Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001472167
Ethics application status
Approved
Date submitted
2/09/2019
Date registered
23/10/2019
Date last updated
23/10/2019
Date data sharing statement initially provided
23/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing health assessments in Aboriginal Community Controlled Health Services
Scientific title
Increasing health assessments in Aboriginal Community Controlled Health Services using a systems-based intervention: a multiple baseline study study
Secondary ID [1] 299156 0
APP1132839
Universal Trial Number (UTN)
U1111-1239-5745
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 314233 0
Cardiovascular disease 314672 0
Depression 314673 0
Cancer 314674 0
Kidney disease 314675 0
Substance use disorders 314676 0
Vision loss 314677 0
Hearing loss 314678 0
Condition category
Condition code
Public Health 312586 312586 0 0
Health service research
Metabolic and Endocrine 313017 313017 0 0
Diabetes
Cardiovascular 313018 313018 0 0
Hypertension
Mental Health 313019 313019 0 0
Depression
Cancer 313020 313020 0 0
Breast
Renal and Urogenital 313021 313021 0 0
Kidney disease
Mental Health 313022 313022 0 0
Addiction
Eye 313023 313023 0 0
Diseases / disorders of the eye
Ear 313024 313024 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multiple baseline study design will be undertaken which utilises a continuous quality improvement (CQI) approach. Three Aboriginal Community Controlled Health Services (ACCHSs) located in New South Wales will be invited to participate. An Aboriginal Advisory Group will be established to provide guidance regarding all aspects of the research including ACCHS selection and engagement, the development of the research protocol and its implementation, and evaluation and reporting of results. Baseline prevalence data will be undertaken immediately prior to intervention implementation. The 9-month intervention will be implemented in all ACCHSs and follow-up data collected upon completion. Repeated, cross-sectional measurement of the primary outcomes will occur for each ACCHS on a monthly basis during the intervention period using automated electronic medical record reports to facilitate feedback to sites. The proportion of active patients aged 18 and over years with an up-to-date Health Assessment in their medical record, and the proportion of smokers who have received best practice smoking cessation care, will be compared between baseline and 9-month follow-up.

Prior to intervention implementation, The intervention will be tailored to the needs of each ACCHS and are designed to address barriers to care at system, healthcare provider and client level. Project record will be kept to monitor the implementation of all intervention strategies.
A base set of strategies will be provided to ACCHSs. The base strategies will include:

1) Establishing targets/successive approximations. It is expected that each ACCHS will be performing at levels in delivering MBS Item 715. Consequently, there will be negotiation each ACCHS regarding changes that might be expected in the initial three month period following the initiation of the intervention phases. This negotiation will follow the principles for behavioural change and therefore attempt to make the targets achievable. This will allow for successive approximations, and provide an opportunity for the clinic to have success.

2) Training regarding Health Assessments and smoking cessation care. The training module will be developed by the researchers in collaboration with the ACCHSs and the Aboriginal Advisory Group. To support the training, training manuals and power point presentations will be developed. A General Practitioner (GP) at each ACCHS will provide the training to other GPs, practice nurses and Aboriginal Health Workers at group training session where practicable or one on one sessions. Training will occur on ACCHS premises. Training will be provided once, however booster training will be provided where ACCHSs conclude where it will be helpful. Training will be provided to all new staff who join an ACCHS during the study period.

3) Electronic medical record template for recording Health Assessments. A template will developed in consultation with the ACCHSs and the Aboriginal Advisory Group that is in line with the National Guide to a Preventive Health Assessment for Aboriginal and Torres Strait Islander People. Although a number of the electronic templates exist, none completely align with these guidelines in terms of the health items to be included and how the health items should be assessed.

4) Monthly feedback on performance regarding the implementation of 715 Health Assessments and smoking cessation care. Feedback to the ACCHS about their baseline performance will be provided by a member of the research teamand will continue to be provided every fortnight. Performance feedback will be provided to ACCHSs every month in a variety of formats tailored for CEOs, Board, ACCHS managers, GPs, nurses and health workers. Graphical and text feedback will indicate the proportion of eligible patients with an up-to-date Health Assessment, highlighting the benefits to patients.

5) Culturally appropriate patient resources. A readily available resource will be used that has been developed by the Australian Governments Health Department (Your Health is in Your Hands).

Dependent upon agreed performance levels (see strategy 1), 3 months after intervention commencement additional strategies will be provided to ACCHSs to address barriers to care delivery. Potential additional strategies will be developed in consultation with ACCHSs staff and will be dependent on ACCHSs existing process and the local context. These strategies may include:

6) Electronic patient recall/follow-up and reminder systems;

7) Prompts in the electronic medical record to opportunistically undertake Health Assessments and provide smoking cessation care;

8) Electronic referral to the NSW Health Aboriginal Quitline:

9) Dedicated Health Assessment clinic days; and

10) Patient incentives to attend for Health Assessments.
Intervention code [1] 315434 0
Early detection / Screening
Intervention code [2] 315435 0
Lifestyle
Intervention code [3] 315436 0
Behaviour
Comparator / control treatment
As this is a multiple baseline study design, the baseline period for each of the participating ACCHS will act as the control. Baseline data (the proportion of elibile clients with an up to date health assessment) will be collected using an automated audit of the electronic medical record for the 6 months prior to intervention commencment at each Aboriginal Community Controlled Health Service.
Control group
Active

