Reducing falls in hospital through education to change patient and staff behaviour: A stepped wedge cluster randomised controlled effectiveness trial

Background: Falls remain the most frequent adverse event reported in hospitals, particularly geriatric rehabilitation wards. Randomised trials reducing fall injuries in hospitals have been elusive. Our previous randomised trial (n = 1206) demonstrated that multimedia education with physiotherapist falls educator support reduced falls among patients with higher cognition levels, but this benefit was offset by a potential increase in falls rates among patients with poor cognition. In the previous trial, hospital staff were blinded to the allocation of individual patients, and only delivered usual care.

Barriers to and facilitators of cervical screening practice among African immigrant women from refugee and non-refugee backgrounds living in Brisbane

This thesis investigated and compared barriers and facilitators of cervical screening among African-born refugee and non-refugee women living in Brisbane. Refugee women were more likely to have limited or no knowledge about cervical cancer and the screening test and also less likely to use Pap smear services than non-refugee women. The analysis identified belief systems, lack of knowledge about cervical cancer and screening practices, and lack of culturally appropriate screening programs as major barriers. In the context of health promotion interventions, these findings will contribute to addressing major differential screening needs among African immigrant refugee and non-refugee women.

Finding My Way: Protocol of a randomised controlled trial evaluating an internet self-help program for cancer-related distress

Background A cancer diagnosis elicits greater distress than any other medical diagnosis, and yet very few studies have evaluated the efficacy of structured online self-help therapeutic programs to alleviate this distress. This study aims to assess the efficacy over time of an internet Cognitive Behaviour Therapy (iCBT) intervention (‘Finding My Way’) in improving distress, coping and quality of life for individuals with a recent diagnosis of early stage cancer of any type. Methods/Design The study is a multi-site Randomised Controlled Trial (RCT) seeking to enrol 188 participants who will be randomised to either the Finding My Way Intervention or an attention-control condition. Both conditions are delivered online; with 6 modules released once per week, and an additional booster module released one month after program-completion. Participants complete online questionnaires on 4 occasions: at baseline (immediately prior to accessing the modules); post-treatment (immediately after program-completion); then three and six months later. Primary outcomes are general distress and cancer-specific distress, with secondary outcomes including Health-Related Quality of Life (HRQoL), coping, health service utilisation, intervention adherence, and user satisfaction. A range of baseline measures will be assessed as potential moderators of outcomes. Eligible participants are individuals recently diagnosed with any type of cancer, being treated with curative intent, aged over 18 years with sufficient English language literacy, internet access and an active email account and phone number. Participants are blinded to treatment group allocation. Randomisation is computer generated and stratified by gender. Discussion Compared to the few prior published studies, Finding My Way will be the first adequately powered trial to offer an iCBT intervention to curatively treated patients of heterogeneous cancer types in the immediate post-diagnosis/treatment period. If found efficacious, Finding My Way will assist with overcoming common barriers to face-to-face therapy in a cost-effective and accessible way, thus helping to reduce distress after cancer diagnosis and consequently decrease the cancer burden for individuals and the health system. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000001​796 16.10.13

Moving from evaluation to trial: How do SMEs start adopting Cloud ERP?

The advent of cloud technology involving low subscription overheads cost has provided small and medium-sized enterprises (SMEs) with the opportunity to adopt new cloud-based corporate-wide systems (i.e., cloud ERP). This technology, operating through subscription-based services, has now provided SMEs with a complete range of IT applications that were once restricted to larger organisations. As anecdotal evidences suggest, SMEs are increasingly adopting cloud-based ERP software. The selection of an ERP is a complex process involving multiple stages and stakeholders, suggesting the importance of closer examination of cloud ERP adoption in SMEs. Yet, prior studies have predominantly treated technology adoption as a single activity and largely ignored the issue of ERP adoption in SMEs. Understanding of the process nature of the adoption and the factors that are important in each stage of the adoption potentially may result in guiding SMEs to make well-informed decisions throughout the ERP selection process. Thus, our study proposes that the adoption of cloud ERP should be examined as a multi-stage process. Using the Theory of Planned Behaviour (TPB) and Ettlie’s adoption stages, as well as employing data gathered from 162 owners of SMEs, our findings show that the factors that influence the intention to adopt cloud ERP vary significantly across adoptive stages.

