ANZCTR search results

A fifth of Australian hospital patients self-report an allergy to antibiotics (“antibiotic allergy label”, AAL) which interferes with their optimal clinical care. There is strong evidence that unverified antibiotic allergy labelling is a substantial and growing public health problem resulting in: • Significant adverse patient outcomes • Increased health economic burden • Suboptimal choice of antibiotic, leading to the overuse of broad spectrum antibiotics and the emergence of microbial antibiotic resistance. International studies suggest that the majority (>90%) of subjects with AAL can safely use antibiotics without restrictions following a clinical assessment (“de-labelling”). Thus, unverified AAL is mostly inaccurate and its associated negative consequences are potentially avoidable. There is currently no effective clinical strategy developed that addresses the high national incidence of AAL in Australia. This study aims to develop a new model of care for paediatric patients with current AAL and to improve management of antibiotic therapy in our hospitals and community. A large randomised prospective study design allows for the analysis of key clinical outcomes for all study participants, with regards to details about GP and hospital visits, infection history, subsequent antibiotics usage and mortality, and compares patients which have been actively de-labelled against those receiving current standard care. This project will also calculate the true health economic cost impact of de-labelling patients at a population level, compared to standard clinical care. We hypothesise that a systematic approach to antibiotic allergy de-labelling patients with AAL will lead to a national improvement in clinical care characterised by both better long-term health outcomes and cost savings to the health budget.

LAY SUMMARY Mini-percutanoeus nephrolithotomy (mini-PCNL) and flexible ureteropyeloscopy are commonly used techniques for treating ureteral and renal stones. Both treatment options are invasive and are associated with complications. There are only a few studies that compare these two treatment modalities. Both modalities are associated with reasonable postoperative stone free rates with minimal complications. Immediate stone free rate is higher with mini-PCNL but comparable in both modalities at 1 month. Pyeloscopy is associated with favourable pain scores and lower haemoglobin drop. We aim to compare both techniques to definitively investigate whether one modality is superior than the other. HYPOTHESIS Few prospective randomised controlled trials have compared mini-PCNL and flexible ureteropyeloscopy for treating renal and proximal ureteral stones.Furthermore, no specific guideline is available regarding the optimal surgical management of renal stones and proximal ureteral stones. We hypothesise that one modality is associated with a greater stone free rate and lower complication rate compared to the other modality for managing nephrolithiasis STUDY AIMS: To compare stone free rate and surgical parameters between flexible ureteropyeloscopy mini-PCNL and RIRS in the management of renal stones and proximal ureteral stones >5 mm in a single session. OUTCOME MEASURES The primary end-point in this study is stone free rate (SFR) in a single session. Before a 3-month follow-up visit, all patients will undergo a low-dose non-contrast CT scan to assess for the presence of residual stone. Stone free status is defined as no residual stones or stones within 3 months postoperatively. The secondary outcomes are intraoperative and postoperative parameters such as operation time, hemoglobin drop, analgesic requirement, hospital stay, and complications. Complications will be evaluated according to the Clavien classification of surgical complications. We have published a systematic review and meta-analysis as part of the background information and research to this randomized controlled trial and have attached it to our application: World J Urol. 2018 Feb 16. doi: 10.1007/s00345-018-2230-x. MINIATURISED PERCUTANEOUS NEPHROLITHOTOMY VERSUS FLEXIBLE URETEROPYELOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS COMPARING CLINICAL EFFICACY AND SAFETY PROFILE. Davis NF1, Quinlan MR2, Poyet C2, Lawrentschuk N2, Bolton DM2, Webb D2, Jack GS2. Our systematic review and meta-analysis provides a detailed and accurate comparative analysis on mini-PCNL and FURS. We found that modifications and advancements in equipment design will continue to improve the performance of both techniques. The continuing evolution of both urological technologies, should facilitate high levels clinical efficacy while maintaining high safety profiles.

To describe clinical outcomes, demographics and assess satisfaction in patients that have been converted from warfarin to a NOAC (rivaroxaban or apixaban). Patient satisfaction will be assessed through the use of a survey utilising the Anti-Clot Treatment Scale questionnaire in addition to several questions focussing on the comparison between previous warfarin therapy and current NOAC therapy. These questions will relate to: medical contact, dietary restriction, drug interactions, travel, side effects, cost and overall satisfaction. Clinical outcomes will be described through retrospective review of patient medical notes.

