
Functional status (questionnaire)
Timepoint [3] 262860 0
28 days from baseline
Secondary outcome [4] 262861 0
proportion of patients who die at home (questionnaire)
Timepoint [4] 262861 0
28 days from baseline
Secondary outcome [5] 262862 0
caregiver quality of life (questionnaire)
Timepoint [5] 262862 0
28 days from baseline
Secondary outcome [6] 262863 0
Modified Family Inventory of needs score (success of meeting caregiver needs)
Timepoint [6] 262863 0
28 days from baseline)

Eligibility
Key inclusion criteria
1.Patient of the Palliative Care Team
2.General Practitioner currently involved in care at home or willing to be involved on discharge from hospital.
3. Patient lives with carer or will have a carer on discharge.
4. Ability to communicate sufficiently in English or have caregiver or family member who can communicate in English and assist them to complete assessments.
5. Informed consent.
6. Age greater than 18.
7. Also must meet one of the following criteria:
a. A patient with complex and unstable symptom management and high care needs whose clinician thinks admission/readmission to hospital may be prevented by the package.
b. A patient with complex and unstable symptom management and high care needs currently admitted in acute hospital /Palliative care unit who may not be discharged without comprehensive community services.
c. A patient wishing to receive end of life care (anticipated to be within 72 hours duration) at home.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not meeting above inclusion criteria

no other exclusion criteria

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 and their caregivers who meet the criteria for a PEACH package will be asked if they are interested in participating in an evaluation of community palliative care services delivered by different approaches. A participant information sheet describing the evaluations and assessments will be provided and written informed consent. This information sheet will explain that the approach will be randomly allocation to the two different ways of providing services to palliative care patients in the community. Once the participant has been randomised staff will be aware of allocation so non blinded.

Allocation concealment was acheived by 1) central randomisation by phone 2) Person determining eligibility and obtaining consent was unaware of group participant would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedules will be developed using random number tables, with intervention for each patient allocated according to a block randomisation schedule held by the central registry
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
1/10/2009
Actual
29/10/2009
Date of last participant enrolment
Anticipated
Actual
11/11/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 256303 0
Government body
Name [1] 256303 0
Commonwealth Dept of Health and Ageing
Country [1] 256303 0
Australia
Primary sponsor type
Hospital
Name
South West Sydney Local Health District
Address
Liverpool Hospital, Elizabeth Street Liverpool New South Wales 2174
Country
Australia
Secondary sponsor category [1] 251623 0
None
Name [1] 251623 0
Address [1] 251623 0
Country [1] 251623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258387 0
Sydney South West Area Health Service (SSWAHS) Human Research Ethics Committeee
Ethics committee address [1] 258387 0
Liverpool Hospital, Elizabeth Street,
Liverpool Sydney 2170 NSW
Ethics committee country [1] 258387 0
Australia
Date submitted for ethics approval [1] 258387 0
Approval date [1] 258387 0
10/09/2009
Ethics approval number [1] 258387 0
HREC/09/LPOOL/108

Summary
Brief summary
This project aims to evaluate individual care packages compared with usual care for complex and unstable symptom management and high care needs patients wishing to return home earlier from hospital or Palliative Care units AND for those requiring high level End of Life Care who wish to remain at home. This may include patients who have cancer or non-cancer diagnoses. Care packages at home could include nursing, domestic support, and equipment provision as well as more expeditious access to Specialist Palliative Care multidisciplinary team (MDT) services and General Practitioners. The evaluation project will explore the net incremental effect on patients and caregivers outcomes and associated net incremental costs relative to usual care.
Trial website
Trial related presentations / publications
McCaffrey, N. Agar, M. Harlum, J. Karnon, J. Currow, D. Eckermann, S. (2013). Is home-based palliative care cost effective? An economic evaluation of the Palliative Care Extended Packages at Home (PEACH) pilot. BMJ Supportive and Palliative Care; 2013;3(4):431-5
Public notes

Contacts
Principal investigator
Name 30698 0
Prof Meera Agar
Address 30698 0
University of Technology Sydney Centre for Cardiovascular and Chronic Care
Faculty of Health, University of Technology Sydney
PO Box 123 Ultimo NSW 2007
Office: Level 3, 235 Jones St, Ultimo NSW 2007
Country 30698 0
Australia
Phone 30698 0
+61 2 9514 4243
Fax 30698 0
Email 30698 0
meera.agar@uts.edu.au
Contact person for public queries
Name 13945 0
Prof Dr Meera Agar
Address 13945 0
University of Technology Sydney
Centre for Cardiovascular and Chronic Care
Faculty of Health, University of Technology Sydney
PO Box 123 Ultimo NSW 2007
Office: Level 3, 235 Jones St, Ultimo NSW 2007
Country 13945 0
Australia
Phone 13945 0
+61 2 9514 4243
Fax 13945 0
Email 13945 0
meera.agar@uts.edu.au
Contact person for scientific queries
Name 4873 0
Prof Dr Meera Agar
Address 4873 0
University of Technology Sydney
Centre for Cardiovascular and Chronic Care
Faculty of Health, University of Technology Sydney
PO Box 123 Ultimo NSW 2007
Office: Level 3, 235 Jones St, Ultimo NSW 2007
Country 4873 0
Australia
Phone 4873 0
+61 2 9514 4243
Fax 4873 0
Email 4873 0
meera.agar@uts.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
SourceTitleYear of PublicationDOI
EmbaseIs home-based palliative care cost-effective? An economic evaluation of the Palliative Care Extended Packages at Home (PEACH) pilot.2013https://dx.doi.org/10.1136/bmjspcare-2012-000361
N.B. These documents automatically identified may not have been verified by the study sponsor.