ANZCTR search results

This project is part of a research program funded by the NHMRC (No. 630560) to develop and evaluate Internet based transdiagnostic education and treatment programs for people with anxiety and depression. This project examines the relative efficacy of a disorder-specific internet-delivered treatment for depression vs. trans-diagnostic internet-delivered treatment for both anxiety and depression. Both interventions will be tested in guided and self-guided formats. We expect that the guided interventions will results in superior outcomes to the unguided interventions. We do not expect differences between the two guided interventions at post-treatment, but expect that the trans-diagnostic treatment will result in superior outcomes at follow-ups.

The aim of this trial is to examine whether D-Cycloserine can augment a single session of graded exposure therapy in children and adolescents with a specific phobia. D-Cycloserine is an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NDMA) agonist, which has recently been shown to facilitate fear extinction in humans and animals and has also demonstrated to improve treatment outcome when combined with exposure therapy in social phobia, acrophobia or fear of heights and OCD in adult samples. The drug has recently been successfully used to augment exposure therapy for children and adolescents with OCD.

Despite the use of high dose chemotherapy and ASCT (a procedure where the patient's own cells are collected, high dose therapy eliminates patient's cancer cells and patient's collected cells are reinfused), multiple myeloma remains incurable. This study aims to: 1.compare induction therapy employing either a chemotherapy regimen employing Bortezomib, melphalan and prednisolone or high dose therapy and ASCT 2. compare consolidation therapy employing either a chemotherapy regimen of bortezomib, lenalidomide and dexamethasone or no treatment 3. investigate maintenance therapy employing lenalidomide The study plans to treat 1500 patients worldwide. Trial details In this study you will receive the drug bortezomib delivered intravenously (i.v) on days 1,4,8 and 11, the drug cyclophosphamide delivered i.v on days 1 and 8, and dexamethasone delivered orally on days 1,2,4,5,8,9,11 and 12 of a 21 day treatment cycle you will then be allocated to receive either option in 1. and either option in 2. below 1. either 4 cycles of the drug bortezomib delivered intravenously (i.v) on days 1,4,8, 11, 22, 25, 29 and 32, the drug melphalan delivered orally on days 1 -4 and prednisolone delivered orally on days 1-4 of a 6 week cycle;or high dose melphalan i.v 3 and 2 days before reinfusion of patient's own stem cells 2. either 2 cycles of consolidation treatment consisting of the drug bortezomib delivered intravenously (i.v) on days 1,4,8 and 11, the drug lenalidomide delivered orally on days 1-21, and dexamethasone delivered orally on days 1,2,4,5,8,9,11 and 12 of a 28 day treatment cycle or no consolidation treatment All patients will then receive repeating 28 day cycles of daily oral lenalidomide therapy as long as the therapy continues to fight the myeloma. Your response to the treatment will be assessed at routine clinical visits using the usual clinical investigations that would monitor the status of your disease. Who is it for? This study is open to male or female patients aged 18-65 with a diagnosis of multiple myeloma. The full details of this study's inclusion and exclusion criteria can be found in the relevant sections within this record.

This study will test the primary hypothesis that nebulised heparin ameliorates the severity of lung damage resulting in faster recovery of physical function in critically ill patients with, or at risk of developing, ARDS. Other aims of the study include determining if nebulised heparin improves quality of life, shortens intensive care and hospital lengths of stay and is cost-effective.

This study is to see whether taking the drug metformin in addition to drug aromatase inhibitor can stop cancer cell activity in hormone receptor positive breast cancer in post menopausal women waiting for surgery. Who is it for? This study is open to postmenopausal women aged 18 and over, with Stage 1 or 2 operable invasive breast cancer scheduled for surgery. Further inclusion and exclusion details for this study can be found in the relevant sections in this form. Trial details In this study, you will be randomised to one of two groups. Arm 1 will involve taking 2 weeks of metformin (oral tablets, 1 gm per day) followed by 2 weeks of metformin (oral tablets, 1gm per day) in addition to aromatase inhibitor (oral tablets 1 mg per day Arimidex (trade name) or oral tablets 2.5 mg per day Femara (trade name)) in the lead up to your scheduled surgery. If you are randomised to Arm 2, you will receive 2 weeks of metformin (oral tablets, 1gm per day) followed by 2 weeks of aromatase inhibitor alone (oral tablets 1 mg per day Arimidex (trade name) or oral tablets 2.5 mg per day Femara (trade name).

