Assessment of a primary care e-support package of automated case finding, simplified treatment algorithm and decision support to increase hepatitis B treatment uptake in primary care clinics in Australia (SIMPLY-B Study): protocol for a pilot evaluation.

INTRODUCTION: Despite the availability of effective, subsidised hepatitis B treatment, linkage to care and treatment rates remain very low globally. In Australia, specially trained primary care physicians (general practitioner, GPs) can prescribe hepatitis B treatment, however, most hepatitis B care occurs in specialist clinics. Increasing hepatitis B management by GPs in primary care clinics is essential to achieve national hepatitis B linkage to care and treatment targets by 2030.This pilot study determines the feasibility, acceptability and effectiveness of Simply B, a novel GP hepatitis B e-support package designed to increase hepatitis B management by GPs in primary care clinics. METHODS AND ANALYSIS: This study will be conducted in three parts:Part A: A prospective open-label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care clinics before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package.Part B: A nested qualitative health services feasibility study using semistructured interviews and thematic analysisPart C: Cost-effectiveness analysis. ETHICS AND DISSEMINATION: This study has received ethics approval by St Vincent's Hospital. Data management and analysis will be centralised through the Department of Gastroenterology, St Vincent's Hospital. TRIAL REGISTRATION NUMBER: NCT05614466.

Costing of an Australian general practice COVID-19 drive-through testing and respiratory clinic.

BACKGROUND: Responding to the COVID-19 pandemic requires safe and efficient testing on a large scale over a prolonged period. Outpatient testing facilities can clinically assess and test symptomatic individuals and test asymptomatic contacts. This study identified the resources required to establish and maintain an Australian general practitioner (GP) led testing facility that combined a respiratory clinic for clinical assessment and testing with a drive-through testing facility. METHODS: Data were taken from clinic administrative records to identify the number of patients tested over the period April-June 2020. An independent auditor's report identified the resources used in establishing, running, and staffing both clinics for the same period. Analyses were performed using the minimum and maximum daily throughput to understand the effect of demand on price per sample collected. RESULTS: The respiratory clinic tested an average of 19 patients per day, at an estimated cost of $340.04 AUD. This varied to $687.99 AUD during the lowest demand scenario, and $281.04 AUD during the high demand scenario. The drive-through clinic tested an average of 47 patients per day, at an estimated cost of $153.57 AUD. This varied to $279.51 AUD during the lowest demand scenario, and $99.92 AUD during the high demand scenario. CONCLUSION: This study provides insight into the cost of testing at a drive through and respiratory clinic in Australia. The evidence highlights importance of considering variation in demand and the impact on efficiency, particularly where resource use is fixed in the short term.

Cost-effectiveness of professional-mode flash glucose monitoring in general practice among adults with type 2 diabetes: Evidence from the GP-OSMOTIC trial.

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.

Assessing the suitability of general practice electronic health records for clinical prediction model development: a data quality assessment.

BACKGROUND: The use of general practice electronic health records (EHRs) for research purposes is in its infancy in Australia. Given these data were collected for clinical purposes, questions remain around data quality and whether these data are suitable for use in prediction model development. In this study we assess the quality of data recorded in 201,462 patient EHRs from 483 Australian general practices to determine its usefulness in the development of a clinical prediction model for total knee replacement (TKR) surgery in patients with osteoarthritis (OA). METHODS: Variables to be used in model development were assessed for completeness and plausibility. Accuracy for the outcome and competing risk were assessed through record level linkage with two gold standard national registries, Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and National Death Index (NDI). The validity of the EHR data was tested using participant characteristics from the 2014-15 Australian National Health Survey (NHS). RESULTS: There were substantial missing data for body mass index and weight gain between early adulthood and middle age. TKR and death were recorded with good accuracy, however, year of TKR, year of death and side of TKR were poorly recorded. Patient characteristics recorded in the EHR were comparable to participant characteristics from the NHS, except for OA medication and metastatic solid tumour. CONCLUSIONS: In this study, data relating to the outcome, competing risk and two predictors were unfit for prediction model development. This study highlights the need for more accurate and complete recording of patient data within EHRs if these data are to be used to develop clinical prediction models. Data linkage with other gold standard data sets/registries may in the meantime help overcome some of the current data quality challenges in general practice EHRs when developing prediction models.

Towards optimising chronic kidney disease detection and management in primary care: Underlying theory and protocol for technology development using an Integrated Knowledge Translation approach.

