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Year of Publication
1.  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.
Background
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.
Methods/design
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.
doi:10.1136/bmjopen-2012-002177
PMCID: PMC3533097  PMID: 23166140
Primary Care; Cardiology
2.  A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol 
Background
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care.
Design
A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP) team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD.
The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate), smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities.
The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related quality of life measures, smoking and immunisation status, medications, inhaler technique, and lung function. Outcomes will be assessed by project officers blinded to patients’ randomization groups.
Discussion
This study will use proven case-finding methods to identify patients with undiagnosed COPD in general practice, where improved care has the potential for substantial benefit in health and healthcare utilization. The study provides the capacity to trial a new model of team-based assessment and management of newly diagnosed COPD in Australian primary care.
Trial registration
ACTRN12610000592044\
doi:10.1186/1748-5908-7-83
PMCID: PMC3457839  PMID: 22958678
3.  Supporting Treatment decision making to Optimise the Prevention of STROKE in Atrial Fibrillation: The STOP STROKE in AF study. Protocol for a cluster randomised controlled trial 
Background
Suboptimal uptake of anticoagulation for stroke prevention in atrial fibrillation has persisted for over 20 years, despite high-level evidence demonstrating its effectiveness in reducing the risk of fatal and disabling stroke.
Methods
The STOP STROKE in AF study is a national, cluster randomised controlled trial designed to improve the uptake of anticoagulation in primary care. General practitioners from around Australia enrolling in this ‘distance education’ program are mailed written educational materials, followed by an academic detailing session delivered via telephone by a medical peer, during which participants discuss patient de-identified cases. General practitioners are then randomised to receive written specialist feedback about the patient de-identified cases either before or after completing a three-month posttest audit. Specialist feedback is designed to provide participants with support and confidence to prescribe anticoagulation. The primary outcome is the proportion of patients with atrial fibrillation receiving oral anticoagulation at the time of the posttest audit.
Discussion
The STOP STROKE in AF study aims to evaluate a feasible intervention via distance education to prevent avoidable stroke due to atrial fibrillation. It provides a systematic test of augmenting academic detailing with expert feedback about patient management.
Trial registration
Australian Clinical Trials Registry Registration Number: ACTRN12611000076976.
doi:10.1186/1748-5908-7-63
PMCID: PMC3443055  PMID: 22770423
Atrial fibrillation; General practice; Anticoagulation; Decisional support
4.  Qualitative evaluation of a diabetes electronic decision support tool: views of users 
Background
Quality care of type 2 diabetes is complex and requires systematic use of clinical data to monitor care processes and outcomes. An electronic decision support (EDS) tool for the management of type 2 diabetes in primary care was developed by the Australian Pharmaceutical Alliance. The aim of this qualitative study was to evaluate the uptake and use of the EDS tool as well as to describe the impact of the EDS tool on the primary care consultation for diabetes from the perspectives of general practitioners and practice nurses.
Methods
This was a qualitative study of telephone interviews. General Practitioners and Practice Nurses from four Divisions of General Practice who had used the EDS tool for a minimum of six weeks were invited to participate. Semi-structured interviews were conducted and the interview transcripts were coded and thematically analysed using NVivo 8 software.
Results
In total 15 General Practitioners and 2 Practice Nurses completed the interviews. The most commonly used feature of the EDS tool was the summary side bar; its major function was to provide an overview of clinical information and a prompt or reminder to diabetes care. It also assisted communication and served an educational role as a visual aide in the consultation. Some participants thought the tool resulted in longer consultations. There were a range of barriers to use related to the design and functionality of the tool and to the primary care context.
Conclusions
The EDS tool shows promise as a way of summarising information about patients’ diabetes state, reminder of required diabetes care and an aide to patient education.
doi:10.1186/1472-6947-12-61
PMCID: PMC3426492  PMID: 22759239
5.  A systematic review of interventions in primary care to improve health literacy for chronic disease behavioral risk factors 
BMC Family Practice  2012;13:49.
Background
To evaluate the effectiveness of interventions used in primary care to improve health literacy for change in smoking, nutrition, alcohol, physical activity and weight (SNAPW).
