Randomised controlled trial of a secondary prevention program for myocardial infarction patients ('ProActive Heart'): study protocol. Secondary prevention program for myocardial infarction patients

Background: \ud Coronary heart disease (CHD) is a significant cause of health and economic burden. Secondary prevention programs play a pivotal role in the treatment and management of those affected by CHD although participation rates are poor due to patient, provider, health system and societal-level barriers. As such, there is a need to develop innovative secondary prevention programs to address the treatment gap. Telephone-delivered care is convenient, flexible and has been shown to improve behavioural and clinical outcomes following myocardial infarction (MI). This paper presents the design of a randomised controlled trial to evaluate the efficacy of a six-month telephone-delivered secondary prevention program for MI patients (ProActive Heart).\ud \ud Methods:\ud 550 adult MI patients have been recruited over a 14 month period (December 2007 to January 2009) through two Brisbane metropolitan hospitals, and randomised to an intervention or control group (n = 225 per group). The intervention commences within two weeks of hospital discharge delivered by study-trained health professionals ('health coaches') during up to 10 × 30 minute scripted telephone health coaching sessions. Participants also receive a ProActive Heart handbook and an educational resource to use during the health coaching sessions. The intervention focuses on appropriate modification of CHD risk factors, compliance with pharmacological management, and management of psychosocial issues. Data collection occurs at baseline or prior to commencement of the intervention (Time 1), six months follow-up or the completion of the intervention (Time 2), and at 12 months follow-up for longer term outcomes (Time 3). Primary outcome measures include quality of life (Short Form-36) and physical activity (Active Australia Survey). A cost-effective analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government.\ud \ud Discussion: The results of this study will provide valuable new information about an innovative telephone-delivered cost-effective secondary prevention program for MI patients

Sharing risk management: an implementation model for cardiovascular absolute risk assessment and management in Australian general practice

Purpose: Despite considerable work in developing and validating cardiovascular absolute risk (CVAR) algorithms, there has been less work on models for their implementation in assessment and management. The aim of our study was to develop a model for a joint approach to its implementation based on an exploration of views of patients, general practitioners (GPs) and key informants (KIs). Methods: We conducted six focus group (three with GPs and three with patients) and nine KI interviews in Sydney. Thematic analysis was used with comparison to highlight the similarities and differences in perspectives of participants. Results: Conducting CVAR was seen as more acceptable for regular patients rather than new patients for whom GPs had to attract their interest and build rapport before doing so at the next visit. GPs' interest and patients' positive attitude in managing risk were important in implementing CVAR. Long consultations, good communication skills and having a trusting relationship helped overcome the barriers during the process. All the participants supported engaging patients to self-assess their risk before the consultation and sharing decision making with GPs during consultation. Involving practice staff to help with the patient self-assessment, follow-up and referral would be helpful in implementing CVAR assessment and management, but GPs, patients and practices may need more support for this to occur. Conclusions: Multiple strategies are required to promote the better use of CVAR in the extremely busy working environment of Australian general practice. An implementation model has been developed based on our findings and the Chronic Care Model. Further research needs to investigate the effectiveness of the proposed model

Development of a heart failure filter for Medline: an objective approach using evidence-based clinical practice guidelines as an alternative to hand searching

