Publications by authors named "Ralph Audehm"

20 Publications

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Women with type 1 diabetes and women with type 2 diabetes differ in knowledge and beliefs about contraception and pregnancy.

Diabet Med 2021 Apr 2;38(4):e14521. Epub 2021 Feb 2.

Royal Prince Alfred Hospital, Camperdown, NSW, Australia.

Aims: To assess differences in knowledge and beliefs about pregnancy in women with diabetes.

Methods: Questions were from the Australian 'Contraception, Pregnancy & Women's Health' survey. Women (18-50 years) were eligible if pregnant or planning pregnancy. Knowledge and beliefs items were adapted from the Reproductive Health and Behaviours Questionnaire.

Results: Compared to women with type 2 diabetes (n = 103), women with type 1 diabetes (n = 526) had higher scores for knowledge about pregnancy in diabetes (type 1 diabetes 9.8 ± 2.4 vs. type 2 diabetes 7.7 ± 3.1), beliefs about benefits (type 1 diabetes 18.4 ± 2.2 vs. type 2 diabetes 17.2 ± 3.3), cues-to-action (type 1 diabetes 2.7 ± 1.4 vs. type 2 diabetes 1.5 ± 1.3) and self-efficacy (type 1 diabetes 22.6 ± 5.5 vs. type 2 diabetes 20.2 ± 6.1 (all p < 0.001) regarding preparing for pregnancy. Major knowledge gaps were the need for higher dose folate compared to women without diabetes and uncertainty about breastfeeding recommendations. Women with type 1 diabetes believed more strongly in the benefits of 'close to target' glucose levels prior to pregnancy and using contraception to prevent unplanned pregnancy; they also felt more confident to access pre-pregnancy care and to wait for optimal glycaemia before pregnancy. Women with type 2 diabetes were less aware of contraceptive choices, and risks associated with hyperglycaemia before or early in pregnancy.

Conclusions: The findings highlighted main gaps in knowledge and beliefs about planning for pregnancy. Especially in type 2 diabetes, there is a need for evidence-based messaging and strategies addressing these gaps, to raise understanding to prepare for future pregnancies.
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http://dx.doi.org/10.1111/dme.14521DOI Listing
April 2021

Epidemiology of heart failure: Study of Heart failure in the Australian Primary carE setting (SHAPE).

ESC Heart Fail 2020 Sep 9. Epub 2020 Sep 9.

Heart Failure Unit and Department of Cardiac Rehabilitation, Concord Hospital, Sydney, NSW, Australia.

Aims: At present, there is no robust information on the prevalence and incidence of heart failure (HF) in the general Australian community. The present study of primary care data sought to estimate the prevalence and incidence of HF in the community and to describe the demographic and clinical profile of Australians with HF.

Methods And Results: We undertook a retrospective cohort study based on analysis of anonymized medical records of adult patients cared for at 43 Australian general practices between 1 July 2013 and 30 June 2018. Data were extracted from coded and uncoded fields in electronic medical records. The prevalence and annual incidence of HF were calculated, along with 95% confidence intervals, using the 'active' population of people who were regular attenders at the practices. Age-standardized estimates were also derived using the 2017 Australian population as reference. The mean age of the population with HF was 69.8 years, 50.6% were female, and mean body mass index was 31.2 kg/m . The age-standardized prevalence was 2.199% [95% confidence interval (CI): 2.168-2.23%], and the age-standardized annual incidence was 0.348% (95% CI: 0.342-0.354%). These estimates accord with almost 420 000 people living with HF in Australia in 2017, and >66 000 new cases of HF occurring that year. Only 18.9% of patients with definite HF had this formally captured as a 'diagnosis' in their medical record. HF was more frequent among those of lower socio-economic status.

Conclusions: HF is common in Australia. The majority of HF patients do not have this diagnosis optimally noted in their primary care medical records.
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http://dx.doi.org/10.1002/ehf2.12979DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7754764PMC
September 2020

Guiding Glucose Management Discussions Among Adults With Type 2 Diabetes in General Practice: Development and Pretesting of a Clinical Decision Support Tool Prototype Embedded in an Electronic Medical Record.

JMIR Form Res 2020 Sep 2;4(9):e17785. Epub 2020 Sep 2.

Department of General Practice, University of Melbourne, Melbourne, Victoria, Australia.

Background: Managing type 2 diabetes (T2D) requires progressive lifestyle changes and, sometimes, pharmacological treatment intensification. General practitioners (GPs) are integral to this process but can find pharmacological treatment intensification challenging because of the complexity of continually emerging treatment options.

