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Trial registered on ANZCTR


Registration number
ACTRN12617000335392
Ethics application status
Approved
Date submitted
27/02/2017
Date registered
3/03/2017
Date last updated
2/07/2021
Date data sharing statement initially provided
2/07/2021
Date results provided
2/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised stepped wedge control interventional trial assessing the impact of a novel disease management software module on disease risk factor detection, disease diagnosis rates and disease key management items in the primary care setting.
Scientific title
A randomised stepped wedge control interventional trial assessing the impact of the disease management software module (Chronic Disease IMPACT) on disease risk factor detection, disease diagnosis rates and disease key management items in the primary care setting.
Secondary ID [1] 291287 0
Nil known
Universal Trial Number (UTN)
U1111-1193-5419
Trial acronym
Chronic Disease IMPACT (Chronic Disease early detection and Improved Management in PrimAry Care ProjecT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 302242 0
Type II Diabetes Mellitus 302243 0
Cardiovascular Disease including Peripheral Arterial Disease, Coronary Heart Disease & Ischaemic Stroke 302244 0
Heart Failure 302245 0
Familial Hypercholesterolaemia 302246 0
Condition category
Condition code
Cardiovascular 301839 301839 0 0
Coronary heart disease
Stroke 301840 301840 0 0
Ischaemic
Metabolic and Endocrine 301841 301841 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Chronic Disease IMPACT e-technology module is designed to be a one stop shop for chronic vascular disease risk factor detection, disease detection and disease management in the primary care setting. Its design is guided by a team of disease specialists, general practitioners, population health experts and the latest national disease prevention and management guidelines. The module is an add on feature to the widely used primary care clinical auditing desktop software tool, Pen CS CAT. Participating primary care practices are current users of Pen CS CAT. The module will be installed into the participating primary care practices by download of a web link. Access to the module by participating practices will be via stepped wedge entry of 2-3 practices every 16 weeks commencing April 2017 until all practices are entered. The module is to be used for the primary care routine clinical auditing activities including determination of disease detection rates & disease risk factor detection rates and proportion of patients at target/not at target for key disease management items. It will be used by general practice managers and nurses and general practitioners Education on use of the module and disease detection and management will be provided to these primary care practice staff on site or via teleconference for up to 6hrs over the 15 months (method, frequency and duration is selected by the primary care practice staff). Primary care practice staff participating in the education will be asked to complete feedback (via completion of a word document) on the education immediately after each session (approx 10 mins). Data extracts will be collected from each practice at baseline and thereon every 16 weeks for 64 weeks and collated into aggregated form for benchmark reporting back to practices. A nominated practice staff member will be asked to complete an evaluation (10 min approx. duration) of the module on a quarterly basis by email, phone or face to face (method is selected by the nominated practice staff member), Intervention adherence will be assessed via a completion of clinical auditing activity log by the nominated practice staff member on a weekly basis (up to 5 mins duration) which will record how much time was spent clinical auditing using the module, who performed the clinical auditing and what specific clinical auditing activity was carried out. This log will be completed by email, phone or face to face (method is selected by the nominated practice staff member)
Intervention code [1] 297307 0
Early detection / Screening
Intervention code [2] 297308 0
Prevention
Comparator / control treatment
This is a stepped wedge design. The design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed to the intervention. Standard care is administered throughout the control period prior to administration of intervention
Control group
Active

