Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000218594
Ethics application status
Approved
Date submitted
5/02/2024
Date registered
5/03/2024
Date last updated
30/08/2024
Date data sharing statement initially provided
5/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Enhanced Advance care planning and life Review Longitudinal Intervention Community Outreach (EARLI-comm) Project
Scientific title
Assessing the impact of the Enhanced Advance care planning and life Review Longitudinal Intervention Community Outreach (EARLI-comm) program on advance care planning engagement
Secondary ID [1] 311469 0
None
Universal Trial Number (UTN)
U1111-1303-7799
Trial acronym
EARLI-comm
Linked study record
This record is a follow-up study of ACTRN12622001399785 (EARLI trial)

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 332773 0
Frailty 332774 0
Cancer 332775 0
Cardiovascular disease 332776 0
Neurological disorders 332777 0
Respiratory disorders 332778 0
Kidney disease 332779 0
Liver disease 332780 0
Human Immunodeficiency Virus (HIV) 332781 0
Condition category
Condition code
Neurological 329490 329490 0 0
Neurodegenerative diseases
Neurological 329491 329491 0 0
Other neurological disorders
Cancer 329492 329492 0 0
Any cancer
Cardiovascular 329493 329493 0 0
Other cardiovascular diseases
Cardiovascular 329494 329494 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 329495 329495 0 0
Other cardiovascular diseases
Oral and Gastrointestinal 329496 329496 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 329497 329497 0 0
Kidney disease
Respiratory 329498 329498 0 0
Other respiratory disorders / diseases
Respiratory 329499 329499 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EARLI-comm intervention

The modular EARLI-comm intervention is delivered by a trained study facilitator in each region. The study facilitators will be qualified health professionals (e.g. nurse, social worker or allied health practitioner) or an appropriately trained higher degree research student (e.g. PhD or Masters student in similar discipline) with Good Clinical Practice Certification. Training in the intervention will be designed by the EARLI-comm investigator team, and delivered by the Chief Investigator, with input from investigators with specific expertise (clinical psychology, palliative care, geriatrics) and partner organisations (e.g. HIV service providers) or third party training organisations (e.g. trauma-informed practice training) as relevant. The training will be delivered face to face where possible, or by video-conference in situations where the study facilitator is not based in Sydney. It is anticipated that the duration of the training will be approximately 22 hours (3 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 or at a designated study site. The intervention culminates in a meeting (visit 4) with 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-comm intervention study visits are described below:

Session 1 (Life Review Interview): in an approximately 60 minute session, the study facilitator 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 study facilitator 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 study facilitator 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 study facilitator 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 facilitator, participant, supporter, and a member of participant’s primary care team.

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, within the twelve week period post study consent. 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 assisting the supporter in their role as a substitute decision-maker (if relevant).

A post-visit review form will be used to monitor intervention adherence for every visit.
Intervention code [1] 327918 0
Treatment: Other
Comparator / control treatment
The wait-list control group receives usual care for the period of the 12-week follow up, while being asked to complete all PROMs as per the intervention group. After completion of the 12-week PROMs, participants in this group are then invited to participate in the intervention, with no requirement for further collection of PROMs.
Control group
Active

Outcomes
Primary outcome [1] 337295 0
Advance care planning engagement for participants
Timepoint [1] 337295 0
Baseline, 8 weeks, 12 weeks post-consent. Primary endpoint is 12 weeks post-consent
Secondary outcome [1] 431370 0
Readiness to engage as a substitute decision-maker among supporters
Timepoint [1] 431370 0
Baseline, 8 weeks and 12 weeks post consent.
Secondary outcome [2] 431374 0
Decisional conflict among participants
Timepoint [2] 431374 0
Baseline and 8-weeks post-consent.
Secondary outcome [3] 431375 0
Decisional conflict among supporters
Timepoint [3] 431375 0
Baseline and 8-weeks post-consent.
Secondary outcome [4] 431376 0
Participant preferred treatment approach
Timepoint [4] 431376 0
Baseline and 8-weeks post-consent.
Secondary outcome [5] 431377 0
Psychosocial wellbeing among participants
Timepoint [5] 431377 0
Baseline and 12-weeks post-consent.
Secondary outcome [6] 431378 0
Psychosocial wellbeing among supporters
Timepoint [6] 431378 0
Baseline and 12-weeks post-consent.
Secondary outcome [7] 431379 0
Participant relationship quality with the supporter among participants
Timepoint [7] 431379 0
Baseline and 8-weeks post-consent.
Secondary outcome [8] 431380 0
Supporter relationship quality with the participant among supporters
Timepoint [8] 431380 0
Baseline and 8-weeks post-consent.
Secondary outcome [9] 431381 0
Meaning-based coping among participants
Timepoint [9] 431381 0
Baseline and 8-weeks post-consent.
Secondary outcome [10] 431382 0
Self-transcendence among participants
Timepoint [10] 431382 0
Baseline and 8-weeks post-consent.

