ANZCTR search results

Adverse drug events (ADEs) cause around 2–3% of all Australian hospital admissions at a cost of about AUD$1.2 billion annually, and are the focus of this proposal. Older people are at high risk of ADEs, and we have shown that exposure to medicines that might harm them is very common in older people and can have important clinical consequences. The problem is hard to identify. Many older people may benefit from taking fewer medicines, but doctors rarely stop medicines in older people, even those close to death. There is now good evidence that some medicines can be stopped safely in older people, and that reducing unnecessary medicines has survival benefits for older people. The barriers and enablers to stopping medicines are now well described. However an important gap persists in translating what we know about problem medicines use to inform doctors and patients’ shared decision making around this issue. We have designed the present study to systematically address the known barriers to deprescribing. We will evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) framework to address multiple medicines use in older inpatients taking 5 or more medicines. This randomised controlled trial will compare the AusTAPER intervention to usual care. Addressing multiple medicines use in older people may reduce adverse events and save money. There is evidence to suggest that there will be cost benefits by both reduced medicines costs, and reduced adverse events leading to reduced health service utilisation.

Older people are at high risk of adverse drug reactions. We have shown exposure to potentially harmful medicines is very common in older people, can have substantial clinical consequences, but is problematic to identify. Older people with multiple comorbidities have rarely been included in clinical trials and there is genuine clinical equipoise as to the risks and benefits of many medicines in older people. In addition, there is uncertainty about the validity of the default practice of extrapolating from trial data in younger groups when prescribing to older people. Many older people may benefit from taking fewer medicines, but doctors rarely cease medicines in older people, even those close to death. There is now substantial evidence some medicines can be safely and carefully ceased in older people, with reduction in polypharmacy having survival benefits for older people. The barriers and enablers to deprescribing are now well described. However, an important gap persists in translating the evidence about the benefits of more appropriate prescribing and safety of deprescribing into everyday clinical practice. Currently this body of evidence is not being used enough to inform GPs and patients’ shared decision making around this issue. The present pilot study is designed to investigate the feasibility of an approach to systematically address the known barriers to deprescribing and evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) in addressing polypharmacy. The AusTAPER intervention integrates patient priorities and decision support tools to electronically flag potentially inappropriate medicines, and provides a clinical pathway for structured assessment and follow-up by GPs and community pharmacists in a web-based system. The ‘Team’ in this intervention model refers to the patient (‘participant’), study pharmacist and GP.

This is a study evaluating the safety and maximum tolerated dose of HLX20, a Human Monoclonal Antibody, in participants with advanced or metastatic solid tumours. Who is it for? You may be eligible for this study if you are aged at least 18 years old and have a confirmed advanced or metastatic tumour, for which treatment has failed or not tolerated. Study details All participants in the study will receive intravenous treatment with the study drug HLX20. The dose may vary depending on when the participant joins the study. Blood and tissue samples will be collected for safety analysis, efficacy and tolerability of HLX20. Additionally, patients may also undergo imaging/scans and a biopsy if archival tissue sample is unavailable. There is no guarantee that you will receive any benefits from this study, and taking part in this study may or may not cause your health to improve. Information from this study may help doctors learn more about HLX20 on the treatment of your cancer

Background: Infection in orthopaedic surgery can be catastrophic. Increased perspiration from theatre staff has been associated with higher rates of wound contamination. Wearing lead safety gowns, which is often done during surgery to allow the use of image intensifier, may result in heavy perspiration. Aim: We aimed to determine feasibility of wearing a neck cooling device during surgery and whether it reduced surgeons’ perspiration levels and decreased the negative impact on surgeons’ comfort levels during orthopaedic procedures requiring the use of lead gowns. Method: A pilot randomised control trial was conducted. Surgeons were randomised to either wearing the neck cooling device (intervention) or not wearing the device (control). Procedure duration, theatre temperature, humidity and perceived technical difficulty of operation were recorded. After the procedure, surgeons completed a questionnaire documenting how the temperature and humidity had a negative effect on their comfort and perceived level of perspiration. Multilevel mixed effects linear regression with random effects, adjusting for potential confounders was performed.

