Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001015538p
Ethics application status
Submitted, not yet approved
Date submitted
3/06/2024
Date registered
21/08/2024
Date last updated
21/08/2024
Date data sharing statement initially provided
21/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting Healthy Futures: Testing care-enhancement strategies to increase annual Health Checks and improve care for Aboriginal and Torres Strait Islander clients in mainstream general practices
Scientific title
Testing the effect of a suite of care-enhancement strategies on the implementation of Health Assessments for Aboriginal and Torres Strait Islander clients in mainstream general practice: a cluster randomised controlled trial
Secondary ID [1] 312078 0
None
Universal Trial Number (UTN)
Trial acronym
SHF (Supporting Healthy Futures)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 332075 0
Hypertension 332076 0
Cardiovascular disease 332078 0
Hyperlipidaemia 332081 0
Condition category
Condition code
Cardiovascular 328794 328794 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 328795 328795 0 0
Hypertension
Cardiovascular 328796 328796 0 0
Other cardiovascular diseases
Metabolic and Endocrine 328802 328802 0 0
Diabetes
Public Health 330746 330746 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cluster randomised controlled trial with general practices randomly allocated to either the usual care or care enhancement group. Practices allocated to the care enhancement group will receive a 2-year intervention designed to improve the implementation of health assessments and best practice care for Aboriginal and Torres Strait Islander clients. Intervention components will include a suite of care-enhancement strategies developed in consultation with the Aboriginal Reference Group and participating Primary Health Networks to ensure the strategies are feasible and acceptable to the participating practices and Aboriginal and Torres Strait islander communities. The Aboriginal Reference Group and Primary Health Network representatives participated in separate two-hour workshops, where the proposed care-enhancement strategies were presented, including a rationale for their inclusion and details of implementation. Attendees had the opportunity to reflect on and discuss each strategy and make recommendations for further refinement. Perceived potential barriers to implementation were also explored. Following the workshops, strategies were revised and circulated to members via email for further review and feedback. Additional meetings with individual members were held, to discuss recommendations in more detail where necessary. This iterative process occurred over a period of 6 months.

All care enhancements strategies will be implemented at each practice allocated to the care enhancement group, with strategies tailored to the individual practices and the Aboriginal and Torres Strait Islander communities they serve as required. For example, practices will be able to select which patient education resources they will display based on suitability for their practice.

Care enhancement strategies include:
Study Champions: Each practice will identify a Study Champion (e.g. Practice Manager or Practice Nurse) to promote buy-in of strategies within their practice and to help drive positive change. The research team will provide ongoing support to Study Champions throughout the study to help problem solve any challenges or issues that arise. The Study Champions duties will include monitoring of strategy implementation, delegation of responsibilities, meeting with the research team regularly, reviewing and updating policies and facilitating discussion of the project at practice team meetings.

Audit and Feedback: Medical record data extraction will be conducted quarterly via Pen CS, with the research team providing summarised data-based reports to participating practices every three months. Pen CS is a health analytics software provider for national population health analysis and reporting in primary care. The report will demonstrate change over time in level of care and include agreed goals for level of care to be achieved by the end of the project. The data will include rates of: identification of Aboriginal and Torres Strait Islander status, Aboriginal and Torres Strait Islander Health Checks, guideline recommended screening, and best-practice pharmacotherapy treatment. All data reported will be based on recommendations from the latest edition of the National Guide to a preventive health assessment for Aboriginal and Torres Strait Islander people. The Study Champions will use the reports to discuss progress towards goals at practice team meetings.