Public Demand for Safer Speeds: Identification of Interventions for Trial

Speeding is a major contributor to road injuries and fatalities and remains prevalent. Changing community perceptions about speeding is an important priority. Austroads commissioned research to identify a range of potential interventions for future trial and evaluation aimed at creating, increasing, and/or sustaining public demand for safer speeds. This project had three phases: a literature review; consultations with key stakeholders regarding intervention options (including feasibility, and likely benefits and costs of identified interventions); and providing research results, including recommendations for future phases of the program of work. The literature review led to the development of a draft Campaign Strategy targeting nine aims across three themes underpinning this research: 1) creating, 2) increasing, and 3) sustaining public demand for safer speeds on the road. Twenty-one stakeholders commented on the suitability and feasibility of, and likely barriers to, countermeasures within the draft Campaign Strategy and its applicability to the Australian and New Zealand context. There was overwhelming positive support for the proposed Campaign Strategy by the majority of respondents; many, noting that it addressed key misperceptions and complemented many existing approaches. A small number of respondents expressed some concerns with various aspects. Stakeholder feedback was incorporated into the final proposed Campaign Strategy to enhance its potential effectiveness. Wide diversity across jurisdictions makes the recommendation of individual interventions for specific areas problematic. Individual jurisdictions should consider a range of costs and benefits of the proposed Campaign Strategy to determine the likely feasibility from their unique perspective. Issues to be addressed when considering implementation of the proposed Campaign Strategy include speed limit setting policies, resourcing, messaging and advertising strategies, and political will associated with promoting safer speeds.

A randomized controlled trial protocol testing a decision support intervention for older patients with advanced kidney disease

Aim To assess the effectiveness of a decision support intervention using a pragmatic single blind Randomized Controlled Trial. Background Worldwide the proportion of older people (aged 65 years and over) is rising. This population is known to have a higher prevalence of chronic diseases including chronic kidney disease. The resultant effect of the changing health landscape is seen in the increase in older patients (aged ≥65 years) commencing on dialysis. Emerging evidence suggests that for some older patients dialysis may provide minimal benefit. In a majority of renal units non-dialysis management is offered as an alternative to undertaking dialysis. Research regarding decision-making support that is required to assist this population in choosing between dialysis or non-dialysis management is limited. Design. A multisite single blinded pragmatic randomized controlled trial is proposed. Methods Patients will be recruited from four Queensland public hospitals and randomizd into either the control or intervention group. The decision support intervention is multimodal and includes counselling provided by a trained nurse. The comparator is standard decision-making support. The primary outcomes are decisional regret and decisional conflict. Secondary outcomes are improved knowledge and quality of life. Ethics approval obtained November 2014. Conclusion This is one of the first randomized controlled trials assessing a decision support intervention in older people with advance chronic kidney disease. The results may provide guidance for clinicians in future approaches to assist this population in decision-making to ensure reduced decisional regret and decisional conflict.

Validating adult and paediatric nutrition screening and assessment tools in Vietnamese language in two acute hospital in Ho Chi Minh City, Vietnam

Despite being commonly prevalent in acute care hospitals worldwide, malnutrition often goes unidentified and untreated due to a lack in the implementation of a nutrition care pathway. The aim of this study was to validate nutrition screening and assessment tools in Vietnamese language. After converting into Vietnamese, Malnutrition Screening Tool (MST) and Subjective Global Assessment (SGA) were used to identify malnutrition in the adult setting; and the Paediatric Nutrition Screening Tool (PNST) and paediatric Subjective Global Nutritional Assessment (SGNA) were used in the paediatric setting in two acute care hospitals in Vietnam. This cross-sectional observational study sampled 123 adults (median age 78 years [39–96 years], 63% males) and 105 children (median age 20 months [2–100 months], 66% males). In adults, nutrition risk and malnutrition were identified in 29% and 45% of the cohort respectively. Nutrition risk and malnutrition were identified in 71% and 43% of the paediatric cohort respectively. The sensitivity and specificity of the screening tools were: 62% and 99% for the MST compared to the SGA; 89% and 42% for the PNST compared to the SGNA. This study provides a stepping stone to the potential use of evidence-based nutrition screening and assessment tools in Vietnamese language within the adult and paediatric Vietnamese acute care setting. Further work is required into integrating a complete nutrition care pathway within the acute care setting in Vietnamese hospitals.

A randomised controlled clinical trial of a post-discharge, nurse-led educational intervention to reduce anxiety and enhance self-efficacy in percutaneous coronary intervention (PCI) patients within the first week post-discharge: A pilot study

This research investigated the efficacy of a post-discharge nurse-led clinic, for patients who underwent a cardiovascular interventional procedure in Australia. A randomised controlled clinical trial measured the effects of the clinic on patient confidence to self-manage and minimise psychological distress given the strong link between anxiety, depression and coronary heart disease. Hospitalisation for the procedure is short and stressful, and patients may wait up to 7-64 days for post-discharge review. This study provides preliminary quantitative and qualitative evidence that nurse-led clinics undertaken within the first week post-percutaneous coronary intervention may fill a much-needed gap for patients during a potentially vulnerable period.