This is a preliminary study which will provide information on whether it is possible to conduct a larger clinical trial on acupuncture or ear acupuncture for weight loss in Polycystic Ovary Syndrome (PCOS). We are recruiting adult women with PCOS aged up to 45 years old who have a BMI of over 25. All women will receive 3 months of telephone-based health coaching. Women will be randomly allocated to receive either health coaching alone; acupuncture and health coaching; or ear acupuncture and health coaching. The aim of this study is to see if acupuncture may be effective, whether it is possible (feasible) to conduct a larger study, and whether our proposed treatment is acceptable to women in the community with PCOS. We will be collecting data on weight, insulin and glucose tolerance, testosterone levels, and other symptoms and signs of PCOS as well as measuring heart rate variability.

This study aims to evaluate the feasibility, acceptability and efficacy of a new cognitive behavioral intervention designed to help children with epilepsy improve their social competence. The new intervention uses a number of non-invasive, child friendly techniques previously used with children with developmental disorders and typically developing children to teach children with epilepsy how to respond in social situations. The intervention is focused on development of perspective taking, which means understanding what another person is thinking (cognitive perspective taking) and feeling (affective perspective taking); also called theory of mind. We decided to focus our intervention on perspective taking, as it is a core social cognitive skill that is important for socialisation. Also, research has shown that children with epilepsy have marked difficulties perspective taking about thoughts and feelings of others, which affects their ability to respond in social situations. Children with epilepsy also have difficulty identifying and labelling their own thoughts and feelings, which is a precursor for knowing about the thoughts and feelings of others. This is the first intervention that addresses this critical area of clinical need. Social difficulties are frequent in children with epilepsy and have significant clinical implications including increased risk of anxiety, depression and ongoing social and emotional difficulties as adolescents and adults. This feasibility study will involve four face-to-face groups led by registered psychologists. The groups will involve role-plays, videos, social stories, group discussions, and paper and pen tasks. The groups will be held in clinical rooms designed for child and family therapy. The study will also involve four one-to-one assessments with a psychologist (15 to 35 minutes each) that will take place at baseline (4 to 6 weeks before the first day of the intervention), pre-treatment (first day of the intervention) post-treatment (last day of the intervention), and follow-up (4 to 6 weeks after the intervention has been completed). The assessments will involve paper and pen and computerized tasks. All tasks are similar to those that would be completed in a normal clinical setting. At no point during the study will children be exposed to activities that will pose undue physical or psychological strain. However, in the unlikely event a child becomes distressed, this will be sensitively managed by the psychologists running the groups.

The primary purpose of this study is to conduct a series of Single Case Experimental Designs (SCEDs) that compare the effectiveness of conservative multimodal physiotherapy in reducing daily neck pain and improving self-efficacy whilst performing daily activities in individuals with Chronic Whiplash Disorder (WAD), in 3 individuals with Post Traumatic Stress Symptoms (PTSS) and 3 individuals without PTSS. The hypothesis is that multimodal conservative physiotherapy when performed in individuals without PTSS will be more effective in reducing daily neck pain intensity and improving self-efficacy whilst performing daily activities when compared to individuals with PTSS. This multiple baseline design study has several dependent variables that are measure simultaneously - including the Neck Disability Index, the Depression Anxiety and Stress Scale, EQ-5D-5L, the Pain Catastrophising scale, patient specific questions based on a self efficacy questionnaire and the Global Impression of Change scale. The intervention is introduced in a staggered sequence. Thus, at different stages of the study some tiers will be in the baseline (A) phase and others will be in the intervention (B) phase. This study will utilise an A1-B-A2 design to measure the effectiveness of a standard multimodal conservative physiotherapy intervention across the three phases: a baseline phase with no intervention (A1), intervention phase (B) and lastly a no intervention phase with follow-up (A2). The onset of the intervention start point will be randomly allocated, with two participants starting at day 5, another two on day 8 and the last two on day 11. During this 4 week intervention period, participants will have 8 one hour sessions of physiotherapy treatment. Afterwards, there will be a 4 week follow-up phase where the participants will have no contact with the intervention personnel, in order to determine the possible duration of improvement post intervention.

