Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000450516
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
12/04/2024
Date last updated
30/06/2024
Date data sharing statement initially provided
12/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
To examine the impact of the Network-Centred Palliative Care Service Delivery Model using a digital Healthy End of Life Planning (HELP) App on end-of-life care experiences and outcomes of Australians
Scientific title
To examine the impact of the Network-Centred Palliative Care Service Delivery Model using a digital Healthy End of Life Planning (HELP) App on end-of-life care experiences and outcomes of Australians
Secondary ID [1] 311564 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Terminal illness 332930 0
Chronic illness 333309 0
Cancer 333310 0
Dementia 333311 0
Age-related issues 333312 0
Disability-related issues 333313 0
Grief 333314 0
Bereavement 333461 0
Condition category
Condition code
Public Health 329648 329648 0 0
Other public health
Cardiovascular 329993 329993 0 0
Other cardiovascular diseases
Cardiovascular 329994 329994 0 0
Coronary heart disease
Neurological 329995 329995 0 0
Dementias
Neurological 329996 329996 0 0
Parkinson's disease
Neurological 329997 329997 0 0
Multiple sclerosis
Neurological 329998 329998 0 0
Neurodegenerative diseases
Neurological 329999 329999 0 0
Alzheimer's disease
Renal and Urogenital 330000 330000 0 0
Kidney disease
Respiratory 330132 330132 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Healthy End of Life Planning (HELP) Brief Intervention (BI) introduces Network-Centred Care (NCC) using a digital platform, the HELP App, to enable palliative care organisations and services to leverage community assets and capacity and increase societal participation to support their clients and their carers and improve their end-of-life care experiences. It is an outcome of the comprehensive research at PHPCU to develop a sustainable strategy to integrate expert palliative health care with the informal needs and wishes of patients and carers. The HELP BI can be easily delivered within the day-to-day context of care and requires as little as 5 minutes of thoughtful interaction in any healthcare or community settings by all health care workers, including volunteers.

The HELP App is an efficient and economically viable digital platform accessible at no cost to Australians in palliative care (La Trobe University Palliative Care Unit, 2023). The app can be downloaded and used in a personal device like phone, ipad, tablets etc. It offers one central place for clients or their carers to connect with informal networks and plan what tasks and activities they would like support with, and for friends and families to provide support as required. The app facilitates in providing clear idea of what is needed and when, as well as what is not needed, thereby reducing the social barriers that exist in informal setting. At the same time, the HELP App also systematically collects data on the informal end-of-life care networks, allowing services and organisations to measure and report upon the impact of social interventions. By using the HELP App, people agree to contributing their data for research purposes through La Trobe University (Ethics Approval HEC22173). Clients’ data on network-centred care will be generated as the clients or their carers begin using the HELP App, and this data will be collected from the backend of the app.


The features of the HELP App includes:
- Invite and add contacts to join the network
- Clients or their carers can create personalised care needs
- Members can choose to offer the help as asked
- Members can share the tasks responsibilities among them
- Add appointments to the calendar
- Chat function for the whole network or the inner circle chosen by the user
- Have a conversation in any language
- Share documents and photos
- Professional in-app tips and education, for instance, how to get started with advance care planning, finding local palliative care services, Aboriginal and Torres Strait Islander resources for end of life, etc.


This study uses an Effectiveness-Implementation Hybrid Type I Design, which combines a randomised controlled trial (RCT) to examine the effectiveness of the NCC using the HELP App in improving palliative care outcomes, alongside a qualitative method to evaluate user perspectives. The implementation strategy of the HELP BI will be assessed using a qualitative method, guided by the Normalisation Process Theory (NPT) (Murray et al., 2010)and Consolidated Framework for Implementation Research (CFIR) (Damschroder et al., 2022). This mixed-methods approach enables us to quantify intervention variables for comparison with control groups (Greene et al., 1989) and gain a comprehensive understanding of the factors contributing to successful implementation (Curran et al., 2012). To conduct this study, the Public Health Palliative Care Unit, La Trobe University (LTU PHPCU), is conducting a pilot HELP BI study in collaboration with Australia’s largest community-based specialist palliative care service provider, Eastern Palliative Care Association Incorporated (EPC).


As part of the intervention, a half-day introductory workshop on the HELP program, the HELP App and HELP BI will be conducted by by the chief investigator (CI), who is the director of the HELP Program at LTU PHPCU. Following the workshop, a chain of communication and meeting among the research team at LTU PHPCU and EPC team, will be conducted to codesign the study. The next step involves training EPC volunteers on social prescribing and network-centred care approaches, how the HELP app facilitates network-centred care, and how to facilitate clients downloading and using the HELP App. The training will be led by the CI. The training for volunteers will be followed up by a webinar, a questions and answers session, and a follow-up meeting before they interact with clients. The research team will conduct a regular online monthly meeting with volunteers to monitor the implementation process and provide support to volunteers as required. Meeting notes will be collected with volunteers' consent during the workshop, training sessions, and monthly meetings throughout the study period to assess the implementation barriers and facilitators. A separate survey will also be conducted to understand the facilitators and barriers to implementing HELP BI from the EPC staff perspective.

