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1.  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 
Cardiovascular 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.
Following 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.
The 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 registration
Australian New Zealand Clinical Trials Registry ACTRN12616000233426
PMCID: PMC5034506  PMID: 27664074
Cardiovascular disease; General practitioners; Pharmacists; Clinical decision support system; Polypill; Primary health care
2.  Amygdala Reactivity to Emotional Faces in the Prediction of General and Medication-Specific Responses to Antidepressant Treatment in the Randomized iSPOT-D Trial 
Neuropsychopharmacology  2015;40(10):2398-2408.
Although the cost of poor treatment outcomes of depression is staggering, we do not yet have clinically useful methods for selecting the most effective antidepressant for each depressed person. Emotional brain activation is altered in major depressive disorder (MDD) and implicated in treatment response. Identifying which aspects of emotional brain activation are predictive of general and specific responses to antidepressants may help clinicians and patients when making treatment decisions. We examined whether amygdala activation probed by emotion stimuli is a general or differential predictor of response to three commonly prescribed antidepressants, using functional magnetic resonance imaging (fMRI). A test–retest design was used to assess patients with MDD in an academic setting as part of the International Study to Predict Optimized Treatment in Depression. A total of 80 MDD outpatients were scanned prior to treatment and 8 weeks after randomization to the selective serotonin reuptake inhibitors escitalopram and sertraline and the serotonin–norepinephrine reuptake inhibitor, venlafaxine-extended release (XR). A total of 34 matched controls were scanned at the same timepoints. We quantified the blood oxygen level-dependent signal of the amygdala during subliminal and supraliminal viewing of facial expressions of emotion. Response to treatment was defined by ⩾50% symptom improvement on the 17-item Hamilton Depression Rating Scale. Pre-treatment amygdala hypo-reactivity to subliminal happy and threat was a general predictor of treatment response, regardless of medication type (Cohen's d effect size 0.63 to 0.77; classification accuracy, 75%). Responders showed hypo-reactivity compared to controls at baseline, and an increase toward ‘normalization' post-treatment. Pre-treatment amygdala reactivity to subliminal sadness was a differential moderator of non-response to venlafaxine-XR (Cohen's d effect size 1.5; classification accuracy, 81%). Non-responders to venlafaxine-XR showed pre-treatment hyper-reactivity, which progressed to hypo-reactivity rather than normalization post-treatment, and hypo-reactivity post-treatment was abnormal compared to controls. Impaired amygdala activation has not previously been highlighted in the general vs differential prediction of antidepressant outcomes. Amygdala hypo-reactivity to emotions signaling reward and threat predicts the general capacity to respond to antidepressants. Amygdala hyper-reactivity to sad emotion is involved in a specific non-response to a serotonin–norepinephrine reuptake inhibitor. The findings suggest amygdala probes may help inform the personal selection of antidepressant treatments.
PMCID: PMC4538354  PMID: 25824424
3.  A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial 
Trials  2016;17:119.
Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking.
This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 − 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children.
We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers.
The trial will provide evidence for the safety and effectiveness of watchful waiting for the management of AOM in Aboriginal and Torres Strait Islander children living in urban settings who are considered to be at low risk of complications.
Trial registration
The trial is registered with Australia New Zealand Clinical Trials Registry (ACTRN12613001068752). Date of registration: 24 September 2013.
PMCID: PMC4778283  PMID: 26941013
Otitis media; Acute otitis media; Aboriginal and Torres Strait Islander peoples; Indigenous population; Children; Antimicrobial agents; Randomised controlled trial
4.  Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study 
Trials  2015;16:425.
Pragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for ‘real life’ implementation challenges in routine practice. The methodological challenges of PRCT implementation, particularly in primary care, are not well understood. The Kanyini Guidelines Adherence to Polypill study (Kanyini GAP) was a recent primary care PRCT involving multiple private general practices, Indigenous community controlled health services and private community pharmacies. Through the experiences of Kanyini GAP participants, and using data from study materials, this paper identifies the critical enablers and barriers to implementing a PRCT across diverse practice settings and makes recommendations for future PRCT implementation.
