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Trial registered on ANZCTR


Registration number
ACTRN12619001703190
Ethics application status
Approved
Date submitted
19/11/2019
Date registered
4/12/2019
Date last updated
4/12/2019
Date data sharing statement initially provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Care Plus Study: A multi-site implementation of early palliative care in routine practice to improve health outcomes and reduce hospital admissions for people with advanced cancer.
Scientific title
Care Plus Study: A multi-site implementation of early palliative care in routine practice to improve health outcomes and reduce hospital admissions for people with advanced cancer
Secondary ID [1] 299736 0
MRFF-Research Grant/APP1174028
Universal Trial Number (UTN)
U1111-1243-1526
Trial acronym
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 315084 0
Early Palliative Care 315085 0
Condition category
Condition code
Cancer 313422 313422 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Usual oncology care + Care Plus. Care Plus involves standardised early palliative care introduced at key transition points in the cancer illness trajectory. The Care Plus palliative care consultation involves a discussion with patients and their caregiver about their individual needs, including assessment of physical, psychological, social and practical needs. The approximate duration of each consultation is between 30 minutes and 1 hour. The introduction of Care Plus will be developed, implemented and evaluated in three tertiary cancer treatment centres in the following order: (1) St Vincent's Hospital Melbourne, (2) Peter MacCallum Centre and (3) Lyell McEwin Hospital. This design stipulates 'control' periods when usual oncological care is observed, and the process of implementing Care Plus itself which includes phases of planning, engagement, intervention (practice change) and evaluation.

This study will target five types of advanced cancers across the three participating sites. The study population consists of adults with one of the five targeted advanced cancers who present to the three participating sites at the time or within 6 weeks of reaching a cancer-specific 'transition point' (e.g. multiday admission with metastatic disease). The five cancer types and definition of their corresponding transition points will be nominated, and defined by key clinicians at each site.

During the implementation of Care Plus (intervention arm), ALL patients with targeted advanced cancers reaching transition point will continue to receive usual oncological care + Care Plus.

Care Plus involves palliative care consultation within 6 weeks of the transition point, with follow-up occurring at a minimum monthly for 3 months +/- an additional 3 month bolster as needed (determined by the treating palliative care specialist in consultation with patient and their caregiver).

Care Plus is delivered by specialist palliative care consultants, or certified nurse practitioners/clinical nurse specialists. The care provided will be personalized based upon patient and caregiver need, including review of symptoms, psychological distress, additional community supports required, informational needs, illness understanding, discussion of prognosis, preferences for care, advance care planning, GP case conference.

Care Plus is provided face-to-face upfront, with follow-up face-to-face or by telephone as needed. Caregivers are invited to participate in consultations. All Care Plus consultations will be recorded using the domains of PC-NAT for auditing, and cross-checked against a medical record audit of outpatient visits and GP case conferences.



Intervention code [1] 316001 0
Treatment: Other
Comparator / control treatment
Control arm - Usual oncology care (including palliative care with referral at the discretion of the treating clinician).
Control group
Active

Outcomes
Primary outcome [1] 321898 0
Hospitalisation days in the last three months of life for people with advanced cancer as assessed by data linkage to hospital medical records, routinely collected state-based administration datasets (i.e. MBS/PBS), and the death registry.
Timepoint [1] 321898 0
6 months post-Care Plus intervention
Secondary outcome [1] 376622 0
The proportion of patients with advanced cancer referred to palliative care at least 90 days before death as assessed by data linkage to hospital medical records, routinely collected state-based administration datasets (i.e. MBS/PBS), and the death registry.
Timepoint [1] 376622 0
First contact at least 90 days before death for people with advanced cancer
Secondary outcome [2] 376623 0
The proportion of people experiencing >1 indicator of poor-quality end of life care as assessed by data linkage to hospital medical records, routinely collected state-based administration datasets (i.e. MBS/PBS), and the death registry.
Timepoint [2] 376623 0
6 months post-Care Plus intervention
Secondary outcome [3] 376624 0
The acceptability of Care Plus to patients, families and healthcare providers as assessed by focus groups and individual interviews with patients and healthcare providers. This is a composite secondary outcome.
Timepoint [3] 376624 0
Focus group and individual interviews with patients and health care providers 3 months post-Care Plus intervention
Secondary outcome [4] 376625 0
The fidelity of Care Plus delivery in more than 50% of patients as assessed by a review of Care Plus consultations recorded using PC-NAT + medical audit of outpatients visits and GP case conferences.
Timepoint [4] 376625 0
Review of Care Plus consultations recorded using PC-NAT + medical audit of outpatient visits, GP case conferences 6 month post-Care Plus Intervention.
Secondary outcome [5] 376626 0
Total health system costs incurred in the last 90 days of life as assessed by data linkage to hospital and MBS/PBS data.
Timepoint [5] 376626 0
Comparison of total health system costs for patients enrolled during the control versus the intervention arm using linked hospital and MBS/PBS data 6 months post-Care Plus intervention.

Eligibility
Key inclusion criteria
1. Patients with a targeted advanced cancer in receipt of usual care
* Inclusion criteria: Adults with a targeted advanced cancer

2. Patients with a targeted advanced cancer in receipt of Care Plus (intervention) - In this period, the study will collect and analyse aggregate data of health service use and cost of patients with a targeted advanced cancer enrolled in the intervention period, and in receipt of usual care + Care Plus.
* Inclusion criteria: (a) Adults with a targeted cancer; and (b) in attendance at participating hospital sites at a time of (or within 6 weeks following) defined cancer-specific 'transition point'.

