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Abstract
Introduction The multifaceted impact of dementia means that people living with dementia require multidisciplinary care across different services and settings; however, these care transitions pose a risk of fragmented care. Models that improve integration and coordination of care in the community are needed.
Methods and analysis This randomised control trial will test the effectiveness and cost effectiveness of a dementia nurse-led intervention to: (1) increase days lived in the community at 12-month follow-up (primary outcome) among people living with dementia and (2) improve quality of life for people living with dementia and their carers, compared with usual care. Participants are recruited from several sources including private and public geriatric medicine clinics, carer support groups and self-referral. People living with dementia and their carers are randomised as a dyad to (1) usual care or (2) dementia nurse-led care-coordination. The dementia nurse will provide care coordination and direct support through a tailored, integrated and patient-centred approach. The needs of people living with dementia will be identified and addressed, with a focus on improving the management of comorbidities, risk reduction and symptoms. Carers will also receive support. The model for people living with dementia will focus on days lived in their community as the outcome variable. Differences between groups in quality of life at 12-month follow-up will be assessed using linear mixed effects regression. Analysis will follow the intention to treat principles. People living with dementia and carers’ data will be analysed separately and collectively for the economic study.
Ethics and dissemination The trial has been approved by the Hunter New England Research Ethics Committee (2023/ETH01221) and the University of Newcastle Ethics Committee (R-2024–0021). Trial findings will be disseminated via peer-reviewed publications and conference presentations. If the intervention is effective, the research team aims to further implement the intervention as usual care within the participating services and beyond.
Trial registration number The trial was prospectively registered via the Australian New Zealand Clinical Trials Registry: ACTRN12624000235505. Registration date: 11 March 2024.
- Quality of Life
- Dementia
- Nursing Care
- Randomized Controlled Trial
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The primary outcome (days lived in community at 12-month follow-up) is measured using objective, routinely collected health service data. This trial uses a large-scale randomised controlled trial design to assess intervention effectiveness.
People living with dementia will not be eligible to participate in the trial if they do not also have a carer that agrees to participate. This limits the generalisability of results to those without a carer.
Due to the nature of the intervention, it is not possible to blind care providers or participants.
Introduction
Dementia is incurable and progressive; thus, the goals of care are maximising quality of life (QoL) and supporting independence for as long as possible. Its impact on the QoL is profound.1 As dementia progresses, difficulties may extend to core activities of daily living, communicating and self-care.1 People living with dementia may require multidisciplinary care across different services and settings; however, these care transitions pose a risk of fragmented care.2 Unplanned transitions place added strain on the health system and are also linked to adverse health outcomes3 and decreased QoL.4
Two-thirds of people living with dementia live in the community, supported by informal carers.5 Carers assist with self-care, mobility, communication, cognitive tasks, household chores and management of healthcare and finances.6 However, carers also report a reduced QoL7 and depression.8 Dyadic interventions that address the inter-related needs of people living with dementia and their carers, in tandem, are required.
A person-centred approach to care is considered best practice.2 Given the complex causes of unplanned transitions,3 interventions should have a multifocal, tailored approach to address the range of factors that contribute to these adverse outcomes. This includes chronic disease and multimorbidity management, as multimorbidity places people living with dementia at greater risk of unplanned care transitions.9 More than 90% of people living with dementia have a physical comorbidity,10 and the greater the number of comorbid chronic conditions, the poorer the QoL.11 Cognitive impairment is also associated with lower levels of therapeutic adherence to chronic condition care,12 posing further challenges for primary care. Factors such as polypharmacy, falls and carer strain have all been associated with an increased risk of transition from community to hospital for people living with dementia.13 To some extent, these factors are potentially preventable in the community.