Qualitative data from 94 semi-structured interviews (47 healthcare providers (pharmacists, general practitioners, Aboriginal health workers; 47 patients) conducted for the process evaluation of Kanyini GAP was used. Data coded to ‘trial impact’, ‘research motivation’ and ‘real world’ were explored and triangulated with data extracted from study materials (e.g. Emails, memoranda of understanding and financial statements).
PRCT implementation was facilitated by an extensive process of relationship building at the trial outset including building on existing relationships between core investigators and service providers. Health providers’ and participants’ altruism, increased professional satisfaction, collaboration, research capacity and opportunities for improved patient care enabled implementation. Inadequate research infrastructure, excessive administrative demands, insufficient numbers of adequately trained staff and the potential financial impact on private practice were considered implementation barriers. These were largely related to this being the first experience of trial involvement for many sites. The significant costs of addressing these barriers drew study resources from the task of achieving recruitment targets.
Conducting PRCTs is crucial to generating credible evidence of intervention effectiveness in routine practice. PRCT implementation needs to account for the particular challenges of implementing collaborative research across diverse stakeholder organisations. Reliance on goodwill to participate is crucial at the outset. However, participation costs, particularly for organisations with little or no research experience, can be substantial and should be factored into PRCT funding models. Investment in a pool to fund infrastructure in the form of primary health research networks will offset some of these costs, enabling future studies to be implemented more cost-effectively.
Trial registration
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0956-y) contains supplementary material, which is available to authorized users.
PMCID: PMC4581084  PMID: 26399503
Pragmatic randomised controlled trial; Primary healthcare; Indigenous health services; Implementation; Clinical trial
5.  Demographic and clinical predictors of unplanned hospital utilisation among chronically ill patients: a prospective cohort study 
In urban Australia, patients with serious and continuing illnesses make frequent use of hospital emergency department (ED) services. However, the risk factors for hospital utilisation among the broad population of people with chronic illness are not well known. The aim of this study was to assess the predictors of hospital utilisation (either inpatient admissions or ED visits) in a cohort of 308 patients with chronic illness.
We studied patients with serious and continuing chronic illnesses presenting to an ED in a large periurban hospital in western Sydney, Australia, between 2010 and 2013. ED presentations and hospital admissions were observed over two years. Multivariate negative-binomial regression analyses were used to identify risk factors for the number of presentations to hospital.
The main risk factors for hospital utilisation were having a live-in carer, and a history of hospital utilisation. Having a live-in carer was associated with an increase in number of ED presentations by 88% (RR 1.88; 95% CI 1.41-2.51), and of admissions by 116% (RR 2.16; 95% CI 1.61-2.92). Seventy-seven percent of hospital utilisation in the cohort was attributable to carer status. Each additional ED presentation that a person had in the 12 months prior to the study led to an increased risk of an ED presentation in the follow-up period by 6% (RR = 1.06, 95% CI = 1.03-1.08). Between 20% and 25% of variability in hospital utilisation in the cohort was attributable to the number of hospital admissions or ED presentations in the previous 12 months.
Patients with a live-in carer and with a history of hospital utilisation are at high risk for future hospital use.
PMCID: PMC4443504  PMID: 25889292
Coordinated care; Presentations; Unplanned; Admissions; Emergency department; Health services; Electronic medical record
6.  Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials 
Primary-care based randomized controlled trials (RCTs) build an important evidence base for general practice but little evidence exists about barriers to recruitment which often hamper such trials.
We investigated the issues that impeded and facilitated recruitment to a clinical trial in general practice.
GPs participating in a cluster RCT that tested interventions for improving medication adherence and asthma control completed a survey comprising quantitative and free text questions about their recruitment experiences. We used backward regression to analyze quantitative data and coded free text responses into themes.