<p>Abstract</p> <p>Background</p> <p>Heart failure is a highly debilitating syndrome with a poor prognosis primarily affecting the elderly. Clinicians wanting timely access to heart failure evidence to provide optimal patient care can face many challenges in locating this evidence.</p> <p>This study developed and validated a search filter of high clinical utility for the retrieval of heart failure articles in OvidSP Medline.</p> <p>Methods</p> <p>A Clinical Advisory Group was established to advise study investigators. The study set of 876 relevant articles from four heart failure clinical practice guidelines was divided into three datasets: a Term Identification Set, a Filter Development Set, and a Filter Validation Set. A further validation set (the Cochrane Validation Set) was formed using studies included in Cochrane heart failure systematic reviews. Candidate search terms were identified via word frequency analysis. The filter was developed by creating combinations of terms and recording their performance in retrieving items from the Filter Development Set. The filter's recall was then validated in both the Filter Validation Set and the Cochrane Validation Set. A precision estimate was obtained post-hoc by running the filter in Medline and screening the first 200 retrievals for relevance to heart failure.</p> <p>Results</p> <p>The four-term filter achieved a recall of 96.9% in the Filter Development Set; 98.2% in the Filter Validation Set; and 97.8% in the Cochrane Validation Set. Of the first 200 references retrieved by the filter when run in Medline, 150 were deemed relevant and 50 irrelevant. The post-hoc precision estimate was therefore 75%.</p> <p>Conclusions</p> <p>This study describes an objective method for developing a validated heart failure filter of high recall performance and then testing its precision post-hoc. Clinical practice guidelines were found to be a feasible alternative to hand searching in creating a gold standard for filter development. Guidelines may be especially appropriate given their clinical utility. A validated heart failure filter is now available to support health professionals seeking reliable and efficient access to the heart failure literature.</p

The effect of modifiable risk factors on geographic mortality differentials: a modelling study

Background Australian mortality rates are higher in regional and remote areas than in major cities. The degree to which this is driven by variation in modifiable risk factors is unknown. Methods We applied a risk prediction equation incorporating smoking, cholesterol and blood pressure to a national, population based survey to project all-causes mortality risk by geographic region. We then modelled life expectancies at different levels of mortality risk by geographic region using a risk percentiles model. Finally we set high values of each risk factor to a target level and modelled the subsequent shift in the population to lower levels of mortality risk and longer life expectancy. Results Survival is poorer in both Inner Regional and Outer Regional/Remote areas compared to Major Cities for men and women at both high and low levels of predicted mortality risk. For men smoking, high cholesterol and high systolic blood pressure were each associated with the mortality difference between Major Cities and Outer Regional/Remote areas--accounting for 21.4%, 20.3% and 7.7% of the difference respectively. For women smoking and high cholesterol accounted for 29.4% and 24.0% of the difference respectively but high blood pressure did not contribute to the observed mortality differences. The three risk factors taken together accounted for 45.4% (men) and 35.6% (women) of the mortality difference. The contribution of risk factors to the corresponding differences for inner regional areas was smaller, with only high cholesterol and smoking contributing to the difference in men-- accounting for 8.8% and 6.3% respectively-- and only smoking contributing to the difference in women--accounting for 12.3%. Conclusions These results suggest that health intervention programs aimed at smoking, blood pressure and total cholesterol could have a substantial impact on mortality inequities for Outer Regional/Remote areas. Background: Australian mortality rates are higher in regional and remote areas than in major cities. The degree to which this is driven by variation in modifiable risk factors is unknown. Methods. We applied a risk prediction equation incorporating smoking, cholesterol and blood pressure to a national, population based survey to project all-causes mortality risk by geographic region. We then modelled life expectancies at different levels of mortality risk by geographic region using a risk percentiles model. Finally we set high values of each risk factor to a target level and modelled the subsequent shift in the population to lower levels of mortality risk and longer life expectancy. Results: Survival is poorer in both Inner Regional and Outer Regional/Remote areas compared to Major Cities for men and women at both high and low levels of predicted mortality risk. For men smoking, high cholesterol and high systolic blood pressure were each associated with the mortality difference between Major Cities and Outer Regional/Remote areas - accounting for 21.4%, 20.3% and 7.7% of the difference respectively. For women smoking and high cholesterol accounted for 29.4% and 24.0% of the difference respectively but high blood pressure did not contribute to the observed mortality differences. The three risk factors taken together accounted for 45.4% (men) and 35.6% (women) of the mortality difference. The contribution of risk factors to the corresponding differences for inner regional areas was smaller, with only high cholesterol and smoking contributing to the difference in men - accounting for 8.8% and 6.3% respectively - and only smoking contributing to the difference in women - accounting for 12.3%. Conclusions: These results suggest that health intervention programs aimed at smoking, blood pressure and total cholesterol could have a substantial impact on mortality inequities for Outer Regional/Remote areas