However, barriers to reducing risks of unplanned transitions among people living with dementia exist. A systematic review identified general practitioner (GP) barriers to dementia care, including a lack of clear referral pathways, a lack of time to manage patients with dementia and an inability to support carers.14 To optimise outcomes, people living with dementia require a horizontal integration of care across health and social sectors, as well as vertical integration across primary, community and hospital settings.15
Nurse-led care coordination interventions are a promising mechanism for integrating dementia care.2 Care coordination models that include structured assessments and care planning with input from a primary care provider show promise as best-practice service delivery.16 17 None of the studies included in these reviews were conducted in Australia. However, the published Australian feasibility studies of nurse-led approaches demonstrate the potential for such care models. In one study, the feasibility of a community nurse-led reablement intervention for people living with dementia was demonstrated.18 The feasibility of a nurse-led intervention for people living with dementia that involved integration with general practice care has also been examined.19 The latter study involved a structured assessment conducted as part of a home visit, followed by a case conference with the patient’s GP and general practice nurse, to develop a care plan.19 The intervention was valued by GPs, general practice nurses and patients.19
The dementia nurse-led intervention, in the current work, builds on a prior feasibility study19 and will embed the dementia nurse’s role in an existing primary health service and extend the dementia nurse’s role to include the coordination of postdiagnostic care, assessment of the impact on unplanned transitions and QoL.
Methods and analysis
Aims
To test the effectiveness and cost effectiveness of a dementia nurse-led intervention in achieving:
Increased days lived in the community at 12-month follow-up among people living with dementia (primary outcome),
Improved QoL of people living with dementia and their carers.
Design
Using an unblinded randomised controlled design, dyads of people living with dementia and their carers will be randomly assigned to receive either (1) usual care or (2) usual care plus dementia nurse-led care-coordination. Data will be collected at baseline (study entry) and at 6-month and 12-month follow-ups. This study’s design and analysis were preregistered with the Australian New Zealand Clinical Trials Registry: ACTRN12624000235505. Registration date: 11 March 2024. This study protocol is reported in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) recommendations, SPIRIT checklist and Template for Intervention Description and Replication checklist (online supplemental material).
Supplemental material
Setting
The study will be conducted in the Greater Newcastle and Lake Macquarie regions of New South Wales, Australia. Participants will be recruited from several sources (see Recruitment section below).
Trial status
Recruitment commenced on 10 May 2024. As of 4 October 2024, 14 participants are enrolled. Data collection is expected to conclude in June 2027.
Sample
Eligibility criteria for people living with dementia
People who are aged 65 years or older, have a medical diagnosis of any type and stage of dementia or who have suspected dementia with a score of 88 or below on the Addenbrooke’s Cognitive Examination-III (ACE-III),20 attend a participating health or support service, are living in the community and have an adult carer are eligible. Those who have a clinician-judged life expectancy of less than 12 months or are receiving intensive and ongoing support from the Hunter New England Community Dementia Services will be excluded.
Eligibility criteria for carers
Participants living with dementia will be asked to nominate an informal, adult carer. This is defined as a person who is the main source of practical and/or emotional support for the person living with dementia. Eligible carers are those aged ≥18 years and able to provide informed consent.
Recruitment
Participant recruitment
Participants will be recruited from several sources including private and public geriatric medicine clinics, as well as services that fall under Hunter New England Local Health District’s Aged and Community Care Services, such as: Aged Care Assessment Services, Regional Assessment Services, Hospital in the Home, Out of Hospital Care Program, Transitional Care Program, Community Dementia Nurse Service and Dementia Advisory Service (for carers of people living with dementia). The study will be promoted on social media, including Facebook pages of dementia organisations, Hunter Medical Research Institute (HMRI), Hunter Primary Care and other reputable healthcare or dementia-specific services. This will enable people living with dementia and/or their carers to self-refer to the study. Further, the study will be promoted at community meetings (such as carer support groups), Dementia Australia community groups and other forums. A study brochure will be given to people who are interested in the study or who wish to pass the brochure onto a friend/family member. In addition, the StepUp for dementia research platform will be used. This platform provides a register of potentially eligible people living with dementia who have registered their interest in taking part in dementia-related research; those registered are matched to eligible studies being undertaken in their local government area. The research team contacts those who are matched, via their registered preferred method of contact, regarding potential recruitment to this study.
