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BACKGROUND: This study evaluates primary care practices' engagement with various features of a quality improvement (QI) intervention for patients with coronary heart disease (CHD) in four Australian states. METHODS: Twenty-seven practices participated in the QI intervention from November 2019 -November 2020. A combination of surveys, semi-structured interviews and other materials within the QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with heart disease (QUEL) study were used in the process evaluation. Data were summarised using descriptive statistical and thematic analyses for 26 practices. RESULTS: Sixty-four practice team members and Primary Health Networks staff provided feedback, and nine of the 63 participants participated in the interviews. Seventy-eight percent (40/54) were either general practitioners or practice managers. Although 69% of the practices self-reported improvement in their management of heart disease, engagement with the intervention varied. Forty-two percent (11/26) of the practices attended five or more learning workshops, 69% (18/26) used Plan-Do-Study-Act cycles, and the median (Interquartile intervals) visits per practice to the online SharePoint site were 170 (146-252) visits. Qualitative data identified learning workshops and monthly feedback reports as the key features of the intervention. CONCLUSION: Practice engagement in a multi-featured data-driven QI intervention was common, with learning workshops and monthly feedback reports identified as the most useful features. A better understanding of these features will help influence future implementation of similar interventions. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134.

BACKGROUND: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality among cancer survivors. Mental health is considered an important risk factor affecting the treatment of cardiovascular disease. However, little is known about the use of secondary prevention strategies for CVD in patients with both cancer and CVD. This study aimed to compare the utilisation of primary care chronic disease management plans, mental health care and guideline-indicated cardioprotective medications among CVD patients with and without cancer. METHODS: Retrospective cross-sectional study utilising clinical data of patients with CVD from 50 Australian primary care practices. Outcomes included the use of chronic disease management plans, mental health care, guideline-indicated cardioprotective medications and influenza vaccination. Logistic regression, accounting for demographic and clinical covariates and clustering effects by practices, was used to compare the two groups. RESULTS: Of the 15,040 patients with CVD, 1,486 patients (9.9%) concurrently had cancer. Patients with cancer, compared to those without, were older (77.6 vs 71.8 years, p<0.001), more likely to drink alcohol (62.6% vs 55.7%, p<0.001), have lower systolic (130.3±17.8 vs 132.5±21.1 mmHg, p<0.001) and diastolic (72.2±11 vs 75.3±34 mmHg, p<0.001) blood pressure. Although suboptimal for both groups, patients with cancer were significantly more likely to have general practice management plans (GPMPs) (51.4% vs 43.2%, p<0.001), coordination of team care arrangements (TCAs) (46.2% vs 37.0%, p<0.001), have a review of either GPMP or TCA (42.8% vs 34.7%, p<0.001), have a mental health treatment consultation (15.4% vs 10.5%, p=0.004) and be prescribed blood pressure-lowering medications (70.1% vs 66.0%, p=0.002). However, there were no statistical differences in the prescription of lipid-lowering or antiplatelet medications. After adjustments for covariates and multiple testing, patients with cancer did not show

Objective: To determine the cost-effectiveness and cost-utility of a quadpill containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg and bisoprolol 2.5 mg in comparison with irbesartan 150 mg for people with hypertension who are either untreated or receiving monotherapy. Methods: We conducted a within-trial and modelled economic evaluation of the Quadruple UltrA-low-dose tReaTment for hypErTension trial. The analysis was preplanned, and medications and health service use captured during the trial. The main outcomes were incremental cost-effectiveness ratios (ICERs) for cost per mm Hg systolic blood pressure (BP) reduction at 3 months, and modelled cost per quality-adjusted life year (QALY) over a lifetime. Results: The within-trial analysis showed no clear difference in cost per mm Hg BP lowering between randomised treatments at 3 months ($A10 (95% uncertainty interval (UI) $A -18 to $A37) per mm Hg per person) for quadpill versus monotherapy. The modelled cost-utility over a lifetime projected a mean incremental cost of $A265 (95% UI $A166 to $A357) and a mean 0.02 QALYs gained (95% UI 0.01 to 0.03) per person with quadpill therapy compared with monotherapy. Quadpill therapy was cost-effective in the base case (ICER of $A14 006 per QALY), and the result was sensitive to the quadpill cost in one-way sensitivity analysis. Conclusion(s): Quadpill in comparison with monotherapy is comparably cost-effective for short-term BP lowering. In the long-term, quadpill therapy is likely to be cost-effective. Trial registration number: ANZCTRN12616001144404.