Culturally Safe and Responsive Care: Study Champions will be asked to complete the National Aboriginal Community Controlled Health Organisation (NACCHO) and Royal Australian College of General Practitioners (RACGP) Good Practice Tables (at baseline, 12-months and 24-months). The five Good Practice Tables provide practical actions the practice can take to support culturally responsive healthcare for Aboriginal and Torres Strait Islander people, and are mapped to practice accreditation standards. For example, "Posters, artwork, flags and map of Aboriginal and Torres Strait Islander Australia are displayed" and "Cultural safety is a standing agenda item in practice team meetings". Completion of the tables requires the participant to indicate whether each activity has been achieved at their practice (Yes/No) and if not, what actions are needed, by whom and by when to complete the activity. It is expected each table will take approximately 1 hour to complete. Practices will be encouraged to seek feedback on their completed Good Practice Tables from the local Primary Health Network Aboriginal Health and Wellbeing Leadership Group representative (or equivalent) to ensure the proposed actions support culturally safe practices. To assist practices to implement the proposed actions, the research team will develop a resource list of publicly available professional education tools, training and guidelines regarding culturally responsive care.

Patient Education and Resources: A resource list of existing culturally appropriate patient education resources will be provided to practices by the research team. Information and education will focus on the benefits of identifying as an Aboriginal and/or Torres Strait Islander person to the practice, as well as annual Aboriginal and Torres Strait Islander Health Checks and what to expect, and other preventative health topics. Patient education and resources may include social media templates, brochures, posters, videos to be played in waiting rooms, and fact sheets. Practices will be encouraged to ensure materials are visible and accessible to clients and to actively disseminate information where clinically appropriate.

Continuing Professional Education: Practice Managers (or delegate) will be asked to complete a clinical record audit of up to 20 clients per practice who have received an Aboriginal and Torres Strait Islander Health Check between 3-12 months ago (at baseline and 24-months). Where practices opt to complete the audit as a CPE exercise, the clinical record audit will be conducted by clinical staff responsible for the conduct of Health Checks at the practice. The clinical audit will be completed electronically, using a data collection tool provided by the research team. The tool will collect information including: patient age and gender, registration for government-funded programs (e,g. Integrated Team Care), details of Health Check administration, recording of patient goals, priorities and recommended actions, and requested investigations, and referrals provided. The clinical record audit tool will also provide an opportunity to reflect on and rate the quality of the Health Checks, and to identify areas for quality improvement. Relevant staff may also be encouraged to participate in additional training activities related to delivery of high-quality Health Checks, including webinars or training videos delivered by experienced Aboriginal clinicians, training programs offered by local PHNs, or peer-learning activities. Practices will identify relevant staff to complete the training, encourage completion of CPE activities and plan to maximise attendance. A list of additional pre-existing professional education tools and resources to support self-directed learning to conduct high quality health checks will also be provided by the research team.

Recall and Reminders: Culturally appropriate reminders will be sent via SMS to eligible patients who are due for an Aboriginal and Torres Strait Islander Health Check. A template for the reminder SMS has been co-designed by the research team and Aboriginal Reference Group. The content of the SMS will be further tailored to the practice and the Community(ies) they serve. For example, greetings in the local Aboriginal language will be incorporated through consultation with Community representatives. Reminders may be automated via the medical record software or sent manually depending on the practice preferences. Practices may also opt to implement a follow-up reminder phone call to overdue patients. Suggested communication strategies for reminder phone calls have also been co-designed by the research team and Aboriginal Reference Group.

Adherence to the care enhancement protocol, including progress and barriers to implementation of strategies will be explored during bi-monthly meetings (video-conference) between the Study Champion(s) and the research team at each practice, as well as a semi-structured interview at the end of the implementation period (24-months).
Intervention code [1] 327414 0
Behaviour
Intervention code [2] 327420 0
Early detection / Screening
Intervention code [3] 327421 0
Prevention
Comparator / control treatment
Practices randomised to the Usual Care group will provide their standard care to patients. Practices will be provided with a link to the publicly available ‘Resources to support health checks for Aboriginal and Torres Strait Islander people’ webpage of the Royal Australian College of General Practitioners (RACGP).
Control group
Active

