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Trial registered on ANZCTR


Registration number
ACTRN12621000905864
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
13/07/2021
Date last updated
18/11/2021
Date data sharing statement initially provided
13/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can community-level strategies improve timely diagnosis of chronic conditions and best-practice care for older Aboriginal and Torres Strait Islander people including dementia?
Scientific title
Investigating the effect of multi-component, community, health practitioner and system-level strategies on diagnosis of chronic conditions and provision of best-practice care for older Aboriginal and Torres Strait Islander people including dementia
Secondary ID [1] 297646 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 322638 0
Alzheimer's disease 322639 0
Stroke 322640 0
Chronic obstructive pulmonary disease 322641 0
Kidney disease 322642 0
Diabetes 322643 0
Coronary heart disease 322644 0
Hypertension 322645 0
Depression 322646 0
Condition category
Condition code
Neurological 310508 310508 0 0
Dementias
Neurological 319005 319005 0 0
Alzheimer's disease
Neurological 319006 319006 0 0
Neurodegenerative diseases
Stroke 319007 319007 0 0
Ischaemic
Respiratory 319008 319008 0 0
Chronic obstructive pulmonary disease
Renal and Urogenital 319009 319009 0 0
Kidney disease
Metabolic and Endocrine 319010 319010 0 0
Diabetes
Cardiovascular 319011 319011 0 0
Coronary heart disease
Cardiovascular 319012 319012 0 0
Hypertension
Mental Health 319013 319013 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cluster randomised controlled trial with 16 eligible communities randomised to either (i) a community based multi-component intervention (n=8); or (ii) usual care (n=8).
Interventions: Aboriginal Community Controlled Health Services (ACCHSs) allocated to the intervention condition will receive a 3-year multi-component community-based intervention designed to address barriers to the timely diagnosis of dementia and the provision of best practice care. Intervention components are based on an extensive review of the literature and recommendations of multidisciplinary experts, and will be further refined by the Aboriginal Advisory Group and through a local community consultation and engagement process. Timing of the implementation of each strategy will be determined in consultation with each individual ACCHS. The intervention will be implemented in Years 2-4. Further strategy development, consultation and baseline data collection will occur in the first 12 months (Year 1). A 3-year community-based intervention will commence in Year 2 and will completed at the end of Year 4.

1. Community-level strategies
a) Community information sessions to raise dementia knowledge. Each ACCHS will be supported to hold a series of 1-hour community dementia knowledge sessions in Years 2, 3 and 4 (one session annually). A trained ACCHS staff member will be supported by the research team to deliver the session.
b) Supportive Care Community Networks
The community consultation processes will identify agencies that could form a Supportive Care Network. Likely representation will include those from ACCHSs, hospitals, aged care services, allied healthcare, legal services and Aboriginal people living with chronic disease, their carers and families. Where required ACCHS representatives who facilitate the meetings (4 meetings/year) will be offered facilitation training and consumers will be offered advocacy training. The remit of the Supportive Care Network will be determined in consultation with each Aboriginal Medical Service (AMS) and will reflect the local community needs. Prior to further consultation, it is envisaged that the Supportive Care Network's role will be to ensure coordination of care for older Aboriginal people. This is likely to result in improved communication between community-based organisations and ACCHSs. The Support Care Networks will map and identify gaps in existing referral pathways and communication processes, and problem solve in regards to care for people living with dementia and their carers and families.
c) The development of culturally appropriate and locally tailored information resources.
The community consultation will allow for the identification of knowledge gaps, and local, state and not-for-profit resources (e.g. brochures, websites, apps, online forums) which will be of benefit for the community information sessions and the Supportive Care Networks. Resources will be developed and may include information regarding ageing and the common signs of cognitive impairment, depression, anxiety, diabetes, hypertension, high cholesterol, coronary heart disease (CHD), stroke, COPD, cancer (all types) and kidney disease.