Eligibility
Key inclusion criteria
The inclusion criteria for participants are:
1. Belonging to one of the three eligible study populations:
a) aged 45 years or older and diagnosed with a progressive (life-limiting) neurological condition (dementia, Parkinson's disease, Huntington's disease, Motor Neurone disease or mitochondrial disease); or
b) aged 45 years or older and diagnosed with Human Immunodeficiency Virus (HIV); or
c) aged 65 years or older and scoring between 3 and 7 on the Rockwood Clinical Frailty Scale
d) to avoid ambiguity, a person with a cancer-related diagnosis who also meets criteria 1a, 1b or 1c (and does not meet exclusion criteria 5) will be eligible;
2. Living in a private residence in Western Australia or New South Wales (own or rented dwelling, including retirement village or other co-operative housing, but NOT a residential aged care facility);
3. Able to communicate in English, Italian, or Chinese (Mandarin or Cantonese);
4. (if self-referred) Able and agree to visit one of the approved study sites to undertake screening assessment, written informed consent and baseline data collection in person;
5. Capable of providing informed consent at initial recruitment and answering baseline questions (successfully completing at least 75% of baseline questions.

The inclusion criteria for supporters are:
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
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for participants are:
1. Unable to or refuse to nominate a general practitioner, treating medical specialist or care navigator for liaison with the study team;
2. The participant's nominated general practitioner, treating medical specialist or care navigator expresses significant concern about participant or research team safety (either for the participant or for the facilitator) which cannot be appropriately managed (e.g. via use of personal protective equipment and physical distancing, or use of video-conferencing;
3. A baseline cognitive assessment indicates greater than moderate level of cognitive impairment (Telephone Montreal Cognitive Assessment Score <8);
4. (only for older adults experiencing frailty study population) A baseline assessment on the Clinical Frailty Scale (CFS) indicates a complete absence of frailty (CFS score <3) or greater than severe frailty (CFS score >7);
5. It becomes known that the person is expected to die within 'days or weeks' (based on information provided by a care provider, care navigator, treating medical specialist and/or participant's general practitioner during recruitment process [i.e. between the time of referral and up until the completion of the informed consent process and follow up with care navigator/doctor].

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 to the intervention and wait-list control group will be undertaken at the time of recruitment by a centrally controlled randomisation algorithm not visible to research team personnel who are coordinating recruitment.
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
For the primary outcome – participant advance care planning engagement survey scores at baseline and 12 week follow up will be analysed across groups. Analysis will be undertaken by an analyst blinded to participant allocation, following the collection of 12-week follow up data for all participants. The primary outcome is a comparison of participant scores on the 9-item advance care planning engagement survey at 12-weeks post-consent, between participants in the intervention and waitlist control groups, while controlling for baseilne rates of advance care planning engagement across both groups. The statistical test will be a linear mixed model regressing advance care planning engagement on allocated group, including baseline ACP engagement survey score as a covariate. Covariate adjustments will be applied if the variables assessed in baseline comparisons showed significant differences between groups. Missing data at follow up will be handled by multiple imputation.



For the secondary outcomes – the statistical test (unless otherwise specified) is a linear mixed model, regressing the outcome measure on allocated group, with 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. Missing data at follow up will be handled by multiple imputation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2024
Actual
27/03/2024
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
120
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 315754 0
Government body
Name [1] 315754 0
National Health and Medical Research Council
Country [1] 315754 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 317867 0
None
Name [1] 317867 0
Address [1] 317867 0
Country [1] 317867 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314612 0
The University of New South Wales Committee C
Ethics committee address [1] 314612 0
Ethics committee country [1] 314612 0
Australia
Date submitted for ethics approval [1] 314612 0
22/11/2023
Approval date [1] 314612 0
22/01/2024
Ethics approval number [1] 314612 0
iRECS 5184

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

Contacts
Principal investigator
Name 132174 0
Dr Craig Sinclair
Address 132174 0
Neuroscience Research Australia (NeuRA), 139 Barker Street, Randwick NSW 2031
Country 132174 0
Australia
Phone 132174 0
+61 2 9399 1095
Fax 132174 0
Email 132174 0
c.sinclair@unsw.edu.au
Contact person for public queries
Name 132175 0
Craig Sinclair
Address 132175 0
Neuroscience Research Australia (NeuRA), 139 Barker Street, Randwick NSW 2031
Country 132175 0
Australia
Phone 132175 0
+61 2 9399 1095
Fax 132175 0
Email 132175 0
c.sinclair@unsw.edu.au
Contact person for scientific queries
Name 132176 0
Craig Sinclair
Address 132176 0
Neuroscience Research Australia (NeuRA), 139 Barker Street, Randwick NSW 2031
Country 132176 0
Australia
Phone 132176 0
+61 2 9399 1095
Fax 132176 0
Email 132176 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.


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.