Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001399785
Ethics application status
Approved
Date submitted
27/10/2022
Date registered
1/11/2022
Date last updated
29/10/2024
Date data sharing statement initially provided
1/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) Project Cluster Randomised Controlled Trial
Scientific title
Efficacy of the Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) Project: A Cluster Randomised Controlled Trial
Secondary ID [1] 308244 0
None
Universal Trial Number (UTN)
U1111-1284-3743
Trial acronym
EARLI-Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 328015 0
Frailty 328016 0
Cancer 328017 0
Cardiovascular disease 328018 0
Neurological disorders 328019 0
Respiratory disorders 328020 0
Kidney disease 328021 0
Liver disease 328022 0
Condition category
Condition code
Neurological 325074 325074 0 0
Neurodegenerative diseases
Neurological 325075 325075 0 0
Other neurological disorders
Cancer 325076 325076 0 0
Any cancer
Cardiovascular 325077 325077 0 0
Other cardiovascular diseases
Cardiovascular 325078 325078 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 325079 325079 0 0
Other cardiovascular diseases
Oral and Gastrointestinal 325080 325080 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 325081 325081 0 0
Kidney disease
Respiratory 325082 325082 0 0
Other respiratory disorders / diseases
Respiratory 325083 325083 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EARLI intervention
The modular EARLI intervention is delivered by a trained interventionist (nurse, social worker or allied health practitioner). Training in the intervention will be designed by the EARLI investigator team, and delivered by the Chief Investigator, with input from investigators with specific expertise (clinical psychology, palliative care, geriatrics) as relevant. The training will be delivered face to face where possible, or by video-conference in situations where the interventionist is not based in Sydney. It is anticipated that the duration of the training will be approximately 15 hours (2 full days), undertaken in multiple sessions as required. Attendance and completion of the training activities will be monitored by the research team. For each participant, the intervention is delivered over four, approximately fortnightly sessions in the participant's home, supplemented by fortnightly (~15 minute, alternate week) phone follow up with the interventionist, to provide follow up support in undertaking the life story work. The intervention culminates in a meeting (visit 4) with the participant's home care coordinator (or delegated staff with ongoing role in managing the participant's home care services) and a member of the participant's primary care team (e.g. General Practitioner or General Practice nurse, by telehealth). Scheduled visit sessions are planned to be delivered in person, however if video-conference options are used this will be documented. The contents of the EARLI intervention study visits are described below:
Session 1 (Life Review Interview): in an approximately 60 minute session, the interventionist builds rapport and activates meaning-based coping through a structured reminiscence intervention (Life Review Interview) which focuses on valued domains from the participant's life story (roles, places, relationships, qualities), leading to identification of a tangible memento or 'life story project' to work on during the remainder of the intervention period.
Session 2 (My Wishes Part 1): in an approximately 60 minute session, the interventionist provides follow up support on the life story project, in addition to exploring the participant's key life values and thoughts on 'living well', now and in the future. The concept of advance care planning will be explained and explored using a values clarification aid (discussion starter card set).
Session 3 (My Wishes Part 2): in an approximately 60 minute session, the interventionist provides follow up support on the life story project, and provides facilitated advance care planning for the participant, focusing on developing goals for future care into more specific care and treatment preferences.
Session 4 (Care Provider Review Meeting): in an approximately 60 minute session, the interventionist assists the participant to summarise their discussions and communicate their goals and values for future care to key members of their aged care and primary care teams. The second half of this session includes a 30 minute facilitated discussion, involving the study interventionist, care recipient (participant), care partner (participant), aged care provider home care coordinator and general practitioner (GP) or general practice nurse (GPN) (Anticipated that GP/GPN will attend by telehealth).
A follow up fifth session (up to 30 minutes, telehealth) is available to intervention participants if they experience a sentinel event (assessment of higher care needs, unplanned hospital admission or residential respite stay, residential aged care facility admission) or otherwise request the follow up session. The purpose of this session is to enable follow up support, review/revision of previous advance care planning documentation. In a situation in which the care recipient participant has deteriorated significantly and is unable to participate, this fifth session may focus on supporting the care partner in their role as a substitute decision-maker (if relevant).
A post-visit review form will be used to monitor intervention adherence for every completed visit. In addition, a random sub-sample of intervention audio recordings (collected with participant consent) will be assessed by the Chief Investigator and other members of the Investigator group, with feedback on intervention adherence provided as part of ongoing clinical supervision for the interventionist.
Intervention code [1] 324708 0
Treatment: Other
Comparator / control treatment
The active control group receive a brief advance care planning (ACP) education session (30 minutes duration), which mirrors the aspects covered in the second half of ‘Session 2’ for the intervention group. The interventionist will explain the concept of advance care planning and introduce an information brochure. The supplied information brochure (official jurisdictional specific ACP information from WA Health Department or NSW Ministry of Health) will be promoted as communication support tools, to assist in conversations with professionals. Participants wishing to explore these topics further will be advised to consult with a relevant professional, typically their GP in the first instance.
*Those in the 'active control' group will not receive the full intervention at any point during the study.
Control group
Active