As population aging progresses, demands of patients with cardiovascular diseases (CVD) on the primary care services is inevitably increased. However, the utilisation of primary care services across varying age groups is unknown. The study aims to explore age-related variations in provision of chronic disease management plans, mental health care, guideline-indicated cardiovascular medications and influenza vaccination among patients with CVD over differing ages presenting to primary care. Data for patients with CVD were extracted from 50 Australian general practices. Logistic regression, accounting for covariates and clustering effects by practices, was used for statistical analysis. Of the 14,602 patients with CVD (mean age, 72.5 years), patients aged 65–74, 75–84 and ≥85 years were significantly more likely to have a GP management plan prepared (adjusted odds ratio (aOR): 1.6, 1.88 and 1.55, respectively, p < 0.05), have a formal team care arrangement (aOR: 1.49, 1.8, 1.65, respectively, p < 0.05) and have a review of either (aOR: 1.63, 2.09, 1.93, respectively, p < 0.05) than those < 65 years. Patients aged ≥ 65 years were more likely to be prescribed blood-pressure-lowering medications and to be vaccinated for influenza. However, the adjusted odds of being prescribed lipid-lowering and antiplatelet medications and receiving mental health care were significantly lowest among patients ≥ 85 years. There are age-related variations in provision of primary care services and pharmacological therapy. GPs are targeting care plans to older people who are more likely to have long-term conditions and complex needs.

Background: Practice-level quality improvement initiatives using rapidly advancing technology offers a multidimensional approach to reduce cardiovascular disease burden. For the “QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with heart disease” (QUEL) cluster randomised controlled trial, a 12-month quality improvement intervention was designed for primary care practices to use data and implement progressive changes using “Plan, Do, Study, Act” cycles within their practices with training in a series of interactive workshops. This protocol aims to describe the systematic methods to conduct a process evaluation of the data-driven intervention within the QUEL study. Methods: A mixed-method approach will be used to conduct the evaluation. Quantitative data collected throughout the intervention period, via surveys and intervention materials, will be used to (1) identify the key elements of the intervention and how, for whom and in what context it was effective; (2) determine if the intervention is delivered as intended; and (3) describe practice engagement, commitment and capacity associated with various intervention components. Qualitative data, collected via semi-structured interviews and open-ended questions, will be used to gather in-depth understanding of the (1) satisfaction, utility, barriers and enablers; (2) acceptability, uptake and feasibility, and (3) effect of the COVID-19 pandemic on the implementation of the intervention. Conclusion: Findings from the evaluation will provide new knowledge on the implementation of a complex, multi-component intervention at practice-level using their own electronic patient data to enhance secondary prevention of cardiovascular disease. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134.

