Data-driven quality improvement program to prevent hospitalisation and improve care of people living with coronary heart disease: Protocol for a process evaluation.

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.

INFLATE: a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children.

BACKGROUND: Otitis media with effusion (OME) is common and occurs at disproportionately higher rates among Indigenous children. Left untreated, OME can negatively affect language, development, learning, and health and wellbeing throughout the life-course. Currently, OME care includes observation for 3 months followed by consideration of surgical ventilation tube insertion. The use of a non-invasive, low-cost nasal balloon autoinflation device has been found beneficial in other populations but has not been investigated among Aboriginal and Torres Strait Islander children. METHODS/DESIGN: This multi-centre, open-label, randomised controlled trial will determine the effectiveness of nasal balloon autoinflation compared to no nasal balloon autoinflation, for the treatment of OME among Aboriginal and Torres Strait Islander children in Australia. Children aged 3-16 years with unilateral or bilateral OME are being recruited from Aboriginal Health Services and the community. The primary outcome is the proportion of children showing tympanometric improvement of OME at 1 month. Improvement is defined as a change from bilateral type B tympanograms to at least one type A or C1 tympanogram, or from unilateral type B tympanogram to type A or C1 tympanogram in the index ear, without deterioration (type A or C1 to type C2, C3, or B tympanogram) in the contralateral ear. A sample size of 340 children (170 in each group) at 1 month will detect an absolute difference of 15% between groups with 80% power at 5% significance. Anticipating a 15% loss to follow-up, 400 children will be randomised. The primary analysis will be by intention to treat. Secondary outcomes include tympanometric changes at 3 and 6 months, hearing at 3 months, ear health-related quality of life (OMQ-14), and cost-effectiveness. A process evaluation including perspectives of parents or carers, health care providers, and researchers on trial implementation will also be undertaken. DISCUSSION: INFLATE will answer the important clinical question of whether nasal balloon autoinflation is an effective and acceptable treatment for Aboriginal and Torres Strait Islander children with OME. INFLATE will help fill the evidence gap for safe, low-cost, accessible OME therapies. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12617001652369 . Registered on 22 December 2017. The Australia New Zealand Clinical Trials Registry is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set. Retrospective registration.

Gender Comparison of Receipt of Government-Funded Health Services and Medication Prescriptions for the Management of Patients With Cardiovascular Disease in Primary Care.

BACKGROUND: Cardiovascular disease (CVD) and risk factors remains a major burden in terms of disease, disability, and death in the Australian population and mental health is considered as an important risk factor affecting cardiovascular disease. A multidisciplinary collaborative approach in primary care is required to ensure an optimal outcome for managing cardiovascular patients with mental health issues. Medicare introduced numerous primary care health services and medications that are subsidised by the Australian government in order to provide a more structured approach to reduce and manage CVD. However, the utilisation of these services nor gender comparison for CVD management in primary care has been explored. Therefore, the aim is to compare the provision of subsidised chronic disease management plans (CDMPs), mental health care and prescription of guideline-indicated medications to men and women with CVD in primary care practices for secondary prevention. METHODS: De-identified data for all active patients with CVD were extracted from 50 Australian primary care practices. Outcomes included the frequency of receipt of CDMPs, mental health care and prescription of evidence-based medications. Analyses adjusted for demography and clinical characteristics, stratified by gender, were performed using logistic regression and accounted for clustering effects by practices. RESULTS: Data for 14,601 patients with CVD (39.4% women) were collected. The odds of receiving the CDMPs was significantly greater amongst women than men (preparation of general practice management plan [GPMP]: (46% vs 43%; adjusted OR [95% CI]: 1.22 [1.12, 1.34]). Women were more likely to have diagnosed with mental health issues (32% vs 20%, p<0.0001), however, the adjusted odds of men and women receiving any government-subsidised mental health care were similar. Women were less often prescribed blood pressure, lipid-lowering and antiplatelet medications. After adjustment, only an antiplatelet medication or agent was less likely to be prescribed to women than men (44% vs 51%; adjusted OR [95% CI]: 0.84 [0.76, 0.94]). CONCLUSION: Women were more likely to receive CDMPs but less likely to receive antiplatelet medications than men, no gender difference was observed in the receipt of mental health care. However, the receipt of the CDMPs and the mental health treatment consultations were suboptimal and better use of these existing services could improve ongoing CVD management.

QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with coronary heart disease (QUEL): protocol for a 24-month cluster randomised controlled trial in primary care.

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 log-binomial regression or robust Poisson regression, if necessary. DISCUSSION: Despite extensive research with surrogate outcomes, to the authors' knowledge, this is the first randomised controlled trial to evaluate the effectiveness of a data-driven collaborative quality improvement intervention on hospitalisations, CVD events and cardiovascular risk amongst patients with CHD in the primary care setting. The use of data linkage for collection of outcomes will enable evaluation of this potentially efficient strategy for improving management of risk and outcomes for people with heart disease. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).

The association between patient activation and self-care practices: A cross-sectional study of an Australian population with comorbid diabetes and chronic kidney disease.

OBJECTIVE: This study aimed to examine the association between performance of self-care activities and patient or disease factors as well as patient activation levels in patients with diabetes and chronic kidney disease (CKD) in Australia. METHODS: A cross-sectional study was conducted among adults with diabetes and CKD (eGFR <60 mL/min/1.73m2 ) who were recruited from renal and diabetes clinics of four tertiary hospitals in Australia. Demographic and clinical data were collected, as well as responses to the Patient Activation Measure (PAM) and the Summary of Diabetes Self-Care Activities (SDSCA) scale. Regression analyses were performed to determine the relationship between activation and performance of self-care activities. RESULTS: A total of 317 patients (70% men) with a mean age of 66.9 (SD=11.0) years participated. The mean (SD) PAM and composite SDSCA scores were 57.6 (15.5) % (range 0-100) and 37.3 (11.2) (range 0-70), respectively. Younger age, being male, advanced stages of CKD and shorter duration of diabetes were associated with lower scores in one or more self-care components. Patient activation was positively associated with the composite SDSCA score, and in particular the domains of general diet and blood sugar checking (P<.05), but not specific diet, exercising and foot checking. CONCLUSION: In people with diabetes and CKD, a high level of patient activation was positively associated with a higher overall level of self-care. Our results identify subgroups of people who may benefit from tailored interventions to further improve their health outcomes. Further prospective studies are warranted to confirm present findings.

Implementation of a consumer-focused eHealth intervention for people with moderate-to-high cardiovascular disease risk: protocol for a mixed-methods process evaluation.

INTRODUCTION: Technology-mediated strategies have potential to engage patients in modifying unhealthy behaviour and improving medication adherence to reduce morbidity and mortality from cardiovascular disease (CVD). Furthermore, electronic tools offer a medium by which consumers can more actively navigate personal healthcare information. Understanding how, why and among whom such strategies have an effect can help determine the requirements for implementing them at a scale. This paper aims to detail a process evaluation that will (1) assess implementation fidelity of a multicomponent eHealth intervention; (2) determine its effective features; (3) explore contextual factors influencing and maintaining user engagement; and (4) describe barriers, facilitators, preferences and acceptability of such interventions. METHODS AND ANALYSIS: Mixed-methods sequential design to derive, examine, triangulate and report data from multiple sources. Quantitative data from 3 sources will help to inform both sampling and content framework for the qualitative data collection: (1) surveys of patients and general practitioners (GPs); (2) software analytics; (3) programme delivery records. Qualitative data from interviews with patients and GPs, focus groups with patients and field notes taken by intervention delivery staff will be thematically analysed. Concurrent interview data collection and analysis will enable a thematic framework to evolve inductively and inform theory building, consistent with a realistic evaluation perspective. Eligible patients are those at moderate-to-high CVD risk who were randomised to the intervention arm of a randomised controlled trial of an eHealth intervention and are contactable at completion of the follow-up period; eligible GPs are the primary healthcare providers of these patients. ETHICS AND DISSEMINATION: Ethics approval has been received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council (AH&MRC) of New South Wales. Results will be disseminated via scientific forums including peer-reviewed publications and national and international conferences. TRIAL REGISTRATION NUMBER: ANZCTR 12613000715774.

Self-management in patients with diabetes and chronic kidney disease is associated with incremental benefit in HRQOL.