Demographic trends resulting in increased longevity and an increasingly aged population, combined with the current economic climate, indicate that there will be rising demand placed on already stretched health resources. This is accentuated by the rural location of the Mackay Health Service District (MHSD) which leads to a disproportionate amount of patient and clinician time being spent on travel, as compared to metropolitan services. Within Mackay Base Hospital there are pressures on bed availability (average 96.5% bed occupancy), necessitating innovative early discharge / admission prevention strategies. In addition, patients may be admitted unnecessarily because; they are nearing their emergency department (ED) wait limit target; there are limited and variable Allied Health (AH) services available for ED referrals; or existing ED staff do not have a detailed awareness of community services available to address these patients’ rehabilitation needs. Compounding this, anecdote suggests that there are inefficiencies within existing AH service delivery models; that tasks are duplicated by health professionals, that patients are frustrated by repeating information to AH staff involved in their care, that Allied Health Assistants (AHAs) are under utilised and that services are often fragmented. Increasing pressures on services, staff shortages and lone working, common in regional areas, has led to clinicians informally skill sharing, albeit in an ad-hoc and unstructured fashion, often without the requisite training and competence to enable them to be effective, or to recognise when they are out of their depth. There is inherent risk in this practice, unless a rigorous process has been followed to identify and risk analyse tasks for their appropriateness to share across professional boundaries or delegate. There is subjective information indicating that many tasks are undertaken by qualified practitioners that could be delegated to AHAs, and that there are tasks that can’t be delegated but don’t require highly specialist knowledge and skills to perform, for example routine assessments / interventions. In these instances, it is intuitively sensible to identify which tasks could be delegated / shared across professional boundaries, to use the skill set of the multi-disciplinary team (MDT) more effectively. The Calderdale Competency Framework is a systematic approach to identifying tasks carried out in teams, deciding which can be shared across professional boundaries, or delegated, and assessing competence. Following implementation of the Calderdale Framework, AH practitioners share professional skills across AH disciplines and increase delegation of tasks to AHAs, reducing the number of professionals involved in a patient’s care and minimising duplication of interviews, assessments, interventions, documentation and travel. The Calderdale Competency Framework has numerous potential benefits for the patients, clinicians and organisations, including: Patients are able to form a rapport with 1 individual who can meet most needs, reducing the number of visitors to their home or bedside - more rounded, holistic knowledge of the patient Access to a wider range if interventions for patients living in rural / remote areas Reduced repetition of personal details, condition history and assessments - reduced travel costs and duplication of tasks / roles Closer MDT working - Multi skilled staff - effective team built around the patient Increased awareness and respect of one another’s roles - more issues are identified and addressed - awareness of when staff need to seek the involvement of their colleagues Each discipline’s areas of expertise are identified - guides focus of resources Safe skill sharing / transferable skills Multi skilled workforce using the full scope of practice and delegating appropriately Increased job satisfaction – clarified roles and responsibilities - reduction in staff absence Less ‘hand offs’ - No need for patient handover Improved service productivity / patient flow Management of increased demands Although this framework has been applied in many settings in the UK, it has not been used previously in Australia and the clinical effectiveness of this model of care (MoC) has never been evaluated. In Queensland Health, this model of care is known as shared competencies and delegation practice (SCDP). The proposed study aims to examine the clinical and cost effectiveness in SCDP in relation to its current implementation in the Mackay Health Service District. All AH tasks carried out within the Emergency Department (ED) in the Mackay Health Services District will be identified and, using a risk management decision tool, tasks will be categorised into those that should be delegated to support staff, those that could be professionally skill shared and those which should remain uni-disciplinary. Competencies will be written / sourced and multi-disciplinary team (MDT) staff will teach each other skills, which have historically been considered their role. An Occupational Therapist and a Physiotherapist will then operate Shared Competencies and Delegation Practice within the ED setting. MDT staff will be fully engaged at all stages of the process to ensure sign up. The model is likely to enable patients, triaged to ED categories 2/3/4 (n=27,156 July 2010 - February 2011), to be assessed by AH staff quickly and admission avoided or length of stay reduced, as MDT assessments would have already been completed and discharge planning initiated. The nursing and medical input to patients will not be affected by this study. Aim(s) of project/study This study aims to determine the clinical and cost effectiveness in implementing a SCDP MoC with older people presenting to the ED. Research questions Is Shared Competencies and Delegation Practice (SCDP) clinically effective in enhancing patients’ functional independence, in an Emergency Department (ED) setting, as compared to usual care? Is SCPD cost effective? A prospective Randomised Controlled Trial design will be used with blinding of participants, outcome assessors and statistical analysts. Data will be collected at baseline, on discharge from Allied Health intervention and at 4 months post randomisation. The Cost Utility Study will be carried out from a societal perspective with both direct and indirect costs identified. The primary measure of benefit will be quality of life as measured by the Euroqol. Clients who attend the ED between the hours of 8am – 6pm Monday to Saturday, meet the study inclusion criteria and provide written informed consent to participate will be randomised to the intervention or control groups. The intervention group will receive AH input from clinicians trained in Shared Competencies and Delegation Practice whilst in ED, with follow-up on the ward or in the community if required. The AH clinicians based in the ED will be an occupational therapists and physiotherapists, by clinical background, but will be additionally trained in occupational therapy / physiotherapy / speech pathology / dietetics / podiatry and social work competencies. Thus, clinicians will be able to complete a more a rounded assessment and target intervention to meet the client’s complex needs. Intervention will aim to maximise functional independence, prevent admission and minimise the number of AH clinicians involved in a client’s care. An intervention protocol will be developed to ensure consistency in this approach. The control group will receive standard care, which comprises of clients being referred to individual disciplines, as the need is identified by the Community: Hospital Interface Programme (CHIP) nurses in the ED. Individual disciplines will then intervene with the clients using existing uni-disciplinary approaches and refer on to other services as indicated. Standard care will be documented via an audit prior to trial commencement to ensure that it can be clearly defined at the outset.