Health services taking part in recruitment will provide information about the study to their potentially eligible clients. This will involve identifying people living with a confirmed or likely diagnosis of dementia and providing them with a study information pack or study brochure. Services will send up to two blanket reminder letters or emails to eligible clients who receive an information pack.
Carer recruitment
If the main carer is not present when the person living with dementia has contact with the service/geriatrician, the service staff will confirm with the client who their main carer is and seek permission to email/mail the carer a study information pack; or if preferred by the client, the client will be provided with a study information pack to pass onto their carer.
Eligibility confirmation and informed consent
People living with dementia and their carers who are interested in the study will contact the research team via phone. Researchers will provide an overview of the study and answer any questions. If the person living with dementia and their carer agree, then the researcher will organise an appointment to visit the person with dementia and their carer in their home. During this visit, the researcher will provide a verbal overview of the study, answer any further questions and seek written informed consent. See online supplemental material: consent form. The ACE-III will be administered to all the potential participants to determine the level of cognitive impairment and to confirm eligibility in the case of those without a formal diagnosis of dementia. The need for supported decision making will be determined by administering the ‘evaluation to consent form’. This form asks the person living with dementia to explain in their own words the purpose of the research, its risks and benefits and whether consent is voluntary. If supported decision-making is required, the person living with dementia and their carer will discuss and confirm consent together. If the person living with dementia is unable to demonstrate the ability to consent but wishes to participate and has an enduring guardianship arrangement in place, enduring guardian consent will be sought. At each follow-up home visit, the researcher will reconfirm understanding of what the project involves and willingness to continue to participate. The methods used at initial consent will be used to establish whether guardian or supported decision-making is required. If the person with dementia is unable to complete the follow-up survey due to declining health, data from the carer’s proxy Dementia QoL (DEMQOL) survey can be used.
Research staff are provided with training to ensure they have appropriate skills to conduct home visits, including sensitivity and privacy protection, and are aware of any minor possible health and safety risks and can respond appropriately and follow the protocols approved by the ethics committee. Training related to recruiting participants with cognitive difficulties and conducting the ACE-III is provided by an experienced clinical psychologist (MK) who has worked closely with people living with dementia as well as their carers for more than 10 years.
Recruitment of general practitioners and practice nurses
Consenting persons living with dementia, who are allocated to the intervention group, will be asked to nominate their regular treating GP. The GP will be sent a study information letter informing them that their patient is participating in the study. The dementia nurse will also contact the patient’s GP and ask if they would be willing to participate, together with their practice nurse(s), in a case conference (or similar consultation funded under the Medicare Benefits Schedule (MBS)) with the study dementia nurse. If the GP is willing for the practice nurse to be involved, the nurse’s contact details will be obtained, and a study information sheet will be sent. The practice will be offered $A100 as a contribution towards the cost of the practice nurse’s time. An MBS item number is available for the GP to claim participation in a case conference.
GPs and practice nurses may also be invited to take part in an interview (at approximately 6 months postrecruitment). Consent for this component will be audio-recorded at the time of the interview.
Randomisation and blinding
People living with dementia are randomised after confirming their eligibility (ACE-III score >88) to either the usual care group or the intervention group. Randomisation will be stratified by referral source ((a) geriatrician clinic; (b) other health service; (c) community group or self-referral) and time since diagnosis ((a) diagnosed within the last 3 months or no formal diagnosis but meets ACE threshold for cognitive impairment; (b) prevalent dementia (diagnosed more than 3 months ago)).
