BackgroundRandomised controlled trials (RCTs) of complex interventions in primary health care (PHC) are needed to provide evidence-based programmes to achieve the Declaration of Alma Ata goal of making PHC equitable, accessible and universal and to effectively address the rising burden from chronic disease. Process evaluations of these RCTs can provide insight into the causal mechanisms of complex interventions, the contextual factors, and inform as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. To build on this emerging body of work, we aim to consolidate the methodology and methods from process evaluations of complex interventions in PHC and their findings of facilitators and barriers to intervention implementation in this important area of health service delivery.MethodsSystematic review of process evaluations of randomised controlled trials of complex interventions which address prevalent major chronic diseases in PHC settings. Published process evaluations of RCTs will be identified through database and clinical trial registry searches and contact with authors. Data from each study will be extracted by two reviewers using standardised forms. Data extracted include descriptive items about (1) the RCT, (2) about the process evaluations (such as methods, theories, risk of bias, analysis of process and outcome data, strengths and limitations) and (3) any stated barriers and facilitators to conducting complex interventions. A narrative synthesis of the findings will be presented.DiscussionProcess evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts. Publishing this protocol serves to encourage transparency in the reporting of our synthesis of current literature on how process evaluations have been conducted thus far and a deeper understanding of potential challenges and solutions to aid in the implementation of effective interventions in PHC beyond the research setting.Systematic review registrationPROSPERO CRD42016035572Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0314-5) contains supplementary material, which is available to authorized users.

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

IntroductionCardiovascular disease (CVD) remains a major cause of morbidity and premature mortality globally. Despite the availability of low-cost evidence based medicines, there is a significant treatment gap in those with established or at high risk of CVD in the primary care setting. Pharmacist-based interventions have shown to improve patient outcomes for many chronic diseases including CVD. However, there is little synthesised evidence that has examined the effects of collaborative care between general practitioners (GPs) and pharmacists on patients’ cardiovascular risk outcomes. This protocol aims to outline the methods employed in a systematic review of current literature to assess whether interprofessional collaboration between GPs and pharmacists has an impact on improving cardiovascular risk outcomes among patients in the primary care setting.Methods and analysisRandomised controlled trials (RCTs) will be identified through database searches, scanning reference lists of relevant studies, hand searching of key journals and citation searching of key papers. Two independent reviewers will screen studies against eligibility criteria and extract data using standardised forms. Databases including MEDLINE, EMBASE, Cochrane, CINAHL and International Pharmaceutical Abstracts, will be searched from the beginning of each database until October 2018. Primary outcome includes improvement in cardiovascular risk factors, such as hypertension, due to GP and pharmacist cooperation. Secondary outcome is to describe the different types of GP and pharmacist collaborative models of care. A narrative synthesis of findings will be presented. A meta-analysis will be performed if the data are homogenous.Ethics and disseminationThis study does not require ethics approval. The results of the systematic review described within this protocol will be disseminated through presentations at relevant conferences and publication in a peer-reviewed journal. The methods will be used to inform future reviews.PROSPERO registration numberCRD42017055259.