An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial

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

Medication non-adherence in a cohort of chronically ill Australians: A case of missed opportunities

“…With the remuneration of community pharmacies' non-dispensing services a contested and divisive area of health policy, 28 one solution might be to invest in technology to better connect GP services with the services provided by community pharmacists rather than create and fund 'new' adherence services. 29,30 This is particularly relevant with respect to pharmacists' dispensing of generic medications, whose different colours, shapes and sizes could confuse patients. Alternatively, the inclusion of pharmacists in the 'Health Care Home', as done in other contexts, could be explored.…”

Health information technology in ambulatory care in a developing country

“…Therefore, the physicians had no electronic access to the test results and reports of radiology and pharmaceutical prescriptions of their patients in necessary situations and for this reason, they are not able to constantly check the clinical status of their patients. In this regard, the study of Hayek et al showed that the physicians recorded patients’ pharmaceutical prescriptions in the computerized system of their clinics, and these requests had an integrated relation with the electronic medical record of their patients, and the requests were forwarded to the pharmacies after checking the pharmaceutical interferences and then the patients received their pharmaceutical prescriptions after the reference to the pharmacies ( 24 ).…”

Fixed‐dose combination therapy to reduce the growing burden of cardiovascular disease in low‐ and middle‐income countries: feasibility and challenges

“…11,13,31 Results of various under way trials (SECURE, PolyIran, TIPS-3, and HOPE-4, among others) are expected to provide the evidence about the effects and safety of polypills. [32][33][34] It is also worth highlighting that many trials that have evaluated prevention is yet to be demonstrated. 11,13,21 The concept of polypills in the primary prevention of CVD was first introduced by Wald and Law, 14 who presented these drugs as a mass treatment strategy to reduce CVD by more than 80%.…”

“…It is true, however, that most of these effects were not significantly different from those induced by usual medications . Results from ongoing trials (SECURE [Secondary Prevention of Cardiovascular Disease in the Elderly Trial; NCT02596126] and INTEGRATE [Integrated Combination Therapy, Electronic General Practice Support Tool, Pharmacy Led Intervention and Combination Therapy Evaluation; ACTRN12616000233426] and the SCCS Polypill Pilot [NCT02278471] and PolyIran [NCT01271985] trials and the related PolyIran Liver [NCT01245608], TIPS‐3 [The International Polycap Study 3; NCT01646437], and HOPE‐4 [Heart Outcomes Prevention and Evaluation 4; NCT01826019] trials) are urgently awaited to clarify these issues. Nonetheless, polypills seem to surpass usual cardiovascular treatments when considering the ease of prescription and significant increase in adherence.…”

“…Nonetheless, it is worth mentioning that most of these studies were not powered enough to detect any difference between polypills and usual treatments . Results of various under way trials (SECURE, PolyIran, TIPS‐3, and HOPE‐4, among others) are expected to provide the evidence about the effects and safety of polypills …”