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The effectiveness of a clinical practice change intervention in increasing clinician provision of preventive care across a network of community based drug and alcohol services.
Expand descriptionThe study will be undertaken within community drug and alcohol services across one local health district in New South Wales, Australia. A pre-post design will be utilised to assess the effectiveness of a 12 month intervention to increase clinician delivery of preventive care. The 12 month intervention will be implemented simultaneously across all participating community drug and alcohol services. The intervention will utilise clinical practice change strategies to increase clinician provision preventive care to clients, specifically assessment, brief advice and referral, for the health risk behaviours of smoking, inadequate fruit and vegetable consumption, harmful alcohol consumption and inadequate physical activity. Primary data collection will consist of repeated cross-sectional computer assisted telephone interviews (CATIs) undertaken with clients receiving care from eligible community drug and alcohol services. The interviews will measure client reported receipt of preventive care on a weekly basis for 24 months, commencing six months prior to the intervention implementation and continuing until six months post the intervention implementation. To supplement the client data, clinician self-reported provision of preventive care will be measured using CATIs undertaken prior to intervention implementation and immediately following implementation.
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A running training and lifestyle programme for children with cerebral palsy
Expand descriptionEven the most functional children with cerebral palsy (CP) who walk unassisted show limitations of high level mobility relative to their peers. Our clinical experience has been that these children articulate self identified goals around aspects of improving their high level mobility in particular running. In clinical reality these more functional children receive fewer services as they are perceived to be able to participate in aspects of recreation and activity that require higher levels of gross motor function. In daily reality, activity and participation restriction in children with CP who are ambulant exists. There are a number of barriers that may contribute to restricted participation including poor physical capacity to undertake high level mobility tasks proficiently, in particular running. Running is the cornerstone for many individual and team sports and recreational activities, and has been reported to be a significant challenge for individuals with neuromotor dysfunction. There is evidence to suggest that children with CP have lower muscle mass, decreased muscle strength and poorer fitness. Two additional factors worth exploring is whether children have learned the motor components of running and whether they have adapted to a non active lifestyle. It may be that individuals with CP avoid or discontinue membership in sports and recreational activities that require speed and agility due to deficits in running ability. Training programs that focus on teaching the components of running skill in children with CP appear to be unreported. Training the components and skill of running in CP is important for a number of reasons. Firstly, like many determinants of motor change and acquisition of skill in CP, therapy and training to achieve the skill is required. Unlike many therapeutic interventions that address the ability to walk, therapists working with CP rarely address the components in running to the same level. Secondly, running is often identified as a goal of intervention for school aged children, particularly as many school activities are focused around running such as school fun runs, lap-a-thons, daily fitness, general sport. Thirdly, although many interventions have been shown to improve muscle strength, anaerobic and aerobic capacity and even walking capacity in CP, few have demonstrated a translation of these gains into higher level mobility and increases in community participation. We propose to run a three month running skill acquisition and training programme to determine its effect on running skill acquisition, improvement in higher level skill improvements in walking and running capacity and engagement into community programmes and participation. This is important because evidence suggests that physically inactive children are more likely to become physically inactive adults and that encouraging positive physical activity habits in children helps establish patterns that continue into adulthood. The running programme will be run through The Centre for Cerebral Palsy (TCCP) at two of their metropolitan sites. In addition to the running training, a lifestyle aspect will be incorporated into the programme. The lifestyle component will focus on strategies to enable the child or young person to adopt an active lifestyle within their family and school context. This component will include cognitive based coaching and motivational interviewing to coach strategies to practice/continue with the activity related training in the daily situation. The programme will be carried out collaboratively by therapists from TCCP and PMH. The Research Coordinator Physiotherapist from PMH was instrumental in initiating the idea of developing a running skills program, researching the ABI running program model and developing the proposal about how it may be best modified to suit children with CP. In addition PMH has physiotherapists involved in exercise lifestyle models in the obesity related programmes and the eating disorders programs. These PMH therapists have the specialised skills to guide the lifestyle intervention aspect of the proposed running model. This aspect of the intervention differs to that run by Williams and other adult facilities and is grounded in the family context of working with children and young people. It was recognized the programme is best implemented in a community based setting by community providers. Physiotherapists at TCCP have extensive experience and knowledge in community based intervention programmes and working with families in the community. The collaboration of PMH with TCCP will bring together the specialist skills of each of these service providers to benefit the formulation and application of programme.