40/55 of enrolled GPs recruited patients, but only one-third reached the planned recruitment target (5 patients/GP). In univariate analyses, poor patient recruitment by GPs was significantly associated with longer time to first patient enrolment, GP-perceived poor access to eligible patients and GP working in a practice training medical students. In regression analysis, only the first was significant (p = 0.001); the explained variance of the model was 48%. Themes from free text responses described recruitment barriers at the level of GP (e.g. GPs excluding patients for whom research appeared too challenging), practice (e.g. practice cultures disempowered GPs), patient (e.g. reluctance to change treatment for research) and study (e.g. protocol requirements complicating recruitment). Facilitators included GPs perceiving good support from the research team.
Targeted recruitment support early in the recruitment phase may enhance recruitment rates. Over time, interventions to enhance a general practice research culture are also likely to enhance skills to recruit patients, even for complex interventions. We recommend systematic evaluation of recruitment approaches and outcomes in future RCTs to optimize feasibility and success of these important trials.
Trial registration
Australian and New Zealand Clinical Trials Registry ACTRN12610000854033 (date registered 14/10/2010).
PMCID: PMC4369080  PMID: 25887970
Attitude of health personnel; Patient selection; General practitioners; Physician-patient relations; Randomized controlled trials as topic; Asthma/prevention & control
7.  AMH Aged Care Companion 
Australian Prescriber  2015;38(1):5.
PMCID: PMC4654040
8.  A multifaceted quality improvement intervention for CVD risk management in Australian primary healthcare: a protocol for a process evaluation 
Cardiovascular disease (CVD) is the leading cause of death and disability worldwide. Despite the widespread availability of evidence-based clinical guidelines and validated risk predication equations for prevention and management of CVD, their translation into routine practice is limited. We developed a multifaceted quality improvement intervention for CVD risk management which incorporates electronic decision support, patient risk communication tools, computerised audit and feedback tools, and monthly, peer-ranked performance feedback via a web portal. The intervention was implemented in a cluster randomised controlled trial in 60 primary healthcare services in Australia. Overall, there were improvements in risk factor recording and in prescribing of recommended treatments among under-treated individuals, but it is unclear how this intervention was used in practice and what factors promoted or hindered its use. This information is necessary to optimise intervention impact and maximally implement it in a post-trial context. In this study protocol, we outline our methods to conduct a theory-based, process evaluation of the intervention. Our aims are to understand how, why, and for whom the intervention produced the observed outcomes and to develop effective strategies for translation and dissemination.
We will conduct four discrete but inter-related studies taking a mixed methods approach. Our quantitative studies will examine (1) the longer term effectiveness of the intervention post-trial, (2) patient and health service level correlates with trial outcomes, and (3) the health economic impact of implementing the intervention at scale. The qualitative studies will (1) identify healthcare provider perspectives on implementation barriers and enablers and (2) use video ethnography and patient semi-structured interviews to understand how cardiovascular risk is communicated in the doctor/patient interaction both with and without the use of intervention. We will also assess the costs of implementing the intervention in Australian primary healthcare settings which will inform scale-up considerations.
This mixed methods evaluation will provide a detailed understanding of the process of implementing a quality improvement intervention and identify the factors that might influence scalability and sustainability.
Trials registration
PMCID: PMC4279909  PMID: 25515217
Knowledge translation; Process evaluation; Quality improvement intervention; Clinical decision support systems; Cardiovascular prevention; Cardiovascular risk; Primary healthcare; Mixed methods; Theory-based
9.  Sexual behaviour, sexually transmitted infections and attitudes to chlamydia testing among a unique national sample of young Australians: baseline data from a randomised controlled trial 
BMC Public Health  2014;14:12.
Chlamydia infection is the most common notifiable sexually transmitted infection (STI) in Australia and mostly affects young people (15 – 25 years). This paper presents baseline data from a randomised controlled trial that aimed to increase chlamydia testing among sexually active young people. The objectives were to identify associations between sexual behaviour, substance use and STI history and explore attitudes to chlamydia testing.
This study was conducted in cyberspace. Study recruitment, allocation, delivery of interventions and baseline and follow up data collection all took place online. Participants were 16 – 25 years old and resided in Australia. Substance use correlates of sexual activity; predictors of history of STIs; barriers to and facilitators of chlamydia testing were analysed.