Methods
A systematic review of intervention studies that included outcomes for health literacy and SNAPW behavioral risk behaviors implemented in primary care settings.
We searched the Cochrane Library, Johanna Briggs Institute, Medline, Embase, CINAHL, Psychinfo, Web of Science, Scopus, APAIS, Australasian Medical Index, Google Scholar, Community of Science and four targeted journals (Patient Education and Counseling, Health Education and Behaviour, American Journal of Preventive Medicine and Preventive Medicine).
Study inclusion criteria: Adults over 18 years; undertaken in a primary care setting within an Organisation for Economic Co-operation and Development (OECD) country; interventions with at least one measure of health literacy and promoting positive change in smoking, nutrition, alcohol, physical activity and/or weight; measure at least one outcome associated with health literacy and report a SNAPW outcome; and experimental and quasi-experimental studies, cohort, observational and controlled and non-controlled before and after studies.
Papers were assessed and screened by two researchers (JT, AW) and uncertain or excluded studies were reviewed by a third researcher (MH). Data were extracted from the included studies by two researchers (JT, AW). Effectiveness studies were quality assessed. A typology of interventions was thematically derived from the studies by grouping the SNAPW interventions into six broad categories: individual motivational interviewing and counseling; group education; multiple interventions (combination of interventions); written materials; telephone coaching or counseling; and computer or web based interventions. Interventions were classified by intensity of contact with the subjects (High ≥ 8 points of contact/hours; Moderate >3 and <8; Low ≤ 3 points of contact hours) and setting (primary health, community or other).
Studies were analyzed by intervention category and whether significant positive changes in SNAPW and health literacy outcomes were reported.
Results
52 studies were included. Many different intervention types and settings were associated with change in health literacy (73% of all studies) and change in SNAPW (75% of studies). More low intensity interventions reported significant positive outcomes for SNAPW (43% of studies) compared with high intensity interventions (33% of studies). More interventions in primary health care than the community were effective in supporting smoking cessation whereas the reverse was true for diet and physical activity interventions.
Conclusion
Group and individual interventions of varying intensity in primary health care and community settings are useful in supporting sustained change in health literacy for change in behavioral risk factors. Certain aspects of risk behavior may be better handled in clinical settings while others more effectively in the community. Our findings have implications for the design of programs.
doi:10.1186/1471-2296-13-49
PMCID: PMC3444864  PMID: 22656188
Health literacy; Behavioral risk factors
6.  Which providers can bridge the health literacy gap in lifestyle risk factor modification education: a systematic review and narrative synthesis 
BMC Family Practice  2012;13:44.
Background
People with low health literacy may not have the capacity to self-manage their health and prevent the development of chronic disease through lifestyle risk factor modification. The aim of this narrative synthesis is to determine the effectiveness of primary healthcare providers in developing health literacy of patients to make SNAPW (smoking, nutrition, alcohol, physical activity and weight) lifestyle changes.
Methods
Studies were identified by searching Medline, Embase, Cochrane Library, CINAHL, Joanna Briggs Institute, Psychinfo, Web of Science, Scopus, APAIS, Australian Medical Index, Community of Science and Google Scholar from 1 January 1985 to 30 April 2009. Health literacy and related concepts are poorly indexed in the databases so a list of text words were developed and tested for use. Hand searches were also conducted of four key journals. Studies published in English and included males and females aged 18 years and over with at least one SNAPW risk factor for the development of a chronic disease. The interventions had to be implemented within primary health care, with an aim to influence the health literacy of patients to make SNAPW lifestyle changes. The studies had to report an outcome measure associated with health literacy (knowledge, skills, attitudes, self efficacy, stages of change, motivation and patient activation) and SNAPW risk factor.
The definition of health literacy in terms of functional, communicative and critical health literacy provided the guiding framework for the review.
Results
52 papers were included that described interventions to address health literacy and lifestyle risk factor modification provided by different health professionals. Most of the studies (71%, 37/52) demonstrated an improvement in health literacy, in particular interventions of a moderate to high intensity.
Non medical health care providers were effective in improving health literacy. However this was confounded by intensity of intervention. Provider barriers impacted on their relationship with patients.
