Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000749606
Ethics application status
Approved
Date submitted
24/05/2023
Date registered
11/07/2023
Date last updated
11/07/2023
Date data sharing statement initially provided
11/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Diabetes Training Program for Aboriginal Health Workers and Practitioners
Scientific title
Translation of culturally informed diabetes training for Aboriginal primary health care providers on Aboriginal client outcomes: a cluster randomised trial of effectiveness.
Secondary ID [1] 308103 0
None
Universal Trial Number (UTN)
U1111-1283-5257
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 327796 0
Condition category
Condition code
Metabolic and Endocrine 324874 324874 0 0
Diabetes
Public Health 327059 327059 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Diabetes Training Program consists of 3 components:

1) Peer Support Network (PSN)
A state-wide virtual PSN for Aboriginal Health Workers and Practitioners. The PSN will commence and convene for 6 months prior to Group A doing the e-learning modules and the OS. The PSN will run online via Teams, once a month, for 1.5 to 2 hours duration, and will be facilitated by a diabetes nurse educator (DNE) who is a research team member.
This will include topics aligned with the professional scope of practice and topics covering diabetes-related content. Activities to be included are mentorship support, reflections and readings, stories and lived experiences.
A peer support network satisfaction evaluation survey will be collected monthly after each peer support network meeting. Data collected from this survey will help to improve the PSN by responding to positive suggestions and addressing barriers and evaluating the PSN.

2) E-Learning Modules
There are 9 self-paced e-Learning modules. Each module takes approximately 1 hour to complete. Ten weeks have been allocated to complete the e-learning modules. All participants will do the e-learning modules. Nine self-paced e-Learning modules on the following topics of diabetes care:
- Introduction
- About Diabetes
- Healthy living
- Glucose monitoring
- Low and high blood glucose levels
- Medicines and insulin
- Diabetes-related complications
- Support for self-management
- Other priority groups

Link to the online modules: https://www.ndss.com.au/living-with-diabetes/about-you/aboriginal-and-torres-strait-islander-peoples/health-diabetes-learning/

The modes of training will include interactive activities and stories, short videos, PowerPoint presentations, and culturally appropriate resources to support people living with diabetes and their families, with pre and post-knowledge evaluation.
Participants will receive 10 professional development points and a certificate on completion of the modules.
During the training intervention, a weekly email will be sent out to participants doing the training program to remind and keep participants moving through the modules, and if they need any further help

3) Onsite Support (OS)
Practical support for staff to assist with implementing knowledge into practice within their primary care service. The OS sessions will occur during the same 10-week period as the e-Learning modules. The OS will be face-to-face at the primary healthcare service.

The number of OS sessions and what is covered during them will be negotiated between the participants and the OS Facilitator. It is suggested that each service hold a minimum of 2 sessions with the OS Facilitator. OS sessions will be held as a group, if there is more than one AHW/P or multidisciplinary health care providers within the health service. The group sessions will be held with AHW/Ps for the first half of the session and then include multidisciplinary healthcare providers for the remainder of the session. This format will be assessed and adapted as needed.

The OS will be facilitated by a credentialled diabetes educator (CDE) employed by Diabetes SA, who is a research team member.

The study will be implemented in the Aboriginal primary health care services in South Australia. These services primarily provide primary health care to Aboriginal and Torres Strait Islander people. This will be across Metropolitan, Regional and remote South Australian healthcare services.

All sites will have a period of 6 months for washout where PSN is only running.

All participants will be advised in the training program information sheet and participant consent form that they will be invited to participate in an interview about the barriers and enablers of the training program after they have completed the project. On completing the training program participants will be directly approached by email by research team members up to three times over 3 weeks to be invited to participate in an interview.

Interviews about enablers and barriers of participation, sustainability and effectiveness of the training program:

Semi-structured interviews will be conducted by an experienced qualitative researcher who is a team member with a medical background with support from a practicing Aboriginal Health Practitioner. The participants will be provided with the interview questions prior to the interview. Interviews will be conducted face-to-face or by Zoom.
The interview will last up to 60 minutes.

Participants will be asked for permission to record the interview for translation and be given an opportunity to review their transcript to add or remove information.

Focus group for system assessment:
This assessment will be conducted to understand the service infrastructure, resourcing, supports for best practice chronic disease care. Focus groups with the chronic disease team or staff will be conducted to assess the system characteristics of each service. These will be conducted face-to-face or via Zoom. Focus groups will occur at a time suitable to the service, within the first 12 months of trial commencement. Three research team members will conduct the focus groups. The Assessment of Chronic Care Scale will be used to inform the focus of discussions and system assessment. Participants will be provided with the assessment scale prior to the focus group. The focus groups will not be recorded. Staff who participated will be given the opportunity to review the assessment and provide feedback which will be added.