Objective: This study aimed to use a co-design method to develop and pretest a clinical decision support (CDS) tool prototype (GlycASSIST) embedded within an electronic medical record, which uses evidence-based guidelines to provide GPs and people with T2D with recommendations for setting glycated hemoglobin (HbA1c) targets and intensifying treatment together in real time in consultations.

Methods: The literature on T2D-related CDS tools informed the initial GlycASSIST design. A two-part co-design method was then used. Initial feedback was sought via interviews and focus groups with clinicians (4 GPs, 5 endocrinologists, and 3 diabetes educators) and 6 people with T2D. Following refinements, 8 GPs participated in mock consultations in which they had access to GlycASSIST. Six people with T2D viewed a similar mock consultation. Participants provided feedback on the functionality of GlycASSIST and its role in supporting shared decision making (SDM) and treatment intensification.

Results: Clinicians and people with T2D believed that GlycASSIST could support SDM (although this was not always observed in the mock consultations) and individualized treatment intensification. They recommended that GlycASSIST includes less information while maintaining relevance and credibility and using graphs and colors to enhance visual appeal. Maintaining clinical autonomy was important to GPs, as they wanted the capacity to override GlycASSIST's recommendations when appropriate. Clinicians requested easier screen navigation and greater prescribing guidance and capabilities.

Conclusions: GlycASSIST was perceived to achieve its purpose of facilitating treatment intensification and was acceptable to people with T2D and GPs. The GlycASSIST prototype is being refined based on these findings to prepare for quantitative evaluation.
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http://dx.doi.org/10.2196/17785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7495264PMC
September 2020

The epidemiology of heart failure in the general Australian community - study of heart failure in the Australian primary carE setting (SHAPE): methods.

BMC Public Health 2020 May 11;20(1):648. Epub 2020 May 11.

Director Heart Failure Unit and Department of Cardiac Rehabilitation, Concord Hospital, Sydney, Australia.

Background: There is a paucity of information on the epidemiology of heart failure (HF) in Australia. The Study of Heart failure in the Australian Primary carE setting (SHAPE) study aims to estimate the prevalence and annual incidence of HF in the general Australian community and to describe the demographic and key clinical profile of Australians with HF.

Methods: We undertook a retrospective cohort study based on analysis of non-identifiable medical records of adult patients cared for at 43 general practices between 1 July 2013 and 30 June 2018. Data were extracted from coded (diagnosis, pathology and prescription fields) and uncoded fields (clinical notes) in the medical records. The latter searches of free text looked for common synonyms relevant to HF. The population was stratified into three groups based on a hierarchy of selection criteria: (1) definite HF, (2) probable HF and (3) possible HF. The prevalence and annual incidence of HF were calculated, along with 95% confidence intervals.

Results: The practices provided care to 2.3 million individual patients over the five-year study period, of whom 1.93 million were adults and 1.12 million were regular patients. Of these patients 15,468 were classified as having 'definite HF', 4751 as having 'probable HF' and 33,556 as having 'possible HF'. A further 39,247 were identified as having an aetiological condition associated with HF. A formal HF diagnosis, HF terms recorded as text in the notes and HF-specific medication were the most common methods to identify 'definite' HF patients. Typical signs and symptoms in combination with a diuretic prescription was the most common method to identify 'probable HF' patients. The majority of 'possible' HF patients were identified by the presence of 2 or more of the typical signs or symptoms. Dyspnoea was the commonest recorded symptom and an elevated jugular venous pressure the commonest recorded sign.

Conclusions: This novel approach to undertaking retrospective research of primary care data successfully analysed a combination of coded and uncoded data from the electronic medical records of patients routinely managed in the GP setting. SHAPE is the first real-world study of the epidemiology of HF in the general Australian community setting.
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http://dx.doi.org/10.1186/s12889-020-08781-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7216401PMC
May 2020

Use of professional-mode flash glucose monitoring, at 3-month intervals, in adults with type 2 diabetes in general practice (GP-OSMOTIC): a pragmatic, open-label, 12-month, randomised controlled trial.

Lancet Diabetes Endocrinol 2020 01;8(1):17-26

Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore; Imperial College London, London, UK.

Background: Continuous glucose monitoring, either real-time (personal) or retrospective (professional mode), can identify day-to-day glucose profiles to guide management decisions for people with type 2 diabetes. We aimed to examine the effects of professional-mode flash glucose monitoring, done at 3-month intervals, in adults with type 2 diabetes in general practice.