The aim is to assess the feasibility and efficacy of an evidence-based internet anxiety and depression prevention program for year 9-10 of high school. Currently, evidence-based programs do exist, but are largely not implemented in schools due to implementation (e.g., limited resources and teacher training) and dissemination failure. The aim of developing CRUfAD Schools: Alcohol Module is to overcome such concerns by developing a online intervention which would have the advantage of providing complete, consistent and flexible delivery on every occasion, without demanding excess teacher’s time, resources and training. CRUfAD Schools: Overcoming Anxiety and Combating Depression would also have the potential advantage of being an interactive program which would allow high-risk populations, who often do not seek help, to seek help with relative anonymity and confidentiality.

The project will aim to test a single-session parenting group for parents of children with problem eating. It is anticipated that the group will improve child feeding, the strategies parent use at mealtimes, and how parents think and feel about mealtimes. The study will also seek to identify which types of feeding problems respond best to this intervention.

This study seeks to determine if the use of a simple questionnaire can enhance the detection of carer distress in the Palliative care carer population.

This study will assess the effect and overall survival outcomes of radiotherapy following mastectomy in women with breast cancer. Who is it for? You may be eligible to join this study if you are a female with confirmed unilateral breast cancer with 'intermediate risk' of loco-regional recurrence following mastectomy. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo radiotherapy 5 days a week for 3-5 weeks commencing 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy. Participants in the other group will receive standard of care and observation only. Participants are followed up twice in the first year, and then annually for 10 years in order to asses the study endpoints.