Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000619842
Ethics application status
Approved
Date submitted
2/03/2021
Date registered
24/05/2021
Date last updated
24/05/2021
Date data sharing statement initially provided
24/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Taking action: the effect of a community action intervention on advance personal planning by older adults
Scientific title
Taking action: the effect of a community action intervention on advance personal planning by older adults
Secondary ID [1] 303580 0
Australian Research Council: DP190100861
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advance care planning 320949 0
elderly 321500 0
Condition category
Condition code
Public Health 318757 318757 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Community Action Intervention (12 months duration).
Individuals with legitimacy in each community, representing key stakeholder groups and consumer advisors will be identified by the research team. Individuals will be invited to be involved in the study as members of Coalition Groups. Coalition Groups will be established to support the implementation of the intervention strategies in each community. Membership will be dependent on local context. Standard resource packages will be developed by the research team to facilitate implementation of the intervention, including: an implementation manual; inter-professional and community information education materials (e.g. PowerPoints, checklists); print and audio-visual materials. Where possible, publically available materials (e.g. from organisations such as Advance Care Planning Australia) will be incorporated into the packages. Members of the Coalition Groups will meet as needed during the study via face-to-face and/or videoconference meetings.

Comprehensive toolbox of intervention strategies. A comprehensive toolbox of strategies will be available for implementation and strategies will be selected for implementation at the discretion of the community Coalition Groups. The research team will provide advice and support to communities to identify and prioritise specific barriers and enablers to APP, and select and implement strategies to promote APP uptake.

Strategy 1: Inter-professional education workshops to improve capacity assessment and promote APP. A list of potential workshop attendees in each community (e.g. lawyers, GPs, nurses, hospital staff) will be generated based on lists from relevant organisations (e.g. Primary Health Networks). Individuals will be mailed/emailed an invitation to attend the workshop (either face-to-face or via zoom). The 2-hour workshop will be directed by two facilitators trained by the research team (i.e. a lawyer & health professional from the community) and will involve a combination of didactic lectures, small group discussions and role plays. Topics will include: legal rights and responsibilities, capacity assessment, strategies and resources to facilitate APP. They will also be given access to a suite of resources, including: links to existing capacity assessment toolkits (e.g. NSW Government Planning Ahead, NSW Justice); downloadable APP fact sheets, proformas and guides available from Advance Care Planning Australia and the Law Society of NSW; and information about existing education and training resources materials they can access (e.g. https://end-of-life.qut.edu.au/; https://www.advancecareplanning.org.au/resources/education-and-training#/). Up to 3 sessions will be held in each community over a period of 12 months. The number of attendees will be recorded and attendees will complete a survey of knowledge, attitudes, and acceptability at session end.

Strategy 2: Community APP sessions for older people. Eligible community organisations will be informed via email and letter about free 1.5 hour APP information session(s) (face-to-face or via zoom) and asked to invite members. Sessions will also be advertised via local media. Sessions will be facilitated by trained health and legal professionals, with information on the purpose and benefit of APP; legal rights and responsibilities; and techniques for facilitating discussions presented. Instructions for accessing existing resources and hard copies of documents will be provided. Attendees will complete a survey of knowledge, attitudes, and acceptability at session end. Instructions for accessing existing resources and hard copies of documents will be provided. These publically available documents will include: Advance Care Planning Australia Factsheets, NSW Enduring Guardian Booklet and Form and Advance Care Directive Booklet. Links to additional online resources and organisations where attendees can seek assistance or further information will also be provided, including: Advance Care Planning Australia, COTA NSW and Seniors Rights Service. Up to 3 sessions will be held in each community over a period of 12 months. The number of attendees will be recorded and attendees will complete a survey of knowledge, attitudes, and acceptability at session end.

Strategy 3: Information for older people attending health and legal services regarding APP. General practices, ACCHSs and legal firms will be approached by the Coalition Group for consent to place print materials including posters and APP documents in waiting rooms. Information about the potential benefits of APP instruments, local services and additional resources available to assist people to engage in APP will be provided. Information about the potential benefits of APP instruments, local services and additional resources available to assist people to engage in APP will be provided. These publically available documents will include: Advance Care Planning Australia Factsheets, NSW Enduring Guardian Booklet and Form and Advance Care Directive Booklet. The number of materials distributed to each practice will be recorded.