Outcomes
Primary outcome [1] 332939 0
Care-recipient-completed advance care planning documentation (statutory or non-statutory advance care directives) in the aged care provider's client record (recorded as 'yes' or 'no')
Timepoint [1] 332939 0
Baseline and 3 months post consent
Primary outcome [2] 332940 0
Advance care planning readiness, as measured on the 4-item advance care planning engagement tool, among participating care recipients
Timepoint [2] 332940 0
Baseline and 3 months post consent
Secondary outcome [1] 415234 0
Readiness to engage as a substitute decision-maker (as measured by a 4-item measure of substitute decision-maker engagement) among participating care partners
Timepoint [1] 415234 0
Baseline and 3 months post consent
Secondary outcome [2] 415235 0
Decisional conflict, as measured by scores on a 10-item 'easy read' measure of decisional conflict, with respect to hypothetical care and treatment preference scenarios among participating care recipients
Timepoint [2] 415235 0
Baseline and 8 weeks post consent
Secondary outcome [3] 415236 0
Decisional conflict, as measured by scores on a 10-item ‘easy read’ measure of decisional conflict (with respect to hypothetical care and treatment preference scenarios) among participating care partners
Timepoint [3] 415236 0
Baseline and 8 weeks post consent
Secondary outcome [4] 415237 0
Participant preferred treatment or care approach in response to a hypothetical care or treatment scenario, as chosen from a list of treatment approaches reflecting overall goals of care
Timepoint [4] 415237 0
Baseline and 8 weeks post consent
Secondary outcome [5] 415238 0
Psychosocial wellbeing (as measured by scores on the 14-item Hospital Anxiety and Depression Scale) among participating care recipients.
Timepoint [5] 415238 0
Baseline and 3 months post consent
Secondary outcome [6] 415239 0
Psychosocial wellbeing (as measured by scores on the 14-item Hospital Anxiety and Depression Scale) among participating care partners.
Timepoint [6] 415239 0
Baseline and 3 months post consent
Secondary outcome [7] 415240 0
Relationship quality with the primary care partner (as measured by scores on the 8-item ‘warmth and affection’ subscale of the Quality of the Patient Caregiver Relationship scale) among participating (sub-study) care recipients who opt-in to the 'extended module' survey questions.
Timepoint [7] 415240 0
Baseline and 8 weeks post consent
Secondary outcome [8] 415241 0
Relationship quality with the care recipient (as measured by scores on the 8-item ‘warmth and affection’ subscale of the Quality of the Patient Caregiver Relationship scale) among participating (sub-study) care partners who opt-in to the 'extended module' survey questions.
Timepoint [8] 415241 0
Baseline and 8 weeks post consent
Secondary outcome [9] 415242 0
Meaning-based coping (measured as a composite of the 4-item ‘reflections on the past’ subscale 4-item ‘purpose’ subscales from the Meaning in Life scale) among participating (sub-study) care recipients who opt-in to the 'extended module' survey questions.
Timepoint [9] 415242 0
Baseline and 8 weeks post consent
Secondary outcome [10] 415243 0
Clinical usefulness of the advance care planning documentation in the aged care provider’s client record for care recipients in the intervention group compared to those in the active control group (as assessed by a clinician panel blinded to participant allocation) as assessed on a visual analogue rating scale.
Timepoint [10] 415243 0
3 months post consent
Secondary outcome [11] 415244 0
Among care partners who are required to undertake a substitute decision-making role during the 12-months following intervention implementation, we will compare experiences of distress associated with substitute decision-making (as measured by a composite of scores on a 5-item measure of decisional regret and associated decision experience items) in the intervention and active control groups
Timepoint [11] 415244 0
12 months post consent
Secondary outcome [12] 415245 0
Among care partners who are bereaved during the 12-months following intervention implementation (i.e. the care recipient has died), we will compare reported understanding of the care recipient’s end of life wishes, and levels of satisfaction these these wishes were met in end of life care, using a 2-item questionnaire measure, for care partners in the intervention and active control groups.