Worldwide, Chronic Kidney Disease (CKD), directly or indirectly, causes more than 2.4 million deaths annually with symptoms generally presenting late in the disease course. Clinical guidelines support the early identification and treatment of CKD to delay progression and improve clinical outcomes. This paper reports the protocol for the codesign, implementation and evaluation of a technological platform called Future Health Today (FHT), a software program that aims to optimise early detection and management of CKD in general practice. FHT aims to optimise clinical decision making and reduce practice variation by translating evidence into practice in real time and as a part of quality improvement activities. This protocol describes the co-design and plans for implementation and evaluation of FHT in two general practices invited to test the prototype over 12 months. Service design thinking has informed the design phase and mixed methods will evaluate outcomes following implementation of FHT. Through systematic application of co-design with service users, clinicians and digital technologists, FHT attempts to avoid the pitfalls of past studies that have failed to accommodate the complex requirements and dynamics that can arise between researchers and service users and improve chronic disease management through use of health information technology.

Professional flash glucose monitoring and health service utilisation in type 2 diabetes: A secondary analysis of the GP-OSMOTIC study.

AIM: Professional flash glucose monitoring involves people with diabetes wearing a glucose monitor for up to two weeks, with the data downloaded by their health professional, and the information used to help guide treatment. This study describes if professional flash glucose monitoring was associated with a change in health services utilisation. METHODS: Administrative claims data from three data sources were linked to 288 participants from the GP-OSMOTIC study, a randomised controlled trial evaluating the use of professional flash glucose monitoring versus usual care in people with type 2 diabetes in primary care. Generalised linear models with the Poisson family specified and log link function were used to compare general practice consultations between the intervention and control groups at 0-6- and 6-12-month time points, with adjustment for baseline health services utilisation. RESULTS: GP consultations increased in the flash glucose monitoring group in the 6 months following initial flash glucose monitoring sensor application from a median (IQR) 6 (4,9) to 8 (5,11); (P < 0.001). Participants in the professional FGM group were 1.2 times (95 % CI 1.1-1.4 (P = 0.0014)) more likely at 6-12 months to have GP consultation visits. CONCLUSIONS: Administrative claims data identified changes in health services utilisation associated with professional flash glucose monitoring, despite minimal changes in glycaemic control.

Future Health Today: codesign of an electronic chronic disease quality improvement tool for use in general practice using a service design approach.

OBJECTIVE: To codesign an electronic chronic disease quality improvement tool for use in general practice. DESIGN: Service design employing codesign strategies. SETTING: General practice. PARTICIPANTS: Seventeen staff (general practitioners, nurses and practice managers) from general practice in metropolitan Melbourne and regional Victoria and five patients from metropolitan Melbourne. INTERVENTIONS: Codesign sessions with general practice staff, using a service design approach, were conducted to explore key design criteria and functionality of the audit and feedback and clinical decision support tools. Think aloud interviews were conducted in which participants articulated their thoughts of the resulting Future Health Today (FHT) prototype as they used it. One codesign session was held with patients. Using inductive and deductive coding, content and thematic analyses explored the development of a new technological platform and factors influencing implementation of the platform. RESULTS: Participants identified that the prototype needed to work within their existing workflow to facilitate automated patient recall and track patients with or at-risk of specific conditions. It needed to be simple, provide visual snapshots of information and easy access to relevant guidelines and facilitate quality improvement activities. Successful implementation may be supported by: accuracy of the algorithms in FHT and data held in the practice; the platform supporting planned and spontaneous interactions with patients; the ability to hide tools; links to Medicare Benefits Schedule; and prefilled management plans. Participating patients supported the use of the platform in general practice. They suggested that use of the platform demonstrates a high level of patient care and could increase patient confidence in health practitioners. CONCLUSION: Study participants worked together to design a platform that is clear, simple, accurate and useful and that sits within any given general practice setting. The resulting FHT platform is currently being piloted in general practices and will continue to be refined based on user feedback.

Preparing the public for COVID-19 vaccines: How can general practitioners build vaccine confidence and optimise uptake for themselves and their patients?

BACKGROUND: The availability of a COVID-19 vaccine is being heralded as the solution to control the current COVID-19 pandemic, reduce the number of infections and deaths and facilitate resumption of our previous way of life. OBJECTIVE: The aim of this article is to provide a framework for primary care of what will be needed to optimise COVID-19 vaccine confidence and uptake in Australia once the vaccine prioritisation schedule and key target groups are known. DISCUSSION: While a number of vaccines are currently under development, with at least seven undergoing phase III trials (28 August 2020), it is hoped that an effective COVID-19 vaccine will become available to the public in 2021. Ensuring public confidence in vaccine safety and effectiveness will be crucial to facilitate uptake. General practitioners are at the forefront of public health, and one of the most trusted sources for patients. In this article, the authors discuss the expedited vaccine development process for COVID-19 vaccines; the likely vaccine prioritisation schedule and anticipated key target groups; the behavioural and social drivers of vaccination acceptance, including the work required to facilitate this; and the implications for general practice.

