KANYINI-GAP

Kanyini Guidelines Adherence with the Polypill Study

This is a prospective, open, randomised controlled clinical trial (n=1000 non-Indigenous and Indigenous individuals) of a polypill-based strategy compared to usual care among individuals at high risk of cardiovascular events based in general practices and Indigenous specific health services, augmented by a cost-effectiveness analysis and a formal process evaluation.

The Kanyini GAP study comprises of two collaborations:  The Kanyini Vascular Collaboration (KVC) is a 5 year health services research program, established between Indigenous and non-Indigenous health service and clinical researchers and conducted in close collaboration with several Aboriginal Community Controlled Health Services (ACCHS) in metropolitan, rural and remote communities in NSW, NT, and QLD and one government funded Indigenous health service in QLD.  The Guidelines Adherence with the Polypill collaboration has been formed between the George Institute for International Health, the Department of General Practice, Western Clinical School, University of Sydney and CTC, Monash University.  These three groups have developed a research collaboration comprising of a diverse network of general practices in NSW and Victoria.  The CTC is responsible for recruiting approximately 100 non-Indigenous study participants in the Melbourne area in association with local general practices.  Ethics approval was obtained for this study at the end of 2009 and recruitment will start in 2010.

The aim of the study is to assess whether provision of a polypill (containing low dose aspirin, a statin and two blood pressure lowering medicines) compared to usual cardiovascular medications improves adherence to indicated therapies and clinical outcomes among high-risk patients.  Secondary aims are to measure prescription of combination therapy, barriers to adherence, quality of life, safety, cardiovascular events, prescriber acceptability, and healthcare resource consumption.  The study will be conducted within mainstream general practices and the participating health service partners in the Kanyini Vascular Collaboration.  This is an investigator-initiated study sponsored by The George Institute for International Health and is funded by an NHMRC grant.