ANZCTR search results

This project aims to assess the safety of Metformin and how well it works in patients with active Ulcerative Colitis. Metformin is approved in Australia to treat Type 2 Diabetes and has been used for over 50 years. In addition its effect on blood glucose metformin has more recently been shown to have anti-inflammatory effects, which are important in the activity and severity of ulcerative colitis. Metformin may have a therapeutic benefit in ulcerative colitis via this anti-inflammatory effect.

BACKGROUND Ultrasound guided regional anaesthesia (UGRA) is a complex component of anaesthesia practice to learn. UGRA has evidence of improved safety, efficacy and is considered standard of care for peripheral nerve blocks. To safely practice UGRA, procedural accuracy is required when introducing the nerve block needle into the patient and guiding that needle to the target nerve structure under real time ultrasound guidance. This procedural task encompasses several domains of knowledge and manual dexterity skills: 1. Ability to manipulate the ultrasound transducer to visualise and optimise the nerve and surrounding tissue sonoanatomy 2. Ability to plan a needle path trajectory that maintains an in-plane visualisation of the needle shaft and tip from skin surface to deeper structures 3. Motor skill ability to guide the needle under real time visualisation to inject local anaesthesia at positions around the nerve to create a circumferential deposition of injectate (local anaesthesia) 4. Ability to recognise an optimal spread of injectate and to correct the needle position appropriately Successful performance of UGRA thus requires hand-eye coordination and needle guidance techniques to maximise efficacy while minimising potential complications. Learning curve patterns of novices performing UGRA in patients has revealed an initial high rate of errors, from a mean of 12.6 errors per block during the first 10 attempts, decreasing to 4.6 errors per block by the end of the 39th attempt. In a study using cadavers, 28 UGRA attempts were required to reach competency as defined by needle visualisation under ultrasound and transducer steadiness. Both studies revealed wide variability in novices' error and success rates. This suggests that UGRA skills are difficult to master and individuals reach proficiency at different times, due to innate psychomotor abilities. For ethical reasons, initial teaching of these procedural skills has thus focused on in vitro models. It allows repeated practice of high stakes procedural skills without risk of patient harm. It concentrates trainees and trainers in a single learning environment. A curriculum can be devised without distractions of clinical duties as occurs in hospital-based teaching. The ideal in vitro model should be inexpensive, has similar properties to human tissue both under ultrasound (echogenicity, fascial planes, muscle texture, hyperechoic peripheral nerves, arterial and venous blood vessels that collapse appropriately under pressure, spread of injectate along fascial planes and around nerves, swelling of the nerve sheath if an intraneural injection was performed), as well as tactile feedback of resistance and fascial plane pops when a facet tipped nerve block needle is used. Commonly used in vitro models include the gelatin model, meat model, and fresh frozen human cadaveric model. None of these satisfy as an ideal model, and all have advantages and disadvantages. Inexpensive and easily procured models such as gelatin and meat based models are commonly used in teaching, but offer a low fidelity experience of what a trainee would expect when performing UGRA in patients. Anatomical relationships, tactile feedback, appearance of human tissues and fascial planes under ultrasound, and nerve block needle echogenicity are not realistic. In our experience, these models are useful in introducing novices to UGRA but create overconfidence in performance as they do not reflect the clinical reality. The meat model, usually constructed out of turkey, beef or pork, is relatively inexpensive, easy to construct, and has more similar properties to human tissue in terms of echogenicity and texture. Hydrodissection by injections of simulated local anaesthetic can also be performed. However, meat models do not have realistic human anatomical relationships. Unlike traditional formalin based cadaveric dissections, fresh frozen human cadavers retain all of the in vivo anatomical relationships and currently represents the highest fidelity model for UGRA training. Nerves, fascial planes, and muscle textures are similar to live patients. Tactile feedback is retained when performing needling manoeuvres. Injection spreads patterns are similar to live patients. Limitation to access include financial cost and scarcity of centres accredited to handle fresh cadavers. This study will compare the effectiveness of two in vitro models commonly used to teach UGRA: pork meat model, and fresh frozen cadavers. Effectiveness is measured using objective assessment of proficiency in procedural skills before and after exposure to different in vitro models. RATIONALE FOR PERFORMING THE STUDY The traditional apprenticeship model of teaching medicine has emphasised clinical exposure and supervised tutelage of procedural skills in our patients. Due to multiple factors including ethical concerns of relatively unskilled trainees performing invasive procedures on patients, reduction in caseload due to safe working hours directives, and reduction of available teaching staff, this apprenticeship model may be inappropriate. In UGRA, poor needle visualisation and suboptimal sonoanatomical imaging have been identified as the two most common mistakes in novices, which may contribute to patient complications during nerve blocks. Educators are still uncertain as to the best methods of teaching UGRA, including what are the best in vitro models. In this study, we will compare the effectiveness of 2 commonly used in vitro models. The models range from low fidelity (but low cost, easily accessible) to high fidelity (but high cost, not easily accessible). Each model has been used and reported in literature, but no previous study has compared each model's effectiveness in teaching procedural skills to trainees. The results of this study will inform us of the value of fresh frozen cadavers in UGRA teaching. We will compare the relative skills of trainees taught with different models using an objective assessment tool. If the hypothesis is confirmed, we would recommend that fresh frozen cadavers be incorporated into regular UGRA teaching. HYPOTHESIS That fresh frozen human cadavers, representing a high fidelity simulator of human anatomy, is the most effective in vitro model to teach UGRA technical skills to doctors training in anaesthesia when measured against time taken, error rates, and success rates. STUDY OBJECTIVES Primary objective is time taken from insertion of the needle using an in-plane technique (maintaining visualisation of needle shaft and tip) to the 6 o’clock and 12 o’clock positions of the target, and injecting 0.5mls of saline at each position. Secondary outcomes were selected based on common problems exhibited by novices in UGRA. 1. Number of needle passes 2. Number of errors during performance of task 3. Image quality score of best sonoanatomical image