3. Patients in receipt of Care Plus will be invited to participate in an interview to provide their perspectives and experiences of Care Plus as part of routine cancer care.
* Inclusion criteria: (a) Adults in receipt of Care Plus as part of their routine cancer practice at participating hospital sites; and (b) able to provide consent/comply with study procedures.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Under 18 years
2. Unwilling or unable to provide consent

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised, multi-site step wedged design was employed.
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
Analysis will be conducted at a system level. A retrospective medical audit will be conducted to compare and analyse the health service use and cost of the targeted patient cohort enrolled during the control versus the practice change (intervention) periods using linked data from hospital medical records, routinely collected state-based administrative health service datasets (i.e. Medicare/Pharmaceutical Benefits Schedule) and the death registry.

The primary objective is to reduce the acute hospitalisation days in the last 90 days of life by 25% for patients with advanced cancer. This corresponds to approximately 6 days.
Assuming an intracluster correlation (ICC) of 0.01, a two-sided alpha of 0.05, a cell size of 30 participants provides >99% power to detect a difference of 6 days. Varying the ICC from 0.001-0.1 whilst holding all other assumptions constant does not appreciably change the power. This translates to a total sample in the control and intervention periods of 450.

Description of individual and cell cluster characteristics to assess balance between control and practice change periods will be conducted using means (standard deviations) or median (intraquartile range) for continuous factors and frequencies (percentiles) for categorical variables. To assess the significance of differences in receipt of timely palliative care, a logistic regression model will be fitted with a random effect for cluster and a fixed effect for each step. Further analyses will assess for potential differences in 1) effect size of the practice change periods by site; and 2) temporal decrease in the proportion of participants accessing care during the successive practice change/maintenance periods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 15117 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 15118 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 15119 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 28411 0
3065 - Fitzroy
Recruitment postcode(s) [2] 28412 0
3000 - Melbourne
Recruitment postcode(s) [3] 28413 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 304211 0
Government body
Name [1] 304211 0
NHMRC-MRFF Keeping Australians Out of Hospital Research Grant
Address [1] 304211 0
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 304211 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 304449 0
None
Name [1] 304449 0
Address [1] 304449 0
Country [1] 304449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304673 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 304673 0
Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 304673 0
Australia
Date submitted for ethics approval [1] 304673 0
01/10/2019
Approval date [1] 304673 0
21/10/2019
Ethics approval number [1] 304673 0
Project ID 57523/HREC 188/19

Summary
Brief summary
This study aims to integrate early palliative care known as Care Plus in routine practice for patients with advanced cancers.

Who is it for?
Adults with a targeted advanced cancer who present to one of the study's hospital sites (St Vincent's Hospital Melbourne, Peter MacCallum Cancer Centre and Lyell McEwin Hospital), and who have reached a certain point in their illness will receive Care Plus as part of the hospital's new practice change.

Study Details
Six months prior to introducing Care Plus at each hospital site, patients with targeted advanced cancers who reach a key point in their illness will receive usual oncological care (Control group). This involves the treating clinician making referral to palliative care at their discretion.

During the practice change period, in which Care Plus is introduced, all patients with targeted advanced cancers reaching a key point in their illness will, by default, receive usual oncological care by their treating clinician AND Care Plus as part of the hospital's new practice change. This involves a scheduled palliative care consultation and ongoing follow-up visits with specialists and nurse specialists. During these consultations, patients and their caregivers will have the opportunity to discuss pain and nausea management, and any other physiological, psychological, practical, social and spiritual needs.

It is hoped this research will contribute to reduced hospitalisations for cancer patients, improved quality of life and improved efficiency for the healthcare system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97810 0
Prof Jennifer Philip
Address 97810 0
Level 4, Clinical Sciences Building
St Vincent's Hospital Melbourne,
29 Regent Street, Fitzroy, VIC 3065
Country 97810 0
Australia
Phone 97810 0
+61 03 9231 1267
Fax 97810 0
Email 97810 0
j.philip@unimelb.edu.au
Contact person for public queries
Name 97811 0
Prof Jennifer Philip
Address 97811 0
Level 4, Clinical Sciences Building
St Vincent's Hospital Melbourne,
29 Regent Street, Fitzroy, VIC 3065
Country 97811 0
Australia
Phone 97811 0
+61 03 9231 1267
Fax 97811 0
Email 97811 0
j.philip@unimelb.edu.au
Contact person for scientific queries
Name 97812 0
Prof Jennifer Philip
Address 97812 0
Level 4, Clinical Sciences Building
St Vincent's Hospital Melbourne,
29 Regent Street, Fitzroy, VIC 3065
Country 97812 0
Australia
Phone 97812 0
+61 03 9231 1267
Fax 97812 0
Email 97812 0
j.philip@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
1. For the quantitative aspect of the project, data will be aggregate form and therefore,
no IPD is available.

2. For the qualitative aspect of the project, all focus group/interview data will be de-identified at the earliest stage in the data collection process to protect the confidentiality of participants. Therefore, no IPD will be available.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5587 0
Ethical approval
Citation [1] 5587 0
Link [1] 5587 0
Email [1] 5587 0
roslyn.legautier@unimelb.edu.au
Other [1] 5587 0
Attachment [1] 5587 0
Type [2] 5588 0
Statistical analysis plan
Citation [2] 5588 0
Link [2] 5588 0
Email [2] 5588 0
roslyn.legautier@unimelb.edu.au
Other [2] 5588 0
Attachment [2] 5588 0
Type [3] 5589 0
Informed consent form
Citation [3] 5589 0
Link [3] 5589 0
Email [3] 5589 0
roslyn.legautier@unimelb.edu.au
Other [3] 5589 0
Attachment [3] 5589 0
Type [4] 5590 0
Clinical study report
Citation [4] 5590 0
Link [4] 5590 0
Email [4] 5590 0
roslyn.legautier@unimelb.edu.au
Other [4] 5590 0
Attachment [4] 5590 0
Summary results
No Results