Of 856 participants (79.1% female), 704 had experienced penetrative intercourse. Sexually active participants were more likely to smoke regularly or daily, to drink alcohol, or to have binge drunk or used marijuana or other illicit substances recently. Risk factors for having a history of any STI were 3 or more sexual partners ever, 6 or more partners in the past 12 months, condom non-use and being 20 years or older. Almost all sexually active participants said that they would have a chlamydia test if their doctor recommended it.
Sexually active young people are at risk of STIs and may engage in substance use risk behaviours. Where one health risk behaviour is identified, it is important to seek information about others. Chlamydia testing can be facilitated by doctors and nurses recommending it. Primary care providers have a useful role in chlamydia control.
Trial Registration
Australian and New Zealand Trials Registry ACTRN12607000582459
PMCID: PMC3909293  PMID: 24400743
Adolescents; Young people; Chlamydia; Sexually transmitted infections; Health risk behaviour
10.  A patient-centred approach to health service delivery: improving health outcomes for people with chronic illness 
The Wagner Model provides a framework that can help to facilitate health system transition towards a chronic care oriented model. Drawing on elements of this framework as well as health policy related to patient centred care, we describe the health needs of patients with chronic illness and compare these with services which should ideally be provided by a patient-centred health system. This paper aims to increase understanding of the challenges faced by chronically ill patients and family carers in relation to their experiences with the health care system and health service providers.
We interviewed patients, carers and health care professionals (HCPs) about the challenges faced by people living with complicated diabetes, chronic heart failure or chronic obstructive pulmonary disease.
Patients indicated that they had a range of concerns related to the quality of health care encounters with health care professionals (HCPs), with these concerns being expressed as needs or wants. These included: 1) the need for improved communication and information delivery on the part of HCPs; 2) well organised health services and reduced waiting times to see HCPs; 3) help with self care; 4) greater recognition among professionals of the need for holistic and continuing care; and 5) inclusion of patients and carers in the decision making processes.
In order to address the challenges faced by people with chronic illness, health policy must be more closely aligned with the identified needs and wants of people affected by chronic illness than is currently the case.
PMCID: PMC3706210  PMID: 23819721
11.  Implementation and effectiveness of 'care navigation', coordinated management for people with complex chronic illness: rationale and methods of a randomised controlled 
Chronic illness is a significant driver of the global burden of disease and associated health care costs. People living with severe chronic illness are heavy users of acute hospital services; better coordination of their care could potentially improve health outcomes while reducing hospital use. The Care Navigation trial will evaluate an in-hospital coordinated care intervention on health service use and quality of life in chronically ill patients.
A randomised controlled trial in 500 chronically ill patients presenting to the emergency department of a hospital in Western Sydney, Australia. Participants have three or more hospital admissions within a previous 12 month period and either aged ≥70 years; or aged ≥45 years and of Aboriginal or Torres Strait Islander descent; or aged ≥ 16 with a diagnosis of a respiratory or cardiology related illness. Patients are randomised to either the coordinated care program (Care Navigation), or to usual care. The Care Navigation program consists of dedicated nurses who conduct patient risk assessments, oversee patient nursing while in hospital, and guide development of a care plan for the management of chronic illness after being discharged from hospital. These nurses also book community appointments and liaise with general practitioners. The main outcome variables are the number of emergency department re-presentations and hospital readmissions, and quality of life during a 24 month follow-up. Secondary outcomes are length of hospital stay, mortality, time to first hospital re-admission, time to first emergency department re-presentation, patient satisfaction, adherence to prescribed medications, amount and type of in-hospital referrals made for consultations and diagnostic testing, and the number and type of community health referrals. A process evaluation and economic analysis will be conducted alongside the randomised trial.
A trial of in-hospital care coordination may support recent evidence that engaging primary health services in care plans linked to multidisciplinary team support improves patient outcomes and reduces costs to the health system. This will inform local, national and international health policy.
