Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000834752
Ethics application status
Approved
Date submitted
28/04/2022
Date registered
14/06/2022
Date last updated
10/09/2023
Date data sharing statement initially provided
14/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) Project Pilot Feasibility Study
Scientific title
The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) Project Pilot Feasibility Study
Secondary ID [1] 307025 0
None
Universal Trial Number (UTN)
U1111-1277-8220
Trial acronym
EARLI-Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 326326 0
Frailty 326327 0
Cancer 326328 0
Cardiovascular disease 326329 0
Neurological disorders 326331 0
Respiratory disorders 326333 0
Kidney disease 326334 0
Liver disease 326335 0
Condition category
Condition code
Neurological 323472 323472 0 0
Neurodegenerative diseases
Neurological 323637 323637 0 0
Other neurological disorders
Cancer 323638 323638 0 0
Any cancer
Cardiovascular 323639 323639 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 323640 323640 0 0
Other cardiovascular diseases
Oral and Gastrointestinal 323641 323641 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 323642 323642 0 0
Kidney disease
Respiratory 323643 323643 0 0
Other respiratory disorders / diseases
Respiratory 323644 323644 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 8 hours (full day), 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. This more detailed monitoring will be undertaken for 10/10 intervention participants during the pilot feasibility trial phase.
Intervention code [1] 323476 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] 331215 0
Screening feasibility: a composite measure, defined as the number of relevant home care clients who are identified as potentially eligible from initial (care provider) screening, AND definitely eligible from follow-up (research team) screening, as a proportion of the overall number of home care clients for which an initial screen was undertaken. The total number of screened clients, number of potentially eligible clients and number of definitely eligible clients will be determined by an audit of the study screening logs.
Timepoint [1] 331215 0
At the completion of active screening
Primary outcome [2] 331395 0
Study acceptability: the number of participants who give consent to participate and complete baseline measures, as a proportion of the overall number of home care clients identified as definitely eligible. Number eligible clients approached, numbers giving consent and numbers completing baseline measures will be determined by an audit of the study database.
Timepoint [2] 331395 0
At the completion of recruitment
Primary outcome [3] 331396 0
Study retention: the number of participants who remain in the study at the completion of allocated study visits (intervention or active control) and complete 3-month follow up measures, as a proportion of the participants who gave consent to participate and completed baseline measures. The number of participants who commenced the study (i.e. gave consent and completed baseline measures) and remained in the study at completion of 3-month follow up measures will be determined by an audit of the study database.
Timepoint [3] 331396 0
3-month follow up after the date of participant consent
Secondary outcome [1] 409212 0
Advance care planning engagement: as measured by a 4-item measure of readiness to engage in key advance care planning behaviours
Timepoint [1] 409212 0
3-month follow up after the date of participant consent
Secondary outcome [2] 409213 0
Care partner advance care planning engagement: measured by a 4-item measure of readiness to engage in a number of relevant advance care planning behaviours as a substitute decision-maker
Timepoint [2] 409213 0
3-month follow up after the date of participant consent
Secondary outcome [3] 409214 0
Decisional conflict: as measured by a 10-item survey answered in relation to a choice made about a hypothetical care or treatment scenario
Timepoint [3] 409214 0
3-month follow up after the date of participant consent
Secondary outcome [4] 409215 0
Care partner decisional conflict: as measured by a 10-item survey answered in relation to a choice made about a hypothetical care or treatment scenario
Timepoint [4] 409215 0
3-month follow up after the date of participant consent
Secondary outcome [5] 409216 0
Psychosocial wellbeing: as measured by the 14-item Hospital Anxiety and Depression Scale
Timepoint [5] 409216 0
3-month follow up after the date of participant consent
Secondary outcome [6] 409217 0
Care partner psychosocial wellbeing: as measured by the 14-item Hospital Anxiety and Depression Scale
Timepoint [6] 409217 0
3-month follow up after the date of participant consent
Secondary outcome [7] 409218 0
Quality of patient-caregiver relationship: as measured by the 8-item 'warmth and affection' subscale of the Quality of Patient-Caregiver Relationship scale
Timepoint [7] 409218 0
3-month follow up after the date of participant consent
Secondary outcome [8] 409219 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 [8] 409219 0
3-month follow up after the date of participant consent
Secondary outcome [9] 409220 0
Care partner 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 [9] 409220 0
3-month follow up after the date of participant consent
Secondary outcome [10] 409728 0
Care-recipient completed advance care directives in the aged care provider client record at 3 month follow up (as assessed by client record audit)
Timepoint [10] 409728 0
3-month follow up after the date of participant consent