Design and baseline characteristics of the 10 Small Steps Study: a randomised controlled trial of an intervention to promote healthy behaviour using a lifestyle score and personalised feedback

Background: Non-communicable diseases (NCDs) are the leading causes of death globally and are associated with a limited set of common, modifiable health behaviours: tobacco use, physical inactivity, harmful use of alcohol and unhealthy diet. General practice offers an ideal avenue for addressing such health behaviours on a population-wide basis. This paper describes the protocol of a multiple health behaviour change intervention designed for implementation in general practice and summarises the baseline characteristics of its participants

Reducing risk in coronary artery disease. Are Australian patients in general practice achieving targets? The coronary artery disease in general practice study (CADENCE)

BACKGROUND The benefits of secondary preventive measures for stable coronary artery disease are well established and risk factor treatment targets are defined. AIM The aim of this study was to examine Australian general practitioners' (GP) perception and management of risk factors in chronic stable angina patients in primary care. METHODS Using a cluster-stratified design, 2031 consecutive stable angina patients were recruited between October 2006 and March 2007 by 207 GP who documented their risk factors and reported if they were optimally controlled. RESULTS Among the patients, 93% had objective evidence of coronary artery disease and 63% were male, and mean age was 71 ± 11 years. Based upon national guidelines, recommended targets were achieved in: 60% for blood pressure, 24% for body mass index, 23% for waist circumference, 17% for lipid profiles (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides) and 54% of diabetics for haemoglobin (A1c). However, GP perceived risk factors to be ‘optimally controlled’ in: 86% for blood pressure (kappa statistic (κ) = 0.37), 44% for weight (κ = 0.3), 70% for lipids (κ = 0.20) and 60% for haemoglobin A(1c) (κ = 0.74). CONCLUSIONS In this representative cohort of chronic stable angina patients attending GP, cardiovascular risk factor control was frequently suboptimal despite being perceived as satisfactory by the clinicians. New strategies that raise awareness and address this treatment gap need to be implemented.A. Driscoll, J. Beltrame, A. Beauchamp, C. Morgan, A. Weekes and A. Tonki

Engaging community pharmacists in the primary prevention of cardiovascular disease: protocol for the Pharmacist Assessment of Adherence, Risk and Treatment in Cardiovascular Disease (PAART CVD) pilot study

Background: Cardiovascular disease (CVD) is the leading cause of death globally. Community pharmacist intervention studies have demonstrated clinical effectiveness for improving several leading individual CVD risk factors. Primary prevention strategies increasingly emphasise the need for consideration of overall cardiovascular risk and concurrent management of multiple risk factors. It is therefore important to demonstrate the feasibility of multiple risk factor management by community pharmacists to ensure continued currency of their role.Methods/Design: This study will be a longitudinal pre- and post-test pilot study with a single cohort of up to 100 patients in ten pharmacies. Patients aged 50-74 years with no history of heart disease or diabetes, and taking antihypertensive or lipid-lowering medicines, will be approached for participation. Assessment of cardiovascular risk, medicines use and health behaviours will be undertaken by a research assistant at baseline and following the intervention (6 months). Validated interview scales will be used where available. Baseline data will be used by accredited medicines management pharmacists to generate a report for the treating community pharmacist. This report will highlight individual patients&rsquo; overall CVD risk and individual risk factors, as well as identifying modifiablehealth behaviours for risk improvement and suggesting treatment and behavioural goals. The treating community pharmacist will use this information to finalise and implement a treatment plan in conjunction with the patient and their doctor. Community pharmacists will facilitate patient improvements in lifestyle, medicines adherence, and medicines management over the course of five counselling sessions with monthly intervals. The primary outcome will be the change to average overall cardiovascular risk, assessed using the Framingham risk equation.Discussion: This study will assess the feasibility of implementing holistic primary CVD prevention programs into community pharmacy, one of the most accessible health services in most developed countries.<br /

Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

<p>Abstract</p> <p>Background</p> <p>The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels.</p> <p>Methods/Design</p> <p>The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations.</p> <p>Discussion</p> <p>The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated.</p> <p>Trial Registration</p> <p>This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.</p