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The effect of dietary fats on appetite and metabolism
Expand descriptionThis project aims to understand the effect of high saturated fat meals differing in saturated fatty acid chain length on energy expenditure and fat metabolism. Evidence suggests that not all fats are metabolised in the same way and not necessarily equivalent in the way they behave to maintain energy balance in the body. Ingesting fats that have a propensity to increase biological energy expenditure, fat oxidation and fullness may ultimately have beneficial effects on body weight control. It is postulated that individuals will find it easier to make changes in the types of fat they eat rather than total amount of fat when aiming to control body weight, especially in adulthood when dietary preferences can already be quite ingrained.
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Investigation of the safety and effectiveness of Dietzia C79793-74 for moderate to severe Crohn's disease
Expand descriptionThe purpose of this study is to see if treatment with Dietzia C79793-74 in patients with Crohn's disease is safe and effective in reducing disease severity and improving quality-of-life.
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A Single-Dose, Randomized, Open-Label, Crossover, Pilot, Comparative Bioavailability Study of Aprepitant 130 mg Injection Versus EMEND Registered Trademark 150 mg Injection and EMEND Registered Trademark 125 mg Capsules in Healthy Male and Female Volunteers under Fasting Conditions.
Expand descriptionThe objective of this pilot study is to estimate the intrasubject variability and to compare the bioavailability of aprepitant from Aprepitant 130 mg Injection (InnoPharma, Inc.), EMEND Registered Trademark 150 mg Injection (Merck Sharp & Dohme Corp.) and EMEND Registered Trademark 125 mg Capsules (Merck Sharp & Dohme Corp.) in healthy, non-smoking male and female volunteers under fasting conditions.
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A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries: The Australasian Paediatric Head Injury Rules Study (APHIRST)
Expand descriptionChildren with clinically significant intracranial injuries require rapid identification in the acute care setting in order to prevent further damage to the brain. Head CT scans can quickly identify the presence or absence of intracranial injuries, and help guide subsequent management (including neurosurgical intervention) where intracranial injuries are identified. However, head CT scans also have negative effects, particularly in children, who are more vulnerable to radiation-associated cell damage and may require sedation to allow imaging with consequent sedation-associated risks. Radiation from cranial CT scans can cause lethal malignancies later in life, with a reported cancer related mortality between 1:1000 and 1:10000 paediatric cranial CT scans, with higher risk in younger age groups. They also have resource implications for Emergency Departments and the health system as a whole. Despite this, the number of cranial CT scans performed for head injuries in children is increasing, in part due to concern amongst physicians regarding the consequences of being unable to reliably identify intracranial injury based solely on a child’s clinical condition. Clinical decision rules are a combination of clinical variables. These may include elements of the patient's history, physical examination findings, or simple tests that guide clinicians in their decision making process for optimal patient care. There are three high-quality, international clinical decision rules that have been developed to decide which children need a CT scan following a head injury and which can be safely managed without. They are very accurate in identifying children with intracranial injuries, however they are quite different in terms of applicable populations and definitions of a significant intracranial injury. In addition these three rules have not been compared in the same population to assess which is the best rule to be used in clinical practice. The primary aim of the current study is to determine the accuracy of the three major international paediatric head injury clinical decision rules when applied to a single population of consecutive children presenting to the Emergency Department with head injury in Australia and New Zealand. The hypothesis is that the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting, will allow the determination of the optimal rule for use in the Australasian Emergency Department setting.
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The effect of Glycomax 'Trademark' lactoferrin and bovine whey immunoglobulin-rich fraction on gene expression patterns in healthy adults: a double-blind placebo-controlled randomised clinical trial
Expand descriptionGrowing research into the effects of several whey-derived proteins (cow’s milk proteins) suggests that bovine lactoferrin and immunonglobulins may have a number of health benefits for consumers including improved metabolic and immune regulation. This study aims to examine any link between bovine lactoferrin and immunoglobulin consumption and gene expression patterns which may reveal which biological pathways are involved in driving responses to these supplements.
