General Practice and Primary Care - Research Publications
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ItemAssessing and addressing diabetes distress among adults with type 2 diabetes: An online survey of Australian general practitioners(ELSEVIER SCI LTD, 2022-10)AIM: Diabetes distress is experienced by up to 36% of adults with type 2 diabetes. Australian type 2 diabetes guidelines recommend annual assessment of diabetes distress in general practice. This study explores general practitioners' knowledge, current practice, and factors influencing implementation of guidelines, including Person Reported Outcome Measure (PROM) use. METHODS: A cross-sectional online survey was disseminated via e-mail to 4776 Australian general practitioners listed on the Australasian Medical Publishing Company database. RESULTS: 264 (5%) surveys were returned. 75% indicated that general practitioners were the most appropriate professionals to assess diabetes distress. Sixteen percent reported asking about diabetes distress during type 2 diabetes consultations more than half the time, with 13% using a PROM more than half the time: 64% use the Kessler-10, and 1.9% use the Problem Areas in Diabetes (PAID) scale. While general practitioners had positive beliefs about the consequences of assessing and addressing diabetes distress, they also reported barriers in motivation, environment, and knowledge of guidelines. CONCLUSION: Most respondents endorsed general practitioners' role in assessing diabetes distress, but few ask about or assess diabetes distress in routine consultations. To support uptake of guideline recommendations for diabetes-specific PROM use, environmental factors, specifically time, need to be addressed.
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ItemEffect of routinely assessing and addressing depression and diabetes distress on clinical outcomes among adults with type 2 diabetes: a systematic review(BMJ PUBLISHING GROUP, 2022-05)OBJECTIVES: This study examined the effect of using patient-reported outcome measures (PROMs) routinely to assess and address depressive symptoms and diabetes distress among adults with type 2 diabetes. DESIGN: A systematic review of published peer-reviewed studies. DATA SOURCES: Medline, Embase, CINAHL Complete, PsycINFO, The Cochrane Library and Cochrane Central Register of Controlled Trials were searched. ELIGIBILITY CRITERIA: Studies including adults with type 2 diabetes, published in English, from the inception of the databases to 24 February 2022 inclusive; and where the intervention included completion of a PROM of depressive symptoms and/or diabetes distress, with feedback of the responses to a healthcare professional. DATA EXTRACTION AND SYNTHESIS: Using Covidence software, screening and risk of bias assessment were conducted by two reviewers independently with any disagreements resolved by a third reviewer. RESULTS: The search identified 4512 citations, of which 163 full-text citations were assessed for eligibility, and nine studies met the inclusion criteria. Five studies involved assessment of depressive symptoms only, two studies assessed diabetes distress only, and two studies assessed both. All studies had an associated cointervention. When depressive symptoms were assessed (n=7), a statistically significant between-group difference in depressive symptoms was observed in five studies; with a clinically significant (>0.5%) between-group difference in HbA1c in two studies. When diabetes distress was assessed (n=4), one study demonstrated statistically significant difference in depressive symptoms and diabetes distress; with a clinically significant between-group difference in HbA1c observed in two studies. CONCLUSION: Studies are sparse in which PROMs are used to assess and address depressive symptoms or diabetes distress during routine clinical care of adults with type 2 diabetes. Further research is warranted to understand how to integrate PROMs into clinical care efficiently and determine appropriate interventions to manage identified problem areas. PROSPERO REGISTRATION NUMBER: CRD42020200246.
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ItemEffect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes: a systematic review protocol(BMJ PUBLISHING GROUP, 2021)INTRODUCTION: Type 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes. METHODS AND ANALYSIS: MEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case-control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate. ETHICS AND DISSEMINATION: Ethics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42020200246.
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ItemCost-effectiveness of professional-mode flash glucose monitoring in general practice among adults with type 2 diabetes: Evidence from the GP-OSMOTIC trial(WILEY, 2022-03)AIM: To assess the cost-effectiveness of professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice compared with usual clinical care. METHODS: An economic evaluation was conducted as a component of the GP-OSMOTIC trial, a pragmatic multicentre 12-month randomised controlled trial enrolling 299 adults with type 2 diabetes in Victoria, Australia. The economic evaluation was conducted from an Australian healthcare sector perspective with a lifetime horizon. Health-related quality of life (EQ-5D) and total healthcare costs were compared between the intervention and the usual care group within the trial period. The 'UKPDS Outcomes Model 2' was used to simulate post-trial lifetime costs, life expectancy and quality-adjusted life years (QALYs). RESULTS: No significant difference in health-related quality of life and costs was found between the two groups within the trial period. Professional-mode flash glucose monitoring yielded greater QALYs (0.03 [95% CI: 0.02, 0.04]) and a higher cost (A$3807 [95% CI: 3604, 4007]) compared with usual clinical care using a lifetime horizon under the trial-based monitoring frequency, considered not cost-effective (incremental cost-effectiveness ratio = A$120,228). The intervention becomes cost-effective if sensor price is reduced to lower than 50%, or monitoring frequency is decreased to once per year while maintaining the same treatment effect on HbA1c . CONCLUSIONS: Including professional-mode flash glucose monitoring every 3 months as part of a management plan for people with type 2 diabetes in general practice is not cost-effective, but could be if the sensor price or monitoring frequency can be reduced.
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ItemGuiding 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 PUBLICATIONS, INC, 2020-09)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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Item'For me, it didn't seem as drastic a step as being controlled by insulin': A qualitative investigation of expectations and experiences of non-insulin injectable therapy among adults with type 2 diabetes(WILEY, 2022-02)AIMS: This qualitative study aims to explore beliefs, attitudes and experiences of injectable glucagon-like-peptide-1 receptor agonists (GLP-1RAs) use and discontinuation, as well as attitudes to further injectable treatment intensification, among adults with type 2 diabetes (T2D). METHODS: Nineteen in-depth semi-structured interviews lasting (mean ± standard deviation) 45 ± 18 min were conducted, face-to-face (n = 14) or via telephone (n = 5). Transcripts were analysed using inductive template analyses. Eligible participants were English-speaking adults with T2D who had recently initiated (≤3 years) GLP-1RA treatment. RESULTS: Participants were aged 28-72 years, who predominantly lived in metropolitan areas (n = 15), and had an experience of daily (n = 11) and/or once-weekly (n = 13) GLP-1RA formulations. Six participants had discontinued treatment and seven had trialled two or more formulations. Expectations and experiences of GLP-1RA were related to the perceived: (1) symbolism and stigma of injectable diabetes treatment; (2) ease of injectable administration and device preferences; (3) treatment convenience and social impact; (4) treatment efficacy and benefits, and; (5) negative treatment side effects. Some participants reported increased receptiveness to insulin therapy following their GLP-1RA experience, others emphasised unique concerns about insulin beyond injectable administration. CONCLUSIONS: This study provides a novel understanding of expectations and experience of non-insulin injectables among Australian adults with T2D. Our data suggest expectations may be informed by attitudes to insulin therapy, while perceived treatment benefits (e.g. weight-related benefits, administration frequency) may motivate uptake and ongoing use despite concerns. Experience of GLP-1RA injections may impact receptiveness to future insulin use.
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ItemUpdate 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(BMC, 2019-01-30)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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ItemGP-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 PUBLISHING GROUP, 2018-09)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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ItemCan primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol(BMC, 2014-02-14)BACKGROUND: Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care. METHODS: This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs. DISCUSSION: The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.