BACKGROUND: Effective integration of evidence and youth perspectives into policy is crucial for supporting the future health and well-being of young people. The aim of this project was to translate evidence from the Access 3 project to support development of a new state policy on youth health and well-being within New South Wales (NSW), Australia. Ensuring the active contribution of young people within policy development was a key objective of the knowledge translation (KT) process. METHODS: The KT activity consisted of a 1-day facilitated forum with 64 purposively sampled stakeholders. Participants included eight young people, 14 policy-makers, 15 academics, 22 clinicians or managers from NSW health services, four general practitioners and one mental health service worker. Research to be translated came from the synthesized findings of the NSW Access 3 project. The design of the forum included stakeholder presentations and group workshops, guided by the 2003 Lavis et al. KT framework that was improved by the Grimshaw et al. KT framework in 2012. Members of the Access 3 research team took on the role of knowledge brokers throughout the KT process. Participant satisfaction with the workshop was evaluated using a brief self-report survey. Policy uptake was determined through examination of the subsequent NSW Youth Health Framework 2017-2024. RESULTS: A total of 25 policy recommendations were established through the workshop, and these were grouped into six themes that broadly aligned with the synthesized findings from the Access 3 project. The six policy themes were (1) technology solutions, (2) integrated care and investment to build capacity, (3) adolescent health checks, (4) workforce, (5) youth participation and (6) youth health indicators. Forum members were asked to vote on the importance of individual recommendations. These policy recommendations were subsequently presented to the NSW Ministry of Health, with some evidence of policy uptake identified. The major

BACKGROUND: High-quality general practice has been demonstrated to provide cost-effective, equitable health care and improve health outcomes. Yet there is currently not a set of agreed comprehensive indicators in Australia. We have developed 79 evidence-based indicators and their corresponding 129 measures of high-quality general practice. This study aims to achieve consensus on relevant and feasible indicators and measures for the Australian context. METHODS: This Delphi consensus study, approved by WSU Human Research Ethics Committee, consists of three rounds of online survey with general practice experts including general practitioners, practice nurses and primary health network staff. The identified indicators and measures are grouped under an attribute framework aligned with the Quadruple Aim, and further grouped under structures, processes and outcomes according to the Donabedian framework. Participants will rate each indicator and measure for relevance and feasibility, and provide comments and recommendations of additional indicators or measures. In the last round, participants will also be asked their views on the implementation of a quality indicator tool. Each indicator and measure will require ≥70% agreement in both relevance and feasibility to achieve consensus. Aggregated ratings will be statistically analysed for response rates, level of agreement, medians, interquartile ranges and group rankings. Qualitative responses will be analysed thematically using a mixed inductive and deductive approach. DISCUSSION: This protocol will add to the current knowledge of the translation of performance guidelines into quality practice across complex clinical settings and in a variety of different contexts in Australian general practice. The Delphi technique is appropriate to develop consensus between the diverse experts because of its ability to offer anonymity to other participants and minimise bias. Findings will contribute to the design of an assessment tool of hi

Objectives: To determine whether a multifaceted primary health care intervention better controlled cardiovascular disease (CVD) risk factors in patients with high risk of CVD than usual care. Design, setting: Parallel arm, cluster randomised trial in 71 Australian general practices, 5 December 2016 – 13 September 2019. Participants: General practices that predominantly used an electronic medical record system compatible with the HealthTracker electronic decision support tool, and willing to implement all components of the INTEGRATE intervention. Intervention: Electronic point-of-care decision support for general practices; combination cardiovascular medications (polypills); and a pharmacy-based medication adherence program. Main outcome measures: Proportion of patients with high CVD risk not on an optimal preventive medication regimen at baseline who had achieved both blood pressure and low-density lipoprotein (LDL) cholesterol goals at study end. Results: After a median 15 months’ follow-up, primary outcome data were available for 4477 of 7165 patients in the primary outcome cohort (62%). The proportion of patients who achieved both treatment targets was similar in the intervention (423 of 2156; 19.6%) and control groups (466 of 2321; 20.1%; relative risk, 1.06; 95% CI, 0.85–1.32). Further, no statistically significant differences were found for a number of secondary outcomes, including risk factor screening, preventive medication prescribing, and risk factor levels. Use of intervention components was low; it was highest for HealthTracker, used at least once for 347 of 3236 undertreated patients with high CVD risk (10.7%). Conclusions: Despite evidence for the efficacy of its individual components, the INTEGRATE intervention was not broadly implemented and did not improve CVD risk management in participating Australian general practices. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12616000233426 (prospective).