Trial registration
Australia New Zealand Clinical Trials Registry ACTRN12609000554268
PMCID: PMC3645952  PMID: 23642145
Randomised controlled trial; Chronic illness; Comorbidity; Hospital admissions; Community health; Hospital length of stay; Coordinated care; Process evaluation
12.  The Treatment of cardiovascular Risk in Primary care using Electronic Decision suppOrt (TORPEDO) study: intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare 
BMJ Open  2012;2(6):e002177.
Large gaps exist in the implementation of guideline recommendations for cardiovascular disease (CVD) risk management. Electronic decision support (EDS) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia. We have developed HealthTracker, a multifaceted EDS and quality improvement intervention to improve the management of CVD risk.
It is hypothesised that the use of HealthTracker over a 12-month period will result in: (1) an increased proportion of patients receiving guideline-indicated measurements of CVD risk factors and (2) an increased proportion of patients at high risk will receive guideline-indicated prescriptions for lowering their CVD risk. Sixty health services (40 general practices and 20 Aboriginal Community Controlled Health Services (ACCHSs) will be randomised in a 1:1 allocation to receive either the intervention package or continue with usual care, stratified by service type, size and participation in existing quality improvement initiatives. The intervention consists of point-of-care decision support; a risk communication interface; a clinical audit tool to assess performance on CVD-related indicators; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance. The control arm will continue with usual care without access to these intervention components. Quantitative data will be derived from cross-sectional samples at baseline and end of study via automated data extraction. Detailed process and economic evaluations will also be conducted.
Ethics and dissemination
The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee (HREC) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC. Formal agreements with each of the participating sites have been signed. In addition to the usual scientific forums, results will be disseminated via newsletters, study websites, face-to-face feedback forums and workshops.
Trial registration
The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910.
PMCID: PMC3533097  PMID: 23166140
Primary Care; Cardiology
13.  What determines adherence to treatment in cardiovascular disease prevention? Protocol for a mixed methods preference study 
BMJ Open  2011;1(2):e000372.
Significant gaps exist between guidelines-recommended therapies for cardiovascular disease prevention and current practice. Fixed-dose combination pills (‘polypills’) potentially improve adherence to therapy. This study is a preference study undertaken in conjunction with a clinical trial of a polypill and seeks to examine the underlying reasons for variations in treatment adherence to recommended therapy.
A preference study comprising: (1) Discrete Choice Experiment for patients; and (2) qualitative study of patients and providers. Both components will be conducted on participants in the trial. A joint model combining the observed adherence in the clinical trial (revealed preference) and the Discrete Choice Experiment data (stated preference) will be estimated. Estimates will be made of the marginal effect (importance) of each attribute on overall choice, the extent to which respondents are prepared to trade-off one attribute for another and predicted values of the level of adherence given a fixed set of attributes, and contextual and socio-demographic characteristics. For the qualitative study, a thematic analysis will be used as a means of exploring in depth the preferences and ultimately provide important narratives on the experiences and perspectives of individuals with regard to adherence behaviour.
Ethics and dissemination
Primary ethics approval was received from Sydney South West Area Health Service Human Research Ethics Committee (Royal Prince Alfred Hospital zone). In addition to usual scientific forums, the findings will be reported back to the communities involved in the studies through site-specific reports and oral presentations.
Article summary
Article focus
To assess patient choices with regard to adherence to long-term therapy for the prevention of cardiovascular disease in indigenous and non-indigenous populations.
To understand, from the perspective of patients and providers, the factors that influence how well guidelines-recommended therapy for cardiovascular disease in indigenous and non-indigenous populations are implemented.
Key messages
This is an innovative study using a mixed methods approach to assess patient medications adherence that combines data on patients' stated preferences and their observed behaviour.
The study will examine underlying reasons why adherence outcomes were (or were not) achieved within the context of a clinical trial of a cardiovascular polypill-based strategy and, as such, serves as a process evaluation.
The findings will extrapolate the level of adherence observed in the trial to different ‘real-world’ settings.
Strengths and limitations of this study
The strengths of the study are that it involves the innovative application of a preference study alongside a clinical trial, provides insights into how patients may respond to factors that influence adherence but not necessarily encounter in a clinical trial setting and addresses an important public-health issue—namely treatment gaps in relation to cardiovascular-disease prevention.