People living with dementia and carers will be randomised as a unit (dyad) using a computer-generated randomisation sequence with block sizes of 4–6. Randomisation will be facilitated by uploading a randomisation schedule into the study’s REDCap database, hosted on a secure HMRI server. Given the nature of the intervention, it is not possible to blind care providers or participants. Therefore, the primary outcome selected is an objective measure: days lived in the community at 12-month follow-up.
Usual care
Geriatricians and/or GPs will provide usual care. For example, at the time of dementia diagnosis, geriatricians may refer to My Aged Care and Dementia Australia. GPs manage ongoing care and may refer to My Aged Care. In Australia, people may receive subsidies for certain services through the MBS item numbers. For example, up to five allied health consultations and reviews of care plans. However, there is no established common structured method for assessing needs or facilitating access to multidisciplinary care or interventions aimed at improving QoL specifically for people living with dementia.
Intervention
The intervention will be delivered via a partner organisation—Hunter Primary Care. This not-for-profit organisation operates and delivers programmes commissioned by the Primary Health Network (PHN). People living with dementia and their carers allocated to the intervention arm will be referred to a dementia nurse, employed by Hunter Primary Care.
The dementia nurse’s role is to provide direct support to the person with dementia, their carer and GP/general practice nurse through care-coordination. This will comprise:
Assessing needs and priorities of the person with dementia and their carer: the dementia nurse will conduct a home visit and complete a well-being assessment. This will assess the person’s need for additional help across a range of areas including mobility, functional (activities of daily living), healthcare needs, mental health and practical support. A shared decision-making approach will be used to identify priorities for care planning.
Case conference or similar MBS-funded consultation: the dementia nurse will organise a case conference with the patient’s GP and practice nurse. Results of the dementia nurse assessment and any recommendations arising from this will be discussed. The discussion will cover the domains listed in Dementia Australia Training GP care plans for dementia: cognitive, functional, psychiatric, behavioural and physical domains. These resources are tailored to the stage of dementia, so the needs of participants who are at early versus later stages can be systematically considered.
Care coordination and integration: in line with any agreements with the GP and practice nurse, the dementia nurse will follow-up on referrals to community programmes, Dementia Australia, community nursing and assist the person living with dementia and their carer to navigate the health and aged care system.
Brief interventions: the dementia nurse will provide up to four targeted brief intervention sessions with the person with dementia and their carer. The focus of these will be informed by priority issues identified in the assessment and care plan. These may include:
Knowing what to expect: the dementia nurse will provide an overview of common behavioural and psychological symptoms of dementia and strategies for management of these symptoms.
Safety management: using a shared decision-making approach, the dementia nurse will explore how risks can be mitigated while supporting reasonable risk that aims to promote ongoing independence and dignity.
Taking control: the dementia nurse will identify strategies to integrate meaningful activities into day-to-day life.
Planning for the future: the dementia nurse will discuss the benefits of establishing an advance care plan, an enduring power of attorney and an enduring guardianship and provide information on respite care, residential aged care and other services that may be required in the future.
Review and second case conference (6 months postreferral): the dementia nurse will reassess the person living with dementia’s needs and discuss the adequacy of existing support with them and their carer. The dementia nurse will contact the patient’s GP and offer to participate in a second case conference (or similar MBS-funded consultation) to provide feedback on the results of the reassessment as well as any other issues arising from the brief interventions delivered.
Managing chronic conditions
The implications for ongoing management of existing chronic conditions in association with a dementia diagnosis will be discussed if applicable. For example, clients may require additional assistance with managing a healthy diet, taking medications or attending appointments.
Care planning and support for multidisciplinary care
The GP/general practice nurse will be asked whether referrals to allied health, specialists or aged care services should be made based on the dementia nurse assessment. A copy of any existing or new/revised care plan will be sent to the dementia nurse. This will specify which team member is responsible for which actions (GP, practice nurse or dementia nurse). Revision of care plans will be subsidised for the patient by Medicare. New care plans may be subsidised by Medicare once annually.
