Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000765820
Ethics application status
Approved
Date submitted
29/04/2021
Date registered
21/06/2021
Date last updated
27/04/2023
Date data sharing statement initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian National Diabetes Audit (ANDA)- Evaluating Facilitated Feedback Enhancement- a Cluster randomised Trial (ANDA-EFFECT): evaluating the acceptability, utility and impact on health outcomes of audit feedback augmented with educational and support resources in diabetes centres in Australia
Scientific title
Australian National Diabetes Audit (ANDA)-Evaluating Facilitated Feedback Enhancement - a Cluster randomised Trial (ANDA-EFFECT): A trial of audit feedback augmented with education and support, compared to feedback alone, on acceptability, utility and health outcomes in diabetes centres in Australia
Secondary ID [1] 303105 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ANDA-EFFECT (Australian National Diabetes Audit - Evaluating Facilitated Feedback Enhancement- a Cluster randomised Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 320199 0
Type 2 Diabetes Mellitus 320200 0
Condition category
Condition code
Metabolic and Endocrine 318143 318143 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm:
Participating staff from diabetes centres randomised to the intervention arm will receive a targeted theory-based intervention designed to address identified, modifiable barriers to implementing recommendations from audit feedback provided by ANDA, in addition to the standard audit feedback report. Design of the intervention is underpinned by a formal qualitative study to elicit current quality improvement practices and barriers to implementation of feedback. This qualitative study sought opinions from clinical staff regarding the acceptability and utility of the audit feedback currently provided, via semi-structured interviews. This study has informed redevelopment of the feedback provided to participating sites and development of the cointerventions in this trial
The intervention involves a reformatted version of the site report currently provided, along with a PowerPoint template for site use. This will be delivered electronically to participants by the ANDA research team at one point in time.
Cointerventions will include a Quality Improvement (QI) webinar, 'change champion' videos, instructional videos and peer led forums. These will all be delivered via the National Association for Diabetes Centres (NADC) website, prior to receiving the new feedback report and PowerPoint presentation and will remain accessible to the intervention group. Access to these resources will be password protected to prevent contamination of the control group.
Centres participating in the intervention arm will be expected to complete a minimum of 3 activities from the educational and peer support resources, including:
1. Attendance at the QI webinar – this will be hosted initially in the evening, with a replay with live question and answer session during a lunch hour, to facilitate maximum uptake
2. Viewing of at least one ‘clinical change champion’ video
3. Participation in at least one peer led forum
We anticipate that the interventions will be delivered during a six month period from August 2020 to January 2021. we anticipate that the webinar will be delivered in the first 4 weeks of the intervention period (to allow for the initial live presentation and subsequent replay) and that the remaining activities ('clinical change champion' video and peer forums) can be completed anytime in the first 3 months of the intervention period. Participants will continue to have access to these resources until follow-up data is collected in February of 2021.

Patient data: The study will not recruit patient participants. Rather, patient data for pre-determined fields will be harnessed from existing routinely collected and de-identified (coded) data reported as part of ANDA annual audit. We are not collecting any additional data directly from patients.

Intervention code [1] 320718 0
Prevention
Comparator / control treatment
Active control: ANDA feedback
Participating diabetes centres randomised to the control arm will receive a standard audit feedback report delivered electronically to the contact person for each diabetes centre
Control group
Active

Outcomes
Primary outcome [1] 326121 0
Mean HbA1c % (assessed via standard laboratory or point of care blood test) of patients attending diabetes centres in intervention arm compared to control arm, collected at 6 and 18 months post-delivery of feedback, recorded by clinicians as part of existing ANDA data collection during clinical encounter/review of patient records for most recent test result.
Timepoint [1] 326121 0
Collected at 6 and 18 months post-delivery of feedback, as part of existing ANDA data collection
Primary outcome [2] 326122 0
Utility and Acceptability of intervention to clinicians – assessed by a specially designed and validated survey, administered at 3 months post-delivery of intervention and active control
Timepoint [2] 326122 0
Administered at 3 months post-delivery of feedback
Secondary outcome [1] 390863 0
Change in mean total cholesterol levels assessed by fasting or non-fasting blood test at 6 and 18 months post-delivery of feedback, as a component of existing ANDA routine data collection, collected with standard ANDA Collection Form
Timepoint [1] 390863 0
6 and 18 months post-delivery of feedback
Secondary outcome [2] 396282 0
Change in mean LDL cholesterol levels assessed by fasting or non-fasting blood test at 6 and 18 months post-delivery of feedback, as a component of existing ANDA routine data collection, collected with standard ANDA Collection Form
Timepoint [2] 396282 0
6 and 18 months post delivery of feedback
Secondary outcome [3] 396283 0
Change in mean HDL cholesterol levels assessed by fasting or non-fasting blood test at 6 and 18 months post-delivery of feedback, as a component of existing ANDA routine data collection, collected with standard ANDA Collection Form
Timepoint [3] 396283 0
6 and 18 m0nths post delivery of feedback
Secondary outcome [4] 410510 0
Mean systolic blood pressure (mm Hg) and associated prescribing rates of hypertensive medications at 6 and 18 months post-delivery of feedback, as a component of existing ANDA routine data collection, collected with standard ANDA Collection Form.
Timepoint [4] 410510 0
6 and 18 months post-delivery of feedback
Secondary outcome [5] 410511 0
Prescribing rates of lipid lowering medications at 6 and 18 months post-delivery of feedback, as a component of existing ANDA routine data collection, collected with standard ANDA Collection Form
Timepoint [5] 410511 0
6 and 18 months post-delivery of feedback