AIMS: There is insufficient and inconsistent data regarding the association between diabetes self-management, the process of facilitating the knowledge, skill, and ability necessary for diabetes self-care, and health-related quality of life (HRQOL) in people with diabetes and moderate to severe chronic kidney disease (CKD). METHODS: In a cross sectional study, participation in diabetes self-management assessed by the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire and HRQOL was examined in 308 patients with diabetes and CKD (stages 3 to 5) recruited from outpatient diabetes and renal clinics of 4 public tertiary hospitals. Associations were examined by Pearson correlation coefficients and hierarchical multiple regression after controlling for potential confounders. An examination of trend across the levels of patient participation in self-management was assessed using a non-parametric test for trend. RESULTS: The median age and interquartile range (IQR) of patients were 68 and 14.8years, respectively with 59% of the population being over 65years old and 69.5% male. The median durations of diabetes and CKD were 18years (IQR-17) and 5years (IQR-8) respectively. General diet, exercise and medication taking were positively associated with at least one HRQOL subscale (all p<0.05) but diabetes specific diet, blood sugar testing and foot checking were not. As levels of participation in self-management activities increased there was a graded increase in mean HRQOL scores across all subscales (p for trend <0.05). CONCLUSIONS: In people with diabetes and moderate to severe CKD, participation in diabetes self-management activities, particularly those focused on general diet, exercise and medication taking, was associated with higher HRQOL.

Identifying health service barriers in the management of co-morbid diabetes and chronic kidney disease in primary care: a mixed-methods exploration.

BACKGROUND: Co-morbid diabetes and chronic kidney disease (CKD) are common in primary care but health care can be suboptimal. OBJECTIVE: In this multi-centre mixed-methods study, we investigated GPs' perspectives on health service barriers in managing diabetes and CKD as an initial step towards health care improvement. METHODS: Four focus groups were conducted among GPs in Australia's two largest cities. Transcripts underwent content analysis to inform development of a survey exploring health service barriers. This survey was then emailed/mailed to 840 GPs. Statistical analyses were performed using STATA v2.1. RESULTS: Responses were received from 13.7% of GPs (n = 115), mean (±SD) age 55.3 (10.1) years and mean duration of practice 26.6 (10.6). The majority (88.4%) reported wanting to manage diabetes and CKD in primary care with specialist assistance. However, 34.8% were unclear about the definition of CKD with 73.2% wanting more education. Access to specialist services was problematic with 39.3% and 28.2% reporting the process of referring patients to diabetes or CKD services, respectively, as hard. Coordination of care was also a problem with 35.6% unclear about each health care provider's role, 50.5% believing patients faced difficulties due to poor coordination across providers and 51.6% reporting duplication of tests. CONCLUSIONS: GPs expressed a clear interest in being the principal health care providers for patients with co-morbid diabetes and CKD. Supporting GPs and health care improvement focusing on overcoming reported barriers such as inadequate knowledge about CKD, access to specialist services and coordination of care may improve outcomes for people with co-morbid diabetes and CKD.

Primary and tertiary health professionals' views on the health-care of patients with co-morbid diabetes and chronic kidney disease - a qualitative study.

BACKGROUND: Health-care for co-morbid diabetes and chronic kidney disease (CKD) is often sub-optimal. To improve health-care, we explored the perspectives of general practitioners (GPs) and tertiary health-care professionals concerning key factors influencing health-care of diabetes and CKD. METHODS: A total of 65 health professionals were purposively sampled from Australia's 2 largest cities to participate in focus groups and semi-structured interviews. Four focus groups were conducted with GPs who referred to 4 tertiary health services in Australia's 2 largest cities, with 6 focus groups conducted with tertiary health-care professionals from the 4 tertiary health services. An additional 8 semi-structured interviews were performed with specialist physicians who were heads of diabetes and renal units. All discussions were facilitated by the same researcher, with discussions digitally recorded and transcribed verbatim. All qualitative data was thematically analysed independently by 2 researchers. RESULTS: Both GPs and tertiary health-care professionals emphasised the importance of primary care and that optimal health-care was an inter-play between patient self-management and primary health-care, with specialist tertiary health-care support. Patient self-management, access to specialty care, coordination of care and a preventive approach were identified as key factors that influence healthcare and require improvement. Both groups suggested that an integrated specialist diabetes-kidney service could improve care. Unit heads emphasised the importance of quality improvement activities. CONCLUSIONS: GPs and tertiary health-care professionals emphasised the importance of patient self-management and primary care involvement in the health-care of diabetes and CKD. Supporting GPs with an accessible, multidisciplinary diabetes-renal health service underpinned by strong communication pathways, a preventive approach and quality improvement activities, may improve health-care and patient outcomes in co-morbid diabetes and CKD.