Conclusion
Capacity to provide interventions of sufficient intensity is an important condition for effective health literacy support for lifestyle change. This has implications for workforce development and the organisation of primary health care.
doi:10.1186/1471-2296-13-44
PMCID: PMC3515410  PMID: 22639799
Health literacy; Lifestyle risk factor modification; Primary health care
7.  Breathe Easier Online: Evaluation of a Randomized Controlled Pilot Trial of an Internet-Based Intervention to Improve Well-being in Children and Adolescents With a Chronic Respiratory Condition 
Background
Chronic respiratory illnesses are the most common group of childhood chronic health conditions and are overrepresented in socially isolated groups.
Objective
To conduct a randomized controlled pilot trial to evaluate the efficacy of Breathe Easier Online (BEO), an Internet-based problem-solving program with minimal facilitator involvement to improve psychosocial well-being in children and adolescents with a chronic respiratory condition.
Methods
We randomly assigned 42 socially isolated children and adolescents (18 males), aged between 10 and 17 years to either a BEO (final n = 19) or a wait-list control (final n = 20) condition. In total, 3 participants (2 from BEO and 1 from control) did not complete the intervention. Psychosocial well-being was operationalized through self-reported scores on depression symptoms and social problem solving. Secondary outcome measures included self-reported attitudes toward their illness and spirometry results. Paper-and-pencil questionnaires were completed at the hospital when participants attended a briefing session at baseline (time 1) and in their homes after the intervention for the BEO group or a matched 9-week time period for the wait-list group (time 2).
Results
The two groups were comparable at baseline across all demographic measures (all F < 1). For the primary outcome measures, there were no significant group differences on depression (P = .17) or social problem solving (P = .61). However, following the online intervention, those in the BEO group reported significantly lower depression (P = .04), less impulsive/careless problem solving (P = .01), and an improvement in positive attitude toward their illness (P = .04) compared with baseline. The wait-list group did not show these differences. Children in the BEO group and their parents rated the online modules very favorably.
Conclusions
Although there were no significant group differences on primary outcome measures, our pilot data provide tentative support for the feasibility (acceptability and user satisfaction) and initial efficacy of an Internet-based intervention for improving well-being in children and adolescents with a chronic respiratory condition.
Trial registration
Australian New Zealand Clinical Trials Registry number: ACTRN12610000214033; http://www.anzctr.org.au/trial_view.aspx?ID=308074 (Archived by WebCite at http://www.webcitation.org/63BL55mXH)
doi:10.2196/jmir.1997
PMCID: PMC3374545  PMID: 22356732
Internet-based intervention; chronic respiratory condition; psychosocial well-being; children and adolescents; randomized controlled trial
8.  Study protocol: the DESPATCH study: Delivering stroke prevention for patients with atrial fibrillation - a cluster randomised controlled trial in primary healthcare 
Background
Compelling evidence shows that appropriate use of anticoagulation in patients with nonvalvular atrial fibrillation reduces the risk of ischaemic stroke by 67% and all-cause mortality by 26%. Despite this evidence, anticoagulation is substantially underused, resulting in avoidable fatal and disabling strokes.
Methods
DESPATCH is a cluster randomised controlled trial with concealed allocation and blinded outcome assessment designed to evaluate a multifaceted and tailored implementation strategy for improving the uptake of anticoagulation in primary care. We have recruited general practices in South Western Sydney, Australia, and randomly allocated practices to receive the DESPATCH intervention or evidence-based guidelines (control). The intervention comprises specialist decisional support via written feedback about patient-specific cases, three academic detailing sessions (delivered via telephone), practice resources, and evidence-based information. Data for outcome assessment will be obtained from a blinded, independent medical record audit. Our primary endpoint is the proportion of nonvalvular atrial fibrillation patients, over 65 years of age, receiving oral anticoagulation at any time during the 12-month posttest period.
