General Practice and Primary Care - Research Publications
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ItemAn exploratory trial of insulin initiation and titration among patients with type 2 diabetes in the primary care setting with retrospective continuous glucose monitoring as an adjunct: INITIATION study protocol(BMC, 2014-05-03)BACKGROUND: Insulin initiation and titration in primary care is necessary to respond to the growing epidemic of type 2 diabetes (T2D). The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse (PN) teams supported by a Credentialed Diabetes Educator-Registered Nurse (CDE-RN) and endocrinologist in initiating and titrating basal and prandial insulin for T2D patients in the Australian healthcare system over 24 weeks. This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring (r-CGM) in comparison with self-monitoring of blood glucose (SMBG) among people with T2D in primary care. METHODS/DESIGN: The study employs a before and after design with a nested exploratory trial of SMBG and r-CGM. A total of 102 insulin naïve T2D patients with a glycated haemoglobin (HbA1c) level of >7.5% in the previous 6 months while treated with maximal oral therapy will be recruited and screened from 22 primary care practices in Melbourne, Australia. All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms, with intensification to a "basal plus" regimen if required. The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne, Australia. DISCUSSION: This article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T2D in primary care. Findings from the INITIATION study will inform development of a larger randomized controlled trial. TRIAL REGISTRATION: ACTRN12610000797077.
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ItemThe "cost" of treating to target: cross-sectional analysis of patients with poorly controlled type 2 diabetes in Australian general practice(BMC, 2013-03-08)BACKGROUND: To describe the current treatment gap in management of cardiovascular risk factors in patients with poorly controlled type 2 diabetes in general practice as well as the associated financial and therapeutic burden of pharmacological treatment. METHODS: Cross-sectional analysis of data from the Patient Engagement and Coaching for Health trial. This totalled 473 patients from 59 general practices with participants eligible if they had HbA1c > 7.5%. Main outcome measures included proportions of patients not within target risk factor levels and weighted average mean annual cost for cardiometabolic medications and factors associated with costs. Medication costs were derived from the Australian Pharmaceutical Benefits Schedule. RESULTS: Average age was 63 (range 27-89). Average HbA1c was 8.1% and average duration of diabetes was 10 years. 35% of patients had at least one micro or macrovascular complication and patients were taking a mean of 4 cardio-metabolic medications. The majority of participants on treatment for cardiovascular risk factors were not achieving clinical targets, with 74% and 75% of patients out of target range for blood pressure and lipids respectively. A significant proportion of those not meeting clinical targets were not on treatment at all. The weighted mean annual cost for cardiometabolic medications was AUD$1384.20 per patient (2006-07). Independent factors associated with cost included age, duration of diabetes, history of acute myocardial infarction, proteinuria, increased waist circumference and depression. CONCLUSIONS: Treatment rates for cardiovascular risk factors in patients with type 2 diabetes in our participants are higher than those identified in earlier studies. However, rates of achieving target levels remain low despite the large 'pill burden' and substantial associated fiscal costs to individuals and the community. The complexities of balancing the overall benefits of treatment intensification against potential disadvantages for patients and health care systems in primary care warrants further investigation.
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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.
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ItemOptimizing care and outcomes for people with type 2 diabetes - lessons from a translational research program on insulin initiation in general practice(FRONTIERS MEDIA SA, 2014)BACKGROUND: Clinical inertia, failure to intensify treatment according to evidence-based guidelines, leads to prolonged, avoidable hyperglycemia in people with type 2 diabetes (T2D). This is a challenge for General Practice and Primary Care, where most people with T2D receive most of their care. Sustained, integrated translational research programs are needed to embed effective treatments in routine practice, yet many challenges exist for developing such programs. OBJECTIVES: To explore challenges and facilitators to implementing a translational research program focused on insulin initiation and titration among people with T2D in general practice and to identify key factors important to support and sustain such translation research in primary care. Operationalizing a program of translational work in primary care: We describe a series of studies on insulin initiation and titration in general practice including theory and qualitative work (Phase 1), a small feasibility and acceptability pilot (Phase 2), a large scale pilot (Phase 3), and a pragmatic cluster randomized trial currently under way (Phase 4). We used mixed methods to explore practice level implementation issues, and reflective investigator discussions to explore broader research program sustainability. Challenges for translational research in primary care: Key facilitators and barriers at practice and research program levels, include: Appropriate funding structures to secure long-term capacity building and people support; Building and maintaining linkages between communities of practice, primary and secondary/tertiary care researchers, institutions, and industry partners; Strategies for engagement and support for practitioners and participants. CONCLUSION: Building effective and sustainable translational research programs are critical for developing evidence-based policy that drives improved outcomes at a population level. Diverse sources of funding that support extensive and sustained trans-mural collaboration as well as engagement with practitioners, patients, and policymakers in the field are crucial.
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ItemAn exploratory trial of basal and prandial insulin initiation and titration for type 2 diabetes in primary care with adjunct retrospective continuous glucose monitoring: INITIATION study(ELSEVIER IRELAND LTD, 2014-11)AIMS: To evaluate basal and prandial insulin initiation and titration in people with type 2 diabetes mellitus (T2DM) in primary care and to explore the feasibility of retrospective-continuous glucose monitoring (r-CGM) in guiding insulin dosing. The new model of care features General Practitioners (GPs) and Practice Nurses (PNs) working in an expanded role, with Credentialed Diabetes Educator - Registered Nurse (CDE-RN) support. METHODS: Insulin-naïve T2DM patients (HbA1c >7.5% [>58 mmol/mol] despite maximal oral therapy) from 22 general practices in Victoria, Australia commenced insulin glargine, with glulisine added as required. Each was randomised to receive r-CGM or self-monitoring of blood glucose (SMBG). Glycaemic control (HbA1c) was benchmarked against specialist ambulatory patients referred for insulin initiation. RESULTS: Ninety-two patients mean age (range) 59 (28-77) years; 40% female; mean (SD) diabetes duration 10.5 (6.1) years participated. HbA1c decreased from (median (IQR)) 9.9 (8.8, 11.2)%; 85 (73, 99) mmol/mol to 7.3 (6.9, 7.8)%; 56 (52, 62) mmol/mol at 24 weeks (p < 0.0001). Comparing r-CGM (n = 46) with SMBG (n = 42), there were no differences in major hypoglycaemia (p=0.17) or ΔHbA1c (p = 0.31). More r-CGM than SMBG participants commenced glulisine (26/48 vs. 7/44; p < 0.001). Results were comparable to 82 benchmark patients, with similar low rates of major hypoglycaemia (2/89 vs. 0/82; p = 0.17) and less loss to follow up in the INITIATION group (3/92 vs. 14/82; p = 0.002). CONCLUSIONS: Insulin initiation and titration for T2DM patients in primary care was safe and improved HbA1c with low rates of major hypoglycaemia. CDE-RNs were effective in a new consultant role. r-CGM use in primary care was feasible and enhanced post-prandial hyperglycaemia recognition. Trial registration ACTRN12610000797077.
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ItemNo Preview AvailableEffectiveness 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 PUBLISHING GROUP, 2013-09-18)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.