Outcomes
Primary outcome [1] 301259 0
Disease Detection Rates (for CVDs (Cardiovascular diseases), CHF (Congestive Heart Failure), CKD (Chronic Kidney Disease), T2DM (type 2 Diabetes Mellitus) and FH (Familial Hypercholesterolaemia)) will be assessed by extraction of deindentified clinical audting data (specifically the clinically recorded diagnosis for each disease) collected via the Pen CS CAT tool from the participating primary care practices
Timepoint [1] 301259 0
15 months post baseline extraction
Primary outcome [2] 301260 0
Disease Risk Factor Detection Rates (for CVDs, CHF CKD, T2DM and FH) will be assessed by extraction of deindentified clinical auditing data (specifically risk factors for each disease) collected via the Pen CS CAT tool from the participating primary care practices. Risk factors are those defined by national guidelines including
(1) RACGP Redbook (9th edition)
(2) National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand (Chronic Heart Failure Guidelines Expert Writing
Panel). Guidelines for the prevention, detection and management of chronic heart failure in Australia. Updated October 2011.
(3) Chronic Kidney Disease (CKD) Management in General Practice (3rd edition).
Kidney Health Australia, Melbourne, 2015.
(4) The Royal Australian College of General Practitioners. General practice management of type 2 diabetes: 2016–18. East Melbourne, Vic: RACGP (2016)
(5) National Vascular Disease Prevention Alliance. Guidelines for the management of absolute cardiovascular disease risk. 2012,
Timepoint [2] 301260 0
15 months post baseline Extraction
Primary outcome [3] 301261 0
Disease Key Management Items (for CVDs, CHF, CKD, T2DM and FH) will be assessed by extraction of deindentified clinical audting data collected via the Pen CS CAT tool from the participating primary care practices. Disease management items are those defined by national guidelines including
(1) The Royal Australian College of General Practitioners. General practice management of type 2 diabetes: 2016–18. East Melbourne, Vic: RACGP (2016)
(2) National Stroke Foundation. Clinical Guidelines for stroke Management (2010),
(3) National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand (Chronic Heart Failure Guidelines Expert Writing
Panel). Guidelines for the prevention, detection and management of chronic heart failure in Australia. Updated October 2011.
(4) Chronic Kidney Disease (CKD) Management in General Practice (3rd edition).
Kidney Health Australia, Melbourne, 2015.
(5) National Heart Foundation of Australia. Guideline for the diagnosis and management of hypertension in adults (2016)
(6) National Heart Foundation of Australia and the Cardiac Society of Australia and New
Zealand. Reducing risk in heart disease: an expert guide to clinical practice for secondary prevention of
coronary heart disease. Melbourne: National Heart Foundation of Australia (2012)
Timepoint [3] 301261 0
15 months post baseline extraction
Secondary outcome [1] 332120 0
Quantification of Medicare Benefits Schedule (MBS) items costs will be assessed by data linkage between deidentified MBS items and deidentified primary care practice data
Timepoint [1] 332120 0
up to 10 years post baseline extraction
Secondary outcome [2] 332121 0
Quantification of Pharmaceutical Benefits Scheme (PBS) items costs will be assessed by data linkage between deidentified PBS items and deidentified primary care practice data
Timepoint [2] 332121 0
up to 10 years post baseline extraction
Secondary outcome [3] 332122 0
Time to death for patients managed during the intervention phase of the Primary care practice will be measured by data linkage between death registry deidentified data and deidentified primary care data
Timepoint [3] 332122 0
Up to 10 years post baseline extraction
Secondary outcome [4] 332309 0
Rates of hospitalisation will be measured by data linkage between deidentified hospital data and deidentified primary care data
Timepoint [4] 332309 0
Upto 10 years post baseline extraction

Eligibility
Key inclusion criteria
Any active primary care practice (general practice) in the State of Victoria, Australia
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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation was performed by use of sealed opaque envelopes
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
Practices will be stepped into receiving the intervention quarterly over 15 months
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is the number of primary care practice sites

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/11/2016
Date of last participant enrolment
Anticipated
30/03/2018
Actual
30/03/2018
Date of last data collection
Anticipated
1/08/2026
Actual
11/07/2019
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295751 0
Other
Name [1] 295751 0
North Western Melbourne Medicare Local
Country [1] 295751 0
Australia
Funding source category [2] 298703 0
Government body
Name [2] 298703 0
Better Care Victoria, Department of Health and Human Services
Country [2] 298703 0
Australia
Primary sponsor type
Hospital
Name
Western Health, Sunshine Hospital
Address
176 Furlong Rd, St Albans, 3021, VIC
Country
Australia
Secondary sponsor category [1] 294595 0
None
Name [1] 294595 0
Address [1] 294595 0
Country [1] 294595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297052 0
Western Health Low Risk Ethics Panel
Ethics committee address [1] 297052 0
Western Health Low Risk Ethics Panel
Office for Research, 176 Furlong Rd, St Albans, VIC 3021
Ethics committee country [1] 297052 0
Australia
Date submitted for ethics approval [1] 297052 0
04/07/2016
Approval date [1] 297052 0
15/08/2016
Ethics approval number [1] 297052 0
HREC/16/WH/124