Methods: We did a pragmatic, two-arm, open label, 12-month, individually randomised controlled trial (GP-OSMOTIC) in 25 general practices in Victoria, Australia. Eligible participants were adults aged 18-80 years, with type 2 diabetes diagnosed for at least 1 year and HbA at least 5·5 mmol/mol (0·5%) above their target in the past month despite being prescribed at least two non-insulin glucose-lowering drugs, insulin, or both (with therapy stable for at least 4 months). We randomly assigned participants (1:1) to either use of a professional-mode flash glucose monitoring system or usual clinical care (control). All participants wore the flash glucose monitoring sensor at baseline, and electronic randomisation (using permuted block sizes of four and six, and stratified by clinic) was done after the sensor was attached. Masking of participants and treating clinicians to group allocation was not possible, but the study statistician was masked to allocation when analysing the data. At baseline, and 3, 6, 9, and 12 months, participants in the flash glucose monitoring group wore the professional-mode flash glucose monitoring sensor for 5-14 days before their general practice visit. The sensor recorded interstitial glucose concentrations every 15 min, but the glucose data were not available to the participant until their general practice visit, where the sensor output would be uploaded to a computer by the health professional and discussed. Control group participants wore the sensor at baseline and at 12 months for data analysis only, and had usual care visits every 3 months. The primary outcome was the between-group difference in mean HbA at 12 months. Secondary outcomes were the between-group differences in: mean percentage time in target glucose range (4-10 mmol/L), based on ambulatory glucose profile data at 12 months; mean diabetes-specific distress (assessed with the Problem Areas In Diabetes [PAID] scale) at 12 months; and mean HbA at 6 months. Analysis was done by intention to treat. This trial is registered at the Australian and New Zealand Clinical Trials Registry, ACTRN12616001372471.

Findings: Between Oct 4, 2016, and Nov 17, 2017, we randomly assigned 299 adults: 149 to flash glucose monitoring and 150 to usual care. At 6 months, HbA was lower in the flash glucose monitoring group than in the usual care group (difference -0·5%, 95% CI -0·8% to -0·3%; p=0·0001). However, at 12 months (primary outcome), there was no significant between-group difference in estimated mean HbA (8·2% [95% CI 8·0 to 8·4] for flash glucose monitoring vs 8·5% [8·3 to 8·7] for usual care; between-group difference -0·3%, 95% CI -0·5 to 0·01; [66 mmol/mol, 95% CI 64 to 68 vs 69 mmol/mol, 67 to 72; between-group difference -3·0, 95% CI -5·0 to 0·1]; p=0·059). Mean percentage time spent in target glucose range at 12 months was 7·9% (95% CI 2·3 to 13·5) higher in the flash glucose monitoring group than in the usual care group (p=0·0060). Diabetes-specific distress PAID scores were unchanged at 12 months (between-group difference -0·7, 95% CI -3·3 to 1·9; p=0·61). No episodes of severe hypoglycaemia or treatment-related deaths were reported. One participant died during the study from causes unrelated to the intervention (following complications post-myocardial infarction with multiple comorbidities).

Interpretation: Professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice did not improve the primary outcome of HbA at 12 months or diabetes-specific distress compared with usual care, but did improve time in target glucose range at 12 months and HbA at 6 months. Our findings suggest that professional-mode flash glucose monitoring can be implemented in a pragmatic primary care environment. Although there was no change in HbA at 12 months, the improved time in target range might reflect the potential of the technology to support personalised clinical care by providing insights into glycaemic profiles for some people with type 2 diabetes.

Funding: National Health and Medical Research Council of Australia, Sanofi Australia, and Abbott Diabetes Care.
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http://dx.doi.org/10.1016/S2213-8587(19)30385-7DOI Listing
January 2020

Quantifying Use of a Health Virtual Community of Practice for General Practitioners' Continuing Professional Development: A Novel Methodology and Pilot Evaluation.

J Med Internet Res 2019 11 27;21(11):e14545. Epub 2019 Nov 27.

Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.

Background: Health care practitioners (HPs), in particular general practitioners (GPs), are increasingly adopting Web-based social media platforms for continuing professional development (CPD). As GPs are restricted by time, distance, and demanding workloads, a health virtual community of practice (HVCoP) is an ideal solution to replace face-to-face CPD with Web-based CPD. However, barriers such as time and work schedules may limit participation in an HVCoP. Furthermore, it is difficult to gauge whether GPs engage actively or passively in HVCoP knowledge-acquisition for Web-based CPD, as GPs' competencies are usually measured with pre- and posttests.

Objective: This study investigated a method for measuring the engagement features needed for an HVCoP (the Community Fracture Capture [CFC] Learning Hub) for learning and knowledge sharing among GPs for their CPD activity.