2. Strategies supporting ACCHSs to identify persons with chronic disease & deliver best practice care.
a) GP, Practice Nurse, Aboriginal Health Worker training
During the consultation process, we will invite ACCHS staff to attend a 2-hr meeting, to ascertain educational needs regarding chronic disease, dementia diagnosis and care. Consultation will be conducted in small groups or as one-on-one interviews, via telephone or Zoom. The consultation process will occur during the initial 12-month baseline period, prior to implementation of the community support strategies. Relevant ACCHS staff including GPs, practice nurses and Aboriginal Health workers will receive 1-2 days training in conducting MBS715 health assessments using the tailored 715 template. Training will also cover appropriate management steps for diabetes, anxiety, dementia, depression, hypertension and high cholesterol. Given staff turnover at ACCHSs, refresher training will be repeated each year throughout the C-RCT period to consolidate knowledge and ensure any new staff receive training. Training will be conducted face-to-face or via videoconference by 1) a GP and Aboriginal Health Worker and 2) Communicare support trainer. Training will cover RACGP/NACCHO guidelines in relation to MBS715 health assessments; practical issues for administering these with patients; and the layout and technical features of the MBS715 template. ACCHSs will be reimbursed for the nurse and Aboriginal Health Worker staff time required to complete the training.
b) Embedding cognitive assessment into MBS 715 Health Assessments.
Step one: Each month, an ACCHS staff member will run a tailored PenCAT report to identify active patients aged over 45 years who have not completed a MBS 715 Health Assessment in the previous 12 months. These patients will be triaged based on pre-existing conditions associated with dementia (e.g. diabetes, heart disease) and dementia lifestyle risk factors (e.g. smoking, alcohol misuse). The staff member will contact identified patients and schedule a time for them and their families to come to the clinic and undertake the Assessment.
Step two: An electronic template will be developed and tailored for use by each ACCHS. It will prompt staff to cover relevant items in the MBS 715 screen, including asking the patient and their family members if they have any concerns about the patient’s cognitive functioning. If this is reported, the template will prompt the ACCHS staff member to assess cognitive ability using the Standardised Mini Mental State Examination (SMMSE). The MBS715 Health Assessment can take up to one hour to complete.
Step three: GPs will review the completed health assessment. The GP will undertake further assessment of patients who have scored under 24 on the SMMSE regarding potential causes of suggested cognitive impairment. If a patient is diagnosed with dementia, a Care Management Plan will be developed.
c) Electronic templates in Medical Director/Communicare for: (i) Referral to My Aged Care.
To overcome barriers such as lack of time and knowledge of services available and how to access them, an electronic template will be developed for GPs using their usual medical practice software. The template will include the initial assessment questions asked by My Aged Care staff that determines if the patient will progress to a formal assessment by the Regional Support Services (RAS) or the Aged Care Assessment Team (ACAT). The Case Manager will log the referral on the My Aged Care website to commence the assessment process.
(ii) Dementia management care plan. In line with best care, the GP will develop a dementia management care plan in partnership with each person diagnosed with dementia and their family. The template will include comorbidities, management goals, actions for patient/carers, treatment/referral options, and arrangements to review the plan.
d) Bi-monthly feedback regarding performance.
In collaboration with the Aboriginal Advisory Group, a system change feedback template will be developed and will provide data to each ACCHS regarding: (i) the number and proportion of active patients aged over 45 years who attended the ACCHS in the previous month and had a completed Health Assessment. From this data, the MBS rebate dollar amount received and the potential MBS dollar amount missed will be calculated; and (ii) the number of new confirmed diagnoses of chronic conditions, including dementia recorded in the medical record. ACCHS bi-monthly performance against set targets for the ACCHS will be displayed using text and graphics, and new targets for the next month will be discussed. ACCHSs will be reimbursed for staff time to complete the reports.

3. Strategies to directly support older adults and their families:
A 0.5 FTE Older Persons Care Coordinator, will be appointed at each ACCHS. The Case Manager will act as an advocate and support for older people who have completed an MBS715 health assessment and their families. The role of the care coordinator would be negotiated with the ACCHS. Based on the results of the 715 assessment, the Coordinator will collaborate with the GP, ACCHS staff, and local Aged Care and other services to help ensure access to, and the coordinated delivery of, health and appropriate aged care and other support services.
Intervention code [1] 313881 0
Behaviour
Intervention code [2] 320641 0
Treatment: Other
Intervention code [3] 320642 0
Diagnosis / Prognosis
Comparator / control treatment
Usual care - ACCHSs allocated to the usual care condition will continue to provide their normal chronic disease identification and care. Both usual care and community support strategy ACCHSs will undertake the same data collection procedures for the baseline assessment (Year 1) and follow up assessment (Year 5).
Control group
Active