Summary
Brief summary
Chronic diseases can be burdensome and are often interrelated. Chronic Kidney Disease (CKD), Cardiovascular Disease (CVD) and Type 2 Diabetes Mellitus (T2DM) are a cluster of interrelated chronic diseases sharing cardio-metabolic risk factors including obesity, hypertension and dyslipidaemia. Each are burdensome with around 10% of Australians (1.7 million) showing measured biomedical signs of CKD, an estimated 4.9% (just over 1 million) with diabetes and 22% of adult Australians (3.7 million) reporting that they had 1 or more CVD, including hypertensive disease, stroke, heart failure or heart disease. As many as 1 in 300 of the population have Familial Hypercholesterolemia (FH), the commonest autosomal dominant disorder in the community. Untreated FH can lead to death from coronary heart disease before age 60 while treated patients have a normal life expectancy. CKD, CVD and T2DM are in the top 10 for leading causes of death in Australia. They can have complex causal relationships between them leading to more severe illness and poorer prognosis. For example, CKD and T2DM are strong risk factors for future coronary events and all-cause mortality.
With CKD, CVD and T2DM requiring intensive management often over a long period of time the costs to the Australian community and health-care system is immense. They can lead to disability, loss of quality of life and premature death. In 2009, CKD accounted for approximately 2% of total health care expenditure, equivalent to ~ $900 million. In 2008-09 health care costs attributable to heart disease was $2.03 Billion. Diabetes directly costs the health care system approximately $1.7 billion per year, and indirectly, $14 billion per year.
It is known that 85% of Australians visit a general practitioner (GP) each year. As such, efforts to increase awareness of chronic diseases and their risk factors amongst GPs as well as providing opportunities for improved screening and management in the general practice setting is essential in combating this growing public health concern.

Chronic Disease IMPACT (Chronic Disease early detection and Improved Management in PrimAry Care ProjecT) is an extension of the CKD-EMAP project and an initiative of Western Health, Victoria University the University of Melbourne. It is supported by a legacy grant from the former Macedon Ranges and North Western Melbourne Medicare Local.

The Chronic Disease IMPACT project aims to further enhance primary care software to aid detection and management of chronic diseases focussing on CKD, CVD, Heart Failure, T2DM and risk factors such as Familial Hypercholesterolemia
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72818 0
A/Prof Craig Nelson
Address 72818 0
Renal Services, Sunshine Hospital, 176 Furlong Rd, St Albans, 3021, VIC
Country 72818 0
Australia
Phone 72818 0
+61 3 8395 1348
Fax 72818 0
Email 72818 0
craig.nelson@wh.org.au
Contact person for public queries
Name 72819 0
Natalie Lumsden
Address 72819 0
Renal Research Office, Sunshine Hospital, 176 Furlong Rd, St Albans, 3021, VIC
Country 72819 0
Australia
Phone 72819 0
+61 466 418 183
Fax 72819 0
Email 72819 0
Natalie.Lumsden@wh.org.au
Contact person for scientific queries
Name 72820 0
Craig Nelson
Address 72820 0
Renal Services, Sunshine Hospital, 176 Furlong Rd, St Albans, 3021, VIC
Country 72820 0
Australia
Phone 72820 0
+61 3 8395 1348
Fax 72820 0
Email 72820 0
craig.nelson@wh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
n/a


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Nephrology Dialysis Transplantation, Volume 35, Is... [More Details]
Other filesNo https://www.nhmrc.gov.au/sites/default/files/docum... [More Details]

Documents added automatically
No additional documents have been identified.