Methods: A prototype CFC Learning Hub was developed using an Igloo Web-based social media software platform and involved a convenience sample of GPs interested in bone health topics. This Hub, a secure Web-based community site, included 2 key components: an online discussion forum and a knowledge repository (the Knowledge Hub). The discussion forum contained anonymized case studies (contributed by GP participants) and topical discussions (topics that were not case studies). Using 2 complementary tools (Google Analytics and Igloo Statistical Tool), we characterized individual participating GPs' engagement with the Hub. We measured the GP participants' behavior by quantifying the number of online sessions of the participants, activities undertaken within these online sessions, written posts made per learning topic, and their time spent per topic. We calculated time spent in both active and passive engagement for each topic.

Results: Seven GPs participated in the CFC Learning Hub HVCoP from September to November 2017. The complementary tools successfully captured the GP participants' engagement in the Hub. GPs were more active in topics in the discussion forum that had direct clinical application as opposed to didactic, evidence-based discussion topics (ie, topical discussions). From our knowledge hub, About Osteoporosis and Prevention were the most engaging topics, whereas shared decision making was the least active topic.

Conclusions: We showcased a novel complementary analysis method that allowed us to quantify the CFC Learning Hub's usage data into (1) sessions, (2) activities, (3) active or passive time spent, and (4) posts made to evaluate the potential engagement features needed for an HVCoP focused on GP participants' CPD process. Our design and evaluation methods for ongoing use and engagement in this Hub may be useful to evaluate future learning and knowledge-sharing projects for GPs and may allow for extension to other HPs' environments. However, owing to the limited number of GP participants in this study, we suggest that further research with a larger cohort should be performed to validate and extend these findings.
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http://dx.doi.org/10.2196/14545DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6906624PMC
November 2019

Older People With Type 2 Diabetes-Individualizing Management With a Specialized (OPTIMISE) Community Team: Protocol for a Safety and Feasibility Mixed Methods Study.

JMIR Res Protoc 2019 Jun 7;8(6):e13986. Epub 2019 Jun 7.

Austin Health Clinical School, University of Melbourne, Heidelberg, Australia.

Background: The prevalence of diabetes is rising in older people. In 2018, over 574,000 Australians reported having diabetes. The highest prevalence (19.4%) of diabetes has been observed in people aged 85 years and older. Clinical guidelines recommend that diabetes management should be individualized; however, there is limited information regarding the current management patterns of diabetes in older people, given most clinical trials exclude participants from this age group. Available data identify that few individuals achieve optimal glycemic levels in the general population, potentially leading to adverse health outcomes and impact on quality of life. The data on glycemic profiles of older population are limited.

Objective: The aim of this study is to examine individualized diabetes management intervention for older people through home visits with a credentialed diabetes educator (CDE) and telehealth consultations with an endocrinologist located at a tertiary hospital.

Methods: This paper describes the design and methodology of a mixed methods feasibility and safety study to identify the current management of type 2 diabetes in people aged 65 years or older. We will implement and evaluate a personalized approach to management in the community of an Australian metropolitan city. This management approach will utilize flash glucose monitoring and home visits with the support of a community home nursing service CDE and telehealth consultation with an endocrinologist located at a local tertiary hospital.

Results: The study commenced in February 2017 and has recruited 43 participants, with final data collection to be completed by July 2019. Data analysis will commence after final data collection, with results expected to be published by the end of 2019.

Conclusions: This study is the first of its kind to explore individualized diabetes management for community-dwelling older people, with an aim to achieve optimal glycemic levels (glycated hemoglobin between 53 and 69 mmol/mol [7%-8.5%] depending on the fitness and frailness of the older individual). The data drawn from this study may be used to inform policy makers, service providers, clinicians, and older adults living with diabetes.

International Registered Report Identifier (irrid): DERR1-10.2196/13986.
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http://dx.doi.org/10.2196/13986DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6592394PMC
June 2019

Update on the General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) trial: statistical analysis plan for a multi-centre randomised controlled trial.

Trials 2019 Jan 30;20(1):93. Epub 2019 Jan 30.

Department of General Practice, University of Melbourne, 200 Berkeley St, Carlton, VIC, 3053, Australia.

Background: General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) is a multicentre, individually randomised controlled trial aiming to compare the use of intermittent retrospective continuous glucose monitoring (r-CGM) to usual care in patients with type 2 diabetes attending general practice. The study protocol was published in the British Medical Journal Open and described the principal features of the statistical methods that will be used to analyse the trial data. This paper provides greater detail on the statistical analysis plan, including background and justification for the statistical methods chosen, in accordance with SPIRIT guidelines.

