General Practice and Primary Care - Research Publications
Permanent URI for this collection
Search Results
1 - 10 of 12
-
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.
-
ItemSocioeconomic status and time in glucose target range in people with type 2 diabetes: a baseline analysis of the GP-OSMOTIC study(BMC, 2018-07-21)BACKGROUND: Optimal glycaemia, reflected by glycated haemoglobin (HbA1c) levels, is key in reducing type 2 diabetes (T2D) complications. However, most people with T2D have suboptimal recall and understanding of HbA1c. Continuous glucose monitoring (CGM) measures glucose levels every 5 to 15-min over days and may be more readily understood. Given that T2D is more common in lower socioeconomic settings, we aim to study relationships between socioeconomic status (SES) and percentage time in glucose target range (TIR) which is a key metric calculated from CGM. METHODS: Analysis of baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) randomised controlled trial (October 2016 - November 2017) of 300 people with T2D from 25 Victorian General Practices. FreeStyle Libre Pro® sensor patch was used for this study. SES was defined by the Index of Relative Socio-economic Disadvantage (IRSD) and educational attainment. Univariable and multivariable mixed-effects linear regression analyses controlling for age, BMI, diet, exercise and study arm were performed. RESULTS: One hundred and sixty-seven (60.1%) participants were male, the mean (SD) participant age was 61.0 (9.7) years, and the mean (SD) duration of CGM use was 12.3 (2.5) days. The 10th IRSD decile (least disadvantaged) was associated with a 15% higher TIR vs. the 1st decile (most disadvantaged) (95% CI 5, 25; p = 0.003) and a 0.6% lower HbA1c (95% CI 0.1, 1; p = 0.03). There was no evidence of an association between educational attainment and TIR/HbA1c. CONCLUSION: Higher SES measured at an area level is associated with better achievement of glycaemic target using complementary measures of HbA1c and TIR in the GP-OSMOTIC cohort. Given that TIR may be more easily used in patient education and self-management support compared to HbA1c values, the social gradient identified in TIR provides an opportunity for clinicians and policy makers to address health inequities in T2D. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry Trial ACTRN12616001372471 , prospective, Date registered 4/10/2016.
-
ItemPrescribing of diabetes medications to people with type 2 diabetes and chronic kidney disease: a national cross-sectional study(BMC, 2019-02-18)BACKGROUND: Previous studies in general practice and hospital settings have identified that prescribing of non-insulin diabetes medications may be sub-optimal in people with type 2 diabetes (T2D) and renal impairment. Since these publications, a number of new medications have become available for the management of T2D. Study aims were to, in a cohort of Australians with T2D and renal impairment attending general practice, (1) investigate whether the prescribing of non-insulin diabetes medications is consistent with dosing adjustments recommended within current Australian Diabetes Society (ADS) guidelines; and (2) identify patient socio-demographic and clinical factors associated with at least one prescription of a non-insulin diabetes medication inconsistent with current ADS guidelines for medication doses. METHODS: Cross-sectional study using data from the MedicineInsight general practice database managed by NPS MedicineWise. Patients with T2D who were aged 18 years and over, with an average eGFR< 60 ml/min/1.73m2 and at least one prescription of a non-insulin diabetes medication between 1st January 2015 and 30th June 2017 were included. Descriptive statistics were used to summarise patient characteristics and medication use. Marginal logistic regression models were used to estimate associations between sociodemographic and clinical factors and prescribing of ≥1non-insulin diabetes medicine not consistent with ADS guidelines. RESULTS: The majority of the 3505 patients included (90.4%) had an average eGFR of 30-59 ml/min/1.73m2. In terms of absolute numbers, metformin was the medication most frequently prescribed at a dose not consistent with current ADS guidelines for dosing in renal impairment (n = 1601 patients), followed by DPP4 inhibitors (n = 611) and sulphonylureas (n = 278). The drug classes with the highest proportion of prescriptions with dosage not consistent with ADS guidelines were SGLT2 inhibitors (83%), followed by biguanides (58%) and DPP4 inhibitors (46%). Higher HbA1c, longer known diabetes duration and diagnosis of retinopathy were associated with receiving ≥1prescription with a dosage not consistent with guidelines. CONCLUSIONS: Prescribing of non-insulin diabetes medications at doses inconsistent with current ADS guideline recommendations for dosing adjustments for people with renal impairment was common. Further research is needed to understand how general practitioners access, interpret and apply the ADS guidelines and the impact this may have on patient outcomes.
-
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.
-
ItemAssociations between multimorbidity, all-cause mortality and glycaemia in people with type 2 diabetes: A systematic review(Public Library of Science (PLoS), 2018-12-26)Introduction: Type 2 diabetes (T2D) is a major health priority worldwide and the majority of people with diabetes live with multimorbidity (MM) (the co-occurrence of ≥2 chronic conditions). The aim of this systematic review was to explore the association between MM and all-cause mortality and glycaemic outcomes in people with T2D. Methods: The search strategy centred on: T2D, MM, comorbidity, mortality and glycaemia. Databases searched: MEDLINE, EMBASE, CINAHL Complete, The Cochrane Library, and SCOPUS. Restrictions included: English language, quantitative empirical studies. Two reviewers independently carried out: abstract and full text screening, data extraction, and quality appraisal. Disagreements adjudicated by a third reviewer. Results: Of the 4882 papers identified; 41 met inclusion criteria. The outcome was all-cause mortality in 16 studies, glycaemia in 24 studies and both outcomes in one study. There were 28 longitudinal cohort studies and 13 cross-sectional studies, with the number of participants ranging from 96–892,223. Included studies were conducted in high or upper-middle-income countries. Fifteen of 17 studies showed a statistically significant association between increasing MM and higher mortality. Ten of 14 studies showed no significant associations between MM and HbA1c. Four of 14 studies found higher levels of MM associated with higher HbA1c. Increasing MM was significantly associated with hypoglycaemia in 9/10 studies. There was no significant association between MM and fasting glucose (one study). No studies explored effects on glycaemic variability. Conclusions: This review demonstrates that MM in T2D is associated with higher mortality and hypoglycaemia, whilst evidence regarding the association with other measures of glycaemic control is mixed. The current single disease focused approach to management of T2D seems inappropriate. Our findings highlight the need for clinical guidelines to support a holistic approach to the complex care needs of those with T2D and MM, accounting for the various conditions that people with T2D may be living with.
