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Trial registered on ANZCTR


Registration number
ACTRN12622001438741
Ethics application status
Approved
Date submitted
6/10/2022
Date registered
10/11/2022
Date last updated
10/11/2022
Date data sharing statement initially provided
10/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diabetes Alliance: Adult Diabetes Integrated Care Delivered in General Practice
Scientific title
Diabetes Alliance: Effectiveness of Adult Diabetes Integrated Care Delivered in General Practice on Testing and Clinical Outcomes
Secondary ID [1] 308094 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 327789 0
Type 1 diabetes 327871 0
Other types of adult diabetes (e.g. Maturity Onset Diabetes of the Young, Latent Autoimmune diabetes in Adults etc.) 327874 0
Condition category
Condition code
Metabolic and Endocrine 324860 324860 0 0
Diabetes
Public Health 324955 324955 0 0
Health service research
Public Health 324956 324956 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Diabetes Alliance integrated care intervention includes three core activities:
1. Specialist-led case conferences in general practices with adult patients with diabetes:-
Each general practice enrolled in the Diabetes Alliance initially receives 3 days of diabetes case conferences. Case conferences of 40 minutes duration are held for 10 new patients per day (i.e. 30 patients seen after 3 days), within the general practice setting. A single Diabetes Alliance review appointment of 20 minutes duration is booked approximately 6 months after the initial case conference. For all case conferences, patients are seen by a visiting tertiary specialist (Endocrinologist/Diabetologist) and Diabetes Educator, together with their own General Practitioner (GP) and Practice Nurse. Consultations include discussions of diabetes classification, complications and comorbidities, and treatment planning. Smoking, nutrition, alcohol, physical activity, psychosocial issues, diabetes-related distress, and depression are discussed. Each patient is asked to complete a 3-day food and physical activity diary, and blood glucose profile (all pre- and post-meal levels) in lead up to the case conference, so advice can be tailored to the individual. Recommendations are then implemented by patients and their usual GP without the need for ongoing specialist follow up. GPs are encouraged to deliver the Annual Cycle of Care across all practice patients with type 2 diabetes. Minimum requirements for the diabetes cycle of care are based on general practice guidelines produced by The Royal Australian College of General Practitioners (RACGP) and Diabetes Australia. Adherence is measured by recording the number of case conferences per practice and time to follow-up.
2. Whole general practice diabetes data analysis and feedback:-
Aggregate feedback reports are used for practice-level monitoring and evaluation of clinical and process outcomes. Feedback is provided by the visiting endocrinologist and NPS MedicineWise facilitator, and the general practice staff develop a plan for their own quality improvement. Practices receive performance reports every 6 months. Aggregate performance reports include data for adults with type 2 diabetes at the general practice site, compared to all general practices in the Hunter New England Region, and nationally. The reports provide a summary of the practice profile, prevalence of modifiable lifestyle factors, proportion of patients reaching the treatment goals, and treatments being used.
3. Educational programs for primary care clinicians:-
Endocrinologists provide 3 x 3 hour face-to-face Masterclasses for GPs, registrars, and allied health staff. Examples of topics included screening, diagnosis, and classification of diabetes, pathophysiology of types of diabetes, and medications. Diabetes Educators also provided a full day of education for practice nurses on similar topics. Diabetes Alliance Masterclasses are not exclusive to those primary care clinicians who participate in the case conferencing and/or general practice feedback activities; they are intended to have a broader reach. Attendance records are collected, which can be used to determine participation in all three Diabetes Alliance activities.
The Diabetes Alliance is a real-world model of care, being implemented on a rolling basis. The pre-intervention period begins 13 months prior to the start of the Diabetes Alliance case conferencing at each general practice, through to 1 month prior (i.e. 12 months). The post-intervention period begins 6 months after the last case conferencing at each site, and lasts 12 months to capture tests that are required annually.
Intervention code [1] 324543 0
Treatment: Other
Comparator / control treatment
Each General Practice acts as their own control, crossing over from control to intervention once they have received the Diabetes Alliance case conferencing. General practices provide standard care while in the control phase. Standard care can vary by practice and practitioner but should be informed by The Royal Australian College of General Practitioners and Diabetes Australia 'Management of type 2 diabetes: A handbook for general practice'.
Control group
Active