(Johnson S, et al. BMJ Open 2016;6:e012387. doi:10.1136/bmjopen-2016-012387)
Timepoint [12] 415245 0
12 months post consent
Secondary outcome [13] 415246 0
Cost effectiveness, comparing intervention costs (determined by costing of actual materials, labour and on costs for intervention delivery) to health and social care costs (determined through linked administrative data to quantify primary care, aged care and hospital utilisation, along with informal care, quantified by a survey of participating care partners)
Timepoint [13] 415246 0
12 months post consent (first tranche of linked administrative data)
Secondary outcome [14] 415258 0
Cost effectiveness, comparing intervention costs (determined by costing of actual materials, labour and on costs for intervention delivery) to health and social care costs (determined through linked administrative data to quantify primary care, aged care and hospital utilisation, along with informal care, quantified by a survey of participating care partners)
Timepoint [14] 415258 0
Five years post consent (second tranche of linked administrative data)

Eligibility
Key inclusion criteria
1. aged 65 years or older (50 years or older for Aboriginal or Torres Strait Islander people);
2. a previous aged care assessment team (ACAT) assessment;
3. living in a private residence (own or rented dwelling, including retirement village or other co-operative housing, but NOT a residential aged care facility) with an address within the study region(s);
4. receiving home care services from one of the participating aged care provider study sites (Home Care Package Level 1-4, or commensurate self-funded service);
5. able to communicate in English, Italian or Chinese (Mandarin or Cantonese);
6. capable of providing informed consent at initial recruitment and answering baseline questions (successfully completing at least 75% of baseline questions).