Effect of antidepressant treatment on cognitive impairments associated with depression: a randomised longitudinal study.

BACKGROUND: Antidepressant treatment failure is a common problem worldwide. In this study, we assess whether or not an important aspect of depression, cognitive impairment, is untreated by antidepressants by studying the effect of acute antidepressant treatment on a range of cognitive domains. METHODS: In this randomised longitudinal study, which is part of the International Study to Predict Optimized Treatment in Depression (iSPOT-D) trial, we assessed the effects of acute antidepressant treatment in a large patient population, across clinical remission outcomes, on a range of cognitive domains: attention, response inhibition, executive function during visuospatial navigation, cognitive flexibility, verbal memory, working memory, decision speed, information processing speed, and psychomotor response speed. We enrolled patients from primary or specialty care clinics in a multicentre, international, open-label, randomised, prospective trial. Eligible patients (aged 18-65 years) were previously untreated or were willing to undergo a 1-week medication washout before the study start, and could not have had inadequate response to study medications in the past. We enrolled a large population of medication-free (ie, untreated) outpatients in a depressive episode and assessed them for cognitive function at enrolment (pre-treatment), and again after 8 weeks of treatment with one of three antidepressant drugs (escitalopram, sertraline, or venlafaxine extended-release). Patients were randomly assigned (1:1:1) to one of the three antidepressants using a blocked randomisation procedure (block size of 12). As a comparison group, we also simultaneously enrolled matched healthy participants. Healthy participants received no medication or intervention, but were assessed for change in cognitive and clinical measures during the same interval and testing protocol. Therefore, this group acts as a test-retest control for the primary outcome measure examined in this study, change in cognitive measures over 8 weeks of treatment in depressed patients. This study is registered with ClinicalTrials.gov, number NCT00693849. FINDINGS: Between Dec 8, 2008, and Sept 30, 2011, we enrolled 1008 eligible people into the study. Impairment in five domains-attention, response inhibition, verbal memory, decision speed, and information processing-showed no relative improvement with acute treatment (controlling for time or repeated testing), irrespective of antidepressant treatment group, even in patients whose depression remitted acutely according to clinical measures. Broader cognitive impairment was associated with greater illness chronicity (earlier illness onset) but not with symptom severity or previous antidepressant failures. INTERPRETATION: Depression is associated with impairments in higher-order cognitive functions and information processing, which persist independently of clinical symptom change with treatment. We recorded no difference between the three antidepressants tested, with none showing efficacy for these impairments. Although the 8-week treatment period limits interpretation to acute treatment effects, it does highlight cognitive impairment as an untargeted contributor to incomplete treatment success. FUNDING: Brain Resource Company Operations Pty Ltd and NIH.

A cognitive-emotional biomarker for predicting remission with antidepressant medications: a report from the iSPOT-D trial.

Depression involves impairments in a range of cognitive and emotional capacities. It is unknown whether these functions can inform medication choice when considered as a composite predictive biomarker. We tested whether behavioral tests, grounded in the neurobiology of cognitive and emotional functions, predict outcome with common antidepressants. Medication-free outpatients with nonpsychotic major depressive disorder (N=1008; 665 completers) were assessed before treatment using 13 computerized tests of psychomotor, executive, memory-attention, processing speed, inhibitory, and emotional functions. Matched healthy controls (N=336) provided a normative reference sample for test performance. Depressed participants were then randomized to escitalopram, sertraline, or venlafaxine-extended release, and were assessed using the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16) and the 17-item Hamilton Rating Scale for Depression. Given the heterogeneity of depression, analyses were furthermore stratified by pretreatment performance. We then used pattern classification with cross-validation to determine individual patient-level composite predictive biomarkers of antidepressant outcome based on test performance. A subgroup of depressed participants (approximately one-quarter of patients) were found to be impaired across most cognitive tests relative to the healthy norm, from which they could be discriminated with 91% accuracy. These patients with generally impaired cognitive task performance had poorer treatment outcomes. For this impaired subgroup, task performance furthermore predicted remission on the QIDS-SR16 at 72% accuracy specifically following treatment with escitalopram but not the other medications. Therefore, tests of cognitive and emotional functions can form a clinically meaningful composite biomarker that may help drive general treatment outcome prediction for optimal treatment selection in depression, particularly for escitalopram.