Outcomes
Primary outcome [1] 332679 0
Difference in mean HbA1c (% or mmol/mol). HbA1c assessed by blood test or point of care testing.
Timepoint [1] 332679 0
The pre-intervention period began 13 months prior to the start of the intervention at each site, through to 1 month prior (12 months). The post-intervention period began 6 months after the last case conferencing at each site, and lasted 6 months.
Secondary outcome [1] 414341 0
Difference in mean weight (kg). Weight assessed using digital scales.
Timepoint [1] 414341 0
The pre-intervention period began 13 months prior to the start of the intervention at each site, through to 1 month prior (12 months). The post-intervention period began 6 months after the last case conferencing at each site, and lasted 6 months.
Secondary outcome [2] 414342 0
Difference in mean blood pressure (mm/Hg). Blood pressure assessed using a sphygmomanometer.
Timepoint [2] 414342 0
The pre-intervention period began 13 months prior to the start of the intervention at each site, through to 1 month prior (12 months). The post-intervention period began 6 months after the last case conferencing at each site, and lasted 6 months.
Secondary outcome [3] 414343 0
Difference in mean blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides in mmol/L), assessed using blood tests.
Timepoint [3] 414343 0
The pre-intervention period began 13 months prior to the start of the intervention at each site, through to 1 month prior (12 months). The post-intervention period began 6 months after the last case conferencing at each site, and lasted 12 months.
Secondary outcome [4] 414344 0
Difference in mean estimated glomerular filtration rate, assessed using blood tests.
Timepoint [4] 414344 0
The pre-intervention period began 13 months prior to the start of the intervention at each site, through to 1 month prior (12 months). The post-intervention period began 6 months after the last case conferencing at each site, and lasted 12 months.
Secondary outcome [5] 414345 0
Difference in mean albumin-to-creatinine ratio (mg/mmol), assessed from urine.
Timepoint [5] 414345 0
The pre-intervention period began 13 months prior to the start of the intervention at each site, through to 1 month prior (12 months). The post-intervention period began 6 months after the last case conferencing at each site, and lasted 12 months.

Eligibility
Key inclusion criteria
- General practices that consent to receiving the Diabetes Alliance intervention.
- Adults with a diagnosis of diabetes who are active patients of the enrolled general practices.
- Active patients are defined as having 3 or more visits to the general practice in the past 2 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- General practices that do not receive the Diabetes Alliance intervention.
- Patients <18 years of age.

Study design
Purpose of the study
Educational / counselling / training
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
Crossover
Other design features
Stepped wedge
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be summarised as mean and standard deviation for continuous variables; frequency and percentage for categorical variables.
Linear mixed models will be used to test for changes in clinical results (continuous) before and after the Diabetes Alliance intervention, with a random effect for patient within each site to account for repeated measures on participants and clustering within sites. Where the residuals violate the assumption of normality, log-transformations will be performed.
Logistic mixed models will be used to test whether the intervention is associated with compliance with test intervals (yes/no) before and after Diabetes Alliance for each outcome, with a random effect for patient within site.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/05/2015
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
6000
Accrual to date
1072
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312350 0
Government body
Name [1] 312350 0
Hunter New England Local Health District
Country [1] 312350 0
Australia
Funding source category [2] 312355 0
Government body
Name [2] 312355 0
Hunter New England and Central Coast Primary Health Network
Country [2] 312355 0
Australia
Funding source category [3] 312356 0
Charities/Societies/Foundations
Name [3] 312356 0
Colonial Foundation
Country [3] 312356 0
Australia
Funding source category [4] 312357 0
Charities/Societies/Foundations
Name [4] 312357 0
Hunter Medical Research Institute
Country [4] 312357 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Shamasunder Acharya
Address
Endocrinology and Diabetes
John Hunter Hospital, Lookout Road
New Lambton Heights, NSW 2310
Country
Australia
Secondary sponsor category [1] 313914 0
Individual
Name [1] 313914 0
Associate Professor Alexis Hure
Address [1] 313914 0
Level 3 Pod, Hunter Medical Research Institute
School of Medicine and Public Health, University of Newcastle
Callaghan, NSW 2308
Country [1] 313914 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311713 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 311713 0
Ethics committee country [1] 311713 0
Australia
Date submitted for ethics approval [1] 311713 0
Approval date [1] 311713 0
15/04/2015
Ethics approval number [1] 311713 0
15/04/15/5.02

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

Contacts
Principal investigator
Name 122098 0
A/Prof Shamasunder Acharya
Address 122098 0
Endocrinology and Diabetes
John Hunter Hospital, Lookout Road
New Lambton Heights, NSW 2310
Country 122098 0
Australia
Phone 122098 0
+61 2 49223361
Fax 122098 0
Email 122098 0
Shamasunder.Acharya@health.nsw.gov.au
Contact person for public queries
Name 122099 0
Martha Parsons
Address 122099 0
Diabetes Alliance, Wisteria House
James Fletcher Hospital, 72 Watt Street
Newcastle, NSW 2300
Country 122099 0
Australia
Phone 122099 0
+61 412357750
Fax 122099 0
Email 122099 0
Martha.Parsons@health.nsw.gov.au
Contact person for scientific queries
Name 122100 0
Alexis Hure
Address 122100 0
Level 3 Pod, Hunter Medical Research Institute
School of Medicine and Public Health, University of Newcastle
Callaghan, NSW 2308
Country 122100 0
Australia
Phone 122100 0
+61 2 40420683
Fax 122100 0
Email 122100 0
Alexis.Hure@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


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.