Outcomes
Primary outcome [1] 319365 0
Proportion of eligible patients with a diagnosis of dementia recorded in their medical record at follow-up will be compared between community support and usual care communities. The medical records of ACCHSs will be electronically audited using a tailored PenCAT tool.
Timepoint [1] 319365 0
At baseline and following cessation of the intervention
Primary outcome [2] 326542 0
Provision of NHMRC recommended care to eligible patients with a recorded diagnosis of dementia in their medical record. A composite score summing together the three indicators of best practice dementia care (presence of a dementia care management plan, referral to community aged care service and a record of an advance care plan) will be calculated for each patient with a recorded diagnosis of dementia. The composite score will be assessed through the review of patient medical records.
Timepoint [2] 326542 0
At baseline and following cessation of the intervention
Secondary outcome [1] 391812 0
The change from baseline in health knowledge (percentage of correct items in the dementia knowledge questionnaire) will be compared between Community Support and usual care groups. This analysis will be undertaken separately for clients and staff. As there are no existing dementia knowledge tools specifically for Aboriginal and Torres Strait Islander people, the research team has developed the dementia knowledge questionnaire. The survey has been developed and pilot tested with Aboriginal people and it includes items in the following domains: early signs, diagnostic process, natural history and expectations from a diagnosis.
Timepoint [1] 391812 0
At baseline and following cessation of the intervention
Secondary outcome [2] 391813 0
Proportion of patients aged over 45 years who receive a new diagnosis of a chronic condition over a 12-month period. As per Primary Aim 1, the medical records of ACCHSs will be electronically audited using a tailored PenCAT tool. Chronic diseases to be included are depression, anxiety, diabetes, hypertension, hyperlipidaemia (high cholesterol), coronary heart disease (CHD), stroke, COPD, cancer (all types) and kidney disease. This will be assessed as a composite secondary outcome.
Timepoint [2] 391813 0
At baseline and following cessation of the intervention
Secondary outcome [3] 391814 0
For those newly diagnosed with a chronic condition, the proportion who have (a) a care management plan developed, (b) monitoring of disease status, and (c) healthy levels for disease management indicators (where relevant). As per Primary Aim 1, the medical records of ACCHSs will be electronically audited using a tailored PenCAT tool. This will be assessed as a composite secondary outcome.
Timepoint [3] 391814 0
At baseline and following cessation of the intervention
Secondary outcome [4] 391815 0
Proportion of patients aged over 45 years with an up to date MBS715 Health Assessment. As per Primary Aim 1, the medical records of ACCHSs will be electronically audited using a tailored PenCAT tool.
Timepoint [4] 391815 0
At baseline and following cessation of the intervention
Secondary outcome [5] 391816 0
Proportion of patients aged over 45 years who have received repeated MBS715 assessments at 12 monthly intervals. As per Primary Aim 1, the medical records of ACCHSs will be electronically audited using a tailored PenCAT tool.
Timepoint [5] 391816 0
At baseline and following cessation of the intervention

Eligibility
Key inclusion criteria
ACCHSs in NSW and QLD are eligible to participate if they have: (i) a minimum of 500 patients aged over 45 years of age (ii) at least one GP; and (iii) a practice nurse, Aboriginal Health Worker or other health worker.

To be eligible for inclusion in the PenCAT report and manual audit of electronic records, individuals must: have attended the ACCHS at least once in the 12-month baseline and/or follow-up period; be aged 45 years and older; and be community-dwelling.