Improving paediatric asthma outcomes in primary health care: a randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of the Practitioner Asthma Communication and Education (PACE) Australia program, an innovative communication and paediatric asthma management program for general practitioners. DESIGN: Randomised controlled trial. SETTING: General practices from two regions in metropolitan Sydney. PARTICIPANTS: 150 GPs, who were recruited between 2006 and 2008, and 221 children with asthma in their care. INTERVENTION: GPs in the intervention group participated in two 3-hour workshops, focusing on communication and education strategies to facilitate quality asthma care. MAIN OUTCOME MEASURES: Patient outcomes included receipt of a written asthma action plan (WAAP), appropriate medication use, parent days away from work, and child days away from school or child care. GP outcomes included frequency of providing a WAAP and patient education, communication and teaching behaviour, and adherence to national asthma guidelines regarding medication use. RESULTS: More patients of GPs in the intervention group reported receipt of a WAAP (difference, 15%; 95% CI, 2% to 28%; adjusted P=0.046). In the intervention group, children with infrequent intermittent asthma symptoms had lower use of inhaled corticosteroids (difference, 24%; 95% CI, -43% to -5%; P=0.03) and long-acting bronchodilators (difference, 19%; 95% CI, -34% to -5%; P=0.02). GPs in the intervention group were more confident when communicating with patients (difference 22%; 95% CI, 3% to 40%; P=0.03). A higher proportion of GPs in the intervention group reported providing a WAAP more than 70% of the time (difference, 23%; 95% CI, 11% to 36%; adjusted P=0.002) and prescribing spacer devices more than 90% of the time (difference, 29%; 95% CI, 16% to 42%; adjusted P=0.02). CONCLUSIONS: The PACE Australia program improved GPs' asthma management practices and led to improvements in some important patient outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12607000067471.

Potential implications of genomic medicine in general practice.

Genomic research can link specific molecular genetic information with specific diseases. Implications of genomic medicine in general practice include developments in screening and diagnosis, predicting disease prognosis, and optimising preventive and therapeutic care. As users or co-producers of genomic information, or as collaborators in genomic research, general practitioners can help realise the potential of advances in genomic research.

General practice consultations - how well do doctors predict patient satisfaction?

BACKGROUND: While patient satisfaction with the general practice consultation has been extensively researched, there have been relatively few studies of doctors' perception of patient satisfaction. This study sought to measure how accurately doctors are able to predict patient satisfaction with consultations in general practice. METHODS: Adult patients consulting about new episodes of illness in general practice completed a consultation satisfaction questionnaire. The scores from the questionnaire were compared with doctors' predictions of patient satisfaction. RESULTS: Nine general practitioners completed the study and returned a total of 167 pairs of questionnaires. On average, the patients gave their doctors higher scores on the general satisfaction and professional care scales than on the depth of relationship and perceived time scales of the questionnaire. On every scale, patients reported higher levels of satisfaction than their doctors predicted they would. There was poor correlation between patient and doctor scores for the perceived time scale, but moderate correlation for the other three scales. DISCUSSION: Our findings suggest that a doctor's sense that a patient was not satisfied following a consultation may be valid, but that doctors may underestimate their patients' satisfaction.

Asthma and older people in general practice.

WHAT WE NEED TO KNOW: Why is there undiagnosed and untreated asthma in older people in the community and in general practice? What patient, general practitioner and organisational factors contribute to this? Are current best practice guidelines appropriate for older people with asthma? WHAT WE NEED TO DO: Undertake broad community and general practice screening to identify characteristics of older people with undiagnosed asthma. Analyse GPs' perspectives and decision-making processes for older people with dyspnoea. Undertake targeted research in general practice, trialling decision-making frameworks for older patients with dyspnoea. Undertake appropriate and relevant community and GP awareness campaigns about the prevalence of asthma in older people. Analyse current best practice management of asthma, including self-management and the Asthma 3+ Visit Plan, in older people.