RecruitingACTRN12622001399785

The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) Project Cluster Randomised Controlled Trial

Efficacy of the Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) Project: A Cluster Randomised Controlled Trial

Sponsor

University of New South Wales

Enrollment

384 participants

Start Date

Feb 17, 2023

Study Type

Interventional

Conditions

Cancer Frailty Respiratory disorders

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 a defined period of time, 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 that this study will determine whether this program is effective in helping older adults in the home care setting to be clearer about their values, preferences and plans for the future, while strengthening relationships and improving wellbeing.

Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

The EARLI project is testing a structured program to help older Australians who receive home care services think through and document their wishes for future medical care — a process called Advance Care Planning (ACP). ACP allows people to express their values and preferences for healthcare in advance, so that if they reach a point where they can no longer make decisions themselves, those caring for them know what matters most. This is especially important for older adults living with chronic illness, frailty, or early cognitive changes. Participants in the EARLI program will meet with a trained researcher every two weeks for up to 10 weeks. These sessions walk participants through a guided ACP process, helping them think about their goals, discuss their preferences with their GP and aged care team, and put those wishes into writing. The comparison group receives a single 30-minute introduction to ACP resources instead. The full program runs for three months. You may be eligible if you are 65 or older (or 50+ if you identify as Aboriginal or Torres Strait Islander), currently receive a Home Care Package, live in your own home (not a residential aged care facility), and are able to communicate in English, Italian, or Mandarin/Cantonese. You would not be eligible if you have significant cognitive impairment, are extremely frail, or are expected to pass away within days to weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 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.