Discussion
Successful translation of evidence into clinical practice can reduce avoidable stroke, death, and disability due to nonvalvular atrial fibrillation. If successful, DESPATCH will inform public policy, providing quality evidence for an effective implementation strategy to improve management of nonvalvular atrial fibrillation, to close an important evidence-practice gap.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12608000074392
doi:10.1186/1748-5908-6-48
PMCID: PMC3121604  PMID: 21599901
9.  Quit in General Practice: a cluster randomised trial of enhanced in-practice support for smoking cessation 
BMC Family Practice  2010;11:59.
Background
This study will test the uptake and effectiveness of a flexible package of smoking cessation support provided primarily by the practice nurse (PN) and tailored to meet the needs of a diversity of patients.
Methods/Design
This study is a cluster randomised trial, with practices allocated to one of three groups 1) Quit with Practice Nurse 2) Quitline referral 3) GP usual care. PNs from practices randomised to the intervention group will receive a training course in smoking cessation followed by access to mentoring. GPs from practices randomised to the Quitline referral group will receive information about the study and the process of written referral and GPs in the usual care group will receive information about the study. Eligible patients are those aged 18 and over presenting to their GP who are daily or weekly smokers and who are able to give informed consent. Patients on low incomes in all three groups will be able to access free nicotine patches.
Primary outcomes are sustained abstinence and point prevalence abstinence at the three month and 12 month follow-up points; and incremental cost effectiveness ratios at 12 months. Process evaluation on the reach and acceptability of the intervention approached will be collected through Computer Assisted Telephone Interviews (CATI) with patients and semi-structured interviews with PNs and GPs.
The primary analysis will be by intention to treat. Cessation outcomes will be compared between the three arms at three months and 12 month follow-up using multiple logistic regression. The incremental cost effectiveness ratios will be estimated for the 12 month quit rate for the intervention groups compared to usual care and to each other. Analysis of qualitative data on process outcomes will be based on thematic analysis.
Discussion
High quality evidence on effectiveness of practice nurse interventions is needed to inform health policy on development of practice nurse roles. If effective, flexible support from the PN in partnership with the GP and the Quitline could become the preferred model for providing smoking cessation advice in Australian general practice.
Trial Registration
ACTRN12609001040257
doi:10.1186/1471-2296-11-59
PMCID: PMC2931485  PMID: 20701812
10.  What evidence is there to support skill mix changes between GPs, pharmacists and practice nurses in the care of elderly people living in the community? 
Background
Workforce shortages in Australia are occurring across a range of health disciplines but are most acute in general practice. Skill mix change such as task substitution is one solution to workforce shortages. The aim of this systematic review was to explore the evidence for the effectiveness of task substitution between GPs and pharmacists and GPs and nurses for the care of older people with chronic disease. Published, peer reviewed (black) and non-peer reviewed (grey) literature were included in the review if they met the inclusion criteria.
Results
Forty-six articles were included in the review. Task substitution between pharmacists and GPs and nurses and GPs resulted in an improved process of care and patient outcomes, such as improved disease control. The interventions were either health promotion or disease management according to guidelines or use of protocols, or a mixture of both. The results of this review indicate that pharmacists and nurses can effectively provide disease management and/or health promotion for older people with chronic disease in primary care. While there were improvements in patient outcomes no reduction in health service use was evident.
Conclusion
When implementing skill mix changes such as task substitution it is important that the health professionals' roles are complementary otherwise they may simply duplicate the task performed by other health professionals. This has implications for the way in which multidisciplinary teams are organised in initiatives such as the GP Super Clinics.
doi:10.1186/1743-8462-6-23
PMCID: PMC2749853  PMID: 19744350
11.  The management of non-valvular atrial fibrillation (NVAF) in Australian general practice: bridging the evidence-practice gap. A national, representative postal survey 
BMC Family Practice  2008;9:62.
Background
General practitioners (GPs) are ideally placed to bridge the widely noted evidence-practice gap between current management of NVAF and the need to increase anticoagulant use to reduce the risk of fatal and disabling stroke in NVAF. We aimed to identify gaps in current care, and asked GPs to identify potentially useful strategies to overcome barriers to best practice.