The purpose of this study is to define the value of strain in patient management, by identification of subclinical left ventricular (LV) dysfunction, which will be used to guide cardioprotective therapy. Who is it for? You may be eligible to join if you are aged between 18 and 80 years old (inclusive), and actively undergoing chemotherapy at increased risk of cardiotoxicity. Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will undergo screening echocardiography for the development of cardiotoxicity with the inclusion of myocardial mechanics to measure LV strain. The measurement of LV strain will be used to guide the participant's cardioprotection treatment to avoid cardiotoxicity. Serial screening tests are envisaged to take place at 3 monthly intervals for one year with each screening session taking approximately 30 minutes. Participants in the other group will undergo standard echocardiogram and an ultrasound test of the heart where ejection fraction (EF) is measured. The measurement of EF will be used to guide the participant's cardioprotection treatment to avoid cardiotoxicity. This screening test is envisaged to take place at 3 monthly intervals for a year with each session taking approximately 30 minutes.

The proposed study has as its focus, the important shared role patients can have in determining the outcomes of their healthcare in the context of postoperative recovery after orthopaedic surgery, specifically, total knee replacement (TKR). The research program has two major aims: 1) to test a multimedia intervention to improve patients’ participation in their postoperative care; and 2) to model various patient processes of care and system factors that may impact on patients’ overall experience and satisfaction with hospital care after surgery. A nurse-led, multimedia intervention expected to increase both the capability (through information) and opportunity (through facilitation) of patients to participate in their goals of care will be introduced during the immediate postoperative period after elective TKR surgery. Advances in information technology, hand held devices and multimedia techniques provide innovative ways to embed nurse-led approaches into the processes of care that can facilitate patients’ participation in their care. A cluster randomised, crossover designed study will be implemented in conjunction with mixed-methods data collection and analysis. The setting will be three orthopaedic wards located at a major, private, metropolitan hospital. Patients undergoing primary TKR surgery and able to provide consent will be recruited to the study, patients in the cross over groups will receive usual care as per the TKR pathway. The intervention will be the application of the nurse-led, multimedia goals of care education package designed to be delivered daily to patients at the bedside by nurses in order to improve patient participation during their recovery. Structural equation modeling will be used to analyse relationships between patient participation, patient satisfaction and patient experience. Data collection methods will include patient interviews, naturalistic observations of practice, patient outcome questionnaires and staff focus groups.

Over half of Australians fail to reach the physical activity guidelines necessary to reduce the risk of cardiovascular disease, diabetes and cancer. Due to rising levels of chronic disease placing a significant burden on Australia’s health care and economy, there is a need for effective population-based physical activity interventions. The internet provides a practical platform to deliver physical activity interventions as it can reach large numbers of people at low cost. Whilst the short term effectiveness of web-based interventions has been established, participant engagement and retention into the intervention have been identified as problems affecting population-level reach and long term effectiveness. This project will measure the effectiveness of brief online coaching provided via Skype versus personally tailored advice alone will be examined in terms of improving website usage, retention and physical activity outcomes. Overall study findings will inform the next generation of web-based physical activity interventions effective in improving physical activity levels in a large range of Australians, and reducing the prevalence of disease in Australia.