High blood pressure is the leading cause of preventable morbidity and mortality globally. Many patients remain on single-drug treatment with poor control, although guidelines recognize that most require combination therapy for blood pressure control. Our hypothesis is that a single-pill combination of 4 blood pressure–lowering agents each at a quarter dose may provide a simple, safe, and effective blood pressure–lowering solution which may also improve long-term adherence. The Quadruple UltrA-low-dose tReaTment for hypErTension (QUARTET) double-blind, active-controlled, randomized clinical trial will examine whether ultra-low-dose quadruple combination therapy is more effective than guideline-recommended standard care in lowering blood pressure. QUARTET will enroll 650 participants with high blood pressure either on no treatment or on monotherapy. Participants will be randomized 1:1 and allocated to intervention therapy of a single pill (quadpill) containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or to control therapy of a single identical-appearing pill containing irbesartan 150 mg. In both arms, step-up therapy of open-label amlodipine 5 mg will be provided if blood pressure is >140/90 at 6 weeks. The primary outcome is the difference between groups in the change from baseline in mean unattended automated office systolic blood pressure at 12-week follow-up. The primary outcome and some secondary outcomes will be assessed at 12 weeks; there is an optional 12-month extension phase to assess longer-term efficacy and tolerability. Our secondary aims are to assess if this approach is safe, has fewer adverse effects, and has better tolerability compared to standard care control. QUARTET will therefore provide evidence for the effectiveness and safety of a new paradigm in the management of high blood pressure.

BACKGROUND: Current health-care models are ill-equipped for managing people with diabetes and chronic kidney disease (CKD). We evaluated the impact of a new diabetes and kidney disease service (DKS) on hospitalisation, mortality, clinical and patient relevant outcomes. METHOD(S): Longitudinal analyses of adult patients with diabetes and CKD (stages 3a to 5) were performed using outpatient and hospitalisation data from January 2015 to October 2018. Data was handled according to whether patients received the DKS intervention (n=196) or standard care (n=7511). The DKS provided patient-centered, coordinated multi-disciplinary assessment and management of patients. Primary analyses examined hospitalisation and mortality rates between the two groups. Secondary analyses evaluated the impact of the DKS on clinical target attainment, changes in eGFR, HbA1c, self-care and patient activation at 12months. RESULT(S): Patients who received the intervention had a higher hospitalisation rate (incidence rate ratio (IRR), 1.20; 95% CI, 1.13 to 1.30; P<0.0001), shorter median length of stay (2days [interquartile range (IQR), 6-1] versus 4days [IQR 9-1]; P<0.0001) and lower all-cause mortality rate (IRR 0.4; 95% CI, 0.29 to 0.64; P<0.0001) than those who received standard care. Improvements in overall self-care (MD 2.26, 95% CI 0.83, 3.69; P<0.001) and in statin use, foot and eye examination were observed. Mean eGFR did not significantly change after 12months (MD 1.30, 95% CI -4.17, 1.67; P=0.40) mls/min per 1.73m2. HbA1c levels significantly decreased by 0.40, 0.35, 0.34 and 0.23% at 3, 6, 9 and 12months follow-up respectively. CONCLUSION(S): A co-designed, person-centred integrated model of care improved all-cause mortality, kidney function, glycaemic control and self-care for patients with diabetes and CKD.Copyright © The Author(s) 2021. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Introduction After first stroke, the transition from rehabilitation to home can be confronting and fraught with challenges. Although stroke clinical practice guidelines recommend predischarge occupational therapy home visits to ensure safe discharge and provision of appropriate equipment, there is currently limited evidence to support this recommendation. Methods and analysis The HOME Rehab trial is a national, multicentre, phase III randomised controlled trial with concealed allocation, blinded assessment and intention-to-treat analysis being conducted in Australia. The trial aim is to determine the effect and potential cost-effectiveness of an enhanced occupational therapy discharge planning intervention that involves pre and postdischarge home visits, goal setting and occupational therapy in the home (the HOME programme) in comparison to an in-hospital predischarge planning intervention. Stroke survivors aged >=45 years, admitted to a rehabilitation ward, expected to return to a community (private) dwelling after discharge, with no significant prestroke disability will be randomly allocated 1:1 to receive a standardised discharge planning intervention and the HOME programme or the standardised discharge planning intervention alone. The primary outcome is participation measured using the Nottingham Extended Activities of Daily Living. Secondary outcome areas include hospital readmission, disability, performance of instrumental activities of daily living, health-related quality of life, quality of care transition and carer burden. Resources used/costs will be collected for the cost-effectiveness analysis and hospital readmission. Recruitment commenced in 2019. Allowing for potential attrition, 360 participants will be recruited to detect a clinically important treatment difference with 80% power at a two-tailed significance level of 0.05. Ethics and dissemination This study is approved by the Alfred Health Human Research Ethics Committee and site-specific ethics ap