Methods
We obtained contact details for a random sample of 1000 GPs from a national commercial data-base. Randomly selected GPs were mailed a questionnaire after an advance letter. Standardised reminders were administered to enhance response rates. As part of a larger survey assessing GP management of NVAF, we included questions to explore GPs' risk assessment, estimates of stroke risk and GPs' perceptions of the risks and benefits of anticoagulation with warfarin. In addition, we explored GPs' perceived barriers to the wider uptake of anticoagulation, quality control of anticoagulation and their assessment of strategies to assist in managing NVAF.
Results
596 out of 924 eligible GPs responded (64.4% response rate). The majority of GPs recognised that the benefits of warfarin outweighed the risks for three case scenarios in which warfarin is recommended according to Australian guidelines. In response to a hypothetical case scenario describing a patient with a supratherapeutic INR level of 5, 41.4% of the 596 GPs (n = 247) and 22.0% (n = 131) would be "highly likely" or "likely", respectively, to cease warfarin therapy and resume at a lower dose when INR levels are within therapeutic range. Only 27.9% (n = 166/596) would reassess the patient's INR levels within one day of recording the supratherapeutic INR. Patient contraindications to warfarin was reported to "usually" or "always" apply to the patients of 40.6% (n = 242/596) of GPs when considering whether or not to prescribe warfarin. Patient refusal to take warfarin "usually" or "always" applied to the patients of 22.3% (n = 133/596) of GPs. When asked to indicate the usefulness of strategies to assist in managing NVAF, the majority of GPs (89.1%, n = 531/596) reported that they would find patient educational resources outlining the benefits and risks of available treatments "quite useful" or "very useful". Just under two-thirds (65.2%; n = 389/596) reported that they would find point of care INR testing "quite" or "very" useful. An outreach specialist service and training to enable GPs to practice stroke medicine as a special interest were also considered to be "quite" or "very useful" by 61.9% (n = 369/596) GPs.
Conclusion
This survey identified gaps, based on GP self-report, in the current care of NVAF. GPs themselves have provided guidance on the selection of implementation strategies to bridge these gaps. These results may inform future initiatives designed to reduce the risk of fatal and disabling stroke in NVAF.
doi:10.1186/1471-2296-9-62
PMCID: PMC2611987  PMID: 19014560
12.  A cluster randomised controlled trial of nurse and GP partnership for care of Chronic Obstructive Pulmonary Disease 
Background
Chronic obstructive pulmonary disease (COPD) is a significant health problem worldwide. This randomised controlled trial aims at testing a new approach that involves a registered nurse working in partnership with patients, general practitioners (GPs) and other health professionals to provide care to patients according to the evidence-based clinical practice guidelines. The aim is to determine the impact of this partnership on the quality of care and patient outcomes.
Methods
A cluster randomised control trial design was chosen for this study. Randomisation occurred at practice level. GPs practising in South Western Sydney, Australia and their COPD patients were recruited for the study.
The intervention was implemented by nurses specifically recruited and trained for this study. Nurses, working in partnership with GPs, developed care plans for patients based on the Australian COPDX guidelines. The aim was to optimise patient management, improve function, prevent deterioration and enhance patient knowledge and skills. Control group patients received 'usual' care from their GPs.
Data collection includes patient demographic profiles and their co-morbidities. Spirometry is being performed to assess patients' COPD status and CO analyser to validate their smoking status. Patients' quality of life and overall health status are being measured by St George's Respiratory Questionnaire and SF-12 respectively. Other patient measures being recorded include health service use, immunisation status, and knowledge of COPD. Qualitative methods will be used to explore participants' satisfaction with the intervention and their opinion about the value of the partnership.
Analysis
Analysis will be by intention to treat. Intra-cluster (practice) correlation coefficients will be determined and published for all primary outcome variables to assist future research. The effect of the intervention on outcomes measured on a continuous scale will be estimated and tested using mixed model analysis of variance in which time and treatment group will be fixed effects and GP practice and subject nested within practice will be random effects. The effect of the intervention on the dichotomous variables (such as smoking status, patient knowledge) will be analysed using generalised estimating equations with a logistic link and a model structure that is analogous to that described above.
Trial registration
ACTRN012606000304538
doi:10.1186/1471-2466-8-8
PMCID: PMC2442044  PMID: 18519003

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