Outcomes
Primary outcome [1] 336598 0
Proportion of adult Aboriginal and Torres Strait Islander clients attending participating mainstream general practices with an up-to-date Health Check (in the last 12 months)
Timepoint [1] 336598 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [1] 434696 0
Provider adherence to best evidence screening practice for blood pressure
Timepoint [1] 434696 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [2] 436457 0
Provider adherence to best evidence screening practice for cholesterol
Timepoint [2] 436457 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [3] 436458 0
Provider adherence to best evidence screening practice for Total CVD risk
Timepoint [3] 436458 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [4] 436459 0
Provider adherence to best evidence screening practice for diabetes
Timepoint [4] 436459 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [5] 436460 0
Provider adherence to recommended pharmacotherapeutic treatments for blood pressure where clinically indicated
Timepoint [5] 436460 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [6] 436464 0
Provider adherence to recommended pharmacotherapeutic treatments for high cholesterol where clinically indicated.
Timepoint [6] 436464 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [7] 436472 0
Provider adherence to recommended pharmacotherapeutic treatments for diabetes where clinically indicated.
Timepoint [7] 436472 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [8] 436473 0
Clinical outcomes for patients with hypertension
Timepoint [8] 436473 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [9] 436475 0
Clinical outcomes for patients with hyperlipidaemia
Timepoint [9] 436475 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [10] 436476 0
Clinical outcomes for patients with diabetes
Timepoint [10] 436476 0
Following completion of the intervention period (24-months post-baseline)
Secondary outcome [11] 436477 0
Identification of Aboriginal and/or Torres Strait Islander patients within the practice
Timepoint [11] 436477 0
Following completion of the intervention period (24-months post-baseline)

Eligibility
Key inclusion criteria
General practices will be eligible to participate if they are located in New South Wales, not classified as an Aboriginal Medical Service or Aboriginal Community Controlled Health Organisation, agree to use Pen CS CAT4 for research data collection, and have at least 40 active clients recorded as Aboriginal and/or Torres Strait Islander (at least three visits to the practice in the last two years).

Clients will be included in data collection via the electronic medical record data extraction if they are 18+ years of age and a current active patient of a participating general practice.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
To prevent experimental contamination, if a recruited practice has GPs who work at a second practice, the second practice will be ineligible.

Clients under 18 years of age are not eligible for inclusion in medical record data extraction.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting practices will be randomised (1:1) to either care enhancement or usual care using permuted block randomisation. Randomisation will be stratified by size of practice and the proportion of active eligible clients that have had an Aboriginal and Torres Strait Islander Health Check in the 12 months prior to the baseline data extraction.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
3300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315238 0
Government body
Name [1] 315238 0
National Health and Medical Research Council
Country [1] 315238 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] 317270 0
None
Name [1] 317270 0
Address [1] 317270 0
Country [1] 317270 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314162 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 314162 0
Ethics committee country [1] 314162 0
Australia
Date submitted for ethics approval [1] 314162 0
16/04/2024
Approval date [1] 314162 0
Ethics approval number [1] 314162 0

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

Contacts
Principal investigator
Name 130638 0
Dr Megan Freund
Address 130638 0
Health Behaviour Research Collaborative, HMRI Building, University of Newcastle, University Drive, Callaghan NSW 2308
Country 130638 0
Australia
Phone 130638 0
+61 02 40420834
Fax 130638 0
Email 130638 0
megan.freund@newcastle.edu.au
Contact person for public queries
Name 130639 0
Rochelle Watson
Address 130639 0
Health Behaviour Research Collaborative, HMRI Building, University of Newcastle, University Drive, Callaghan NSW 2308
Country 130639 0
Australia
Phone 130639 0
+61 02 40420700
Fax 130639 0
Email 130639 0
SHF@newcastle.edu.au
Contact person for scientific queries
Name 130640 0
Dr Megan Freund
Address 130640 0
Health Behaviour Research Collaborative HMRI Building, University of Newcastle, University Drive, Callaghan NSW 2308
Country 130640 0
Australia
Phone 130640 0
+61 02 40420834
Fax 130640 0
Email 130640 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 general practices participating in the research.


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.