OBJECTIVE: To construct a whole-of-system model to inform strategies that reduce the burden of cardiovascular disease (CVD) in Australia. METHODS: A system dynamics model was developed with a multidisciplinary modelling consortium. The model population comprised Australians aged 40 years and over, and the scope encompassed acute and chronic CVD as well as primary and secondary prevention. Health outcomes were CVD-related deaths and hospitalisations, and economic outcomes were the net benefit from both the healthcare system and societal perspectives. The eight strategies broadly included creating social and physical environments supportive of a healthy lifestyle, increasing the use of preventive treatments, and improving systems response to acute CVD events. The effects of strategies were estimated as relative differences to the business-as-usual between 2019-2039. Probabilistic sensitivity analysis produced uncertainty intervals of interquartile ranges (IQR). FINDINGS: The greatest reduction in CVD-related deaths was seen in strategies that improve systems response to acute CVD events (8.9%, IQR: 7.7-10.2%), yet they resulted in an increase in CVD-related hospitalisations due to future recurrent admissions (1.6%, IQR: 0.1-2.3%). This flow-on effect highlighted the importance of addressing underlying CVD risks. On the other hand, strategies targeting the broad environment that supports a healthy lifestyle were effective in reducing both hospitalisations (7.1%; IQR: 5.0-9.5%) and deaths (8.1% reduction; IQR: 7.1-8.9%). They also produced an economic net benefit of AU$43.3 billion (IQR: 37.7-48.7) using a societal perspective, largely driven by productivity gains. Overall, strategic planning to reduce the burden of CVD should consider the varying effects of strategies over time and beyond the health sector.

INTRODUCTION: After first stroke, the transition from rehabilitation to home can be confronting and fraught with challenges. Although stroke clinical practice guidelines recommend predischarge occupational therapy home visits to ensure safe discharge and provision of appropriate equipment, there is currently limited evidence to support this recommendation. METHODS AND ANALYSIS: The HOME Rehab trial is a national, multicentre, phase III randomised controlled trial with concealed allocation, blinded assessment and intention-to-treat analysis being conducted in Australia. The trial aim is to determine the effect and potential cost-effectiveness of an enhanced occupational therapy discharge planning intervention that involves pre and postdischarge home visits, goal setting and occupational therapy in the home (the HOME programme) in comparison to an in-hospital predischarge planning intervention. Stroke survivors aged ≥45 years, admitted to a rehabilitation ward, expected to return to a community (private) dwelling after discharge, with no significant prestroke disability will be randomly allocated 1:1 to receive a standardised discharge planning intervention and the HOME programme or the standardised discharge planning intervention alone. The primary outcome is participation measured using the Nottingham Extended Activities of Daily Living. Secondary outcome areas include hospital readmission, disability, performance of instrumental activities of daily living, health-related quality of life, quality of care transition and carer burden. Resources used/costs will be collected for the cost-effectiveness analysis and hospital readmission. Recruitment commenced in 2019. Allowing for potential attrition, 360 participants will be recruited to detect a clinically important treatment difference with 80% power at a two-tailed significance level of 0.05. ETHICS AND DISSEMINATION: This study is approved by the Alfred Health Human Research Ethics Committee and site-specific ethics