To be eligible for inclusion in the dementia knowledge survey: individuals must be aged over 18 years, not diagnosed with dementia, able to complete the survey in English and either attending an ACCHS or a clinical staff member of an ACCHS.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by cluster (site)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed using a free online blocked randomizer
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
Primary Aims:
Increasing timely diagnosis of dementia.
Data will be analysed using mixed effects logistic regression analysis and the model will include fixed effects for experimental group, cluster-level variables (including the proportion of eligible patients with a dementia diagnosis at baseline), individual-level patient characteristics (age, gender, and other comorbidities), and will account for the clustered design with a random site-specific intercept. A previous Australian study assessing dementia prevalence estimated a prevalence of 3.7%. However, this was based on multiple health related records and thus the rate of recorded dementia in ACCHS records is expected to be substantially lower. Correspondence with a large NSW-based ACCHS indicated only 1% of current patients aged >45 years had a diagnosis of dementia. Based on this, we conservatively estimate that 2% of eligible patients from usual care communities will have a diagnosis recorded in the medical record at follow-up, compared to 5% of patients from intervention communities. Using an intra-cluster correlation (ICC) of 0.01 and a significance threshold of 0.05, a sample size of 3,600 patients across 8 clusters per arm (average 400 clients per clinic) will provide 80% power to detect a difference of this size. This would equate to minimum of 110 additional people receiving a dementia diagnosis in the intervention ACCHSs, and if extrapolated to all Aboriginal people aged 45 years and over in Australia would result in 3673 more Aboriginal people receiving a timely dementia diagnosis. We believe a ICC value of 0.01 is consistent with similar outcomes found in different populations. However, the proposed sample size could detect a between-group difference in dementia prevalence of 6% with an ICC as large as 0.03.

Primary Aim 2: Increasing provision of best practice care.
A composite score summing together the three indicators of best practice dementia care will be calculated for each patient with a recorded diagnosis of dementia. The odds of receiving a higher number of care items will be compared between people diagnosed with dementia in the community support and usual care groups using an ordinal logistic mixed effects model with fixed and random effects as described above. In the event that the assumptions for this model are not satisfied, a multinomial mixed effects model will be used to estimate between-group differences. Assuming that 2% of the usual care group, and 5% of the community support group will have a recorded diagnosis of dementia (based on estimated prevalence from aim 1), allowing for a design effect of 1.1 there will be an effective sample size of n=40 in the usual care group and n=130 in the community support group. Assuming 10% of those in usual care receive all three care items (the proportion that have 0, 1 or 2 items are 10%, 50% and 30% respectively, based on discussion with content experts about the current standard of care), the study will have 80% power to detect an increase of 15% in the proportion that receive all three care items between the community support and usual care group (with proportion that receive 0, 1 or 2 items as 5%, 25% and 25% respectively) with a 5% significance threshold.

Secondary Aim 1: The change from baseline health knowledge (percentage of correct items in the dementia knowledge questionnaire) will be compared between treatment groups at follow-up using mixed effects regression models. This analysis will be undertaken separately for clients and staff.
Clients: Assuming there will be on average 100 patients aged over 18 attending each ACCHS for a one month period of baseline and at post community support, and 70% of these consent to be in the study, allowing for an intraclass correlation of 0.01, there will be approximately 80% power to detect a difference of 0.2SD in the percentage of correct knowledge items between groups with 5% significance.
Staff: Based results from the Aboriginal and Torres Strait Islander-specific primary health care OSR and nKPI collections, ACCHSs have an average of 23 full time equivalent health staff. A number of these FTE’s would be expected to be part-time. Assuming a 70% consent rate, it is expected that 184 clinical staff in each of the community support group and the usual care group will complete the survey. Allowing for an intraclass correlation of 0.01, there will be approximately 80% power to detect a difference of 0.2 SD in the percentage of correct knowledge items between groups with 5% significance.

Secondary Aim 2: The change from baseline in the proportion of patients who have a new chronic disease diagnosis will be compared between treatment groups at follow-up using mixed effects regression models..

Secondary Aim 3: The change from baseline for these outcomes will be compared between treatment groups at follow-up using mixed effects regression models.

Secondary Aim 4: The change from baseline in the proportion of eligible patients who had received at least one completed MBS715 Health Assessment in the past 12 months will be compared between Community Support and usual care groups.