Strategy 4: Public awareness campaigns. The media component of this action approach will be the primary mechanism by which ongoing APP data obtained from lawyers will be fed back to the general community. The purpose is to generate a substantive increase in the number of APP-related news items. The benefits of APP and services available to assist in APP preparation will be communicated by: advertisements in local newspaper/radio every 4 months; media releases; short videos played as part of loop advertising at community organisations (e.g. bowling clubs, RSLs); written leaflets distributed via mail outs (e.g. with council rate notices); posters and handouts distributed in public libraries and/or pharmacies. These publically available documents have been obtained via organisations such as Advance Care Planning Australia (e.g. Factsheets) and NSW Health. This strategy will be implemented over a period of 12 months. The number of APP-related news items published will be recorded.

Audit of APP performance with feedback APP over time. GPs and lawyers in each intervention community will be asked to collect de-identified data on the number of clients who request, complete or update APP instruments during the intervention period. Aggregate data only is needed. No individuals will be identified. Data will be collected every month to ensure accuracy. Follow up reminders will enhance adherence. Data will be mapped against previous data to monitor progress. This community-specific data will be presented to Coalition Group members to aid monitoring of strategies.

Intervention code [1] 319865 0
Behaviour
Comparator / control treatment
Arm 2 – Usual care. Communities randomly allocated to this condition will not receive any intervention. Information on designated outcomes will be collected from older people via surveys mailed out by community organisations to their membership lists to provide benchmarking for intervention communities. To minimise potential effects of answering questions about APP, participants will also answer health status and service care utilisation items.
Control group
Active

Outcomes
Primary outcome [1] 326700 0
Self-reported APP: Participants will indicate on an investigator-developed survey whether they have completed or updated financial APP instruments including: (i) a will or (ii) EPA; and medical instruments: including (iii) ACD, (iv) enduring guardian (‘yes’, ‘no’, or ‘unsure’ for each item). Participants will also be asked to indicate if they have discussed their wishes for care with families or other important people in their lives; health care professionals or lawyers. Standard, easy to understand definitions will be provided. A composite APP outcome will be created indicating evidence of financial (i.e. will and/or EPA); and personal and medical (i.e. enduring guardian and/or AD) instruments.
Timepoint [1] 326700 0
Baseline, 12 months post-intervention commencement (primary endpoint) and 24 months post-intervention commencement.
Secondary outcome [1] 392404 0
APP knowledge and attitudes. Will be assessed by a modified version of the ACP Engagement Survey. The survey measures multiple APP behaviours that relate to engaging decision makers, considering acceptable quality of life and having conversations with key others (e.g. doctors). Questions pertain to processes, including knowledge, self-efficacy and attitudes towards APP.
Timepoint [1] 392404 0
Will be assessed via items in the investigator-developed 12 and 24 month follow-up surveys completed by older people.
Secondary outcome [2] 392405 0
Additional cost of each strategy compared to consequences measured by the change in proportion of people with APP instruments. Modelling will use evidence collected by researchers i.e. recorded time and materials required to deliver inter-professional workshops and information sessions by facilitators; and have APP-related materials available in waiting rooms of law offices and general practices.
Timepoint [2] 392405 0
12 months post-intervention commencement
Secondary outcome [3] 393895 0
Acceptability of inter-professional workshops will be assessed by an investigator-developed evaluation survey completed by attendees.
Timepoint [3] 393895 0
Immediately post each inter-professional workshop
Secondary outcome [4] 393897 0
Acceptability of community information sessions will be assessed by an investigator-developed evaluation survey completed by attendees.
Timepoint [4] 393897 0
At the conclusion of each session, attendees will be asked to complete the survey.
Secondary outcome [5] 393906 0
Exposure to intervention strategies: Total number of community information sessions attended

Timepoint [5] 393906 0
Will be assessed via items in the investigator-developed 12 and 24 month follow-up surveys completed by older people.
Secondary outcome [6] 395937 0
Exposure to intervention strategies: Total number of APP-related articles seen/heard in local media
Timepoint [6] 395937 0
Will be assessed via items in the investigator-developed 12 and 24 month follow-up surveys completed by older people.
Secondary outcome [7] 395938 0
Exposure to intervention strategies: Whether their GP/lawyer had APP materials available in waiting rooms (Y/N)
Timepoint [7] 395938 0
Will be assessed via items in the investigator-developed 12 and 24 month follow-up surveys completed by older people.