Facilitating timely communication across settings
The dementia nurse will recommend the general practice nurse to provide the person living with dementia and carer with a copy of the health summary. This is an automated summary that is produced by practice software that shows key diagnoses and medications. They will be asked to advise the carer that in the event of an unplanned transition (eg, Emergency Department (ED) presentation), they should provide the health summary to the treating doctor.
Addressing carer needs
The intervention aims to address carer needs as well as the needs of the person living with dementia. Carers will attend dementia nurse sessions with the person living with dementia and be provided with strategies to support their family member at home. Care coordination aspects of the intervention will aim to support the role of the carers in navigating the health system. Carers will also be supported to discuss, together with the person living with dementia, safety issues and planning for future healthcare transitions. If the carer is experiencing significant stress or burden in their carer role, displaying symptoms of depression or other mental illness or needing their own aged care services, then the carer will be supported to access relevant services. Carers will be able to contact the dementia nurse with questions in between scheduled appointments and will receive information about where to access help outside of business hours.
Nurse training and resources
Registered nurses with experience in aged and dementia care are trained in the intervention procedures to fulfil the role of the dementia nurse, meeting the needs of this project. An intervention training manual was developed by the multidisciplinary team with input from consumers. It comprises recommendations to map to specific psychosocial, functional and cognitive impairments identified as part of the assessment. These include recommendations on types of interventions/supports that may be helpful and how to modify chronic condition self-management tasks to align with the needs of people with cognitive impairment. These intervention resources will ensure that the intervention can be replicated if successful.
Patient and public involvement statement
Intervention development and study design was based on a codesign process with consumers, clinicians and dementia service providers to examine current gaps in dementia care and solutions for the future. Participants perceived that people living with dementia were likely to experience fragmented care, resulting in unnecessary health crises and a more rapid decline in health compared with those that would occur under optimal care conditions. Recommendations included the need for a proactive approach to care, including enhanced support for GPs via dementia nurses. This intervention is directly informed by: (1) needs identified in the peer-reviewed literature; (2) findings from a needs analysis of Australian community-dwelling people living with dementia and their carers exploring unmet needs21 22; people living with dementia’s perceptions of quality of care and depression23; (3) recommendations arising from our codesign process. It will build on a previous feasibility study19 by: (1) extending the dementia nurse’s role to include the coordination of care; (2) assessing impact on unplanned transitions and QoL; (3) embedding the dementia nurse’s role in an existing primary health service funded by a PHN. Results of the codesign process and the feasibility study19 suggest that this model will be feasible and acceptable to stakeholders.
Data collection
Data will be collected from people living with dementia and carers at baseline and 6-month and 12 month follow-ups (see figure 1 for a summary of measures at each timepoint). Data will be collected from people living with dementia via face to face interviews administered in the participant’s home by a trained research assistant. Remote options will be provided in the event of COVID-19 outbreaks or participant preferences. Carers will complete telephone interviews or paper surveys, depending on preference. Carers will be sent one written reminder followed by one telephone reminder. Linked hospitalisation data will also be obtained for participants. As a token of appreciation of participants’ time, people living with dementia and their carers will be offered a $A20 gift voucher following completion of the 6-month and 12-month follow-up measures.
Participant timeline: Standard Protocol Items: Recommendations for Interventional Trials chart. PCompleted by proxy carer. 6FU, 6-month follow-up; 12FU, 12-month follow-up.
Outcomes
Primary outcome (people living with dementia)
The primary outcome will be days spent in the community in the 12 months of follow-up. This objective outcome will be calculated by total days (365) minus days spent in an emergency department admission, unplanned hospital admission, permanent residential aged care and days where the person was deceased (if applicable). Time spent in respite will not be included because planned use of respite may be a strategy to reduce unplanned/crises transitions. Data will be collected by carer self-report with verification of ED presentations and unplanned hospitalisation using Hunter New England Local Health District (HNELHD) administrative records.
