ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31330 results sorted by trial registration date.
  • Physician attitudes towards, and experiences with the implementation of a scribe program in an Australian Emergency Department

    Currently, Emergency Physicians in Australia perform a significant amount of clerical tasks in the provision of direct patient care. These clerical tasks may take up to 44% of the time dedicated to an individual patient and include the writing of notes, obtaining results, faxing and organising investigations, contacting other healthcare providers and billing. More broadly, the aging population and increasing use of the healthcare system in Australia, coupled with restrictions on the funding of healthcare is mounting pressure on emergency departments to make productivity gains and ensure their economic sustainability. Currently, physicians in the Cabrini Emergency department see 1.0 patients per hour on average however 2-3 patients per hour are seen with the assistance of medical scribes in other health systems (1,2). This gain in productivity forms an economic basis for the use of scribes in emergency departments, but the implementation of a scribe program can be a daunting experience to the physicians they work with. For a physician to work well with a scribe and improve their productivity they need to work differently, working in a team with their scribe, trusting the scribe’s work; letting go of administrative tasks and focusing on higher-level cognitive tasks for the majority of their time. This probably requires a good working relationship with their scribe and a positive experience of using a scribe. Physician experience with scribes is not yet broadly described, however Hess notes that 60% of their providers liked or really liked having a scribe whilst 9% would be happier if they weren’t allocated a scribe. Initial work at Cabrini describes marked differences in productivity gains between providers. There is no work published to date on the experiences of emergency physicians who like or don’t like having scribes and how this relates to the economics gains (or not), of the providers. Work is required to identify what a provider experiences when working with a scribe. What issues are anticipated before working with a scribe? Are these issues real issues as they work scribed shifts? Are there common themes of concerns about scribe utilisation? Can these barriers or concerns be described so that solutions can be considered? How do these concerns relate to productivity gains for each provider? This study aims to investigate the common concerns faced by physicians during the implementation of a scribe program and to compare these to the concerns held once the program is established. This study also aims to correlate the concerns regarding perceived productivity with actual productivity data. References 1. Arya R, Salovich DM, Ohman-Strickland P, Merlin MA. Impact of scribes on performance indicators in the emergency department. Acad. Emerg. Med. 2010; 17: 490–4. 2. ACEP use of scribes in the emergency department – an information paper. June 2011. [Cited 24 Jan 2016.] Available from URL: http://www.ACEP.org

  • Outcomes related to symptomatic vasospasm after aneurysmal subarachnoid haemorrhage before-and-after the introduction of neuro-interventional radiology service

  • A randomised control trial of cognitive behavioural treatment for perfectionism in Athletes

    Research indicates a high prevalence of eating disorder symptomology in elite athletes in comparison to the non-athlete population (Smolak et al., 2000). Perfectionism is an a critical risk and maintaining factor in eating disorders (Egan et al., 2011) and compulsive exercise (Coen & Ogles, 1993). CBT guided self-help treatment has been found to treat effectively perfectionism (Egan et al., 2014). This trial will implement an online, guided self-help treatment for perfectionism in athletes to examine if it reduces Eating Disoder symptomology, compulsive exercise and burnout in athletes.

  • Early pharmacological treatment with supportive care versus supportive care alone in preterm infants with a patent ductus arteriosus

    Preterm birth continues to be a major health problem throughout the world. Very preterm babies have to adapt to their new extra uterine environment to be able to survive, often with increased risks of abnormal neurodevelopmental outcomes in later life. A patent ductus arteriosus (PDA) is a frequent cardiovascular complication in this patient group, and many would receive treatment with either medication or surgical closure. However, meta-analysis of trials showed no improvement in clinical outcomes, even though PDA was reduced. It is possible that the treatment received is causing more harm than benefit or treatment is being directed at the wrong patient subgroups. A definitive trial, comparing current standard treatment (pharmacological treatment with supportive care) versus supportive care alone, is necessary to resolve doubts regarding the quality or conduct of prior studies. We hypothesise that there will be comparable outcomes between the 2 approaches, and that this data will support the start of a larger trial using neonatal and cardiology collaboration networks. The proposed study design where no open label pharmacological treatment is allowed will be able to describe the natural course of a PDA in preterm infants in the current era of perinatal care. It will allow for detailed prospective study of the PDA using conventional and novel echocardiography techniques to address the issue of which patient subgroups may benefit from treatment.

  • Hominax for improving sperm health

    This is a clinical trial examining the effectiveness of a vitamin supplement, Hominax, in improving sperm health. We are testing whether Hominax can improve sperm health. It is possible that Hominax can help prevent damage to sperm. Men will be allocated to receive either Hominax for 24 weeks. Sperm samples will be tested to look for a difference in sperm health between the pre- and post-treatment.

  • A New Surgical Incision Method To Improving Post Operative Scars in Patients.

    This study aims to evaluate if whether using the “Deckled” incision improves post-operative scars compared to the standard straight line incision in people undergoing surgery for skin lesions. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are scheduled to undergo any plastic surgery procedure involving excision of skin lesions. Study details Participants in this study will be randomly allocated (by chance) to one of two groups in an equal ratio. Participants will not be aware of the group/treatment they have been allocated to receive. For patients with multiple lesions, because each lesion is randomised, they may have both the "Deckled" incision or straight line incision performed. This study will help determine if “Deckled” incision has superior scar outcomes compared to the straight line incision approach.