Secondary Aim 5: The change from baseline in the proportion of eligible patients who had received MBS715 assessments at 12 month intervals over the last 3 years will be compared between Community Support and usual care groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
6560
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 302175 0
Government body
Name [1] 302175 0
National Health and Medical Research Council
Country [1] 302175 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Health Behaviour Research Collaborative
HMRI Building, Level 4, West Wing
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 309025 0
None
Name [1] 309025 0
Address [1] 309025 0
Country [1] 309025 0
Other collaborator category [1] 280590 0
University
Name [1] 280590 0
University of Newcastle's Priority Research Centre for Health Behaviour
Address [1] 280590 0
Health Behaviour Research Collaborative
HMRI Building, Level 4, West Wing
University of Newcastle
Callaghan NSW 2308
Country [1] 280590 0
Australia
Other collaborator category [2] 280591 0
Other
Name [2] 280591 0
Hunter Medical Research Institute (HMRI)
Address [2] 280591 0
Lot 1 Kookaburra Circuit,
New Lambton Heights, NSW 2305
Country [2] 280591 0
Australia
Other collaborator category [3] 280592 0
University
Name [3] 280592 0
Menzies School of Health Research
Address [3] 280592 0
Red 9, Casuarina campus,
University Drive North, Casuarina NT 0811
Country [3] 280592 0
Australia
Other collaborator category [4] 280594 0
University
Name [4] 280594 0
James Cook University
Address [4] 280594 0
14-88 McGregor Road
Smithfield, Cairns, QLD 4878
Country [4] 280594 0
Australia
Other collaborator category [5] 280595 0
Commercial sector/Industry
Name [5] 280595 0
Northern Territory Department of Health
Address [5] 280595 0
87 Mitchell St,
Darwin City NT 8000
Country [5] 280595 0
Australia
Other collaborator category [6] 280596 0
University
Name [6] 280596 0
University of Sydney
Address [6] 280596 0
Camperdown NSW 2006
Country [6] 280596 0
Australia
Other collaborator category [7] 280597 0
University
Name [7] 280597 0
University of Technology of Sydney
Address [7] 280597 0
15 Broadway St
Ultimo NSW 2007
Country [7] 280597 0
Australia
Other collaborator category [8] 280598 0
Other
Name [8] 280598 0
Maari Ma Health
Address [8] 280598 0
428 Argent St,
Broken Hill NSW 2880
Country [8] 280598 0
Australia
Other collaborator category [9] 280599 0
University
Name [9] 280599 0
University of Melbourne
Address [9] 280599 0
Parkville, VIC 3010
Country [9] 280599 0
Australia
Other collaborator category [10] 281658 0
Other
Name [10] 281658 0
Durri Aboriginal Corporation Medical Service
Address [10] 281658 0
15-19 York Lane
Kempsey NSW 2440
Country [10] 281658 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302857 0
Aboriginal Health and Medical Research Council Human Research Ethics Committee
Ethics committee address [1] 302857 0
Ethics committee country [1] 302857 0
Australia
Date submitted for ethics approval [1] 302857 0
30/04/2019
Approval date [1] 302857 0
19/07/2019
Ethics approval number [1] 302857 0
1518/19
Ethics committee name [2] 302892 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 302892 0
Ethics committee country [2] 302892 0
Australia
Date submitted for ethics approval [2] 302892 0
26/07/2019
Approval date [2] 302892 0
31/07/2019
Ethics approval number [2] 302892 0

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

Contacts
Principal investigator
Name 91626 0
Prof Rob Sanson-Fisher
Address 91626 0
Health Behaviour Research Collaborative
HMRI Building, Level 4, West Wing
University of Newcastle
Callaghan NSW 2308
Country 91626 0
Australia
Phone 91626 0
+61 02 4042 0713
Fax 91626 0
Email 91626 0
rob.sanson-fisher@newcastle.edu.au
Contact person for public queries
Name 91627 0
Megan Freund
Address 91627 0
Health Behaviour Research Collaborative
HMRI Building, Level 4, West Wing
University of Newcastle
Callaghan NSW 2308
Country 91627 0
Australia
Phone 91627 0
+61 02 40420834
Fax 91627 0
Email 91627 0
megan.freund@newcastle.edu.au
Contact person for scientific queries
Name 91628 0
Megan Freund
Address 91628 0
Health Behaviour Research Collaborative
HMRI Building, Level 4, West Wing
University of Newcastle
Callaghan NSW 2308
Country 91628 0
Australia
Phone 91628 0
+61 02 40420834
Fax 91628 0
Email 91628 0
megan.freund@newcastle.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
Individual participant data will not be shared in order to preserve participant confidentiality. Data is the property of Aboriginal communities that are part of the research. We do not have ethics approval to share individual level data publicly.


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.