To recruit the participants, the EPC staff will invite the clients or their authorised carer in the intervention arm via email to participate in the study. A unique code will also be provided to them to include in the HELP App to indicate their participation in the study. Any trusted person may coordinate the network within the app for the clients but on the consent of the clients or their authorised representative. Since the code is solely known to the clients or their authorised representative, the researchers can verify the consent from the code mentioned in the app. The app can be downloaded and used on the personal device of the user at their own place. Following the email invitation, EPC volunteers will also contact the potential clients or their authorised carer via phone call to follow up on the initial email invitation and seek their voluntary consent to participate in the research. They will be offered a home visit if they would like assistance in setting up the network in the app. Clients for whom a network with 2 or more members is established in the app will be included in the study. Health professionals, EPC volunteers, or researchers do not have direct access to the app to review participants’ data. The deidentified data will be collected from the backend of the app. There is no minimum duration set for interacting with the app. The users can use the app at their discretion. Volunteers will check in via phone call with participants using the app once a month and will offer home visits as required during the project duration. Similarly, researchers will periodically review the app activity of the participants to monitor their adherence to the intervention.

After recruiting the palliative care clients, baseline data on the palliative care outcomes for both the intervention and control groups will be gathered. Participants in the intervention arm will receive an introduction to the HELP App and will be regularly monitored by EPC volunteers to ensure effective usage of the app. Any assistance needed in setting up the app or establishing support networks will be provided. Mid-term data will be collected three months after participant recruitment, with final data collection occurring after six months. The final evaluation phase will entail comparing palliative care outcomes between the intervention and control groups to assess the effectiveness of the intervention. The overall duration of the intervention is six months.
Intervention code [1] 328017 0
Prevention
Intervention code [2] 328021 0
Behaviour
Comparator / control treatment
The control group will not be introduced to the HELP App. They will receive all regular services provided by the EPC. EPC provides a holistic, person-centred, specialist home-based palliative care service involving nursing, medical, allied health, and bereavement support in the place the person considers home. The service provides support 24 hours a day, 7 days a week.
Control group
Active

Outcomes
Primary outcome [1] 337435 0
Preferred site of death
Timepoint [1] 337435 0
Baseline (Primary timepoint) post-intervention
3 months post-intervention, and
6 months post-intervention
Primary outcome [2] 337437 0
Bereavement risk level
Timepoint [2] 337437 0
Baseline (Primary timepoint) post-intervention
3 months post-intervention, and
6 months post-intervention
Primary outcome [3] 337438 0
Family carers’ stress
Timepoint [3] 337438 0
Baseline (Primary timepoint) post-intervention
3 months post-intervention, and
6 months post-intervention
Secondary outcome [1] 431854 0
Number of hospital admissions
Timepoint [1] 431854 0
3 months post-intervention, and
6 months post-intervention
Secondary outcome [2] 433205 0
Barriers and facilitators to implementing HELP BI from the organisation perspective
Timepoint [2] 433205 0
Baseline - Post-training before the implementation of the intervention

Mid-term - 3 months post-intervention

Final - 6 months post-randomisation
Secondary outcome [3] 433206 0
Barriers and facilitators to implementing HELP BI from volunteers perspective
Timepoint [3] 433206 0
Monthly meeting post-training to the volunteers until 6 months post-intervention

Eligibility
Key inclusion criteria
EPC clients who have an advanced diagnosis of dementia or any non-malignant chronic diseases such as:
Cardiovascular
Colorectal
Diabetes and its complications
End-stage liver disease
Haematological
Kidney Failure
Lung
Motor Neurone disease
Multiple organ failure
Neurological Disease
Other Urological
Prostate
Respiratory Failure
Sepsis
Stroke
Other terminal illnesses
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients who are:
- under 18 years of age
- at the terminal palliative care phase
- without any carer

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation method - Minimisation
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
Recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
28/05/2024
Date of last participant enrolment
Anticipated
15/07/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
80
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315863 0
University
Name [1] 315863 0
La Trobe University
Country [1] 315863 0
Australia
Funding source category [2] 316142 0
Commercial sector/Industry
Name [2] 316142 0
Eastern Palliative Care Association Incorporated
Country [2] 316142 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 317999 0
Commercial sector/Industry
Name [1] 317999 0
Eastern Palliative Care Association Incorporated
Address [1] 317999 0
Country [1] 317999 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314713 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 314713 0
Ethics committee country [1] 314713 0
Australia
Date submitted for ethics approval [1] 314713 0
02/02/2024
Approval date [1] 314713 0
08/05/2024
Ethics approval number [1] 314713 0

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

Contacts
Principal investigator
Name 132490 0
Dr Andrea Grindrod
Address 132490 0
Public Health Palliative Care Unit, La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country 132490 0
Australia
Phone 132490 0
+61 394798823
Fax 132490 0
Email 132490 0
[email protected]
Contact person for public queries
Name 132491 0
Andrea Grindrod
Address 132491 0
Public Health Palliative Care Unit, La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country 132491 0
Australia
Phone 132491 0
+61 394798823
Fax 132491 0
Email 132491 0
[email protected]
Contact person for scientific queries
Name 132492 0
Sumina Shrestha
Address 132492 0
Public Health Palliative Care Unit, La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country 132492 0
Australia
Phone 132492 0
+61 394795685
Fax 132492 0
Email 132492 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
Individual participant data will not be shared. The outcomes of the trial will share with the public via peer-reviewed journal publications and presentations.


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.