  • Mindfulness-based Stress Release Program for university employees: a pilot, waitlist-controlled trial

    Stress in the workplace is prevalent, with Australians reporting significantly lower overall workplace wellbeing in 2013 compared to previous years. Psychological injury is now the second most common cause of workplace compensation claims in Australia, and the direct cost to employers is estimated to be greater than $10 billion annual in terms of lost productivity. Thus, from an individual and public health perspective, there is an imperative to implement low risk, economically viable and effective programs to reduce workplace-stress and improve employee outcomes such as productivity, satisfaction and engagement. Mindfulness-based programs have become increasingly popular as a means of targeting enhanced wellness at work as well as combatting negative consequences of excessive workplace stress. Mindfulness involves making a commitment to being fully conscious in the present moment without judgement, in an attitude of openness and acceptance. To date, reviews report a small to moderate effect for mindfulness in reducing multiple negative dimensions of psychological distress including anxiety, depression and appraised stress, although this is not specific for the workplace setting. Further research into the benefit of mindfulness programs in reducing workplace stress and quality of productivity is warranted. This study aims to assess the effectiveness of structured, mindfulness-based program on decreasing work related stress and enhancing workplace wellbeing and engagement in fulltime university employees. Based on current available evidence, we hypothesise that mindfulness-based program participation will: 1. Improve employee work-related outcomes including workplace wellbeing and engagement 2. Reduce employee levels of stress, anxiety and improve mood

  • Improving Breast Reconstruction Equity of Access through Stakeholder consultation and Translation into policy and practice (I-BREAST).

    The primary purpose of this study is to systematically explore factors behind the low and uneven rates of breast reconstruction across Australia, It aims to identify practical ways to improve equity of access for women regardless of where they live, their age and ethnic/cultural backgrounds. It will produce acceptable, feasible and readily-translatable recommendations for practice and policy changes to address disparities in women’s breast reconstruction options. Who is it for? You may be eligible to participate in this study if you are a woman who has had mastectomy for breast cancer, a breast care nurse, a breast or plastic surgeon or a clinical or policy person involved in making decisions about breast reconstruction. Study details: The study will primarily involve one-off interviews, either face-to-face or by telephone, with eligible participants. It is hoped that the findings of this study will provide recommendations for practice and policy changes which improve the equity of access to breast reconstruction in Australia.

  • Bright light therapy to improve sleep and quality of life in children with acute lymphoblastic leukaemia

    The primary purpose of this study is to evaluate the efficacy of bright light therapy for improving sleep and quality of life in children undergoing treatment for acute lymphoblastic leukaemia. Who is it for? You may be eligible to participate in this study if you are aged 3 to 9 years of age, and undergoing maintenance treatment for acute lymphoblastic leukaemia. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive either bright light therapy or standard leukaemia care with no bright light therapy. Participants allocated to the bright light therapy group will be asked to wear a bright light visor for 30 minutes immediately after waking up each morning for the 84 days of the second maintenance treatment cycle. To assess sleep, fatigue, mood, and quality of life measures, researchers will use a combination of home-based assessment of sleep (actigraphy), a detailed sleep diary and questionnaires. The questionnaires will be completed by both the child and the parents at the beginning and the end of the light therapy, and six months after therapy, and will take approximately 30 minutes to complete at each time point. It is hoped that bright light therapy will provide a cost-effective method of improving sleep and quality of life for children undergoing treatment for acute lymphoblastic leukaemia who are a group at risk of development of potentially long-term sleep problems, increased psychological distress, poor treatment resilience and low quality of life.

  • Feasibility study – Identification of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy

    The study aims to evaluate the sensitivity and specificity of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above with pathologically diagnosed prostate cancer and biochemical cancer recurrence. Study details: All participants will undergo [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI). If the scans demonstrate a lesion that is amenable to biopsy or surgery, the participants will undergo CT or ultrasound guided biopsy or surgical excision as part of their clinical management. Once a sample has been obtained, the 1st sample will be used for immunohistologic analysis and the 2nd sample will be sent for in vitro culture and further analyses. If archived tissues are available, genomic comparison of primary tumour specimens and metastatic/recurrent lesions will be performed. At 6, 12, 18 and 24 months after the 68Ga-HBED-CC PET/MRI, relevant prostate cancer data will be used for further analysis. The information will include blood tests (Prostate Specific Antigen, Full Blood Count, Urea and Electrolytes, Calcium, Liver Function Tests), imaging (CT, PET, MR or Bone scan) and clinical history. The novel imaging technology may identify evidence of metastatic disease, undetected by standard of care imaging. This information could alter the treatment plan potentially. The benefits of the translational aspects of the study are that a proof of principle precision medicine program may be established to attempt in vitro assessment of a patients’ tumour in a clinically relevant timeframe and to also develop novel cell lines for basic research. This may lead in the future to a larger trial utilizing such data to guide treatment decisions in men with advanced prostate cancer.

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