-
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.
-
ItemImpact of multimorbidity count on all-cause mortality and glycaemic outcomes in people with type 2 diabetes: a systematic review protocol(BMJ GROUP, 2018)Introduction : Type 2 diabetes (T2D) is a leading health priority worldwide. Multimorbidity (MM) is a term describing the co-occurrence of two or more chronic diseases or conditions. The majority of people living with T2D have MM. The relationship between MM and mortality and glycaemia in people with T2D is not clear. Methods and analysis: Medline, Embase, Cumulative Index of Nursing and Allied Health Complete, The Cochrane Library, and SCOPUS will be searched with a prespecified search strategy. The searches will be limited to quantitative empirical studies in English with no restriction on publication date. One reviewer will perform title screening and two review authors will independently screen the abstract and full texts using Covidence software, with disagreements adjudicated by a third reviewer. Data will be extracted using a using a Population, Exposure, Comparator and Outcomes framework. Two reviewers will independently extract data and undertake the risk of bias (quality) assessment. Disagreements will be resolved by consensus. A narrative synthesis of the results will be conducted and meta-analysis considered if appropriate. Quality appraisal will be undertaken using the Newcastle-Ottawa quality assessment scale and the quality of the cumulative evidence of the included studies will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach. This protocol was prepared in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines to ensure the quality of our review. Ethics and dissemination: This review will synthesise the existing evidence about the impact of MM on mortality and glycaemic outcomes in people living with T2D and increase our understanding of this subject and will inform future practice and policy. Findings will be disseminated via conference presentations, social media and peer-reviewed publication.
-
ItemRoles and relationships between health professionals involved in insulin initiation for people with type 2 diabetes in the general practice setting: a qualitative study drawing on relational coordination theory(BMC, 2014-01-31)BACKGROUND: The majority of care for people with type 2 diabetes occurs in general practice, however when insulin initiation is required it often does not occur in this setting or in a timely manner and this may have implications for the development of complications. Increased insulin initiation in general practice is an important goal given the increasing prevalence of type 2 diabetes and a relative shortage of specialists. Coordination between primary and secondary care, and between medical and nursing personnel, may be important in achieving this. Relational coordination theory identifies key concepts that underpin effective interprofessional work: communication which is problem solving, timely, accurate and frequent and relationships between professional roles which are characterized by shared goals, shared knowledge and mutual respect. This study explores roles and relationships between health professionals involved in insulin initiation in order to gain an understanding of factors which may impact on this task being carried out in the general practice setting. METHOD: 21 general practitioners, practice nurses, diabetes nurse educators and physicians were purposively sampled to participate in a semi-structured interview. Transcripts of the interviews were analysed using framework analysis. RESULTS: There were four closely interlinked themes identified which impacted on how health professionals worked together to initiate people with type 2 diabetes on insulin: 1. Ambiguous roles; 2. Uncertain competency and capacity; 3. Varying relationships and communication; and 4. Developing trust and respect. CONCLUSIONS: This study has shown that insulin initiation is generally recognised as acceptable in general practice. The role of the DNE and practice nurse in this space and improved communication and relationships between health professionals across organisations and levels of care are factors which need to be addressed to support this clinical work. Relational coordination provides a useful framework for exploring these issues.
-
ItemRelational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey(BMC, 2014-11-01)BACKGROUND: The majority of people with type 2 diabetes (T2D) receive their care in general practice and will eventually require initiation of insulin as part of their management. However, this is often delayed and frequently involves referral to specialists. If insulin initiation is to become more frequent and routine within general practice, coordination of care with specialist services may be required. Relational coordination (RC) provides a framework to explore this. The aim of this study was to explore RC between specialist physicians, specialist diabetes nurses (DNEs), generalist physicians in primary care (GPs) and generalist nurses (practice nurses (PNs)) and to explore the association between RC and the initiation of insulin in general practice, and the belief that it is appropriate for this task to be carried out in general practice. METHODS: A survey was distributed to a convenience sample of specialist physicians, DNEs, GPs and practice nurses. We collected data on demographics, models of care and RC in relation to insulin initiation. We expected that RC would be higher between specialists than between specialists and generalists. We expected higher RC between specialists and generalists to be associated with insulin initiation in general practice and with the belief that it is appropriate for insulin initiation to be carried out in general practice. We used descriptive statistics and non-parametric tests to explore these hypotheses. RESULTS: 179 health professionals returned completed surveys. Specialists reported higher RC with each other and lower RC with PNs. All groups except PNs reported their highest RC with DNEs, suggesting the potential for DNEs to serve as boundary spanners. Lower RC with specialists was reported by those working within a general practice model of care. Health professionals who felt that a general practice model was appropriate reported lower communication with specialist physicians and higher shared knowledge with GPs. CONCLUSION: Given the need for coordination between specialist and generalist care for the task of insulin initiation, this study's results suggest the need to build relationships and communication between specialist and generalist health professional groups and the potential for DNE's to play a boundary spanner role in this process.
-
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.