The limitation is that it is a conducted in one country, Australia, and thus its generalisability may be limited by prevailing institutional arrangements.
PMCID: PMC3211054  PMID: 22080542
14.  Health professionals, patients and chronic illness policy: a qualitative study 
Background and objective  This study investigates health professionals’ reactions to patients’ perceptions of health issues – a little‐researched topic vital to the reform of the care of chronic illness.
Methods  Focus groups were undertaken with doctors, nurses, allied health staff and pharmacists (n = 88) in two Australian urban regions. The focus groups explored responses to patient experiences of chronic illness (COPD, Diabetes, CHF) obtained in an earlier qualitative study. Content analysis was undertaken of the transcripts assisted by NVivo7 software.
Results  Health professionals and patients agreed on general themes: that competing demands in self‐management, financial pressure and co‐morbidity were problems for people with chronic illness. However where patients and carers focused on their personal challenges, health professionals often saw the patient experience as a series of failures relating to compliance or service fragmentation. Some saw this as a result of individual shortcomings. Most identified structural and attitudinal issues. All saw the prime solution as additional resources for their own activities. Fee for service providers (mainly doctors) sought increased remuneration; salaried professionals (mainly nurses and allied health professionals) sought to increase capacity within their professional group.
Conclusions  Professionals focus on their own resources and the behaviour of other professionals to improve management of chronic illness. They did not factor information from patient experience into their views about systems improvement. This inability to identify solutions beyond their professional sphere highlights the limitations of an over‐reliance on the perspectives of health professionals. The views of patients and carers must find a stronger voice in health policy.
PMCID: PMC5060561  PMID: 20550589
chronic illness; compliance; fragmentation; health professionals; policy
15.  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 
BMC Public Health  2010;10:458.
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.
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.
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.
Trial Registration
This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.
PMCID: PMC2923109  PMID: 20687931
16.  An Electronic Clinical Decision Support Tool to Assist Primary Care Providers in Cardiovascular Disease Risk Management: Development and Mixed Methods Evaluation 
Challenges remain in translating the well-established evidence for management of cardiovascular disease (CVD) risk into clinical practice. Although electronic clinical decision support (CDS) systems are known to improve practitioner performance, their development in Australian primary health care settings is limited.
Study aims were to (1) develop a valid CDS tool that assists Australian general practitioners (GPs) in global CVD risk management, and (2) preliminarily evaluate its acceptability to GPs as a point-of-care resource for both general and underserved populations.
CVD risk estimation (based on Framingham algorithms) and risk-based management advice (using recommendations from six Australian guidelines) were programmed into a software package. Tool validation: Data from 137 patients attending a physician’s clinic were analyzed to compare the tool’s risk scores with those obtained from an independently programmed algorithm in a separate statistics package. The tool’s management advice was compared with a physician’s recommendations based on a manual review of the guidelines. Field test: The tool was then tested with 21 GPs from eight general practices and three Aboriginal Medical Services. Customized CDS-based recommendations were generated for 200 routinely attending patients (33% Aboriginal) using information extracted from the health record by a research assistant. GPs reviewed these recommendations during each consultation. Changes in CVD risk factor measurement and management were recorded. In-depth interviews with GPs were conducted.
Validation testing: The tool’s risk assessment algorithm correlated very highly with the independently programmed version in the separate statistics package (intraclass correlation coefficient 0.999). For management advice, there were only two cases of disagreement between the tool and the physician. Field test: GPs found 77% (153/200) of patient outputs easy to understand and agreed with screening and prescribing recommendations in 72% and 64% of outputs, respectively; 26% of patients had their CVD risk factor history updated; 73% had at least one CVD risk factor measured or tests ordered. For people assessed at high CVD risk (n = 82), 10% and 9%, respectively, had lipid-lowering and BP-lowering medications commenced or dose adjustments made, while 7% newly commenced anti-platelet medications. Three key qualitative findings emerged: (1) GPs found the tool enabled a systematic approach to care; (2) the tool greatly influenced CVD risk communication; (3) successful implementation into routine care would require integration with practice software, minimal data entry, regular revision with updated guidelines, and a self-auditing feature. There were no substantive differences in study findings for Aboriginal Medical Services GPs, and the tool was generally considered appropriate for use with Aboriginal patients.