Randomised controlled trial of three burns dressings for partial thickness burns in children

BACKGROUND This study compared the effects of three silver dressing combinations on small to medium size acute partial thickness burns in children, focusing on re-epithelialization time, pain and distress during dressing changes. METHOD Children (0-15 years) with clean, ≤ 10% total body surface area (TBSA) partial thickness burns who met the inclusion criteria were included in the study. Children received either (1) Acticoat™; (2) Acticoat™ with Mepitel™; or (3) Mepilex Ag™ dressings. Measures of burn re-epithelialization, pain, and distress were recorded at dressing changes every 3-5 days until full re-epithelialization occurred. RESULTS One hundred and three children were recruited with 96 children included for analysis. No infections were detected for the course of the study. When adjusted for burn depth, Acticoat™ significantly increased the expected days to full re-epithelialization by 40% (IRR = 1.40; 95% CI: 1.14-1.73, p < 0.01) and Acticoat™ with Mepitel™ significantly increased the expected days to full re-epithelialization by 33% (IRR = 1.33; 95% CI: 1.08-1.63, p ≤ 0.01) when compared to Mepilex Ag™. Expected FLACC scores in the Mepilex Ag™ group were 32% lower at dressing removal (p = 0.01) and 37% lower at new dressing application (p = 0.04); and scores in the Acticoat™ with Mepitel™ group were 23% lower at dressing removal (p = 0.04) and 40% lower at new dressing application (p < 0.01), in comparison to the Acticoat™ group. Expected Visual Analog Scale-Pain (VAS-P) scores were 25% lower in the Mepilex Ag™ group at dressing removal (p = 0.04) and 34% lower in the Acticoat™ with Mepitel™ group (p = 0.02) at new dressing application in comparison to the Acticoat™ group. There was no significant difference between the Mepilex Ag™ and the Acticoat™ with Mepitel™ groups at all timepoints and with any pain measure. CONCLUSION Mepilex Ag™ is an effective silver dressing, in terms of accelerated wound re-epithelialization time (compared to Acticoat™ and Acticoat™ with Mepitel™) and decreased pain during dressing changes (compared to Acticoat™), for clean, < 10% TBSA partial thickness burns in children.

Cluster randomised-control trial for an Australian child protection education program: Study protocol for the Learn to be safe with Emmy and friends™

Background Child maltreatment has severe short-and long-term consequences for children’s health, development, and wellbeing. Despite the provision of child protection education programs in many countries, few have been rigorously evaluated to determine their effectiveness. We describe the design of a multi-site gold standard evaluation of an Australian school-based child protection education program. The intervention has been developed by a not-for-profit agency and comprises 5 1-h sessions delivered to first grade students (aged 5–6 years) in their regular classrooms. It incorporates common attributes of effective programs identified in the literature, and aligns with the Australian education curriculum. Methods/Design A three-site cluster randomised controlled trial (RCT) of Learn to be safe with Emmy and friends™ will be conducted with children in approximately 72 first grade classrooms in 24 Queensland primary (elementary) schools from three state regions, over a period of 2 years. Entire schools will be randomised, using a computer generated list of random numbers, to intervention and wait-list control conditions, to prevent contamination effects across students and classes. Data will be collected at baseline (pre-assessment), immediately after the intervention (post-assessment), and at 6-, 12-, and 18-months (follow-up assessments). Outcome assessors will be blinded to group membership. Primary outcomes assessed are children’s knowledge of program concepts; intentions to use program knowledge, skills, and help-seeking strategies; actual use of program material in a simulated situation; and anxiety arising from program participation. Secondary outcomes include a parent discussion monitor, parent observations of their children’s use of program materials, satisfaction with the program, and parental stress. A process evaluation will be conducted concurrently to assess program performance. Discussion This RCT addresses shortcomings in previous studies and methodologically extends research in this area by randomising at school-level to prevent cross-learning between conditions; providing longer-term outcome assessment than any previous study; examining the degree to which parents/guardians discuss intervention content with children at home; assessing potential moderating/mediating effects of family and child demographic variables; testing an in-vivo measure to assess children’s ability to discriminate safe/unsafe situations and disclose to trusted adults; and testing enhancements to existing measures to establish greater internal consistency.

Facile synthesis, ex-vivo and in vitro screening of 3-sulfonamide derivative of 5-(4-chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-1H-pyrazole-3-carboxylic acid piperidin-1-ylamide (SR141716) a potent CB1 receptor antagonist

Facile synthesis of biaryl pyrazole sulfonamide derivative of 5-(4-chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-1H-pyrazole-3-carboxylic acid piperidin-1-ylamide (SR141716, 1) and an investigation of the effect of replacement of the –CO group in the compound 1 by the –SO2 group in the aminopiperidine region is reported. Primary ex-vivo pharmacological testing and in vitro screening of sulfonamide derivative 2 showed the loss of CB1 receptor antagonism.