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, Commonwealth Home Support Program, or commensurate self-funded service);
5. able to communicate in English, Italian or Mandarin;
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 Mandarin
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 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)
Simple randomisation using a computer sequence generation procedure
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
One aged care provider home care service 'study site' has agreed to participate in the pilot feasibility trial. For consistency with the cross-over cluster randomised controlled trial design used in the broader trial, the allocation sequence will be the first 10 consecutively recruited participants will be recruited to the 'intervention' group, while the second 10 consecutively recruited participants will be recruited to the 'active control' group. On successful recruitment of the target sample of 20 participants, this study site will be merged into the main trial along with other participating study sites.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Number of participants identified as potentially eligible, approached, screened as definitely eligible, consented and completing the allocated treatments and follow up measures. Where reasons for refusal or loss to study follow up are known, these will be recorded and reported in a CONSORT style flowchart for the pilot study sample.
For measures of advance care planning engagement, advance care planning substitute decision-maker engagement, decisional conflict, psychosocial wellbeing, quality of patient carer relationship and meaning in life – Cohen’s d effect size and ANCOVA (correcting for baseline scores and allocated group) between pre- and post- measures for the EARLI intervention and active control groups.
For measures of dyadic concordance – Cohen’s kappa measures of agreement between care-recipients and care-partners on responses to hypothetical care and treatment scenarios, pre- and post-intervention for the EARLI intervention and active control groups.
For measures of care-recipient completed advance care directives in the client record at 3-month follow up – chi square analysis between pre- and post-intervention for the EARLI intervention and active control groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2022
Actual
16/11/2022
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311337 0
Government body
Name [1] 311337 0
National Health and Medical Research Council
Country [1] 311337 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 312713 0
None
Name [1] 312713 0
Address [1] 312713 0
Country [1] 312713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310834 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 310834 0
Research Ethics & Compliance Support
UNSW Sydney
Barker Street
Sydney NSW 2052 Australia
Ethics committee country [1] 310834 0
Australia
Date submitted for ethics approval [1] 310834 0
02/05/2022
Approval date [1] 310834 0
05/07/2022
Ethics approval number [1] 310834 0
HC220271

Summary
Brief summary
The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) aims to enable older adults to effectively engage with Advance Care Planning (ACP), in the home care setting. Advance care planning is the process by which older adults, or people who are experiencing chronic disease, terminal illness (including cancer) and/or are at risk of dementia and similar conditions can provide instructions to their carer/s about their main preferences and goals for future care, should they reach a stage where they may not be able to make these decisions on a day-to-day basis.

Who is it for?
You may be eligible for this study if you are aged 65 years or older (50 years or older for Aboriginal or Torres Strait Islander people), you have had a previous aged care assessment team (ACAT) assessment, you are living in a private residence (own or rented dwelling, including retirement village or other co-operative housing, but NOT a residential aged care facility) and you are 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). Participants who meet these criteria and have been diagnosed with cancer will also be eligible.

Study details
Participants who choose to enrol in this study will be allocated to one of two groups. The first group will receive the EARLI program which involves meeting with a member of the research team every fortnight for up to 10 weeks. Each meeting is expected to last up to 1 hour and these participants will be guided through the ACP process and given an opportunity to discuss their goals and preferences with members of their aged care and primary care (GP or other specialist) teams. The second group will be given one 30 minute session which provides a brief introduction to ACP and directs participants to available resources. The allocation into the first or second group is randomised (like flipping a coin) - each aged care provider study site will be randomly allocated to recruit for the first or second group for 2 months, before swapping over. Each participant will be invited to participate in just one of the groups, with the allocation depending on which stage of the process the aged care organisation is in at the time the participant is recruited to the study. The overall duration of participation in this study will be 3 months from the date of enrolment.

It is hoped this research will determine whether it is possible to deliver the EARLI program in the Australian home care setting and gather initial details on the effect of these modules on participants' confidence in making decisions. If the current study is positive, these results will be used to guide a larger clinical trial that may enrol participants across multiple sites in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119030 0
Dr Craig Sinclair
Address 119030 0
Neuroscience Research Australia (NeuRA)
139 Barker Street,
Randwick, NSW
2031
Country 119030 0
Australia
Phone 119030 0
+61 2 9399 1095
Fax 119030 0
Email 119030 0
c.sinclair@unsw.edu.au
Contact person for public queries
Name 119031 0
Dr Craig Sinclair
Address 119031 0
Neuroscience Research Australia (NeuRA)
139 Barker Street,
Randwick, NSW
2031
Country 119031 0
Australia
Phone 119031 0
+61 2 9399 1095
Fax 119031 0
Email 119031 0
c.sinclair@unsw.edu.au
Contact person for scientific queries
Name 119032 0
Dr Craig Sinclair
Address 119032 0
Neuroscience Research Australia (NeuRA)
139 Barker Street,
Randwick, NSW
2031
Country 119032 0
Australia
Phone 119032 0
+61 2 9399 1095
Fax 119032 0
Email 119032 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. In the main trial the use of linked administrative data (for hospital, primary care and aged care utilisation) 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.