Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000326998
Ethics application status
Approved
Date submitted
14/02/2020
Date registered
9/03/2020
Date last updated
13/07/2021
Date data sharing statement initially provided
9/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Community supported end of life care
Scientific title
A community and health system partnership to reduce hospitalisation and improve outcomes through Compassionate Communities Model of End of Life Care
Secondary ID [1] 300503 0
Nil known
Universal Trial Number (UTN)
U1111-1248-0038
Trial acronym
CCCP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced illness 316191 0
Condition category
Condition code
Public Health 314483 314483 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project aims to develop, implement and evaluate a model of community volunteer, identified as a Compassionate Community Connector, who can enhance patient, carer and family end of life experiences
and reduce the need for patients to be admitted to hospital. This approach seeks to map and mobilise people’s personal networks of care, through enlisting Caring Helpers (community volunteers) and facilitate access to formal services where necessary. Each Connector will support individuals with advanced illness and their carer/family/social network in the 12 months prior to an expected death. We aim to train up to 10 Connectors to work with at least 30 families identified by the palliative care service as requiring support.
This is a pilot demonstration project that will set the scene for replicating such models of care at the local, national and international levels.

Attachments listed below are for the study implementer:
-Attachment 1-A brief screening tool for healthcare staff to screen patients for their eligibility to enter the study according to inclusion criteria. Health service (Palliative Care team) and SPO work to identify the eligibility of patients/families to enter the study.
-Attachment 2- A form to record demographic information and relevant health service utilisation, place of care over time, use of paid and unpaid resources and unplanned health service utilisation and hospital admissions. This information is collected at the initial interview and then ongoing (except for the demographics).
-Attachment 3- A tool to explore unmet social/practical needs and social networks of adults living at home with advanced life limiting illness and/or their carers, completed pre and post intervention by the SPO (before first visit by the Connector and after last visit)- adapted from the Irish INSPIRE study (McLoughlin et al, 2015).
-Attachment 4- Mapping the person’s social networks (using the Network Enhancement Tool (NET) including formal and informal networks- adapted from the HELP of La Trobe University (Grindrod and Rumbold, 2018). Data collection is on-going by SPO.
-Attachment 5a- A tool to record Connectors’ date and duration of visits and types of tasks undertaken, including identifying support needs. Data collection is on-going by SPO.
-Attachment 5b- This tool will provide a record of the Caring Helpers’ visits, dates and types of tasks. Data Collection is on-going by the SPO.
-Attachment 6- Carers will complete the Carer Alert Thermometer (CAT) to identify their unmet support needs, pre and post intervention, collected by the SPO (Knighting et al, 2015). In addition, the CAT has one question to family carers “Do you know the person’s wishes and preferences for end of life care? If the patient is amenable to having an advance care plan, the palliative care team will be notified to undertake this task.
-Attachment 7- Connectors will complete a death literacy tool at three time-points: before and after the training program and following the intervention period. Collected by the SPO.
-Attachment 8- Patients and carers will complete the m-MOS Social Support Survey, pre and post intervention, collected by the SPO (Moser et al, 2012).
-Attachment 9- Qualitative tools to assess feasibility and acceptability of this model of care: Patients and Family carers (interviews), Connectors (focus group), Caring Helpers (survey) and service providers (focus group) – to be undertaken at the end of the project by SPO
- who will deliver the intervention – the Palliative Care team, Senior Project Officer and
Compassionate Connectors (volunteers) with assistance from Caring Helpers.
- the mode of delivery - patient/carers will be community based, home visits will be conducted by the Senior Project Officer and Compassionate Connectors.
- the number of times the intervention will be delivered and over what period of time, - the Intervention is for a 12 week period initially with the Senior Project Officer visiting Pre-Intervention and Post Intervention; Compassionate Connectors will make contact a minimum of six times by home visit or by telephone call.
- the location/setting where the intervention occurs,
This pilot project will take place in the South West of Western Australia which covers 24,000km2 with a population of approximately 170,000. It comprises one regional port town, Bunbury and many smaller rural towns and communities. Based on the Accessibility/Remoteness Index of Australia the South West is classified 50% outer regional, 40% inner regional and 10% remote. The age structure of the South West differs from the state with a larger proportion of adults aged 45 years and over. The largest growth is in older age groups (Rural Health West, 2016). The leading causes of death in the South West region are: ischaemic heart diseases, cerebrovascular diseases, dementia (including Alzheimer’s disease), lung cancer and chronic obstructive pulmonary disease.