Eligibility
Key inclusion criteria
Communities will be eligible if they have:
(i) Population of 5,000 to 20,000 people.
(ii) At least 15% of total population aged 65 years or over.
(iii) At least 5 GPs and 5 lawyers
(v) At least 50km from each other, and 100 kms from major urban centres.

Older people (community survey component)
Eligible participants will: be members of a selected community organisation(s); reside in a participating community; and be aged 65 years or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by indepedent statistical support unit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be presented for each group. Primary analysis will involve mixed effects logistic regression modelling to compare outcomes between people in usual care and intervention groups at follow-up. A random intercept will be included for each community to adjust for correlation of the outcome within communities. Given the low number of clusters, we will use the Between-Within method of denominator degrees of freedom estimation for the treatment effect. Secondary analyses will adjust for individual characteristics that are potentially prognostic of the outcome and baseline cluster level summary measure of the outcome. Differences in change from baseline for the continuously distributed secondary outcomes will be assessed using hierarchical linear regression modelling, with fixed effects for treatment variable (intervention vs usual care), time (baseline vs follow-up) and interaction between intervention and usual care. The model will also include random intercepts for community, and individuals nested within community to model serial correlations within individuals. The primary analysis will follow the intention to treat principle, with sensitivity analyses using multiple imputation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/03/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
2000
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308001 0
Government body
Name [1] 308001 0
Australian Research Council
Country [1] 308001 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan, NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 308724 0
None
Name [1] 308724 0
Address [1] 308724 0
Country [1] 308724 0
Other collaborator category [1] 281671 0
University
Name [1] 281671 0
University of Technology Sydney
Address [1] 281671 0
15 Broadway, Ultimo NSW 2007
Country [1] 281671 0
Australia
Other collaborator category [2] 281672 0
Other Collaborative groups
Name [2] 281672 0
Hunter Medical Research Institute
Address [2] 281672 0
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country [2] 281672 0
Australia
Other collaborator category [3] 281673 0
University
Name [3] 281673 0
Bond University
Address [3] 281673 0
14 University Dr, Robina QLD 4226
Country [3] 281673 0
Australia
Other collaborator category [4] 281674 0
Hospital
Name [4] 281674 0
John Hunter Hospital
Address [4] 281674 0
Lookout Rd, New Lambton Heights NSW 2305
Country [4] 281674 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307995 0
The University of Newcastle
Ethics committee address [1] 307995 0
Ethics committee country [1] 307995 0
Australia
Date submitted for ethics approval [1] 307995 0
26/04/2019
Approval date [1] 307995 0
19/09/2019
Ethics approval number [1] 307995 0
H-2019-0139
Ethics committee name [2] 308279 0
University of Technology Sydney
Ethics committee address [2] 308279 0
Ethics committee country [2] 308279 0
Australia
Date submitted for ethics approval [2] 308279 0
08/03/2021
Approval date [2] 308279 0
23/03/2021
Ethics approval number [2] 308279 0
ETH21-5852

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

Contacts
Principal investigator
Name 109170 0
Dr Amy Waller
Address 109170 0
Health Behaviour Research Collaborative
Level 4 West Wing, HMRI Building,
University of Newcastle,
University Drive, Callaghan, NSW 2308
Country 109170 0
Australia
Phone 109170 0
+61 2 40420708
Fax 109170 0
Email 109170 0
[email protected]
Contact person for public queries
Name 109171 0
Emilie Cameron
Address 109171 0
Health Behaviour Research Collaborative
Level 4 West Wing, HMRI Building,
University of Newcastle,
University Drive, Callaghan, NSW 2308
Country 109171 0
Australia
Phone 109171 0
+61 2 4042 0701
Fax 109171 0
Email 109171 0
[email protected]
Contact person for scientific queries
Name 109172 0
Amy Waller
Address 109172 0
Health Behaviour Research Collaborative
Level 4 West Wing, HMRI Building,
University of Newcastle,
University Drive, Callaghan, NSW 2308
Country 109172 0
Australia
Phone 109172 0
+61 2 40420708
Fax 109172 0
Email 109172 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
We are seeking advice from the Ethics Committees which have approved our study regarding whether raw line by line data can be shared or whether only processed data (e.g. age category rather than age; ARIA+ classification rather than postcode; APP composite score) can be shared. Processed data may be deemed to pose less risk of identifying individuals than raw data, but still enables the analyses to be replicated. Depending upon advice from the Ethics Committee, either raw line by line or processed data will be made available via NOVA which is the University of Newcastle's data repository.


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.