Objectives To determine whether a multifaceted primary health care intervention better controlled cardiovascular disease (CVD) risk factors in patients with high risk of CVD than usual care. Design, setting Parallel arm, cluster randomised trial in 71 Australian general practices, 5 December 2016 – 13 September 2019. Participants General practices that predominantly used an electronic medical record system compatible with the HealthTracker electronic decision support tool, and willing to implement all components of the INTEGRATE intervention. Intervention Electronic point-of-care decision support for general practices; combination cardiovascular medications (polypills); and a pharmacy-based medication adherence program. Main outcome measures Proportion of patients with high CVD risk not on an optimal preventive medication regimen at baseline who had achieved both blood pressure and low-density lipoprotein (LDL) cholesterol goals at study end. Results After a median 15 months’ follow-up, primary outcome data were available for 4477 of 7165 patients in the primary outcome cohort (62%). The proportion of patients who achieved both treatment targets was similar in the intervention (423 of 2156; 19.6%) and control groups (466 of 2321; 20.1%; relative risk, 1.06; 95% CI, 0.85–1.32). Further, no statistically significant differences were found for a number of secondary outcomes, including risk factor screening, preventive medication prescribing, and risk factor levels. Use of intervention components was low; it was highest for HealthTracker, used at least once for 347 of 3236 undertreated patients with high CVD risk (10.7%). Conclusions Despite evidence for the efficacy of its individual components, the INTEGRATE intervention was not broadly implemented and did not improve CVD risk management in participating Australian general practices.

Objective: To assess the cost-effectiveness of a computer-guided quality improvement intervention for primary health care management of cardiovascular disease (CVD) in people at high risk. Design: Modelled cost-effectiveness analysis of the HealthTracker intervention and usual care for people with high CVD risk, based on TORPEDO trial data on prescribing patterns, changes in intermediate risk factors (low-density lipoprotein cholesterol, systolic blood pressure), and Framingham risk scores. Participants: Hypothetical population of people with high CVD risk attending primary health care services in a New South Wales primary health network (PHN) of mean size. Intervention: HealthTracker, integrated into health care provider electronic health record systems, provides real time decision support, risk communication, a clinical audit tool, and a web portal for performance feedback. Main outcome measures: Incremental cost-effectiveness ratios (ICERs): difference in costs of the intervention and usual care divided by number of CVD events averted with HealthTracker. Results: The estimated numbers of major CVD events over five years per 1000 patients at high CVD risk were lower in PHNs using HealthTracker, both for patients with prior CVD events (secondary prevention; 259 v 267 with usual care) and for those without prior events (primary prevention; 168 v 176). Medication costs were higher and hospitalisation costs lower with HealthTracker than with usual care for both primary and secondary prevention. The estimated ICER for one averted CVD event was $7406 for primary prevention and $17 988 for secondary prevention. Conclusion: Modelled cost-effectiveness analyses provide information that can assist decisions about investing in health care quality improvement interventions. We estimate that HealthTracker could prevent major CVD events for less than $20 000 per event averted. Trial registration (TORPEDO): Australian New Zealand Clinical Trials Registry, ACTRN 12611000478910.

Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88–1.20] p = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97–2.03] p = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control, p = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control, p = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.