The SISTAQUIT™ trial provides training to health providers (HP) at Aboriginal Medical Services (AMS) and GP practices in culturally appropriate smoking cessation care for pregnant Aboriginal and Torres Strait Islander women. Almost 1 in 2 Aboriginal and Torres Strait Islander women smoke during pregnancy. Tobacco smoking in pregnancy is the most important preventable risk factor for poor maternal and infant health outcomes, including chronic lung problems and respiratory infections. Pregnancy is an important window of opportunity for health providers to help smokers quit, however they often lack the confidence and skills to address their patients’ smoking. The SISTAQUIT intervention has been developed over many years of research including an extensive Aboriginal community consultation and co-development phase, pre-testing of resources in three states, and the recent Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy pilot study in 6 Aboriginal Medical Services (AMS) in three states (SA, NSW, QLD). The primary aim of SISTAQUIT is to assess the effectiveness of the HP training intervention at increasing smoking cessation among pregnant Indigenous smokers at 4 weeks post-baseline, compared to standard care. Secondary aims include: 1.) to increase the proportion of health providers offering assistance to pregnant Indigenous smokers; 2.) Reduce the episodes of respiratory illness and adverse perinatal outcomes in their babies (to 6 months); 3.) Conduct an economic evaluation of the intervention which includes cost-effective and cost-benefit analyses. We aim to recruit 30 AMS; 15 will be randomised to receive the intervention and 15 will be randomised to continue usual care (cluster Randomised Controlled Trial (cRCT)). The 15 AMS randomised to continue usual care will receive the intervention and SISTAQUIT resources at the end of data collection (i.e. the cluster RCT uses a ‘wait list’ control group). Each site that is formally recruited will receive reimbursement for the research activities undertaken for the trial. Ideally, all HP at each centre randomised to the intervention group will receive the SISTAQUIT smoking cessation training (as a whole of service approach). Pregnant women up to 32 weeks gestation will be invited to participate in the project; women will be followed at recruitment, 4 & 12 weeks post-recruitment, 36 weeks gestation (4 weeks before their due date), and 4 weeks & 6 months after giving birth, Their babies will also be followed for 6 months for respiratory and general health outcomes. The SISTAQUIT trial is coordinated by research staff from the University of Newcastle, and the research team includes both Indigenous and non-Indigenous investigators and research staff. The study is supported by a grant jointly funded by the Global Alliance for Chronic Disease (GACD) and the National Health and Medical Research Council (NHMRC), and supported by fellowships awarded to GGould from the NHMRC and Cancer Institute NSW.

Long-distance truck drivers, most of whom are men, are one of the most important, yet unhealthiest occupational groups in Australia. Heart disease, type 2 diabetes, hypertension and obesity are endemic within the industry, and these health issues in turn impact sleep quality, fatigue and driving performance. Despite these concerns, truck drivers remain an underserved group, with long hours spent driving and geographically challenging work environments limiting health promotion options and services. A compelling case can be made for high intensity interval training (HIIT) as an effective intervention for male long-distance truck drivers. HIIT involves one or more short bursts of high intensity exercise (e.g. 4 minutes, 3 times/week). This exercise mode resonates with men, improves cardio-respiratory fitness (CRF) and cardio-metabolic risks and conditions in obese adults, and benefits sleep quality, alertness and driving safety. Recognising the need to transition HIIT from the laboratory to real-world settings, this study will test the efficacy of ‘Truck-Fit’, a depot-delivered, scalable exercise referral program, led by an accredited exercise physiologist who will progress high risk drivers from supervised to self-administered HIIT over 16-weeks. The study will be a cluster randomised controlled trial, with driver depots randomly allocated to the 16-week HIIT program or usual behaviour control. To assess program efficacy, we will administer laboratory health and fitness assessments at baseline and end-intervention, process evaluation of HIIT, and a post-intervention driver focus group and depot manager interviews to assess barriers and facilitators to implementation. Our main outcome will be cardiorespiratory fitness; secondary outcomes will be HIIT compliance, impact on driver sleep quality and fatigue, and acceptability of the program for drivers and depot managers. The study findings will provide valuable data to support larger effectiveness trials.

Current DMD therapies are aimed at increasing dystrophin levels and reducing inflammation. Improved anti-inflammatory therapies are needed to safely treat this pathology and delay disease progression. This study will be conducted in a single-centre and assess the safety, efficacy and PK of ATL1102 in non-ambulatory patients with DMD.