The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol]

Leach, Matthew J., Segal, Leonie, Esterman, Adrian, Armour, Caroline, McDermott, Robyn, and Fountaine, Tim (2013) The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol]. BMC Public Health, 13. 1212. pp. 1-9.

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Background: Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost.

Methods/Design: The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month's duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability.

Discussion: This project responds to a need for robust evidence of the clinical and economic effectiveness of coordinated care for the management of diabetes in the Australian primary care setting. The outcomes of the study will have implications not only for diabetes management, but also for the management of other chronic diseases, both in Australia and overseas.

Item ID: 33283
Item Type: Article (Research - C1)
ISSN: 1471-2458
Keywords: cluster randomised controlled trial; coordinated care; diabetes mellitus; economic evaluation; general practice; primary care
Additional Information:

© 2013 Leach et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Funders: Department of Health and Ageing, Victorian Government
Date Deposited: 05 Jun 2014 04:09
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111701 Aboriginal and Torres Strait Islander Health @ 100%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920199 Clinical Health (Organs, Diseases and Abnormal Conditions) not elsewhere classified @ 100%
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