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Improving Secondary Prophylaxis for Rheumatic Heart Disease in Remote Indigenous Communities: A Stepped Wedge Community Randomised Trial
Clancy Read*1, Jonathan Carapetis1, Anna Ralph2, Vanessa Johnston2, Jessica de Dassel2, Kerstin Bycroft2, Alice Mitchell3, Ross Bailie4, Graeme Maguire5, Keith Edwards6, Bart Currie2, Adrienne Kirby7
1Telethon Kids Institute, University of Western Australia, Perth, 2Menzies School of Health Research, Darwin, 3Charles Darwin University, Darwin, 4Menzies School of Health Research, Brisbane, 5BakerIDI Heart and Diabetes Institute, Melbourne, 6Paediatric Department, Royal Darwin Hospital, Darwin, 7National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney
Introduction:
Rheumatic heart disease (RHD), caused by acute rheumatic fever (ARF), is a major health problem in Australian Aboriginal communities. Progress in controlling RHD requires improvements in the delivery of secondary prophylaxis, which comprises regular, long-term injections of penicillin for people with ARF/RHD.
Objectives:
This study aims to improve uptake of secondary prophylaxis among Aboriginal people with ARF/RHD, to reduce progression or worsening of RHD.
Methods:
This is a stepped-wedge, randomised trial in consenting communities in Australia’s Northern Territory. Pairs of randomly-chosen clinics from among those consenting enter the study at three-monthly steps. The intervention to which clinics are randomised comprises a multifaceted systems-based package, in which clinics are supported to develop and implement strategies to improve penicillin delivery, aligned with elements of the Chronic Care Model. Continuous quality improvement processes will be used, including three-monthly feedback to clinic staff of adherence rates of their ARF/RHD clients. The primary outcome is the proportion of people with ARF/RHD receiving ≥80% of scheduled penicillin injections over a minimum 12-month period. The sample size of 300 ARF/RHD clients across five community clusters will power the study to detect a 20% increase in proportion of individuals achieving this target, from a worrying low baseline of 20% to 40%.
Secondary outcomes pertaining to other measures of adherence will be assessed. Within the randomised trial design, a mixed-methods evaluation will be embedded to evaluate the efficiency, effectiveness, impact and relevance, sustainability, process and fidelity, and performance of the intervention. The evaluation will establish any causal link between outcomes and the intervention. The planned study duration is 2013 – 2016.
Results:
The planned study duration is 2013-2016. Results are expected by the end of 2016
Conclusion:
Continuous quality improvement has a strong track record in Australia’s Northern Territory, and its use resulted in modest benefits in a pilot, non-randomised ARF/RHD study. If successful, this new intervention using the Chronic Care Model as a scaffold, evaluated using a well-developed theory-based framework, will provide a practical and transferable approach to ARF/RHD control.
Disclosure of Interest:
None Declared
*This poster was presented at the World Congress of Cardiology and Cardiovascular Health, Mexico City, 2016
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