Abstract
BackgroundCardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden. Despite established evidence that supports the use of preventive medications among patients at high CVD risk, treatment gaps remain. Building on prior evidence and a theoretical framework, a complex intervention has been designed to address these gaps among high-risk, under-treated patients in the Australian primary care setting. This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities; availability of a range of CVD polypills (fixed-dose combinations of two blood pressure lowering agents, a statin ± aspirin) for prescription when appropriate; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification.MethodsFollowing a systematic development process, the intervention will be evaluated in a pragmatic cluster randomized controlled trial including 70 general practices for a median period of 18 months. The 35 general practices in the intervention group will work with a nominated partner pharmacy, whereas those in the control group will provide usual care without access to the intervention tools. The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels at the study end. The outcomes will be analyzed using data from electronic medical records, utilizing a validated extraction tool. Detailed process and economic evaluations will also be performed.DiscussionThe study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients, pharmacists, and general practitioners (GPs) for CVD prevention.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000233426
Highlights
Cardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden
This study aims to assess whether combining (a) HealthTracker with (b) the availability of a range of cardiovascular polypills and (c) a pharmacy-based adherence program will improve CVD preventive medication prescribing and adherence in patients at high absolute CVD risk
Many CVD deaths are preventable with lifestyle measures and medication management
Summary
Cardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden. Building on prior evidence and a theoretical framework, a complex intervention has been designed to address these gaps among high-risk, under-treated patients in the Australian primary care setting. This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities; availability of a range of CVD polypills (fixed-dose combinations of two blood pressure lowering agents, a statin ± aspirin) for prescription when appropriate; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification. CVD is responsible for significant morbidity and economic burden, emphasizing the importance of effective prevention in primary care. A Cochrane review concluded that complex interventions which provide education, counselling, or daily treatment support were likely to be most effective in promoting long-term medication adherence [9]
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