Outcomes
Primary outcome [1] 321240 0
The proportion of eligible patients with a health assessment completed in the previous 12 months. This data will be collected by an automated audit of the ACCHS electronic medical record.
Timepoint [1] 321240 0
For each ACCHS, at baseline (prior to intervention implementation) and at follow-up (9-months after intervention implementation).
Secondary outcome [1] 374430 0
Proportion of eligible patients with a Chronic Disease Management Plan. This data will be collected by an automated audit of the ACCHS electronic medical record.
Timepoint [1] 374430 0
For each ACCHS, at baseline (prior to intervention implementation) and at follow-up (9-months after intervention implementation).
Secondary outcome [2] 374431 0
For patients with a diagnosis of Type 2 diabetes, the proportion who have had an HbA1c test in the past 6 months, This data will be collected by an automated audit of the ACCHS electronic medical record.
Timepoint [2] 374431 0
For each ACCHS, at baseline (prior to intervention implementation) and at follow-up (9-months after intervention implementation).
Secondary outcome [3] 374432 0
For patients with a diagnosis of Type 2 diabetes and who have had an HbA1c test in the past 6 months, the proportion with HbAIc (glycaemia blood) level <7%. This data will be collected by an automated audit of the ACCHS electronic medical record.
Timepoint [3] 374432 0
For each ACCHS, at baseline (prior to intervention implementation) and at follow-up (9-months after intervention implementation).

Eligibility
Key inclusion criteria
All active Aboriginal patients aged 18 years and over at the 3 ACCHS will be eligible to be included in data collection. Active patients are those who have had at least 3 visits to the ACCHS in last 2 years,
Minimum age
18 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
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a multiple baseline study. As such each ACCHS will recieve the intevention in a sequential manner
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proportion of active Aboriginal patients aged 18 years and over with an up-to-date Health Assessment in their medical record will be compared between baseline and 9-months post intervention. This will include a patient-level analysis with an adjustment for cluster effects. Analysis will be conducted using a mixed effects logistic regression, with fixed effects for the baseline prevalence of the outcome at each site, and client (age, gender, chronic disease status, number of ACCHS visits in past 18 months) and practice characteristics (number of active patients, FTE of GP(s) and practice nurse(s), presence of an Aboriginal Health Worker that are known to be associated with the outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
Date of last participant enrolment
Anticipated
2/02/2021
Actual
Date of last data collection
Anticipated
2/02/2021
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27709 0
2839 - Brewarrina
Recruitment postcode(s) [2] 27710 0
2832 - Walgett
Recruitment postcode(s) [3] 27711 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 303699 0
Government body
Name [1] 303699 0
National Health and Medical Research Council
Country [1] 303699 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 303805 0
None
Name [1] 303805 0
Address [1] 303805 0
Country [1] 303805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304222 0
Univerisity of Newcastle Human Research Ethics Committee
Ethics committee address [1] 304222 0
University Drive
Callaghan NSW 2308
Australia
Ethics committee country [1] 304222 0
Australia
Date submitted for ethics approval [1] 304222 0
13/12/2017
Approval date [1] 304222 0
10/05/2018
Ethics approval number [1] 304222 0
H-2017-0403
Ethics committee name [2] 304223 0
Aboriginal Health and Medical Research Human Research Ethics Committee
Ethics committee address [2] 304223 0
Level 3, 66 Wentworth Ave
Surry Hills, NSW, 2010
Ethics committee country [2] 304223 0
Australia
Date submitted for ethics approval [2] 304223 0
07/09/2017
Approval date [2] 304223 0
11/01/2018
Ethics approval number [2] 304223 0
1322/17

Summary
Brief summary
The purpose of this study is to test a health system intervention in Aboriginal Community Controlled Health Services.

Who is it for?
You may be eligible for this study if you are aged 18 or over and have had at least three visits to an Aboriginal Community Controlled Health Service in last two years

Study details
As this is a systems-level intervention, participants will continue their usual practice attending participating ACCHSs. Each ACCHS will have a period of usual practice before introduction of a set of strategies. These strategies include targets, training for ACCHS staff, feedback and introduction of new health resources. As part of this study, health service data will be collected from medical records.

It is hoped this research will improve the quality and of service delivery by Aboriginal Community Controlled Health Services and improve access to health services by Aboriginal Australians.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96190 0
Dr Megan Freund
Address 96190 0
Lot 1 Kookaburra Circuit, New Lambton Heights, NSW 2305
The University of Newcastle (UON)
University Drive, Callaghan NSW 2308 Australia
Country 96190 0
Australia
Phone 96190 0
+61 240420834
Fax 96190 0
Email 96190 0
[email protected]
Contact person for public queries
Name 96191 0
Dr Megan Freund
Address 96191 0
Lot 1 Kookaburra Circuit, New Lambton Heights, NSW 2305
The University of Newcastle (UON)
University Drive, Callaghan NSW 2308 Australia
Country 96191 0
Australia
Phone 96191 0
+61 240420834
Fax 96191 0
Email 96191 0
[email protected]
Contact person for scientific queries
Name 96192 0
Dr Megan Freund
Address 96192 0
Lot 1 Kookaburra Circuit, New Lambton Heights, NSW 2305
The University of Newcastle (UON)
University Drive, Callaghan NSW 2308 Australia
Country 96192 0
Australia
Phone 96192 0
+61 240420834
Fax 96192 0
Email 96192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this research collects data regarding Aboriginal people, and the data custodians are the Aboriginal communities in which the research is undertaken, the particpant data will not be shared


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.