Background: Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is the leading cause of death and disability globally. A large proportion of mortality occurs in people with prior CHD and effective and scalable strategies are needed to prevent associated deaths and hospitalisations. The aim of this study is to determine if a practice-level collaborative quality improvement program, focused on patients with CHD, reduces the rate of unplanned CVD hospitalisations and major adverse cardiovascular events, and increases the proportion of patients achieving risk factor targets at 24 months. Methods: Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up. Eligible practices will be randomised (1:1) to participate in either the intervention (collaborative quality improvement program) or control (standard care) regimens. Outcomes will be assessed based on randomised allocation, according to intention-to-treat. The primary outcome is the proportion of patients with unplanned CVD hospitalisations at 2 years. Secondary outcomes are proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review. Differences in the proportion of patients who are hospitalised (as well as binary secondary outcomes) will be analysed using logbinomial regression or robust Poisson regression, if necessary. (Continued on next page)

Objective: To evaluate the impact of an integrated diabetes and kidney disease model of care on health-related quality of life (HRQOL) of patients with comorbid diabetes and chronic kidney disease (CKD). Research design and methods: A longitudinal study of adult patients (over 18 years) with comorbid diabetes and CKD (stage 3a or worse) who attended a new diabetes kidney disease service was conducted at a tertiary hospital. A questionnaire consisting of demographics, clinical data, and the Kidney Disease Quality of Life (KDQOL-36) was administered at baseline and after 12 months. Paired t-tests were used to compare baseline and 12-month scores. A subgroup analysis examined the effects by patient gender. Multiple regression analysis examined the factors associated with changes in scores. Results: 179 patients, 36% of whom were female, with baseline mean±SD age of 65.9±11.3 years, were studied. Across all subscales, HRQOL did not significantly change over time (p value for all mean differences >0.05). However, on subgroup analysis, symptom problem list and physical composite summary scores increased among women (MD=9.0, 95% CI 1.25 to 16.67; p=0.02 and MD=4.5, 95% CI 0.57 to 8.42; p=0.03 respectively) and physical composite scores decreased among men (MD=-3.35, 95% CI -6.26 to -0.44; p=0.03). Conclusion The HRQOL of patients with comorbid diabetes and CKD attending a new codesigned, integrated diabetes and kidney disease model of care was maintained over 12 months. Given that HRQOL is known to deteriorate over time in this high-risk population, the impact of these findings on clinical outcomes warrants further investigation.

Objective: To evaluate the impact of an integrated diabetes and kidney disease model of care on health-related quality of life (HRQOL) of patients with comorbid diabetes and chronic kidney disease (CKD). Research design and methods: A longitudinal study of adult patients (over 18 years) with comorbid diabetes and CKD (stage 3a or worse) who attended a new diabetes kidney disease service was conducted at a tertiary hospital. A questionnaire consisting of demographics, clinical data, and the Kidney Disease Quality of Life (KDQOL-36) was administered at baseline and after 12 months. Paired t-tests were used to compare baseline and 12-month scores. A subgroup analysis examined the effects by patient gender. Multiple regression analysis examined the factors associated with changes in scores. Result(s): 179 patients, 36% of whom were female, with baseline mean+/-SD age of 65.9+/-11.3 years, were studied. Across all subscales, HRQOL did not significantly change over time (p value for all mean differences >0.05). However, on subgroup analysis, symptom problem list and physical composite summary scores increased among women (MD=9.0, 95% CI 1.25 to 16.67; p=0.02 and MD=4.5, 95% CI 0.57 to 8.42; p=0.03 respectively) and physical composite scores decreased among men (MD=-3.35, 95% CI -6.26 to -0.44; p=0.03). Conclusion The HRQOL of patients with comorbid diabetes and CKD attending a new codesigned, integrated diabetes and kidney disease model of care was maintained over 12 months. Given that HRQOL is known to deteriorate over time in this high-risk population, the impact of these findings on clinical outcomes warrants further investigation.Copyright © 2020 Author(s) (or their employer(s)).