Obstructive sleep apnoea (OSA) is characterised by repeated upper airway obstructions during the night. OSA is associated with excessive daytime sleepiness, lower health status and studies suggest obstructed breathing and snoring in sleep are independent risk factors for high blood pressure, heart disease, stroke and mortality. Thus OSA is a serious and costly public health problem that is growing in prevalence because of population increases in both obesity and ageing. Continuous positive airway pressure (CPAP) therapy is the current treatment of choice for patients with OSA. CPAP is effective in decreasing sleepiness and improves quality of life in patients with OSA. Treatment of OSA with CPAP is cost-effective if worn, but CPAP is poorly tolerated by many patients who find the mask and pressure claustrophobic and uncomfortable. OSA can be effectively treated but poor treatment compliance is a major clinical problem and thus many patients are under treated or not treated at all. Upper airway surgery for OSA is widely used and reported in observational studies but there are few rigorous and randomized clinical trials to provide and validate these studies. The clinical effectiveness and cost effectiveness of this surgical intervention need to be validated. This study is a national, multi-centre, randomised, controlled trial with a recruitment target of 102 participants. Participants with OSA who have failed standard OSA treatments will be randomised into two groups: Group 1 will receive reconstructive surgery of the upper airway and Group 2 will receive the standard non-surgical care for OSA. Participants will undergo follow-up for 6 months. Study participants will be tested for OSA, daytime sleepiness levels, and quality of life improvements before the treatment and at 6 months follow-up. Magnetic resonance imaging of the upper airway will also be used on participants randomised to Group 1, before the surgery and at 6 months, with the aim of developing a prediction model for future patients who will benefit the most from surgery. The study will be carried out at five sites across Australia to examine the universal effect of this standardised surgical protocol. AIM: To establish for the first time whether or not upper airway surgery is clinically effective, safe and cost effective for patients with symptomatic OSA who have failed medical management HYPOTHESIS: Surgery will deliver a better treatment outcome than ongoing medical management of symptomatic OSA as measured by the improvement in Apnoea Hypopnea Index (AHI) and subjective and objective daytime sleepiness in patients who have failed CPAP treatment despite persistent, supervised attempts.

Prospective observational study 3,6,12 and 18 months post discharge using quantitative surveys to assess health related quality of life and mental health followed by a limited number of semi-structured qualitative interviews with patients and relatives.

Falls by older people in the community are frequent and are a major concern worldwide because of their association with disability, institutionalisation and mortality. Older people presenting to the Emergency Department (ED) following a fall have often fallen previously, indicating a failure in secondary prevention. This may be due to a lack of engagement in prevention strategies. There is evidence that suggests only a minority of older people who present to the ED after a fall follow recommendations provided by ED staff. This randomised controlled trial (RCT) will test the RESPOND program which is designed to improve older persons’ participation in falls prevention activities through delivery of patient-centred education and behaviour change strategies. . It will involve 528 patients from two hospitals across Australia; 264 patients will be randomised to the intervention group and will receive the RESPOND program while the other 264 will receive standard care. The RESPOND program incorporates: (1) home-based risk factor assessment and risk stratification; (2) education on risk factor management, goal setting around 4 specific high level evidence interventions, coaching and follow-up telephone support; and (3) healthcare provider communication and community linkage. Primary outcomes are falls and fall injuries per-person-year and ED re-presentations occurring over 1 year. It is hypothesised that falls, fall injuries and ED re-presentation rates will be reduced by at least 30% in the 12-months post-implementation of the RESPOND program for intervention compared with control participants.

Mounting evidence indicates that cognition-based interventions for people with mild cognitive impairment (MCI) are effective in maintaining independence and increase patient satisfaction. Studies to date have primarily focused on clarifying intervention parameters associated with greater efficacy, such as duration and frequency. Less is known, however, about the contribution of health related variables to the outcome of cognition-based treatments. Neuropsychiatric symptoms (NPS) are highly prevalent in people with MCI and are associated with greater impairment, excess disability, and worse outcomes. Despite this, studies evaluating the efficacy of cognition-based interventions in persons with MCI tend to exclude patients with NPS. Understanding the contribution of NPS to the outcome of such interventions is important in terms of their application in clinical settings. A double-blind randomised controlled trial design is proposed to compare the efficacy of a cognitive training intervention between individuals with MCI, individuals with MCI and NPS, and individuals with NPS and no MCI. The outcomes of the study will inform the selection of candidates that have the greatest potential to benefit from cognition-based interventions, with implications for clinical practice.

To compare the pharmacokinetics and safety of dihydroergotamine delivered via 2 nasal spray devices: the investigational device versus the Migranal nasal spray applicator. Methods: Single-center, open-label, randomized, single-dose, 2-sequence, 2-treatment crossover study in healthy adults. The 2 treatment periods will be separated by a washout period of at least 5 days. Investigational product, dosage and mode of administration: IPX234. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the investigational device.