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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.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000335392
Acronym
Chronic Disease IMPACT (Chronic Disease early detection and Improved Management in PrimAry Care Proj
Enrollment
20
Registered
2017-03-03
Start date
2016-11-14
Completion date
2018-03-30
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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. Partic

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)

Sponsors

Western Health, Sunshine Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Any active primary care practice (general practice) in the State of Victoria, Australia

Exclusion criteria

none

Outcome results

None listed

Source: ANZCTR · Data processed: May 30, 2026