Care partner inclusion criteria:
1. Aged 18 years or over
2. Able to communicate in English, Italian or Chinese (Mandarin or Cantonese)
3. Capable of providing informed consent at initial recruitment and answering baseline questions (successfully completing at least 75% of baseline questions).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. the aged care provider study site representative expresses significant concern about home visit safety (either for the care recipient or for the interventionist) which cannot be appropriately managed;
2. a baseline cognitive assessment indicates greater than moderate level of cognitive impairment (Telephone Montreal Cognitive Assessment Score <8);
3. a baseline clinical frailty assessment indicates a complete absence of frailty (CFS score <3) or greater than severe frailty (CFS score >7);
4. it becomes known that the person is expected to die within 'days or weeks' (based on information provided by the aged care provider and/or participant's general practitioner during the recruitment process).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomised allocation of study sites to receive either the intervention or active control phase first, using a computer sequence generation procedure
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Block randomised allocation to the intervention and active control phases within each region will be undertaken based on study site size (the number of clients receiving home care services from the study site, within the study region at the time of randomisation) by a research team member blinded to site identity. Study sites within each region will be ordered by size, with randomisation being undertaken sequentially for sites 1 and 2 (largest and second largest), then sites 3 and 4, and so on, until all sites within each study region are randomly allocated. A random number generator will choose between the numbers 1 and 2, to determine whether the first (1) or second (2) of the sites in each pair is allocated to the intervention condition first. If there are an odd number of study sites in a region at the time of randomisation, the final (unpaired) site, will be allocated through a random generation between numbers 1 (intervention) and 2 (active control) conditions for the first year of recruitment. The research team member undertaking the randomisation will document these results in an electronic document, which will be returned to the Coordinating Principal Investigator, who will archive this documentation prior to unblinding the site list and informing study site representatives of the allocation. Sites will be provided with the resources and research team services associated with their allocated condition for the first year of recruitment, before swapping to the alternative condition in the second year of recruitment. Sites will be informed of the importance of maintaining a consistent approach to screening and recruitment across the study period. If there are delays in the commencement of recruitment which apply across multiple study sites, then the date of cross-over into the alternative condition will also be delayed, by a commensurate amount.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the (system-level) primary outcome - care-recipient-completed advance care directives present in the client record of the aged care provider: each participant will be classified as 'Yes' or 'No' at both baseline and 3 month follow up. Statistical analysis will be by a generalised linear mixed model, regressing advance care directive completion at follow up on allocated group (intervention or active control), including site as a random effect and baseline advance care directive completion as a covariate, Analysis will be participant and site level allocation status.
For the (person-level) primary outcome - care-recipient advance care planning engagement survey scores at 3 month follow up will be analysed across groups. Statistical analysis will be by a linear mixed model regressing advance care planning engagement on allocated group, including site as a random effect and baseline ACP engagement as a covariate. Analysis will be participant and site level allocation status.
For secondary outcomes - unless otherwise specified the statistical test will be a linear mixed model, regressing the outcome measure on allocated group, with site included as a random effect and baseline levels of the outcome measure as a covariate. Covariate adjustments will be applied if the variables assessed in baseline comparisons showed significant differences between groups. Standard model diagnostics will be used to determine if the analysis meets assumptions. Missing data at follow up will be handled by multiple imputation. Planned subgroup analyses will be undertaken as part of the secondary outcome analysis (if pre-specified in relevant sub-studies focused on mechanisms of effect).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
17/02/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
384
Accrual to date
69
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 312501 0
Government body
Name [1] 312501 0
National Health and Medical Research Council
Country [1] 312501 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 314089 0
None
Name [1] 314089 0
Address [1] 314089 0
Country [1] 314089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311837 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 311837 0
Ethics committee country [1] 311837 0
Australia
Date submitted for ethics approval [1] 311837 0
02/05/2022
Approval date [1] 311837 0
05/07/2022
Ethics approval number [1] 311837 0
HC220271

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

Contacts
Principal investigator
Name 122542 0
Dr Craig Sinclair
Address 122542 0
Neuroscience Research Australia (NeuRA)
139 Barker Street,
Randwick, NSW
2031
Country 122542 0
Australia
Phone 122542 0
+61 2 9399 1095
Fax 122542 0
Email 122542 0
c.sinclair@unsw.edu.au
Contact person for public queries
Name 122543 0
Craig Sinclair
Address 122543 0
Neuroscience Research Australia (NeuRA)
139 Barker Street,
Randwick, NSW
2031
Country 122543 0
Australia
Phone 122543 0
+61 2 9399 1095
Fax 122543 0
Email 122543 0
c.sinclair@unsw.edu.au
Contact person for scientific queries
Name 122544 0
Craig Sinclair
Address 122544 0
Neuroscience Research Australia (NeuRA)
139 Barker Street,
Randwick, NSW
2031
Country 122544 0
Australia
Phone 122544 0
+61 2 9399 1095
Fax 122544 0
Email 122544 0
c.sinclair@unsw.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
Participant consent for data sharing is obtained only for use in specific studies that are part of the EARLI project. The use of linked administrative data (for hospital, primary care and aged care utilisation) in this trial will preclude any individual participant data sharing.


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.