Objective: To describe in detail the data management process and statistical methods that will be used to analyse the trial data.

Methods: An overview of the trial design and primary and secondary research questions are provided. Sample size assumptions and calculations are explained, and randomisation and data management processes are described in detail. The planned statistical analyses for primary and secondary outcomes and sub-group analyses are specified along with the intended table layouts for presentation of the results.

Conclusion: In accordance with best practice, all analyses outlined in the document are based on the aims of the study and have been pre-specified prior to the completion of data collection and outcome analyses.

Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12616001372471 . Registered on 3 August 2016.
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http://dx.doi.org/10.1186/s13063-018-3126-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6354399PMC
January 2019

Engagement of primary care practice in Australia: learnings from a diabetes care project.

Aust J Prim Health 2019 Mar;25(1):82-89

Bolton Clarke Research Institute, Suite 1.01, 973 Nepean Highway, Bentleigh, Vic. 3204, Australia; and Present address: Latrobe University, Kingsbury Drive, Bundoora, Vic. 3083, Australia.

Effective community-based chronic disease management requires general practice engagement and ongoing improvement in care models. This article outlines a case study on contributing factors to insufficient participant recruitment through general practice for an evidence-based diabetes care pilot project. Key stakeholder semi-structured interviews and focus groups were undertaken at cessation of the pilot project. Participants (15 GPs, five practice nurses, eight diabetes educators) were healthcare providers engaged in patient recruitment. Through descriptive analysis, common themes were identified. Four major themes were identified: (1) low perceived need for intervention; (2) communication of intervention problematic; (3) translation of research into practice not occurring; and (4) the service providing the intervention was not widely viewed as a partner in chronic disease care. Engaging GPs in new initiatives is challenging, and measures facilitating uptake of new innovations are required. Any new intervention needs to: be developed with GPs to meet their needs; have considerable lead-in time to develop rapport with GPs and raise awareness; and ideally, have dedicated support staff within practices to reduce the demand on already-overburdened practice staff. Feasible and effective mechanisms need to be developed to facilitate uptake of new innovations in the general practice setting.
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http://dx.doi.org/10.1071/PY18057DOI Listing
March 2019

Expert Opinion: Patient Selection for Premixed Insulin Formulations in Diabetes Care.

Diabetes Ther 2018 Dec 3;9(6):2185-2199. Epub 2018 Nov 3.

Institute for Studies on Diabetes Foundation Inc, Marikina City, Philippines.

Premixed insulins are an important tool for glycemic control in persons with diabetes. Equally important in diabetes care is the selection of the most appropriate insulin regimen for a particular individual at a specific time. Currently, the choice of insulin regimens for initiation or intensification of therapy is a subjective decision. In this article, we share insights, which will help in rational and objective selection of premixed formulations for initiation and intensification of insulin therapy. The glycemic status and its variations in a person help to identify the most appropriate insulin regimen and formulation for him or her. The evolution of objective glucometric indices has enabled better glycemic monitoring of individuals with diabetes. Management of diabetes has evolved from a 'glucocentric' approach to a 'patient-centered' approach; patient characteristics, needs, and preferences should be evaluated when considering premixed insulin for treatment of diabetes.Funding: Novo Nordisk, India.
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http://dx.doi.org/10.1007/s13300-018-0521-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250631PMC
December 2018

National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: Australian clinical guidelines for the management of heart failure 2018.

Med J Aust 2018 10 2;209(8):363-369. Epub 2018 Aug 2.

National Heart Foundation of Australia, Melbourne, VIC.

Introduction: Heart failure (HF) is a clinical syndrome that is secondary to an abnormality of cardiac structure or function. These clinical practice guidelines focus on the diagnosis and management of HF with recommendations that have been graded on the strength of evidence and the likely absolute benefit versus harm. Additional considerations are presented as practice points. Main recommendations: Blood pressure and lipid lowering decrease the risk of developing HF. Sodium-glucose cotransporter 2 inhibitors decrease the risk of HF hospitalisation in patients with type 2 diabetes and cardiovascular disease. An echocardiogram is recommended if HF is suspected or newly diagnosed. If an echocardiogram cannot be arranged in a timely fashion, measurement of plasma B-type natriuretic peptides improves diagnostic accuracy. Angiotensin-converting enzyme inhibitors, β-blockers and mineralocorticoid receptor antagonists improve outcomes in patients with HF associated with a reduced left ventricular ejection fraction. Additional treatment options in selected patients with persistent HF associated with reduced left ventricular ejection fraction include switching the angiotensin-converting enzyme inhibitor to an angiotensin receptor neprilysin inhibitor; ivabradine; implantable cardioverter defibrillators; cardiac resynchronisation therapy; and atrial fibrillation ablation. Multidisciplinary HF disease management facilitates the implementation of evidence-based HF therapies. Clinicians should also consider models of care that optimise medication titration (eg, nurse-led titration). Changes in management as a result of the guideline: These guidelines have been designed to facilitate the systematic integration of recommendations into HF care. This should include ongoing audit and feedback systems integrated into work practices in order to improve the quality of care and outcomes of patients with HF.
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http://dx.doi.org/10.5694/mja18.00647DOI Listing
October 2018

GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice.

BMJ Open 2018 07 17;8(7):e021435. Epub 2018 Jul 17.

Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore.

Introduction: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP).

Methods And Analysis: General Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking 'does intermittent r-CGM in adults with T2D in primary care improve HbA1c?'

Primary Outcome: Absolute difference in mean HbA1c at 12 months follow-up between intervention and control arms.

Secondary Outcomes: (a) r-CGM per cent time in target (4-10 mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes).

Eligibility: Aged 18-80 years, T2D for ≥1 year, a (past month) HbA1c>5.5 mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four months). Our general glycaemic target is 53 mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64 mmol/mol (8%)).Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1 hour education by a specialist diabetes nurse.The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5 mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition).

Ethics And Dissemination: University of Melbourne Human Ethics Sub-Committee (ID 1647151.1). Dissemination will be in peer-reviewed journals, conferences and a plain-language summary for participants.

Trial Registration Number: >ACTRN12616001372471; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2017-021435DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059310PMC
July 2018

Factors associated with attendance for pre-pregnancy care and reasons for non-attendance among women with diabetes.

Diabetes Res Clin Pract 2018 Aug 24;142:269-275. Epub 2018 May 24.

Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Bankstown-Lidcombe Hospital, Bankstown, NSW, Australia.

Aims: To describe factors associated with the uptake of diabetes-specific pre-pregnancy care (PPC), determine the perceived helpfulness of attending, reasons for non-attendance and intention to seek PPC in the future.

Methods: A cross-sectional 66-item survey was administered to Australian women with type 1 or type 2 diabetes mellitus (DM) aged 18-50 years.

Results: Of 429 eligible women, 54% reported having attended PPC. In multivariable logistic regression analysis, having Type 1 DM [adjusted OR 1.89, 95% CI (1.07, 3.33)], being married or in a defacto relationship [OR 2.43 (95% CI 1.27, 4.65)], tertiary educated [OR 1.91 (95% CI 1.27, 2.88)] or employed [OR 1.80 (95% CI 1.14, 2.82)] were associated with being more likely to attend PPC. Sixty eight percent (68%) rated attending PPC as helpful. A lack of awareness about the availability of PPC (48%) and unplanned pregnancy (47%) were the main reasons for non-attendance. Of women with future pregnancy plans, 43% were aware of local services offering PPC and 84% indicated they would attend PPC if available.

Conclusion: Australian women who attend PPC differ by type of diabetes and socioeconomic characteristics. Initiatives are needed to address this disparity and encourage all women with diabetes to plan and prepare for pregnancy. Reasons reported for non-attendance suggest that strategies to increase awareness about the availability of diabetes-specific PPC and the risks of unplanned pregnancy are warranted.
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http://dx.doi.org/10.1016/j.diabres.2018.05.030DOI Listing
August 2018

Potentially preventable hospitalisations: are they a useful marker of access to and experience of care in general practice among people with type 2 diabetes?

Aust J Prim Health 2015 ;21(2):214-20

The aim of the present study was to explore access to and experience of care in general practice among patients admitted to hospital with a type 2 diabetes mellitus-related potentially preventable hospitalisation (PPH). Forty-eight patients admitted to two public hospitals in the north and west of Melbourne completed a survey and 13 patients were interviewed. Patients generally had long-standing diabetes with multimorbidity and were relatively socioeconomically disadvantaged. Nearly two-thirds reported more than one hospital admission in the prior 12 months, and 74% of respondents were able to access theirpreferred general practitioner (GP) on either the same or next day. Emotional support, time and continuity of care with their GP were important to patients, but they recognised many patient barriers to optimal care, including self-management and social and economic factors. Patients that accessed specialist care perceived that GPs had limited role in their disease management. Although the patients in this study experienced good access to care, they also identified several factors that were arguably outside the scope of general practice management, indicating that their admissions to hospital may not have been avoidable.
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http://dx.doi.org/10.1071/PY13112DOI Listing
November 2015

Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial.