Secondary outcomes
Quality of life
The DEMQoL will be used to assess QoL among people living with dementia.24 The questionnaire consists of 28 interviewer-administered items for the person with dementia and 31 items in the proxy version (for carers) which can be administered by interviewer or self-administered. Both self-report and carer proxy versions will be completed, and both versions are valid and reliable.24
Sociodemographic and explanatory variables
The Neuropsychiatric Inventory (people living with dementia - completed by carers)
The Neuropsychiatric Inventory Questionnaire will be used to assess the frequency and severity of 12 behavioural disturbances that may occur with dementia. It is a valid and reliable tool, based on carer report and uses screening questions to minimise administration time.27
Sociodemographic and health variables
Standard sociodemographic items will be collected for both people living with dementia and carers, as well as the relationship between the person living with dementia and carer and approximate number of hours per week spent in an informal support role (carers only). The type and date of dementia diagnosis, chronic diseases and falls within the past month for people living with dementia will be obtained via the carer report.
Process data
A mixed methods process evaluation will follow the Medical Research Council Framework.
Reach
The extent to which the target population receives the intervention will be examined by the study consent rate and any provided reasons for ineligibility.
To assess fidelity, uptake and patterns of utilisation (dose) of the intervention components, data on dementia nurse assessments, case conferences, care plans and follow-up sessions and provision of Health Summary will be collected via logbook for intervention participants. Details of the services provided and GP-confirmed comorbidities will be obtained from the client management system used by the dementia nurse to record the care provided.
Acceptability and adaptations
Qualitative interviews exploring the perceived acceptability, ease of use, relevance and quality of intervention components and recommendations for intervention scale-up will be obtained from interviews with purposefully selected people living with dementia, carers, GPs, dementia nurses and partner organisation representatives. As the focus of the interviews will be on the acceptability of the intervention, only those people living with dementia and their carers allocated to the intervention arm will be invited. A maximum variation approach will be used to select people to participate in the interviews. Participants living with dementia and their carers will be invited to take part in the interview after they have completed their 6-month follow-up survey. GPs and practice nurses will be invited to complete an interview after completing at least one case conference. These interviews will additionally examine barriers and facilitators to intervention implementation and expected sustainability.
Economic data
The economic analysis will use the DEMQOL scale and the DEMQOL-proxy (completed by the carer) outcome measures to estimate health-related QoL (HrQOL) for the person living with dementia. The SF-12 will be used to estimate the HrQOL for the Carer.
Data estimating resource use will be collected to measure the incremental difference in costs between the intervention and usual care, including implementation and intervention costs. Implementation costs will be estimated using the project team’s records of the incidence and volume of implementation activities. Resource use estimates will be derived using the logbook data, survey data and linked health service data. A modified version of the Resource Use in Dementia28 will assess changes to primary healthcare use, home care support and admission to residential aged care. The use of inpatient health services, including emergency department attendance and hospital admissions and non-primary healthcare will be estimated through linkage to HNELHD administrative data. A list of each consenting participant’s study ID number, name, date of birth and address will be provided to HNELHD. This data, reflecting the number and form of health service utilisation event for the study period, will be valued using standard national measures, for example, National Weighted Activity Units, for the relevant year. The administrative data will be linked to the survey data to estimate participants’ holistic use of public healthcare and social services.
Minimising attrition
Loss to follow-up will be minimised by (1) obtaining multiple contact details for each participant, (2) completion of surveys face to face at the participant’s home (for people living with dementia) and (3) reminder prompts (mail/phone) if a carer survey response has not been received within 2 weeks.
Sample size
Sample size: a sample of 230 dyads per group at 12-month follow-up will enable the detection of a 0.25 SD difference in days spent in the community between groups with a type 1 error rate of 5% and 80% power. Based on our analysis of Australian Longitudinal Study on Women’s Health data (unpublished), this effect size equates to a difference of approximately 31 days.