This study seeks to examine the efficacy of integrated psychological therapy for co-occurring traumatic stress and substance use among adolescents and young adults aged 12-25 years. Through this trial we hope to improve our understanding of how best to treat young people experiencing traumatic stress, who are also using alcohol or other drugs. Eligible participants will be randomly allocated to receive one of two treatments: i) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A); or ii) Person-Centred Therapy (PCT). Both treatments consist of up to 16, one-on-one, sessions with a psychologist, as well as up to four optional caregiver sessions. Participating adolescents (and caregivers) will also be asked to complete three research interviews at baseline (i.e., study entry), 4- and 12-months post baseline. The primary outcome is change in adolescent PTSD symptom severity. A range of secondary outcomes will also be examined including changes adolescent substance use, and behavioural, physical, emotional, social and educational functioning.

More than 15 million babies are born preterm each year. Life-long pulmonary consequences, including recurrent respiratory symptoms, airway obstruction, airway hyper-reactivity and declining lung function are especially evident in those born very preterm (<32 weeks gestation). However, there are no evidence-based interventions available or recommended to halt or reverse chronic lung disease in survivors of preterm birth after they leave the neonatal intensive care unit. This project aims to assess the effect of a 12-week treatment with inhaled corticosteroids (fluticasone propionate) on the lung function of children born very prematurely and identify the clinical features of those with a positive response to inhaled corticosteroid therapy.

The aim of this partnership project is to support our residential aged care partners by implementing and evaluating (both efficacy and cost of) a staff training program that will facilitate the transition to a Consumer Directed (CDC) model of care in their facilities. The Resident at the Centre of Care (RCC) program will develop of the capacity of senior staff to manage organisational change through transformational leadership, to drastically alter the way in which RACFs provide care for residents and embed CDC into routine practice. We will also conduct a detailed analysis of costings of the resources required. This project will support our partners in this practice transformation and critically, will provide the guiding evidence base to inform government on future CDC implementation strategies, as well as the economic implications of enabling organisations to become “CDC ready”. It is expected that the RCC program will; improve the level of consumer choice, and so their QoL, lead to organisational change, and improve staff perceptions of their work environment. It is hypothesised that the RCC program will be superior in both clinical and cost effectiveness outcomes compared to a ‘care as usual’ condition in improving: Quality of life of residents (primary outcome); the degree to which CDC is implemented; workplace factors: transformational leadership, organisational climate and the relationship between staff and residents (working alliance); staff factors: stress, job satisfaction, and turnover. To support the translation of the training program into everyday service provision, our study will determine whether additional organisational support (that assists facilities to overcome barriers to implement a CDC approach) is required to sustain the above outcomes over 12 months. Supplementing the RCC program with organisational support is hypothesised to lead to greater benefits than the same program without this support.

In patients with ST-elevated myocardial infarction, percutaneous coronary intervention restores epicardial coronary blood flow. Yet half of these patients continue to have impaired perfusion on the myocardial level and this portends a poor prognosis. Poor microcirculatory reperfusion has also been shown to be a predictor of death or rehospitalisation for heart failure after three years in post-PCI STEMI patients . The development of the index of microcirculatory resistance (IMR) by the study team has allowed easy assessment of the coronary microcirculation. Small, randomised trials have shown that intracoronary administration of the thrombolytic agent streptokinase improved the status of the coronary microcirculation and in turn reduced infarct size, preserved left ventricular dimensions and left ventricular function at six months follow-up. Despite these promising results, there has been no adequately powered clinical trial to confirm the long-term benefits of improving microvascular perfusion. PILOT STUDY COHORT: The study hypothesis is that in 50 adults with STEMI who have undergone primary PCI and have an IMR score greater than 32, low dose tenecteplase, compared with placebo treatment, improves long term clinical outcomes, benefits other clinical cardiovascular measures, and does not increase rates of MACE.

The new Perth Children’s Hospital (PCH) is designed to maximise patient and family centred care and improve workflow. The intention is to improve direct patient care, placing children and their families at the centre of care by focusing on systems that will enhance nurse workflow and allow nurses to spend more time at the bedside. Key workflow changes include the physical layout – a larger footprint and single rooms, improved facilities for parents, automatic medication dispensing and hands free communication technology. It is anticipated that the layout, technology and communication platforms will contribute to improved workflow and increase nurse time in direct patient care. Nurse time spent with patients is associated with patient and family satisfaction, less error, improved outcomes for patients, and with nurse satisfaction. It is anticipated the inclusion of new technologies will facilitate workflow and nurse time at the bedside. The single-patient room model also has many reported benefits such as improved privacy and infection control practices. However, nurses have voiced concern about the impact of single rooms on communication, patient safety, and nurse ability to access help. Anecdotally, local consumers have also voiced their concern related to patient and family isolation and decreased nurse accessibility. There has been limited research evidence of the impact that hospital moves have on workflow and communication. This study will measure nurse workflow, patient, family and nurse experience, and patient outcomes before and after the move to PCH. This will provide a comprehensive evaluation of the impact of the new hospital environment for patients, families and nurses. The three stage mixed methods design includes three time periods of data collection with an interrupted times series analysis as well as a before and after comparison. For the interrupted time series there are two sources of data collection; 1) the experiences of 15 children, 15 families and 15 nurses per week for 10 weeks will be captured using surveys at PMH, 3 months after and 12 months after the move to PCH, 2) routinely collected monthly hospital patient outcome data for 12 months at PMH before the move to PCH and 12 months post move. For the before and after comparison, two sources of data will collected at PMH and 12 months after the move to PCH. These data are; 1) time and motion observation of nurse workflow for a total of 60 hours for 15 nurses working in 3 inpatient areas, and 2) the Practice Environment Scale Nurse Workforce Index survey to be completed by all nurses (n=800) at PMH and 12 months after the move to PCH. In addition 3-4 nurse focus groups will be held at 3 and 12 months after the move to PCH to understand nurses’ experience of the PCH work environment and identify areas and opportunities for workflow improvement.