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Assessment of the Effects of Cardiopulmonary Phenotype on Oral and intravenous (IV) Frusemide Pharmacokinetics
Expand descriptionWhile there is currently a paucity of evidence to guide this practice, frusemide is routinely administered IV to patients presenting to Flinders Medical Centre (FMC) with either decompensated heart failure or pulmonary hypertension on the basis that expert opinion considers oral frusemide ineffective for managing these conditions. This study will assess the impact of congestive cardiac failure (acutely decompensated and compensated) and pulmonary hypertension on the oral and intravenous (IV) pharmacokinetics of frusemide, and determine whether altered pharmacokinetics may explain the variability and perceived lack of efficacy of oral frusemide in managing these conditions. It is hypothesised that these conditions will differentially affect the rate of oral frusemide absorption (i.e. the time to maximal concentration / response will be delayed), but that neither will affect the extent of absorption (i.e. bioavailability will remain unchanged). By improving the understanding of the impact of these conditions on frusemide pharmacokinetics, this study will form a framework to facilitate future research here at FMC to deliver more personalised and optimised dosing of frusemide that may combine oral and IV routes of administration, which will provide more effective management of symptoms, while reducing the time to hospital discharge.
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Getting to the CORE: testing a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting.
Expand descriptionThe aim of CORE is to test if a structured co-design method (Mental Health Experience Co-Design, MH ECO) optimises psychosocial recovery outcomes for people affected by mental illnesses. MH ECO is a purposefully designed process to engage consumers, carers and service providers of adult community mental health services in re-designing aspects of services. MH ECO involves talking with consumers and carers to identify the positive and negative aspects of service and care experiences. Focus groups and interviews are conducted with consumers, carers and service providers to explore these negative aspects of care and experiences in-depth. Collaboration and co-design groups comprised of staff, consumers and carers are formed to identify ways to improve services, develop action plans and implement these. CORE is designed as a stepped wedge cluster randomised controlled trial (SWCRCT). This means that the intervention will be rolled out sequentially to participating mental health teams three clusters at a time over three waves. By the end of the trial though all clusters will have received the intervention.
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Capacity for informed consent during labour
Expand descriptionConsidering the background of physical and emotional stressors in labour, it is clear that there are ethical considerations in obtaining consent for research from women at this time. Although there is some literature on the validity of informed consent by women in labour, much of it is from an anaesthetics perspective only. Additionally, despite the availability of literature on women’s opinions of pregnancy and labour, there is a gap in knowledge about women’s ability to comprehend and retain information during labour. The proposed study focuses on addressing this gap and providing an evidence base regarding ethically obtaining consent, including research consent, in labour. Given the current paucity of evidence in this area, the study initially proposed is pilot in nature to ascertain the feasibility of a larger, comprehensive study and to confirm the utility of our proposed study methodology. The primary purpose of the study is to determine the capacity of pregnant women to comprehend (pregnancy and non-pregnancy related) and retain information during labour. This will be assessed, using healthy pregnant volunteers (pregnant women with no major pregnancy complications who are willing to undergo testing at approximately 36 weeks of pregnancy, in labour, and approximately 24 hours after the birth of their baby), through administration of standardised information and word lists, followed by testing of comprehension of the information and recall of the word lists. Participating women will be allocated to one of four groups: 1) Information given at both 35-37 weeks of pregnancy (at time of study enrolment) and during labour, information in written format 2) Information given at both 35-37 weeks of pregnancy (at time of study enrolment) and during labour, information in verbal (spoken) format 3) Information given only during labour, information in written format 4) Information given only during labour, information in verbal (spoken) format. Testing of immediate comprehension/recall will occur at enrolment at 35-37 weeks of pregnancy (if participant is allocated to one of the first 2 groups) and during labour (all participants). Testing of later recall (of information given during labour) will occur approximately 24 hours after the birth of the baby. The main study hypothesis is that the ability of women to comprehend and retain information will not be significantly affected by labour. Secondary aims of the study include comparing the efficacy of written versus verbal information format, and efficacy of provision of relevant information at approximately 36 weeks of pregnancy then again in labour versus information provision in labour only. The study will also consider the effect of other factors (e.g. epidural analgesia vs not, first baby or subsequent baby, woman's baseline behavioural state score) on information comprehension and recall.