Analysis plan
Statistical analyses
Analytic strategies will follow current Consolidated Standards of Reporting Trials guidelines.29 Analysis will follow the intention to treat principles. People living with dementia and their carers’ data will be analysed separately. The model for people living with dementia will focus on days lived in community as the outcome variable. This objective outcome will be calculated by total days (365) minus days spent in an emergency department admission, unplanned hospital admission, permanent residential aged care and days where the person was deceased. Days in hospital and/or emergency department presentations will be obtained from local health district (hospital) records, while date of death and date of moving to permanent residential aged care will be obtained by carer report. The secondary analysis will focus on time to first hospitalisation and will be completed using a competing risk model, where competing risk is mortality, that is, those who die cannot then have an admission to hospital. Models for the analysis of QoL will use linear mixed models to handle repeated measures of QoL at baseline, 6 months and 12 months; these mixed models allow for some missing data by using the others in the sample to extrapolate the trajectory. Differences in dichotomous secondary outcomes will be assessed using logistic mixed effects models and differences in count outcomes (frequency of review) will be assessed using Poisson (or negative binomial) mixed models.
Qualitative analysis
Audio files will be transcribed verbatim. An inductive thematic analysis will be used to analyse the transcribed interview data, using NVivo. This type of analysis is appropriate, as it is important for theme generation to be a largely inductive process, which will allow for an exploratory identification of all aspects of the participant experience relating to perceived acceptability, intervention usefulness and recommendation for scale-up. Approximately 10–15 of each type of participant (eg, 10 carers, 10 GPs etc) will complete an interview, until data saturation is reached.
Economic analysis
To account for potential differences in health, social and aged care service utilisation, the analysis will adopt a public health and social service-payer perspective. A within-trial analysis will initially assess the difference between the trial arms for the period between the baseline and follow-up survey (12 months). The primary measure of cost-effectiveness will be the incremental change in quality adjusted life years (QALYs) for people living with dementia and their carers compared with usual care. QALYs will be estimated using utility weights for the DEMQOL (person living with dementia or proxy versions). QALYs will be generated for carers using the SF-6D preference-based scoring algorithm founded on their responses to SF-12. Costs will be estimated based on the additional resources required for implementation, the incremental difference between trial arms for delivery of the intervention and differences in the resource use associated with subsequent healthcare, home care support and aged care utilisation. The results will be reported as an incremental cost-effectiveness ratio for benchmarking against comparable interventions. Probabilistic and one-way sensitivity analyses will provide evidence on the critical assumptions and the level of uncertainty regarding whether the value of the intervention meets accepted willingness to pay thresholds.
Ethics and dissemination
The trial has been approved by the Hunter New England Research Ethics Committee (2023/ETH01221) and the University of Newcastle Ethics Committee (R-2024–0021). Trial findings will be disseminated via peer-reviewed publications and conference presentations. Lay summaries will be provided to participants and relevant consumer groups and networks. If the intervention is effective, the research team aims for further implementation of the intervention as usual care within the participating services and beyond.
Ethics statements
Patient consent for publication
References
Footnotes
Contributors MLC, MK, DP, BRN, JA, Y-HJ, JJR, AW, KW, SD, JWh, KK, CO, CF, JWa and SL contributed to funding acquisition; MLC, MK, DP, BRN, JA, Y-HJ, JR, AW, KW, SD, JWh, KK, CO, MH, CF, JWa, SL, ES, JJ, AB and KF contributed to study conceptualisation and/or codesign. MC, KF and JJ contributed to writing—original draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript. MC is the guarantor.
Funding This work is funded by the Department of Health and Aged Care, MRFF - Dementia, Ageing and Aged Care Mission grant: grant number: 2022/MRF2022610. The Department of Health and Aged Care had no role in the design of the study and does not have any role in the collection, analysis and interpretation of the data, in the writing of the report or the decision to submit the paper for publication.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.