This study aims to test the feasibility and acceptability of a telehealth supported physical intervention and its effect on functional capacity of palliative care recipients in the community. Who is it for? You may be eligible to join this study if you are aged 18 years or older, living at home and are receiving community palliative care. You should be able to complete a sit-to-stand transfer without any physical assistance. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in both groups will be provided with a chair with arms, and be taught by a physiotherapist or occupational therapist the most effective and safest way to move from sitting to standing rom this chair. Participants will be provided with an iPad to use for the duration of the study. It will have a video on it that shows how to safely complete ‘sit-to-stand’ using the chair provided. Participants in one group will be asked to complete 5 x Sit-To-Stand transfers five times a day or as able throughout the 5 week intervention period. Participants in the other group will not be asked to do this. All participants will be asked to complete two self-report questionnaires via an iPad once a week for 6 weeks to assess their functional capacity and quality of life. They will also be asked to wear an activity monitor for three 7 day monitoring periods. Participants may also be invited to participate in an interview about their participation in this study and their perceptions of its relationship to their activity levels and well-being. The findings from this project may have implications for the care of people receiving community palliative care and for further larger scale studies in this area.

Our primary objective is to develop an app capable of remotely performing a six-minute walk test (6MWT), reporting step-count data, reporting GPS data, extracting historical, pre-morbid step-data and providing responses to health-related quality of life (HRQoL) assessments, namely the world health organisation’s disability assessment schedule 2.0 (WHO-DAS). Ultimately, we want to perform accurate, objective and repeat sequential assessment of a patient’s physical function and level of activity. In this study, we plan to validate the app (Clinical Health Tracker) in 50 patients who attended hospital for a 6MWT over a subsequent five-day study period. The objectives for this component will be achieved by comparing:- The distances reported by the smartphone app during two 6MWT’s performed at recruitment, in clinic, with the actual distance walked and with three remotely performed 6MWTs during the study period. Daily step-counts reported by the app with daily step-counts reported by a Fitbit one. GPS data from the app with data from a BT-3000X GPS transponder WHO-DAS responses from the smartphone app with WHO-DAS responses to the questionnaire asked at the end of the study period. Step-count prior to the smartphone app being installed to step-counts following installation, to assess if the knowledge of being monitored affects the patient’s level of activity. Smartphone app generated GPS and step-count outcomes over a two month follow-up period We aim to validate the smartphone app in 50 individuals who are attending hospital for an outpatient 6MWT. We wish to enrol 50 individuals, 25 iPhone owners and 25 Android phone owners, who have been referred to the 6MWT clinic All patients who are scheduled to attend a 6MWT within CALHN will be written to, advising them of the study. Following consent, we will complete basic demographic details. participants will install our app on their phone using a local Wi-Fi network. Each individual will be provided with a unique ID in order to activate the app and will be provided with written and verbal instructions to the app’s use. They will be provided with a Fitbit one pedometer and a GPS transponder. They will perform their in-clinic 6MWT with the app recording the distance walked and the Fitbit recording the number of steps taken. They will then perform a second 6MWT, in clinic, using the app. They will leave clinic and undergo a 5-day study period, commencing at midnight the same day. They will be instructed to answer the WHO-DAS questionnaire using the app and to perform 3 remote 6MWT’s during the study period. Patients will be visited at home, or given the option to return to the Royal Adelaide Hospital, 5 days following their clinic appointment. The pedometer will be retrieved and step-counts extracted. They will provide verbal responses to the WHO-DAS and patient satisfaction questionnaires. Two months after their follow-up visit they will be phoned to remove the Clinical Health Tracker App.