BMJ 2013 Sep 18;347:f5272. Epub 2013 Sep 18.

General Practice and Primary Health Care Academic Centre, University of Melbourne, 200 Berkeley St, Carlton, VIC 3053, Australia.

Objective: To evaluate the effectiveness of goal focused telephone coaching by practice nurses in improving glycaemic control in patients with type 2 diabetes in Australia.

Design: Prospective, cluster randomised controlled trial, with general practices as the unit of randomisation.

Setting: General practices in Victoria, Australia.

Participants: 59 of 69 general practices that agreed to participate recruited sufficient patients and were randomised. Of 829 patients with type 2 diabetes (glycated haemoglobin (HbA1c) >7.5% in the past 12 months) who were assessed for eligibility, 473 (236 from 30 intervention practices and 237 from 29 control practices) agreed to participate.

Intervention: Practice nurses from intervention practices received two days of training in a telephone coaching programme, which aimed to deliver eight telephone and one face to face coaching episodes per patient.

Main Outcome Measures: The primary end point was mean absolute change in HbA1c between baseline and 18 months in the intervention group compared with the control group.

Results: The intervention and control patients were similar at baseline. None of the practices dropped out over the study period; however, patient attrition rates were 5% in each group (11/236 and 11/237 in the intervention and control group, respectively). The median number of coaching sessions received by the 236 intervention patients was 3 (interquartile range 1-5), of which 25% (58/236) did not receive any coaching sessions. At 18 months' follow-up the effect on glycaemic control did not differ significantly (mean difference 0.02, 95% confidence interval -0.20 to 0.24, P=0.84) between the intervention and control groups, adjusted for HbA1c measured at baseline and the clustering. Other biochemical and clinical outcomes were similar in both groups.

Conclusions: A practice nurse led telephone coaching intervention implemented in the real world primary care setting produced comparable outcomes to usual primary care in Australia. The addition of a goal focused coaching role onto the ongoing generalist role of a practice nurse without prescribing rights was found to be ineffective.

Trial Registration: Current Controlled Trials ISRCTN50662837.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3776648PMC
http://dx.doi.org/10.1136/bmj.f5272DOI Listing
September 2013

The rationale for combining GLP-1 receptor agonists with basal insulin.

Med J Aust 2013 Aug;199(4):246-9

Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia.

• Type 2 diabetes mellitus (T2DM) is progressive; the more intensively it is treated, the greater is the risk of hypoglycaemia and weight gain. Achieving treatment intensification while mitigating these risks presents a challenge to patient management. • Basal insulins provide control of fasting glucose; however, their utility in the control of postprandial glucose excursions is limited. • Glucagon-like peptide-1 (GLP-1) receptor agonists stimulate glucose-medicated insulin secretion, suppress glucagon secretion, delay gastric emptying and decrease appetite. Use of GLP-1 receptor agonists in combination therapy with basal insulin offers an alternative approach to intensification of insulin therapy. • Prospective interventional trials demonstrate that GLP-1 receptor agonists added to basal insulin decrease postprandial glucose levels, lower HbA1c levels, decrease weight and lower basal insulin requirements without increasing the risk of major hypoglycaemic events. • The current clinical data are limited by the lack of any data on the long-term effects of GLP-1 receptor agonists over additional prandial regimens; they may be beneficial or deleterious. • Although cost, gastrointestinal side effects and long-term safety should be taken into account when considering this combination, it appears to be growing in popularity and is likely to be an important therapeutic option for T2DM in the future.
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http://dx.doi.org/10.5694/mja12.11856DOI Listing
August 2013

Feasibility of screening for diabetic retinopathy at an Australian pathology collection service: a pilot study.

Med J Aust 2013 Feb;198(2):97-9

Centre for Eye Research Australia, Melbourne, VIC, Australia.

Objective: To evaluate the feasibility of a novel diabetic retinopathy (DR) screening model using a pathology collection centre (PCC) as a screening site.

Design And Setting: Cross-sectional pilot study conducted in one urban PCC in Victoria between 1 September 2009 and 15 March 2010. Trained pathology staff screened participants for DR using undilated, non-stereoscopic colour fundus photography.

Participants: Participants were patients who spoke English, were aged at least 12 years, had type 1 or type 2 diabetes, and did not undertake biannual DR screening.

Main Outcome Measures: Proportion of patients who do not participate in biannual DR screening; proportion of patients who accept DR screening while attending a PCC; proportion of gradable images; patient acceptance of the screening model; and effectiveness of the follow-up pathway.