Only one focus group is proposed for each service, taking approximately 1 hour. Participation will be during work hours as agreed with the service manager and participants will not be reimbursed for their participation.
There is no certain number for the size of the focus group, it depends on the staff who are available that day.
Intervention code [1] 324554 0
Treatment: Other
Comparator / control treatment
Group B will receive the same intervention and will be active: After the 6-month washout period for both groups, the participating AHW/Ps and multidisciplinary health care providers within the health services randomised to Group B will commence the e-Learning modules and OS, for a duration of 10 weeks. During this time, AHW/Ps from both Group A and Group B will continue to participate in the PSN.

During the washout period, group B will continue to participate in the PSN.
Each group will act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 332686 0
The primary outcomes of this study relate to diabetes management in a primary care setting that measure participant:

- Knowledge measured using the Simplified Diabetes Knowledge Scale – True/False Version.
Timepoint [1] 332686 0
T0- Baseline - groups A & B
T1 - Measure Effect of Peer Support Network - 6 Months Post Baseline Group A & B (Aboriginal Health Workers and Practitioners only)
T2 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group A - 8.5 Months post-baseline (data collected on both group A & B)
T3 – Baseline of group B prior to doing the intervention (data collected on both group A & B), 14.5 months post-baseline.
T4 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group B post group B undertaking the intervention at 17 months from baseline (data collected on both group A & B).
T5 – Sustainability of effect of training program on group A 23 months post-baseline, and group B 6 months post commencement of intervention.
T6 - Sustainability of effect of training program on group A 29 months post-baseline, and group B 12 months post commencement of intervention.
Primary outcome [2] 334835 0
- Attitude is measured using the Diabetes Attitude Scale (DAS-3).
Timepoint [2] 334835 0
T0- Baseline - groups A & B
T1 - Measure Effect of Peer Support Network - 6 Months Post Baseline Group A & B (Aboriginal Health Workers and Practitioners only)
T2 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group A - 8.5 Months post-baseline (data collected on both group A & B)
T3 – Baseline of group B prior to doing the intervention (data collected on both group A & B), 14.5 months post-baseline.
T4 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group B post group B undertaking the intervention at 17 months from baseline (data collected on both group A & B).
T5 – Sustainability of effect of training program on group A 23 months post-baseline, and group B 6 months post commencement of intervention.
T6 - Sustainability of effect of training program on group A 29 months post-baseline, and group B 12 months post commencement of intervention.
Primary outcome [3] 334836 0
- Confidence measured using the Diabetes Confidence Survey (DCS)
Timepoint [3] 334836 0
T0- Baseline - groups A & B
T1 - Measure Effect of Peer Support Network - 6 Months Post Baseline Group A & B (Aboriginal Health Workers and Practitioners only)
T2 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group A - 8.5 Months post-baseline (data collected on both group A & B)
T3 – Baseline of group B prior to doing the intervention (data collected on both group A & B), 14.5 months post-baseline.
T4 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group B post group B undertaking the intervention at 17 months from baseline (data collected on both group A & B).
T5 – Sustainability of effect of training program on group A 23 months post-baseline, and group B 6 months post commencement of intervention.
T6 - Sustainability of effect of training program on group A 29 months post-baseline, and group B 12 months post commencement of intervention.
Secondary outcome [1] 414371 0
This is an additional primary outcome and will be assessed as a composite outcome: Practice and skills using case studies that were developed by the research team and the investigators specifically for the project.
Timepoint [1] 414371 0
T0- Baseline - groups A & B
T1 - Measure Effect of Peer Support Network - 6 Months Post Baseline Group A & B (Aboriginal Health Workers and Practitioners only)
T2 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group A - 8.5 Months post-baseline (data collected on both group A & B)
T3 – Baseline of group B prior to doing the intervention (data collected on both group A & B), 14.5 months post-baseline.
T4 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group B post group B undertaking the intervention at 17 months from baseline (data collected on both group A & B).
T5 – Sustainability of effect of training program on group A 23 months post-baseline, and group B 6 months post commencement of intervention.
T6 - Sustainability of effect of training program on group A 29 months post-baseline, and group B 12 months post commencement of intervention.
Secondary outcome [2] 422452 0
This is an additional primary outcome: Skill assessed using a case study for a diabetes foot check. This measure was adopted from the Foot Forward Project, which was developed by Twigg, Wischer, and Frank 2021. For further information check this link https://nadc.net.au/footforward/publications/
Timepoint [2] 422452 0
T0- Baseline - groups A & B
T1 - Measure Effect of Peer Support Network - 6 Months Post Baseline Group A & B (Aboriginal Health Workers and Practitioners only)
T2 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group A - 8.5 Months post-baseline (data collected on both group A & B)
T3 – Baseline of group B prior to doing the intervention (data collected on both group A & B), 14.5 months post-baseline.
T4 – Measure effect of training program (PSN, Online Modules, Onsite Support) on group B post group B undertaking the intervention at 17 months from baseline (data collected on both group A & B).
T5 – Sustainability of effect of training program on group A 23 months post-baseline, and group B 6 months post commencement of intervention.
T6 - Sustainability of effect of training program on group A 29 months post-baseline, and group B 12 months post commencement of intervention.
Secondary outcome [3] 422453 0
Peer Support Network satisfaction survey
This survey was developed and informed by a scoping review of the literature on communities of practice.
Timepoint [3] 422453 0
This will be collected monthly after each Peer Support Network Meeting for a total of 29 months post-baseline.
Secondary outcome [4] 422469 0
Interviews of enablers and barriers to participation, effectiveness and sustainability of the training program. This will be collected through semi-structured interviews. The interview questions were informed by scoping review of the literature on chronic disease training programs for Community Health Practitioners.
Timepoint [4] 422469 0
Once during the study at T2 with Group A (8.5 Months post-baseline), and T4 with Group B (post group B undertaking the intervention at 17 months from baseline)
Secondary outcome [5] 422470 0
Medical record review: Quality and Outcomes of diabetes care
This will be conducted through an electronic patient information system. Using automated data extraction using a data extraction algorithm, retrospective data collection at three timepoints during the study. This was informed by best practice clinical care guidelines – assessed against RACGP evidence-based care guidelines.
Data will be extracted such as:
Client ID, Month and year of birth, sex, Ethnicity, GP management plan, diabetic retinal check performed, Diabetic foot check performed, Cardiovascular risk assessment, Body mass index, Waist circumference, smoking status, Physical activity, Vaccination status, and Clinical measurements such as :
- Cholesterol (mmol/L)
- LDL (mmol/L)
- HDL (mmol/L)
- Triglycerides (mmol/L)
- Creatinine (µmol/L)
- eGFR (ml/min/1.73m²)
- uACR (mg/mmol)
- Random BGL (mmol/L) - non-fasting, blood glucose test performed at the health service
- HbA1c (mmol/mol) HbA1c (%)
- Systolic BPM (mm/Hg)
- Diastolic BPM (mm/Hg)
Timepoint [5] 422470 0
This will be undertaken during:

T1 - (6 Months Post Baseline Group A & B)

T4 - Measure effect of training program (PSN, Online Modules, Onsite Support) on group B post group B undertaking the intervention at 17 months from baseline (data collected on both group A & B).

T6 - Sustainability of effect of training program on group A 29 months post-baseline, and group B 12 months post commencement of intervention.
Secondary outcome [6] 422471 0
Health Service Characteristics - service systems assessment: System assessment through conducting focus groups with the chronic disease team staff to assess the system characteristics of each service.
Timepoint [6] 422471 0
Once during the study between months 3 and 12 from the start of the study

Eligibility
Key inclusion criteria
Inclusion criteria:

- For the training program:
Aboriginal Health Workers/Practitioners and multidisciplinary health care providers are eligible to participate in the study and must meet the following:

- Aboriginal Health Worker/Practitioner:
• Completed or currently enrolled in Certificate III/IV in Indigenous Primary Health Care
• Employed by a participating South Australian Aboriginal primary health care service.
• Provides diabetes care to Aboriginal clients.

- Multidisciplinary health care provider:
• Broad range of service providers, including enrolled and registered nurses, allied health professionals and medical doctors.
• Employed by or provides services in a participating South Australian Aboriginal primary health care service.
• Provides diabetes care to Aboriginal clients.

- Participants for the interviews for enablers and barriers:
All participants in the training program are eligible to participate in an interview on the enablers and barriers to participation, effectiveness and sustainability of the training program.

- Systems assessment:

Chronic disease team of health services involved in the project.

- Medical record review:

People with diabetes who have attended the participating health service and who fulfil the following criteria at the time of record review:
• aged 18 years and over;
• identify as Aboriginal;
• have a confirmed diagnosis of T2DM and/or a HbA1c is greater than or equal to 6.5 mmol/L;
• have attended the health service at least twice in the preceding 12-month period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria

- Training program: Limited or no access to a stable Internet connection or computer hardware (laptop, desktop, tablet) can be provided by the health service.
- Interviews enablers and barriers: No exclusion criteria
- Systems Assessments: No exclusion criteria
- Medical record review: No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation of sites:
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation drawing names of sites randomly from a hat.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Cluster crossover randomised trial: All participants receive the intervention based on random site allocation. Sites are randomly allocated to cluster one (Group A participants) or two (Group B participants).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A. Quantitative

Directed Acyclic Graphs (DAGs) are being used to determine variables that need to be collected to adjust for potential confounding within statistical models. DAGs enable the conceptualisation of causal pathways. A DAG has been done for each primary outcome.