How do general practitioners access guidelines and utilise electronic medical records to make clinical decisions on antibiotic use? Results from an Australian qualitative study.

OBJECTIVE: This study aimed to explore how general practitioners (GPs) access and use both guidelines and electronic medical records (EMRs) to assist in clinical decision-making when prescribing antibiotics in Australia. DESIGN: This is an exploratory qualitative study with thematic analysis interpreted using the Theory of Planned Behaviour (TPB) framework. SETTING: This study was conducted in general practice in Victoria, Australia. PARTICIPANTS: Twenty-six GPs from five general practices were recruited to participate in five focus groups between February and April 2018. RESULTS: GPs expressed that current EMR systems do not provide clinical decision support to assist with antibiotic prescribing. Access and use of guidelines were variable. GPs who had more clinical experience were less likely to access guidelines than younger and less experienced GPs. Guideline use and guideline-concordant prescribing was facilitated if there was a practice culture encouraging evidence-based practice. However, a lack of access to guidelines and perceived patients' expectation and demand for antibiotics were barriers to guideline-concordant prescribing. Furthermore, guidelines that were easy to access and navigate, free, embedded within EMRs and fit into the clinical workflow were seen as likely to enhance guideline use. CONCLUSIONS: Current barriers to the use of antibiotic guidelines include GPs' experience, patient factors, practice culture, and ease of access and cost of guidelines. To reduce inappropriate antibiotic prescribing and to promote more rational use of antibiotic in the community, guidelines should be made available, accessible and easy to use, with minimal cost to practicing GPs. Integration of evidence-based antibiotic guidelines within the EMR in the form of a clinical decision support tool could optimise guideline use and increase guideline-concordant prescribing.

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.

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.

Medication management of type 2 diabetes in residential aged care

BACKGROUND: Medication management of type 2 diabetes mellitus (T2DM) in residential aged care facilities (RACFs) requires consideration of the residents' goals of care and susceptibility to adverse drug events (ADEs). OBJECTIVE: The aim of this article is to review best practice medication management for residents diagnosed with T2DM. DISCUSSION: Management of T2DM in RACFs is often focused on maintaining residents' quality of life rather than intensive glycaemic management to reduce chronic complications, because the risks of intensive glycaemic management typically outweigh the potential benefits. Australian RACF guidelines recommend individualised glycated haemoglobin targets of 7­8.5% (53­69 mmol/mol). Strategies to reduce the risk of preventable ADEs may include education for residents, carers and staff; assessment of hypoglycaemic risk and renal function; medication review and regimen simplification; de-intensification of glucose-lowering medications; and appropriate end-of-life medication management. Use of a resident-centred multidisciplinary approach and resources tailored to the RACF setting will support residents to achieve best possible health outcomes and quality of life.

Factors associated with relational coordination between health professionals involved in insulin initiation in the general practice setting for people with type 2 diabetes.

AIM: To examine associations between characteristics of general practice settings and primary healthcare providers (general practitioners and practice nurses) and the degree of relational coordination for the task of insulin initiation for type 2 diabetes between primary healthcare providers and diabetes specialists. BACKGROUND: Relational coordination is a component of effective chronic disease management and can be used to measure collaboration and communication between health professionals. High levels of relational coordination may be important to support insulin initiation in general practice. DESIGN: Cross-sectional study. METHODS: Surveys were completed by general practitioners and practice nurses participating in the Stepping Up trial. Data on demographics, practice characteristics and relational coordination were collected between October 2012-June 2014. Univariate and multivariate analyses examined factors associated with relational coordination. RESULTS: General practitioners (n = 174) and 115 practice nurses from 78 general practices were included in the analysis. General practice characteristics associated with relational coordination were geographical location and number of administrative staff. Female general practitioners and older practice nurses reported lower relational coordination. Practice nurses with diabetes educator qualifications and experience in insulin initiation reported higher relational coordination. CONCLUSION: An expanded role and experience of practice nurses in diabetes care increased relational coordination and has the potential to deliver more effective chronic disease management in general practice. Practice and health professional characteristics should be taken into account when designing models of care to increase insulin initiation.

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

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.

Relational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey.

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.

Can 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.

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.

Roles 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.

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.