Eligibility
Key inclusion criteria
Diabetes centres: Diabetes centres registered with the National Association of Diabetes Centres will be eligible for inclusion in the trial if the following criteria are met: (i) at least one representative of the practice (the designated contact person for ANDA) provides written informed consent; (ii) the practice participates in ANDA in 2021 (irrespective of whether they have or have not participated in previous years).
The designated ANDA contact person for each participating site are the participants in this study, as they receive and act on the feedback provided. They must be over 18 years old and employed by the relevant diabetes centres. As the diabetes centres have a range of clinical staff and administrative staff involved in ANDA, there are no other restrictions regarding these staff.



We will harness deidentified existing ANDA data relating to type 1 or type 2 diabetes mellitus in people aged 18 years and over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no additional exclusion criteria related to diabetes centres.
We will not harness ANDA data relating to people with Gestational Diabetes Mellitus (GDM), or diabetes of unknown type.


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)
Cluster randomised trial with central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified block randomisation will be employed with stratification by location (metropolitan or rural) and type of centre (tertiary, secondary or primary).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcomes
Differences between the experimental and control groups will be analysed by intention-to-treat approach. For the first co-primary outcome of difference in HbA1c, we will use the Linear Mixed Effects model to compare the between-group difference in mean HbA1c at 6 months after delivery of the intervention while adjusting for clustering of patients with site by including a centre random intercept. Appropriate transformations of the data will be undertaken in the event of departure from normality. Only if the first co-primary outcome is statistically significant at a two-sided level of significance of <0.05, we will test the second co-primary of acceptability and utility of interventions for superiority using the Chi-squared or Fisher’s Exact test as appropriate. This will preserve the overall type 1 error at <0.05.
Secondary outcomes
Other secondary clinical endpoints (e.g., mean LDL-Ch) and exploratory outcomes (e.g. mean HbA1c at 18 months) will similarly be analysed using the Linear Mixed Effects model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
10/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
41
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307509 0
University
Name [1] 307509 0
Monash University School of Public Health and Preventive Medicine
Country [1] 307509 0
Australia
Primary sponsor type
University
Name
Monash University School of Public Health and Preventive Medicine
Address
553 St Kilda Rd,
Melbourne,
VIC 3004
Country
Australia
Secondary sponsor category [1] 308189 0
None
Name [1] 308189 0
Address [1] 308189 0
Country [1] 308189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307582 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 307582 0
Ethics committee country [1] 307582 0
Australia
Date submitted for ethics approval [1] 307582 0
25/03/2021
Approval date [1] 307582 0
17/06/2021
Ethics approval number [1] 307582 0
RES-21-0000184L

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

Contacts
Principal investigator
Name 107754 0
Prof Sophia Zoungas
Address 107754 0
School of Public Health and Preventive Medicine, Monash University,
Level 3,
553 St Kilda Road,
Melbourne VIC 3004
Country 107754 0
Australia
Phone 107754 0
+61 3 9903 0711
Fax 107754 0
Email 107754 0
sophia.zoungas@monash.edu
Contact person for public queries
Name 107755 0
Sophia Zoungas
Address 107755 0
School of Public Health and Preventive Medicine, Monash University,
Level 3,
553 St Kilda Road,
Melbourne VIC 3004
Country 107755 0
Australia
Phone 107755 0
+61 3 9903 0711
Fax 107755 0
Email 107755 0
sophia.zoungas@monash.edu
Contact person for scientific queries
Name 107756 0
Sophia Zoungas
Address 107756 0
School of Public Health and Preventive Medicine, Monash University,
Level 3,
553 St Kilda Road,
Melbourne VIC 3004
Country 107756 0
Australia
Phone 107756 0
+61 3 9903 0711
Fax 107756 0
Email 107756 0
sophia.zoungas@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing of diabetes centre data may inadvertently identify participants (e.g. if only one centre in a given state takes part in the trial)
Given this cluster trial is harnessing data collected through an existing national audit and data is collated and de-identified (coded), it is not possible to access IPD.


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
SourceTitleYear of PublicationDOI
EmbaseANDA-Evaluating Facilitated Feedback Enhancement - a Cluster randomised Trial (ANDA-EFFECT): protocol for a cluster randomised trial of audit feedback augmented with education and support, compared to feedback alone, on acceptability, utility and health outcomes in diabetes centres in Australia.2022https://dx.doi.org/10.1186/s13063-022-06910-9
N.B. These documents automatically identified may not have been verified by the study sponsor.