Results: Over 6 months, 289 English-speaking patients with diabetes attended the PCC, of whom 99 (34.3%) had not undertaken biannual DR screening. Of these, 93 (93.9%) accepted our screening service. Overall, retinal images were sufficient for interpretation in 88 patients (94.6%) and the median time for photography was 6 minutes (interquartile range, 10 minutes). Two, eight and six cases of minimal, mild and moderate non-proliferative DR (NPDR) in the worst eye were found, respectively. Dissemination of screening results to treating doctors and patients was found to be suboptimal and will need to be revised.

Conclusion: DR screening in one urban PCC appears to be a feasible alternative for diabetic patients who do not undertake biannual screening for DR.
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http://dx.doi.org/10.5694/mja12.11121DOI Listing
February 2013

The Australian Primary Care Collaboratives Program: improving diabetes care.

BMJ Qual Saf 2012 Nov 16;21(11):956-63. Epub 2012 Jun 16.

Improvement Foundation (Australia), Adelaide, SA 5000, Australia.

Problem: Diabetes is a major, growing health problem often managed in primary care but with suboptimal control of risk factors.

Design: A large-scale quality improvement collaborative implemented in seven waves.

Setting: General practices and Aboriginal medical services across Australia.

Key Measures For Improvement: Percentage of patients in each health service with haemoglobin A1C (HbA1C), total cholesterol and blood pressure at target.

Strategy For Change: Health services attended three 2-day workshops, separated by 3-month activity periods and followed by 12 months of further improvement work. Local collaborative program managers supported teams to report measures and plan/do/study/act (PDSA) cycles monthly. Health services received feedback about changes in their measures in comparison with their wave.

Effects Of Change: 743 health services participated in seven waves between 2004 and 2009 serving approximately 150,000 people with diabetes. Mean numbers of patients at target HbA1c levels improved by 50% from 25% at baseline to 38% at month 18. Lipid and blood pressure measures showed similar improvement.

Lessons Learnt: Engagement in the Program and results demonstrated that the collaborative methodology is transferable to Australian primary care. The results may reflect improved data recording and disease coding, and changes in clinical care. Internal evaluation should be built into improvement projects from the start to facilitate improvements and reporting. Enthusing, training and resourcing practice teams appeared to be the key to rapid change. Local support of practice teams was instrumental in improvement. Early investment to facilitate automatic measure collection ensured good data reporting.
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http://dx.doi.org/10.1136/bmjqs-2011-000460DOI Listing
November 2012

Patient Engagement and Coaching for Health: The PEACH study--a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol.

BMC Fam Pract 2007 Apr 11;8:20. Epub 2007 Apr 11.

Department of General Practice, The University of Melbourne, Melbourne, Australia.

Background: The PEACH study is based on an innovative 'telephone coaching' program that has been used effectively in a post cardiac event trial. This intervention will be tested in a General Practice setting in a pragmatic trial using existing Practice Nurses (PN) as coaches for people with type 2 diabetes (T2D). Actual clinical care often fails to achieve standards, that are based on evidence that self-management interventions (educational and psychological) and intensive pharmacotherapy improve diabetes control. Telephone coaching in our study focuses on both. This paper describes our study protocol, which aims to test whether goal focused telephone coaching in T2D can improve diabetes control and reduce the treatment gap between guideline based standards and actual clinical practice.

Methods/design: In a cluster randomised controlled trial, general practices employing Practice Nurses (PNs) are randomly allocated to an intervention or control group. We aim to recruit 546 patients with poorly controlled T2D (HbA1c >7.5%) from 42 General Practices that employ PNs in Melbourne, Australia. PNs from General Practices allocated to the intervention group will be trained in diabetes telephone coaching focusing on biochemical targets addressing both patient self-management and engaging patients to work with their General Practitioners (GPs) to intensify pharmacological treatment according to the study clinical protocol. Patients of intervention group practices will receive 8 telephone coaching sessions and one face-to-face coaching session from existing PNs over 18 months plus usual care and outcomes will be compared to the control group, who will only receive only usual care from their GPs. The primary outcome is HbA1c levels and secondary outcomes include cardiovascular disease risk factors, behavioral risk factors and process of care measures.

Discussion: Understanding how to achieve comprehensive treatment of T2D in a General Practice setting is the focus of the PEACH study. This study explores the potential role for PNs to help reduce the treatment and outcomes gap in people with T2D by using telephone coaching. The intervention, if found to be effective, has potential to be sustained and embedded within real world General Practice.
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http://dx.doi.org/10.1186/1471-2296-8-20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1854904PMC
April 2007