Trial by jury election less of a trial

In Kencian v Watney [2015] QCA 212 the Queensland Court of Appeal allowed an appeal against the decision in Watney v Kencian & Wooley [2014] QSC 290 and ordered, pursuant to r475(1) of the Uniform Civil Procedure Rules 1999 (Qld) that the trial proceed as a trial by jury.

The role of 25-hydroxyvitamin D deficiency in promoting insulin resistance and inflammation in patients with chronic kidney disease: A randomised controlled trial

BACKGROUND Approximately 50% of patients with stage 3 Chronic Kidney Disease are 25-hydroxyvitamin D insufficient, and this prevalence increases with falling glomerular filtration rate. Vitamin D is now recognised as having pleiotropic roles beyond bone and mineral homeostasis, with the vitamin D receptor and metabolising machinery identified in multiple tissues. Worryingly, recent observational data has highlighted an association between hypovitaminosis D and increased cardiovascular mortality, possibly mediated via vitamin D effects on insulin resistance and inflammation. The main hypothesis of this study is that oral Vitamin D supplementation will ameliorate insulin resistance in patients with Chronic Kidney Disease stage 3 when compared to placebo. Secondary hypotheses will test whether this is associated with decreased inflammation and bone/adipocyte-endocrine dysregulation. METHODS/DESIGN This study is a single-centre, double-blinded, randomised, placebo-controlled trial. Inclusion criteria include; estimated glomerular filtration rate 30-59 ml/min/1.73 m(2); aged >or=18 on entry to study; and serum 25-hydroxyvitamin D levels <75 nmol/L. Patients will be randomised 1:1 to receive either oral cholecalciferol 2000IU/day or placebo for 6 months. The primary outcome will be an improvement in insulin sensitivity, measured by hyperinsulinaemic euglycaemic clamp. Secondary outcome measures will include serum parathyroid hormone, cytokines (Interleukin-1beta, Interleukin-6, Tumour Necrosis Factor alpha), adiponectin (total and High Molecular Weight), osteocalcin (carboxylated and under-carboxylated), peripheral blood mononuclear cell Nuclear Factor Kappa-B p65 binding activity, brachial artery reactivity, aortic pulse wave velocity and waveform analysis, and indirect calorimetry. All outcome measures will be performed at baseline and end of study. DISCUSSION To date, no randomised controlled trial has been performed in pre-dialysis CKD patients to study the correlation between vitamin D status with supplementation, insulin resistance and markers of adverse cardiovascular risk. We remain hopeful that cholecalciferol may be a safe intervention, with health benefits beyond those related to bone-mineral homeostasis. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry ACTRN12609000246280.

Researching effective approaches to cleaning in hospitals: Protocol of the REACH study, a multi-site stepped-wedge randomised trial

Background The Researching Effective Approaches to Cleaning in Hospitals (REACH) study will generate evidence about the effectiveness and cost-effectiveness of a novel cleaning initiative that aims to improve the environmental cleanliness of hospitals. The initiative is an environmental cleaning bundle, with five interdependent, evidence-based components (training, technique, product, audit and communication) implemented with environmental services staff to enhance hospital cleaning practices. Methods/design The REACH study will use a stepped-wedge randomised controlled design to test the study intervention, an environmental cleaning bundle, in 11 Australian hospitals. All trial hospitals will receive the intervention and act as their own control, with analysis undertaken of the change within each hospital based on data collected in the control and intervention periods. Each site will be randomised to one of the 11 intervention timings with staggered commencement dates in 2016 and an intervention period between 20 and 50 weeks. All sites complete the trial at the same time in 2017. The inclusion criteria allow for a purposive sample of both public and private hospitals that have higher-risk patient populations for healthcare-associated infections (HAIs). The primary outcome (objective one) is the monthly number of Staphylococcus aureus bacteraemias (SABs), Clostridium difficile infections (CDIs) and vancomycin resistant enterococci (VRE) infections, per 10,000 bed days. Secondary outcomes for objective one include the thoroughness of hospital cleaning assessed using fluorescent marker technology, the bio-burden of frequent touch surfaces post cleaning and changes in staff knowledge and attitudes about environmental cleaning. A cost-effectiveness analysis will determine the second key outcome (objective two): the incremental cost-effectiveness ratio from implementation of the cleaning bundle. The study uses the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework to support the tailored implementation of the environmental cleaning bundle in each hospital. Discussion Evidence from the REACH trial will contribute to future policy and practice guidelines about hospital environmental cleaning. It will be used by healthcare leaders and clinicians to inform decision-making and implementation of best-practice infection prevention strategies to reduce HAIs in hospitals. Trial registration Australia New Zealand Clinical Trial Registry ACTRN12615000325​505

A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial

Background Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking. Methods/Design This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 − 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children. We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers. Discussion The trial will provide evidence for the safety and effectiveness of watchful waiting for the management of AOM in Aboriginal and Torres Strait Islander children living in urban settings who are considered to be at low risk of complications.