RecruitingACTRN12624000218594

The Enhanced Advance care planning and life Review Longitudinal Intervention Community Outreach (EARLI-comm) Project

Assessing the impact of the Enhanced Advance care planning and life Review Longitudinal Intervention Community Outreach (EARLI-comm) program on advance care planning engagement

Sponsor

University of New South Wales

Enrollment

120 participants

Start Date

Mar 27, 2024

Study Type

Interventional

Conditions

Cancer Frailty Human Immunodeficiency Virus (HIV)Respiratory disorders

Summary

The Enhanced Advance care planning and life Review Longitudinal Intervention Community Outreach (EARLI-comm) Project 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. The EARLI-comm project focuses on enabling diverse adults with diagnosed life-limiting conditions and/or emerging frailty to express their values, goals and preferences regarding future care and treatment. Who is it for? You may be eligible for this study if you are aged 45 years or older, you have been diagnosed with a life-limiting neurological condition (dementia, Parkinson's disease, Huntington's disease, Motor Neurone disease, mitochondrial disease) or Human Immunodeficiency Virus (HIV). Adults (aged 18 years or older) who also provide support/care to participants who meet these criteria will also be eligible to participate and provide their feedback on the EARLI-comm program. 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 by chance (similar to flipping a coin) to one of two groups. The first group will receive the EARLI-comm program which involves meeting with a member of the research team every fortnight for up to 12 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 continue with their usual care for 12 weeks. After the 12 weeks of follow-up has been completed for both groups, participants who were allocated to the second group will be able to commence the EARLI-comm program if they wish. The overall duration of participation in this study will be 12 weeks 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: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Advance care planning is the process of thinking through and recording your wishes about future medical treatment — especially important if you later reach a point where you cannot communicate those wishes yourself. While widely recommended for older adults with serious illness or emerging frailty, it is often not done, or not done well. The EARLI-comm project brings advance care planning directly into the homes of people who need it most. Participants will be randomly assigned to meet with a research team member every fortnight for up to 12 weeks, going through a structured process to clarify their values, goals, and preferences for future care, and connecting these with their GP or specialist team. The other group continues with usual care for 12 weeks before being offered the program. You may be eligible if you are 45 or older and have a progressive neurological condition (such as dementia, Parkinson's disease, or motor neurone disease), HIV, or if you are 65 or older and are assessed as frail. Supporters (carers) aged 18 and over are also eligible to participate. You must live in WA or NSW in a private residence and be able to communicate in English, Italian, or Mandarin/Cantonese.

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-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, s

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.