Introduction: While multi-disciplinary diabetes and renal clinics have been shown to improve surrogate clinical outcomes such as HbA1c and renal function decline, their impact on patient self-care is uncertain. We evaluated the impact of an integrated, person-centred diabetes and kidney disease clinic and model of care on diabetes self-care for patients with co-morbid diabetes and CKD. Method(s): We conducted a longitudinal study of adult patients (over 18 years) with comorbid diabetes and CKD (Stage 3a or worse) attending a new co-designed diabetes and kidney disease service at a tertiary hospital. A questionnaire consisting of demographics, clinical data, and the Summary of Diabetes Self Care Activities (SDSCA) was administered at baseline and after 12 months. Paired t-tests were used to compare baseline and 12 month scores. Factors associated with change scores were examined by multiple regression analyses. Result(s): 179 patients, 63% of whom were male, with a baseline mean +/- SD age of 66.0 +/-11.3 years, were studied. Most had type 2 diabetes (97%) and moderate to advanced CKD (83% stages 3 to 4 CKD). Self-care significantly changed across the specific diet, exercising, blood sugar and foot checking subscales as well as the composite SDSCA score (all p<0.05). Factors associated with smaller changes in scores in the exercising subscale were older age and belonging to lower socioeconomic status (p<0.05). Factors associated with larger changes in scores in specific diet, exercising and blood sugar testing subscales were higher BMI, advanced CKD and drinking alcohol respectively (p<0.05). Conclusion(s): An integrated, person-centred diabetes and kidney disease clinic and model of care improved patients' diabetes self-care, an important component of complex multi-morbid chronic disease management.Copyright © 2020

Introduction: The impact of multi-disciplinary diabetes and renal clinics on patient activation, which describes the knowledge, skills, and confidence a person has in managing their own health and health care is uncertain. We evaluated the degree to which an integrated, person-centred diabetes and kidney disease clinic and model of care influenced patient activation among patients with co-morbid diabetes and chronic kidney disease (CKD). Method(s): We conducted a longitudinal study of adult patients (over 18 years) with comorbid diabetes and CKD (Stage 3a or worse) attending a new co-designed diabetes and kidney disease service at a tertiary hospital. A questionnaire consisting of demographics, clinical data, and the Patient Activation Measure (PAM) was administered at baseline and after 12 months. PAM scores (from 0-100) were assessed with higher scores indicating higher activation. The scores were categorised into four levels with level 4 indicating maximal activation. Paired t-tests and chi-squared tests were used to compare PAM scores and activation levels at baseline and 12 months. Result(s): 176 patients, 36% of whom were female, with a median age (IQR) of 68 (13) years, were studied. Most had type 2 diabetes (97%) and 61%, 41% and 22% had CKD stages 3, 4 and 5 respectively. The mean activation score (SD) was 57.1 (16.2) at baseline and 58.9 (13.6) at 12 months follow up. The overall increase in activation score at follow up was not significantly different (MD=1.8, 95% CI: -0.8 to 4.4; p=0.17). However, a significant number of patients moved from a lower to higher level of activation at follow up [chi2 (3, N = 176) = 11.48, p =0.001]. Conclusion(s): A co-designed, integrated diabetes and kidney disease model of care may improve activation levels of patients with comorbid diabetes and CKD leading to positive health outcomes.Copyright © 2020

BACKGROUND: The aim of this study was to measure young people's health status and explore associations between health status and belonging to one or more socio-culturally marginalised group. METHODS: part of the Access 3 project, this cross-sectional survey of young people aged 12-24 years living in New South Wales, Australia, oversampled young people from one or more of the following groups: Aboriginal and or Torres Strait Islander; living in rural and remote areas; homeless; refugee; and/or, sexuality and/or gender diverse. This paper reports on findings pertaining to health status, presence of chronic health conditions, psychological distress, and wellbeing measures. RESULTS: 1416 participants completed the survey; 897 (63.3%) belonged to at least one marginalised group; 574 (40.5%) to one, 281 (19.8%) to two and 42 (3.0%) to three or four groups. Belonging to more marginalised groups was significantly associated with having more chronic health conditions (p = 0.001), a greater likelihood of high psychological distress (p = 0.001) and of illness or injury related absence from school or work (p < 0.05). CONCLUSIONS: increasing marginalisation is associated with decreasing health status. Using an intersectional lens can to be a useful way to understand disadvantage for young people belonging to multiple marginalised groups.