- any strategies used to assess or monitor adherence or fidelity to the intervention, if applicable. All Connectors will attend a two day training program inclusive of practical application of the documents to be used and they will receive ongoing support from the Senior Project Officer who monitors the data collection occurring.
Intervention code [1] 316816 0
Treatment: Other
Comparator / control treatment
For the outcome on reducing hospital admissions, we will have a concurrent matched comparison/control group on socio-demographics, clinical information and hospital and ED use. If a concurrent good match on these variables is not available, we will use a historical matched group from the previous year, so not too far back in time.
Data from healthcare records from: Bunbury Hospital, Busselton Hospital, Collie Hospital, Harvey Hospital from January 2019 to December 2019.
Control group
Active

Outcomes
Primary outcome [1] 322812 0
Change in patient and carer social connectedness This is a composite outcome.
Tool: m-MOS Social Support Survey
Timepoint [1] 322812 0
Immediately pre-intervention and two weeks post intervention completion
Secondary outcome [1] 379870 0
Change in unmet social and practical needs. This is a composite outcome.
Tool: Assessment of unmet social and practical needs and social networks questionnaire
Timepoint [1] 379870 0
Immediately pre-intervention and two weeks post intervention completion
Secondary outcome [2] 379871 0
Change in unplanned hospital usage
Timepoint [2] 379871 0
Data collected during the three month intervention period from the healthcare record and patient administration system.
Secondary outcome [3] 379872 0
Change in carer unmet support needs
Tool: Carer's Alert Thermometer
Timepoint [3] 379872 0
Immediately pre-intervention and two weeks post intervention completion
Secondary outcome [4] 379873 0
Change in death literacy of Connectors (volunteers)
Tool: Death Literacy Tool, designed specifically for this study.
Timepoint [4] 379873 0
Immediately pre-training program, immediately after conclusion of training program and two weeks post intervention completion
Secondary outcome [5] 379874 0
Change in the number of completed Advance Care Plans
Tool: Health Record audit of Advance Care Plans immediately pre-intervention and two weeks post intervention by the Palliative Care team
Timepoint [5] 379874 0
Immediately pre-intervention and two weeks post intervention completion

Eligibility
Key inclusion criteria
The patient cohort will include people who have an awareness of their advanced illness and are likely to die within the next 12 months, as advised by the palliative care service. This cohort will specifically include those with frequent hospital usage and people at risk of hospitalisation for palliative care including patients with Cancer, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure or Renal disease and other chronic conditions such as neurodegenerative conditions. In addition, recruited patients must have unmet social and practical needs, be socially isolated and rely on just one other person to meet the majority of their everyday needs. Patients and carers must be 18 years and older. All participants need to have capacity to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment and those not current clients of the palliative service

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
Quantitative data analysis
Quantitative data will be analysed using the SPSS statistical software package version 24. Descriptive statistics will summarise the quantitative data such as frequencies and percentages for categorical variables; means, standard deviations, and ranges for variables measured on a continuous scale) will be used to describe the demographic (patients and carers) and clinical profile (patients) in the study. A paired t test will be used to compare pre-versus post-intervention responses to all outcome measurement tools if the data are normally distributed. The Wilcox-signed rank test will be used if the data are not normally distributed. The data will be compared using two-tailed tests.

Qualitative data analysis
The interviews will be audio-recorded and transcribed verbatim. Transcripts will be imported into NVivo version 11 software for data management. Thematic analysis will be utilised to guide the development of themes from responses of the three target groups where applicable. Two researchers will work independently and later check coding of data. A third team member will resolve disagreements about coding using the established coding scheme.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2020
Actual
19/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304920 0
Government body
Name [1] 304920 0
Western Australian Health Translation Network
Country [1] 304920 0
Australia
Primary sponsor type
Government body
Name
WA Country Health Service (WACHS) - South West
Address
5th Floor Bunbury Tower
61 Victoria Street
Bunbury WA 6230
Country
Australia
Secondary sponsor category [1] 305270 0
None
Name [1] 305270 0
Address [1] 305270 0
Country [1] 305270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305328 0
WA Country Health Service Human Research Ethics Committee (EC000261)
Ethics committee address [1] 305328 0
Ethics committee country [1] 305328 0
Australia
Date submitted for ethics approval [1] 305328 0
12/12/2019
Approval date [1] 305328 0
10/02/2020
Ethics approval number [1] 305328 0
RGS3419

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

Contacts
Principal investigator
Name 100014 0
Prof Samar Aoun
Address 100014 0
La Trobe University
Kingsbury Drive
BUNDOORA VIC 3086
Country 100014 0
Australia
Phone 100014 0
+61 419 911 940
Fax 100014 0
Email 100014 0
[email protected]
Contact person for public queries
Name 100015 0
Jo Moore
Address 100015 0
WA Country Health Service - South West
5th Floor, Bunbury Tower
61 Victoria Street
BUNBURY WA 6230
Country 100015 0
Australia
Phone 100015 0
+61 4 2968 4236
Fax 100015 0
Email 100015 0
[email protected]
Contact person for scientific queries
Name 100016 0
Samar Aoun
Address 100016 0
La Trobe University
Kingsbury Drive
BUNDOORA VIC 3086
Country 100016 0
Australia
Phone 100016 0
+61 419 911 940
Fax 100016 0
Email 100016 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
Small participant numbers


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6923Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 379239-(Uploaded-23-06-2022-13-13-00)-Basic results summary.docx
Plain language summaryNo DRAFT NOT FOR DISTRIBUTION YET The ... [More Details]

Documents added automatically
No additional documents have been identified.