A fully-integrated, self-populating, and potentially Internet-based CDS tool could contribute to improved global CVD risk management in Australian primary health care. The findings from this study will inform a large-scale trial intervention.
PMCID: PMC2802562  PMID: 20018588
Decision support systems; clinical; cardiovascular diseases; physicians, family; Aborigines, Australian
17.  Challenges for co-morbid chronic illness care and policy in Australia: a qualitative study 
In response to the escalating burden of chronic illness in Australia, recent health policies have emphasised the promotion of patient self-management and better preventive care. A notable omission from these policies is the acknowledgment that patients with chronic illness tend to have co-morbid conditions. Our objectives were: to identify the common challenges co-morbidity poses to patients and carers in their experiences of self-management; to detail the views and perceptions of health professionals about these challenges; and to discuss policy options to improve health care for people with co-morbid chronic illness. The method included semi-structured interviews and focus groups with 129 purposively sampled participants. Participants were people with Type 2 diabetes, chronic obstructive pulmonary disease and/or chronic heart failure as well as carers and health care professionals. Content analysis of the interview data was conducted using NVivo7 software.
Patients and their carers found co-morbidity influenced their capacity to manage chronic illness in three ways. First, co-morbidity created barriers to patients acting on risk factors; second, it complicated the process of recognising the early symptoms of deterioration of each condition, and third, it complicated their capacity to manage medication.
Findings highlight challenges that patients with multiple chronic conditions face in relation to preventive care and self-management. Future clinical policy initiatives need to move away from single illness orientation toward strategies that meet the needs of people with co-morbid conditions and strengthen their capacity to self-manage. These patients will benefit directly from specialised education and services that cater to the needs of people with clusters of co-morbidities.
PMCID: PMC2745419  PMID: 19735576
18.  Access to primary health care for Australian young people: service provider perspectives. 
BACKGROUND: To adequately address the complex health needs of young people, their access to services, and the quality of services received, must be improved. AIMS: To explore the barriers to service provision for young people and to identify the training needs of primary healthcare service providers in New South Wales (NSW), Australia. DESIGN OF STUDY: A cross-sectional, qualitative study of the perspectives of a range of health service providers. SETTING: A range of primary healthcare organisations across NSW. METHODS: Samples of general practitioners (GPs), youth health workers, youth health coordinators, and community health centre staff were drawn from urban and rural clusters across NSW. Focus groups and interviews were used to identify barriers to service provision and the training needs of service providers. Data were tape recorded, transcribed, and analysed. RESULTS: Barriers to service provision among GPs and community health centre staff included inadequate time, flexibility, skills, and confidence in working with young people, and poor linkages with other relevant services. Training needs included better knowledge of and skills in adolescent health requirements, working with adolescents, and working with other services. Barriers to service provision for youth health workers and coordinators included lack of financial resources and infrastructure. There were few linkages between groups of service providers. CONCLUSION: Models of service provision that allow stronger linkages between service providers, sufficient time for consultation with young people, adequate training and support of health professionals, and flexibility of service provision, including outreach, should be explored and evaluated.
PMCID: PMC1314748  PMID: 14960219
19.  The consultation 
BMJ : British Medical Journal  2002;324(7353):1567-1569.
PMCID: PMC1123505  PMID: 12089097
20.  Difficult Asthma 
BMJ : British Medical Journal  1999;319(7217):1141.
PMCID: PMC1116924  PMID: 10531126
21.  What to do in a general practice emergency 
BMJ : British Medical Journal  1998;317(7170):1460.
PMCID: PMC1114316  PMID: 9822423
23.  Sex biased language 
BMJ : British Medical Journal  1992;304(6843):1692.
PMCID: PMC1882336

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