Generalized linear mixed-effects models (GLMMs) with compound symmetric (exchangeable) correlation structure will be used to account for within health care centre (cluster) correlation; logit or log link will be used for binary outcomes such as prevalence resulting in mixed effect logistic regression, while log link will be used for count outcomes resulting in mixed effects negative binomial regression. GLMMs are a missing data method only assuming missing at random – MAR (instead of the more stringent MCAR – missing completely at random). Effect measures will also be presented through calculation of number needed to treat and its associated 95% confidence interval. Analysis after the 12-month intervention follow-up is planned, spending alpha equal to 0.005.

In addition, a descriptive pre-post analysis of survey results due to participating in the PSN alone in the first six months will be calculated using appropriate parametric or non-parametric tests. These analyses will occur after each collection timepoint.

For the PSN, knowledge, attitude and practice of providers will be summarised using descriptive analyses. Differences between pre and post survey results will be calculated using appropriate parametric or non-parametric tests.

Provision of evidence-based care and patient biomedical outcomes will be summarised using counts, means and percentages and differences between time collection points reported. Patients will be stratified by for example, age, gender, diabetes type and existing comorbidities.

B. Qualitative

The qualitative data from the study will be analysed using a data-driven, inductive, thematic analysis based on the Braun and Clarke’s guide for thematic analysis. Inductive analysis is a process of data coding without fitting it into any pre-existing coding framework. The majority of qualitative data for the study will come from the interviews. The interview transcripts will be audio recorded and transcribed verbatim. The analysis will begin by the analyst repeatedly reading and re-reading the data to become familiar with it. The more formal coding will start once the analyst becomes familiarised with the data. Once the data has been coded, these codes will be sorted into potential themes and subthemes. Once the themes are reviewed, refined, and finalised they will be used to write the final report. We will aim to analyse and report the data separately for AHW and multi-disciplinary team. Combining all disciplines, we will aim to analyse the data by metro and remote.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312360 0
Government body
Name [1] 312360 0
National Health and Medical Research Council. - Medical Research Future Fund
Country [1] 312360 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council. - Medical Research Future Fund
Address
National Health and Medical Research Council.
Medical Research Future Fund.
16 Marcus Clarke St, Canberra ACT 2601
GPO Box 1421
Australia
Country
Australia
Secondary sponsor category [1] 315769 0
Other Collaborative groups
Name [1] 315769 0
SAHMRI
Address [1] 315769 0
South Australian Health and Medical Research Institute, North Terrace, Adelaide, 5000
South Australia
Country [1] 315769 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311720 0
SA Department of Health and Wellbeing Human Research Ethics Committee
Ethics committee address [1] 311720 0
Ethics committee country [1] 311720 0
Australia
Date submitted for ethics approval [1] 311720 0
27/04/2022
Approval date [1] 311720 0
20/04/2023
Ethics approval number [1] 311720 0
2021/HRE00334
Ethics committee name [2] 311725 0
Aboriginal Health Research Ethics Committee
Ethics committee address [2] 311725 0
Ethics committee country [2] 311725 0
Australia
Date submitted for ethics approval [2] 311725 0
21/11/2021
Approval date [2] 311725 0
03/05/2022
Ethics approval number [2] 311725 0
04-21-969

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

Contacts
Principal investigator
Name 122126 0
A/Prof Odette Pearson
Address 122126 0
Co-Theme & Population Health Program Lead
Wardliparingga Aboriginal Health Equity
South Australian Health & Medical Research Institute (SAHMRI)
PO Box 11060, Adelaide SA 5001

Country 122126 0
Australia
Phone 122126 0
+61 8 8128 4230
Fax 122126 0
Email 122126 0
odette.pearson@sahmri.com
Contact person for public queries
Name 122127 0
Odette Pearson
Address 122127 0
Co-Theme & Population Health Program Lead
Wardliparingga Aboriginal Health Equity
South Australian Health & Medical Research Institute (SAHMRI)
PO Box 11060, Adelaide SA 5001

Country 122127 0
Australia
Phone 122127 0
+61 8 8128 4230
Fax 122127 0
Email 122127 0
odette.pearson@sahmri.com
Contact person for scientific queries
Name 122128 0
Odette Pearson
Address 122128 0
Co-Theme & Population Health Program Lead
Wardliparingga Aboriginal Health Equity
South Australian Health & Medical Research Institute (SAHMRI)
PO Box 11060, Adelaide SA 5001

Country 122128 0
Australia
Phone 122128 0
+61 8 8128 4230
Fax 122128 0
Email 122128 0
odette.pearson@sahmri.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect the privacy of participants, no individual participant data will be shared. Only aggregate data will be available from this study.


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.